Blood Health by Mediaplanet_USA

FEBRUARY 2016 FUTUREOFPERSONALHEALTH.COM An Independent Supplement by Mediaplanet to USA Today

Blood Health Why Cindy Crawford continues to push the matter of bone marrow donation into the public eye.

A TV star’s daughter battles leukemia Kareem Abdul-Jabbar’s rare CML diagnosis

2 | FUTUREOFPERSONALHEALTH.COM | IN THIS EDITION

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A Tasty Wish Eight-year-old Amina Ihmud takes her turn as a master chef, and sheds her leukemia diagnosis for a very special day. Page 7

Blood-Related A grandfather’s love, and lifelong habit of blood and platelet donations, saves a very important young life. Page 16

Developing Hope New treatments for myeloma patients are bringing a bevy of options that improve quality of life for those battling this deadly disease. Page 30

The Vital Connection Just a single drop of blood can reveal clues about even the most obscure or complex health conditions that might otherwise remain undiagnosed.

lood runs through every organ and tissue in our bodies, and it contains cells and molecules that are vital to our health and wellbeing. Because blood performs a wide variety of essential functions in the body, any abnormality found in the blood can affect a person’s overall health in a number of ways. For example, a patient with sickle cell disease is at risk for a multitude of other health complications, including organ damage and stroke. However, few people understand the complexities that surround this disease and other blood disorders that affect millions of people around the world.

Remarkable advances

For more than 50 years, hematologists have made momentous strides Stay in Touch

in research. These advancements have led to the diagnosis and to the effective treatment and prevention of many serious, costly blood disorders like leukemia, lymphoma, multiple myeloma, hemophilia, blood clots and sickle cell disease.

New forms of anti-clotting drugs have reduced death rates from heart attacks and strokes. As a result of research breakthroughs in hematology, bone marrow transplantation has become a curative treatment for some cancers and other deadly diseases of the blood. Children are now routinely cured of acute lymphocytic leukemia, which is a blood cancer

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that as recently as the 1960s had a 100 percent fatality rate. Additionally promising is the treatment of chronic myeloid leukemia in adults, which can now be treated with a daily, well-tolerated pill. Surviving

Charles S. Abrams, M.D. President, American Society of Hematology

@MediaplanetUSA

Many people are unaware that the research discoveries made by hematologists have had an enormous ripple effect throughout all of medicine. Advances in hematology have helped to treat patients with heart attacks, stroke and some types of cancers. For example, blood thinners can be highly effectively treatment for blood clots and strokes. As a result, new forms of anticlotting drugs have reduced death rates from heart attacks and strokes. As another example, stem cell transplantation can cure inherited pinterest.com/MediaplanetUSA

metabolic disorders, and gene therapy holds the promise of effectively treating many hereditary diseases. Getting involved

More knowledge, policy and advocacy are needed to ensure that strides continue to be made. Blood health goes way beyond the concept of disease and clinical care. It involves you. Perhaps you or a loved one has been affected by a blood disorder and you would like to support new efforts that encourage research that will contribute to novel treatments for the disease. By becoming an advocate for hematology, you can help increase public awareness about blood disorders and support state and federal funding for research, which is critically needed to continue scientific advances in the field. n Please recycle after reading

Publisher Kim Betrus Business Developer Jessica Guggenheimer Managing Director Luciana Olson Content and Production Manager Lauren Hubbard Lead Designer Kathleen Edison Designer Celia Hazard Copy Editor Sean Ryan Production Designer Jennifer Ledbury Contributors Charles Abrams, Faye Brookman, Melinda Carstensen, Kristen Castillo, Meghan Catucci, Desirée Chavis, Roberta Codemo, Jennifer DeMeritt, Ashley Engelman, Patricia Lorusso, Kara Lusk-Dudley, Cindy Riley, I-Hsien Sherwood, Liane Bonin Starr, Nicole Sundermier-Magretto Send all inquiries to editorial@mediaplanet.com Cover Photo Kirk McKoy/ Los Angeles Times/Contour by Getty Images All photos are credited to Getty Images unless otherwise credited. This section was created by Mediaplanet and did not involve USA Today or its Editorial Departments.

We’re committed to bringing new treatment choices to patients with cancer.

UNITE against hematologic malignancies

Together, we’re working to advance a potential new treatment, beginning with indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia. To learn more about our companies and our efforts to improve cancer care, please visit www.infi.com and www.abbvie.com. © 2016 Infinity Pharmaceuticals, Inc. Cambridge, MA 02139 Feb 2016. INFI-2015-057

4 | FUTUREOFPERSONALHEALTH | FACTS & FIGURES

Bad Blood Blood cancers affect the production and function of your blood, and they are more prevalent than most people know.

By the Minute Approximately, every 3 minutes one person in the U.S. is diagnosed with

Leukemia

Leukemia is a type of cancer that affects the blood and bone marrow.

4 Most Common Types Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Myeloid Leukemia

a blood cancer, and...

Chronic Lymphocytic Leukemia

minutes, someone in Every the U.S. dies from a blood cancer. This statistic represents nearly 155 people each day or more than six people per hour.

FACT

An estimated 1,185,053 people in the U.S. are either living with, or are in remission from, leukemia, lymphoma or myeloma.

There are an estimated 327,520 people living with, or in remission from, leukemia in the U.S.

FACT The overall five-year relative survival rate for leukemia has more than quadrupled since 1960.

MEDIAPLANET | 5

SYMPTOMS

Lymphoma Lymphoma starts with a change to a lymphocyte, a type of white blood cell. These cells pile up and form lymphoma cell masses, which are found in the lymph nodes and other parts of the body.

In addition to swollen lymph nodes, tiredness, unexplained weight loss and fever, and a persistent cough, the symptoms of Hodgkin lymphoma may include:

Myeloma Myeloma, also known as multiple myeloma, is a cancer arising from plasma cells, a type of white blood cell that is made in the bone marrow.

FACT An estimated 26,850 new cases of myeloma are expected to be diagnosed in the U.S. in 2015.

An enlarged spleen

SYMPTOMS Signs of Non-Hodgkin lymphoma include: Abdominal pain Bone pain

Lymph node pain after drinking alcohol Shortness of breath during normal activity Itchy skin

Chest Pain

FACT An estimated 95,874 people in the U.S. are living with, or in remission from, myeloma.

Lumps under the skin

Right Now More than 761,600 people are living with, or in remission from, lymphoma in the U.S.

584,133 people are living

with non-Hodgkin lymphoma. Hodgkin lymphoma is now considered to be one of the most curable forms of cancer.

SEX: More men than women develop myeloma.

RACE: Black people are nearly twice as likely as whites to develop myeloma.

AGE: Most who develop myeloma are over the age of 50.

OBESITY: New research suggests that obese people have a higher incidence of myeloma.

177,526 people are living with Hodgkin lymphoma.

Risk Factors

According to the National Cancer Institute, more

75%

than of all Hodgkin lymphoma patients can be cured. That rate rises to 90% for patients 45 and younger.

ENVIRONMENT: Some studies are investigating a link between the development of myeloma and one or more of the following factors: radiation or exposure to certain kinds of chemicals such as pesticides, fertilizers and Agent Orange.

Drop by Drop The more you know about your blood health, the more you can do to protect your body’s most valuable player.

Read the full article online at futureof personalhealth.com

SOURCE: THE LEUKEMIA & LYMPHOMA SOCIETY

Rashes

6 | FUTUREOFPERSONALHEALTH.COM

| News

10 Things You Need to Know About Blood Cancer in 2016 Leukemia, lymphoma and myeloma account for almost 10 percent of new cancer cases in the U.S. each year. Treatment is getting better all the time, but there’s still work to be done. By Jennifer DeMeritt

1. Leukemia affects white blood cells

Healthy white blood cells help your body fight infection. If a person has leukemia, abnormal white blood cells, called leukemia cells, form in the bone marrow and spread into the bloodstream, where they compete with healthy cells and weaken the immune system.

Myeloma affects plasma cells Plasma cells are white blood cells that produce antibodies. In myeloma, abnormal plasma cells (myeloma cells) accumulate in the bone marrow, which can cause weak bones, fractures and other symptoms.

3. Lymphoma affects lymphatic cells

Lymphatic cells are a type of white blood cell that appear in the bloodstream and the lymph system, which fights infection. Lymphoma often causes swelling of the lymph nodes in the neck, armpits and groin, and can appear in many other parts of the body.

They contain multitudes There are four main types of leukemia and dozens of subtypes of lymphoma. Some are extremely rare, and these can

be more difficult to treat because they receive less research funding than other cancers that affect more people.

No screening for early detection Unlike breast or colon cancer, which can be detected and treated early thanks to regular screenings, there are no effective screening tests for blood cancers. This means that people with these diseases usually don’t know something is wrong until they experience symptoms like weight loss, fever or weakened immunity.

6. Living longer

Survival rates have doubled in the last 20 years. According to the National Institutes of Health, 46.4 percent of people diagnosed with leukemia live 5 years or longer. That rate climbs to 70 percent for non-Hodgkin lymphoma and 85.9 percent for Hodgkin lymphoma.

Living better New treatments are being developed that target specific proteins in cancer cells without harming other cells. This leads to fewer side effects and better quality of life for patients.

On the brink of discovery Some cutting-edge treatments seem especially promising. These include immunologic treatments that harness the body’s immune system to fight malignancy, genomic profiling of the many types and subtypes of cancer cells and new developments in stem cell biology.

But there’s still a way to go Scientists have roadmapped what they want to research next, but they have also identified big gaps in funding. Even though Congress increased the NIH’s budget by $2 billion for 2016, years of budget cuts before this have taken their toll. Funding shortfalls are especially frustrating to researchers now, when major breakthroughs seem so close.

10. It takes a village

Over the last two decades, non-government organizations like the Leukemia and Lymphoma Society, the American Society of Hematology and the American Cancer Society have contributed a larger percentage of total cancer research funding. And these organizations wouldn’t be able to help without financial support from other philanthropies and individuals. Fighting blood cancers is a massive effort. We’re all in it together. n

INSPIRATION | MEDIAPLANET | 7

Dinner and a Wish, Is Served

After finishing treatment for leukemia, one eightyear-old was surprised when Make-A-Wish made her biggest dream a reality. By Kristen Castillo

Change of course Make-A-Wish stepped in to make Ihmud’s journey a little easier, fulfilling her wish to be a chef. Together with the kitchen appliance company Thermador, they hosted Amina and her family at the Thermador Pro Kitchen, at Thermador Event & Design Center in Irvine, California. Fully equipped, with top-of-the-line kitchen appliances, cooking utensils, products and food, the test kitchen was transformed into “Amina’s Café.” “I felt so excited, surprised and happy—very happy,” says Ihmud, whose favorite chefs are Giada De Laurentiis and Rachael Ray. The day started with VIP treatment, as Ihmud and her parents were picked up in a limo. She thought she would be spending the day cooking with her mom and dad, but when they arrived at the kitchen Ihmud was surprised to see a team of volunteers

PHOTO: Familia Folks Productions

mina Ihmud loves cooking with her mom. Her favorite dish? Pasta. But the secondgrader wasn’t always having fun in the kitchen. At age five, Ihmud started having back pain and bruising on her legs. She was very tired, too. Doctors soon diagnosed her with leukemia. She started treatment right away, but her recovery was ongoing and tough.

who would help her prepare food for another surprise: 20 family members who were there to share her wish. Cooking up a storm Dressed in a white, personalized chef’s coat and hat, the young chef quickly became busy whipping up culinary creations. On the menu at Amina’s Café: shrimp and steak appetizers, bread, fruit and cupcakes. Ihmud, who enjoys watching cooking shows like “Chopped” and “MasterChef Junior,” enjoyed her café experience and loved the high-tech gear, especially the stove. During those ex-

citing moments in the kitchen, Fahner, M.D., F.A.A.P. and chair of the medical advisory council she forgot she was sick. “I would tell other kids that it’s for Make-A-Wish America. “It’s going to be okay,” says Ihmud. something, in many ways, that’s just as healing as “You’re going to get During those anything you’d get through this really in a clinic or a hosfast, and you can still do a lot of really exciting moments pital.” He says the wish fun things.” in the kitchen, experience provides kids “moments of inWonderful wishes she forgot she nocence” and gives Since its start in them hope. “This is 1980, Make-Awas sick. something that’s goWish has granted over 350,000 wishes to chil- ing to be a positive experience and dren around the world with memory for the child and the famlife-threatening medical condi- ily for a long time,” Fahner says. Amina’s mother, Anabel Martions. “A wish is really a part of our medicine,” says Dr. James B. tinez agrees, saying her daugh-

ter’s wish was and will always be a highlight for the cute girl in glasses, as well as the rest of her family. “That one day that they don’t think about what they have is amazing to us parents—to see our child be normal that one day,” says Martinez. Aspiring chef Now in remission, Ihmid is grateful for her cooking wish and looks forward to one day being a professional chef who owns a café. She wants to inspire others, too. “Everybody, remember to give back to other kids,” Amina says. “You have a lot to give back to other people.” n

ADVOCACY | MEDIAPLANET

In simple terms What is a clinical trial? Basically, it is a carefully controlled and monitored research study in which treatments that are being developed are given to people to see if they are safe and effective against their disease. Cancer clinical trials measure whether new therapies or new combinations are better than the best treatments we have today, which we call standard of care. Through a clinical trial, you may have access to experimental treatments that could be more effective against your disease than the treatment you are receiving now. In many cancer clinical trials, the focus is on patients for whom standard of care didn’t work, or has stopped working, and the experimental treatment may offer another chance to slow or stop the disease. The process Before new treatments are given to people, they are carefully evaluated in the laboratory and in animal studies. With the backing of good research results, the treatment moves into Phase 1 and 2 studies with small numbers of patients starting at the lowest amount of new drug to make sure the new treatment is safe, to determine the best doses to use, and to measure the impact on the disease. When we know that the treatment is safe and that there is some positive effect on the disease, the treatment goes into larger Phase 3 trials with more patients. The purpose of those studies is to see if the new drug or treatment works better than the standard of care.

Understanding the Promise of Clinical Trials

Assigning care Depending on the type of trial, people who enroll are usually randomly assigned to receive either the standard of care only, or the standard of care plus the treatment being tested. That way, you as the patient aren’t missing out on anything—you get at least the treatment you would be receiving anyway. This is true particularly in large Phase 3 trials. Sometimes the new treatment simply doesn’t show any better effect than the standard of care. Or it might show only a slightly better effect. And sometimes the side effects of the new treatment outweigh its positive impact on the disease. But sometimes the new treatment is very effective, causing tumors to shrink or disappear. The impact can last for months and sometimes years. If the positive impact is significant enough, the company developing the drug or therapy can request review by the U.S. Food and Drug Administration so it can be approved and get into doctors’ offices.

Clinical trials determine safe, effective treatments and combinations to better treat cancer and provide participating patients access to new experimental therapies.

PHOTO: Stand Up to Cancer

f you have recently been diagnosed with cancer, or you’ve been living with cancer for some time, you’re probably dealing with fear and uncertainty. Regardless of the treatment you’re receiving, you may be hoping to find a better one, to take advantage of the big strides doctors and scientists are making against this disease. To do that, you may want to consider participating in a clinical trial.

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Lack of volunteers Unfortunately, less than 5 percent of cancer patients in the United States sign up to participate in clinical trials and many proposed trials fail to launch because of the lack of patient participation. Yet none of the successful drugs we have today would be available without people enrolling in clinical trials. If you are interested in looking into a clinical trial, a free clinical trial finder service can identify clinical trials that might be relevant for your—or your loved one’s—cancer. Please discuss it with your doctor at your next visit. Even if a clinical trial that may apply to you is being conducted at a major medical center outside of your area, you may be able to participate. n By Patricia M. Lorusso, D.O. Co-Leader, Stand Up To CancerMelanoma Research Alliance Melanoma Dream Team

12 | FUTUREOFPERSONALHEALTH.COM | INSPIRATION

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Ewing’s Sarcoma: A Family Fights Together Led by the powerful example set by their youngest, one family is sticking together to take on the unique fight that comes with a rare cancer diagnosis.

fter 13-year-old Martha Reidel began walking with a limp during a school field trip to New York City in April 2015, her parents, Ned and Margaret, took her to the doctor, who suspected the discomfort was due to a 25-millimeter difference in leg length. Unwelcome words But when the Boulder, Colorado family sought another opinion at Children’s Hospital Colorado the following August, they learned the

PHOTO: Scott Dressel-Martin

By Melinda Carstensen

true source of her unusual stride: Ewing’s sarcoma, an extremely rare cancer of the bone and soft tissue that primarily affects young people. “It just didn’t seem real, because it’s always somebody else,” Ned, 49, says of Martha’s diagnosis. Now, the family—Martha’s twin sister, Annie; 17-year-old Sean; 19-year-old Ian—are living what Margaret calls their “new normal.” It’s riddled with daily IV bag changes for Martha, who is undergoing chemotherapy, as well as checkups to monitor her white blood cell counts. “Life goes on, but it’s in a different way,” says Margaret.

Knowing illness Ewing’s is a small tumor that microscopically appears round and blue. While a genetic component may be involved, like many cancers, its exact cause is unknown. According to Martha’s primary oncologist, Dr. Carrye Cost, an assistant professor of pediatrics at Children’s Hospital Colorado, Ewing’s presented in Martha’s pelvis and metastasized to her bones upon diagnosis. Standard treatment for Ewing’s requires 14 rounds of chemotherapy over 28 weeks, plus

radiation or surgery. Martha began chemotherapy in September, then underwent six weeks radiation around the holidays. Although she has lost her hair, experienced fatigue and vomiting, the young fighter has coped well with the side effects, says Cost, describing Martha as mature beyond her years. “At [Martha’s] age, the obvious approach would be to turn into herself or her family,” she explains. “But I feel like she’s been the opposite, and not only figured out how to help herself, but how to help others.”

Optimistic outlets Martha has carved handmade rubber stamps for the hospital to use as thank you notes, and befriended other patients undergoing chemotherapy. “I have been amazed at how Martha has been optimistic about her therapy, and done the same for us,” Cost continues. “She would never let me have a bad day or let me feel sad, because she wouldn’t want that for us.” Martha must avoid some activities, like sledding and snowboarding, because treatment has made her bones more fragile. But Ned and Margaret have striven to maintain a sense of normalcy. After checkups, Ned sometimes takes her to their favorite taco shop in town, and they have a stationary bike set up indoors, with a mag trainer. In March, she’ll join 23 other adolescent patients at Children’s for a retreat, during which they will get a break from the hospital atmosphere and attend the Colorado Rockies’ spring training. Looking ahead Martha estimates she’s been able to stay positive by maintaining perspective. “It really sucks,” she begins. “But I feel like it’s been a lot easier for me than other people.” These days, she’s looking forward to getting her hair back post-chemotherapy: “Hair is fun because you get to style it and do whatever you want with it.” Ned and Martha have found strength through their community support but also through their daughter herself. “[Martha] is special and she has proven even more special than I knew she was,” sums Ned. “What gives me my strength is Martha—that she’s just been so strong, and it makes me strong.” n

14 | FUTUREOFPERSONALHEALTH.COM | NEWS

Platelets, as an example, are used for many medical needs: cancer treatment, as well as severe injuries and cardiac surgeries. Plasma is key for trauma and massive blood loss.

afety measures implemented over the past decades ensure the U.S. blood supply is safer than ever. “The blood supply community has done a great job of dealing with the major blood transmittable diseases, such as HIV and hepatitis,” says Dr. Jeffrey McCullough, a professor in University of Minnesota Medical School’s department of Laboratory Medicine and Pathology. “There is minuscule risk—versus 40 years ago.” Emerging threats But with the emergence of new viruses and other pathogens spreading to the U.S., such as West Nile, dengue, Chikungunya and, of course, the Zika virus, concern for the nation’s blood supply is on the front burner. One cause for concern: often enough, those infected may not realize they have the virus at the time they give blood. “Zika is emerging this year. Last year, it was Ebola. There is a never-ending stream of new threats,” sums Dr. Richard J. Benjamin, the chief medical officer for Cerus Corporation. “Blood is safer than ever, but there is

How We Ensure the Safety of U.S. Blood Supply New viruses, along with the threat of bacterial contamination, are igniting interest in pathogen reduction technology that can guard our blood supply. By Faye Brookman

the risk of infection from new threats not protected through existing technology.” Meanwhile, Dr. Alyssa Ziman, the Medical Director of the Clinical Labs and the Division of Transfusion Medicine at UCLA Health, adds, “There are pathogens coming on board we don’t have tests for yet. The world is becoming a smaller place with people traveling more, thereby increasing the risk of global pathogens.” Beyond viruses Compounding the situation is

There are no tests for emerging disease-producing agents, such as Chikungunya and dengue.

the potential for bacterial contamination of blood, especially platelets, which must be stored at room temperature, making them more susceptible to risk. According to recent reports, about 1 out of every 2,500 platelets components are contaminated with bacteria. “It is important for people to understand there are certain diseases where the patient requires blood transfusions—there is no alternative,” says Ziman. “Our goal as blood collectors is to make the blood supply as safe as possible.”

Developing strategy For many, the confluence of these factors calls for change. “The strategy we have used for the past 30 or 40 years has worked well, but extending that process today does not work for the diseases we see emerging,” explains McCullough. Creating new tests is time consuming, costly and can’t be activated until well after a danger is known. For example, donated blood was not tested for HIV until 1985, nearly twhree years after the first case of HIV infection from a blood transfusion was reported. During that three-year period, 14,000 people acquired AIDS from blood transfusions. Four years passed before a test was in place for West Nile Virus, and, by that time, more than 40 patients were infected with the virus through blood transfusions. Turning the key Enter: pathogen reduction technology. Approved by the Federal Drug Administration in 2014, the process is gaining traction with American blood banks and hospitals. Widely used for more than a decade throughout the world, pathogen reduction technology—a fairly simply process—inactivates viruses, bacteria and other pathogens that might be hiding in blood. Currently in the U.S., about seven pathogens are tested, such as HIV and West Nile Virus, but there are no tests for emerging disease-producing agents, such as Chikungunya and dengue. “We can provide assurance for many of these strains,” Benjamin says, referring to pathogen reduction technology. The process is available for platelets and plasma, but will also be available soon for red blood cells in the future. Says McCullough, “This is a fundamentally new paradigm in blood safety. It’s time to get it implemented.” n

MEDIAPLANET | 15

PHOTOS: Barbara Betzens

In the know

The Far-Reaching Benefits of Donating Platelets Platelets are often referred to as “liquid gold.” The blood component is shiny yellow, always in demand and, for patients who need them, priceless.

ome donors have made it their mission to help save lives by giving platelets. Donors like John Betzen, of Wichita, Kansas, are committed to doing their part to help patients in need with a dedication that never wavers. Betzen has already reached a major milestone, giving more than 520 blood and platelet donations. Paid forward For more than 45 years, Betzen has rolled up a sleeve knowing his donations are helping someone. In August 2011, that someone could have been his granddaughter Sarah. She was born with many complications, including an abnormal opening

in her diaphragm. Over several months, Sarah needed surgeries to survive, as well as blood and platelet transfusions. “Our family is very grateful to those donors who donated their platelets and blood,” says Betzen. “This is not something you can go to the store and purchase. We are certain it helped save Sarah’s life.” Precious platelets Platelets are a key clotting component of blood often needed by those who are extremely ill, such as cancer patients, burn victims and bone marrow recipients. Unlike whole blood, which can be safely donated every 56 days, platelets can be donated every seven days, up to 24 times a year. “By donating platelets, more people can be helped because you

can donate more frequently,” explains Betzen. “It makes me feel good to help fill the need.” Platelets must be transfused within five days of donation. It’s important that eligible platelet donors give as often as possible to help ensure this potentially lifesaving blood product is available for patients whenever and wherever needed. Individuals who are age 17 or older (16 with parental consent in most states), weigh at least 110 pounds and are in generally good health may be eligible to donate blood or platelets. High school students and other donors 18 years of age and younger have to meet certain height and weight requirements. n By Kara Lusk-Dudley, American Red Cross

The Latest in Therapy: Beyond Chemo We page Dr. Jennifer R. Brown, the director of Dana-Farber Cancer Institute’s CLL Center, for an overview of the latest in blood cancer diagnosis and treatment. What’s improving the experience for blood cancer patients? The advances in understanding the science that underlies blood cancers are starting to transform our treatments. Overall, this is allowing the development of oral targeted therapies that are sometimes very effective and often have fewer side effects than traditional chemotherapy. In the disease that I study, a chronic form of blood cancer called chronic lymphocytic leukemia, we have several categories of new oral drugs that are completely transforming the way we treat the disease. This transformation started in 2014 with the FDA approvals of the BTK inhibitor ibrutinib and the PI3K inhibitor idelalisib, and now we have additional inhibitors in advanced clinical trials designed to get them approved by the FDA and on the market; these include the BTK inhibitor acalabrutinib, the PI3K inhibitor duvelisib, and a new class of agent, the BCL2 inhibitor venetoclax. These drugs are so profoundly effective that they have already displaced chemotherapy for many patients who have had prior therapy, and they are now being studied for those who have not had prior therapy. What’s the one thing patients and doctors should know about blood cancers? Given all these advancements, I think it is very important for a patient with blood cancers who is newly diagnosed or having disease progression to make sure they are seen by a specialist who can do all the state-of-the-art testing on their cancer, since sometimes we can target specific subtypes of the disease with specific therapies. This testing will also allow patients to learn what clinical trials may be available for their specific situation. I cannot emphasize enough the importance of clinical trials and participating in clinical trials: Not only are trials the way we learn and get these great new drugs to market, they are also the way we provide these drugs to our patients sometimes years before the drugs do come to market.

16 | FUTUREOFPERSONALHEALTH.COM | ADVOCACY

Tips from a Blood Cancer Survivor

Since my diagnosis, I’ve joined the online community I Had Cancer and published my tell-all book, “I Kicked Cancer’s Ass!” to motivate cancer patients to keep fighting.

was diagnosed with a high-risk form of Acute Myeloid Leukemia at age 28, in February 2013. After a successful bone marrow transplant from an unrelated donor in Germany, I am now in remission and cancer free.

Think positive. This is very important on a daily basis. Speak and declare victory into your life. Be grateful. Accept each day as a gift from God and make a conscious effort to be grateful for everything in your life—no matter what challenges you’re facing. Stay strong. Focus on fighting for those around you and for those who did not survive. Do not give up. Be your own advocate. Medical marijuana can help during your cancer battle. It helps to relieve nausea, headaches, stress, anxiety, appetite and sleeplessness. Medical marijuana can indefinitely

replace medications that are expensive and in pill form. Eat healthy and go organic. Consuming fruits, veggies and dairy that are contaminated with pesticides can harm you. Nourish your body properly, from the inside out. Drink plenty of lemon water. Staying hydrated is vital. Aim to drink at least eight glasses of lemon water a day. (The benefits of lemon are amazing.) Get plenty of rest. Adequate sleep is an essential part of a healthy lifestyle: eight hours of sleep every night is recommended. Stick to it. Germ-free is the way to be. Keep hand sanitizer with you at all times and stay away from people who are sick. Be mindful of what you touch when in public places, as well. Eliminate stress. Worrying about things will eventually take a toll on your body. Meditation is a good way to help clear your thoughts.

Seek support. You will need help and words of encouragement during treatments and recovery. Keep a handful of loved ones by your side who can pick you up when you’re feeling down. Exercise. Walking and stretching is very important for the body. Lying around in a hospital bed most of the day will weaken your muscles. Get up and keep that blood pumping. Power of prayer. Keep your faith alive and know that any obstacle you are facing will pass. “With his stripes we are healed”-Isaiah 53:5 Enjoy life. Although you’re battling cancer, remember that you have a second chance at life. Take vacations, make memories and do what makes you happy.

By Nicole Sundermier-Magretto, Cancer Survivor

INSPIRATION | MEDIAPLANET | 17

Fueling Inspiration Years After A Diagnosis After being diagnosed with a rare cancer of the blood and bone marrow, basketball legend Kareem Abdul-Jabbar undertook a full-court press to fight it.

t was a day Kareem Abdul-Jabbar will never forget. “I received the news I had Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) on a Monday morning in December 2008 and was just shocked,” explains the NBA’s alltime leading scorer and six-time MVP. “I had a close friend who had died from a type of leukemia not long before my diagnosis, so I was scared I was facing the same fate.

By Cindy Riley

PHOTOS: Dan Winters

Warning signs Abdul-Jabbar learned of his condition after consulting a doctor about hot flashes and night sweats. “Fortunately, my cancer was detected in its early stages,” he says. “I also am lucky to have a son who, at the time, was training to become a doctor, and was able to calm me down and be a solid sounding board until I could get all my questions answered by my specialist.”

have to go through alone, and that advances in medicine had truly changed the face of CML. I have a unique position as a public figure, and I wanted to use that opportunity to inspire others to take the best care of their health.” “When I speak to other patients, the feedback I get is so rewarding. Many have said they only spoke about their diagnosis once they saw that I went public with mine. It really helped them feel less isolated. I’ve had the chance to meet and speak with so many patients who also have CML. It has been so fulfilling to be seen as not just some untouchable sports figure, and connect with those who have been diagnosed with cancer.”

Knowledge is power For patients struggling with CML, the 68-year-old NBA Hall of Famer advises, “Talk with your doctor about what treatment may be right for you. Work with your doctor to establish clear treatment goals that are specific What’s Ph+CML? to you. Know your PCR levels, Ph+ CML is a slow progress- which means getting tested reging type of blood cancer that’s ularly, and the goals you should characterized by an abnormal- reach according to your personal ity known as the treatment plan. Philadelphia chro“Most important,” It has been mosome, which says Kareem, “Stay produces a protein positive. This disease so fulfilling to called BCR-ABL. is treatable, but you BCR-ABL has been have to stick to your be seen as identified as the prescribed regimen to sole cause and not just some get the most success.” driver of CML. untouchable “Soon after, I Moving forward learned my type In recent years, Absports figure ... dul-Jabbar has pubof cancer could be managed lished an award-winwith drug therning children’s book, apy, regular visits to my doctor written a novel, produced docuand through regular PCR blood mentaries and served as a columtests, which measure the level nist. He’s living proof that CML, of BCR-ABL in your body,” says once a fatal disease, is not the end. Abdul-Jabbar, a spokesman for For him, it’s a way to give back. Novartis Pharmaceuticals Corp. “I had an incredible athletic career, but it is both rewarding and Sharing his story humbling to be able to touch the In 2009, Abdul-Jabbar told the lives of so many outside the sports world about his battle. “I went arena,” he says, adding, “Staying public with my story so I could so active has given me the chance help others with the disease to touch people in ways I never know this was a fight they didn’t knew possible.”n

IN THE TREATMENT OF ADULTS WITH RESISTANT OR INTOLERANT Ph+ CML-CP/AP

TAKE ON Ph+ CML

Get help reaching your treatment goals with TASIGNA® (nilotinib)

“

In basketball, I relied on the skyhook. In treating my Ph+ CML, I rely on TASIGNA. – KAREEM ABDUL-JABBAR NBA ALL-TIME LEADING SCORER

Kareem Abdul-Jabbar is an actual Ph+ CML patient taking TASIGNA and was previously treated with imatinib. He is compensated by Novartis.

TASIGNA® (nilotinib) Indications TASIGNA is a prescription medicine used to treat adults who have: • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular). • Ph+ CML in chronic phase and accelerated phase who are no longer beneﬁting from, or did not tolerate, other treatment including GLEEVEC® (imatinib mesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)

IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules What is the most important information to know about prescription TASIGNA? TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation. • Your doctor should check your heart with a test called an electrocardiogram (ECG): o Before starting TASIGNA o 7 days after starting TASIGNA o With any dose changes o Regularly during TASIGNA treatment Ph+ CML, Philadelphia chromosome-positive chronic myeloid leukemia; CP, chronic phase; AP, accelerated phase.

4 Questions

to Ask Your Doctor IF YOU’VE EXPERIENCED THE SIGNS OF RESISTANCE OR INTOLERANCE, LEARN IF TASIGNA CAN HELP. Get to know the signs: Treatment Resistance • You haven’t reached the treatment goals set by your doctor • Your dose has been increased • You’ve experienced relapse or a loss of response Treatment Intolerance You’re experiencing chronic side effects despite: • Your treatment dose being decreased • Taking new medications to help manage your side effects TASIGNA can help patients who are experiencing resistance or intolerance to imatinib. If you or your loved one have experienced any of these signs, talk with your doctor about whether TASIGNA may be able to help.

For more information about TASIGNA, visit:

If you are currently experiencing treatment resistance or intolerance, TASIGNA may be able to help. Talking with your doctor about your current treatment, and your treatment goals may help you and your doctor decide if a change is needed. These questions may help you start the conversation. Questions to ask your doctor: 1. Have I hit the treatment milestones you would expect at this point in my Ph+ CML treatment? 2. What tests should I be getting to monitor my response to treatment? 3. What side effects might I expect with my Ph+ CML treatment? When should I share any side effects I’m experiencing with you? 4. If I don’t achieve my next treatment milestone, what is the next step in my treatment plan?

www.TASIGNA-Today.com

If you have any additional questions for your doctor, use this space to jot them down.

es • Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood • TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so • Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA Please see adjacent page for a Brief Summary of the Full Prescribing Information including Boxed WARNING for TASIGNA (nilotinib) ›

TASIGNA has been shown to help people who started on imatinib achieve their treatment goals. So talk with your doctor to ﬁnd out if TASIGNA is right for you. Remember to bring this guide with you to your next appointment.

IMPORTANT SAFETY INFORMATION FOR TASIGNA® (nilotinib) Continued Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you: • • • • • • • • • • • • •

Have a heart disorder or are taking medication for the heart Have had a stroke or other problems due to decreased blood flow to the brain Have problems with decreased blood flow to your legs Have an irregular heartbeat Have QT prolongation or a family history of it Have liver problems Have had a pancreas disorder known as pancreatitis Know that you suffer from low blood levels of electrolytes, such as potassium or magnesium Have had a surgical procedure involving the removal of the entire stomach (total gastrectomy) Are lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA Have bleeding problems Are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. Women should not become pregnant while taking TASIGNA. Talk to your health care provider right away if you are pregnant or plan to become pregnant Are breastfeeding or plan to breastfeed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both

It is not known if TASIGNA is safe and effective in children. TASIGNA may cause serious side effects, including: • Low blood counts: Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include: o Unexplained bleeding or bruising o Blood in urine or stool o Unexplained weakness • QT prolongation: Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA.These can be symptoms of QT prolongation, a possible life-threatening heart problem • Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms: o Chest pain or discomfort o Numbness or weakness o Problems walking or speaking o Leg pain o Your leg feels cold o Change in the skin color of your leg • Liver damage: Symptoms include yellow skin and eyes • Pancreas inflammation (pancreatitis): Symptoms include sudden stomach area pain with nausea and vomiting • Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious • Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have: o Kidney failure and the need for dialysis treatment o An abnormal heart beat Your doctor may do blood tests to check you for TLS

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

• Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding • Fluid Retention: Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling Common side effects Most patients experience side effects at some time. Some common side effects you may experience include: • Low blood count • Nausea • Rash • Headache • Tiredness • Itching • Vomiting • Diarrhea • Cough • Constipation • Muscle and joint pain • Runny or stuffy nose, sneezing, sore throat • Fever • Night sweats Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. • Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you • TASIGNA is a long-term treatment • Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take: • A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA • An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA Please visit www.TASIGNA.com for full Prescribing Information including the Boxed WARNING, and the TASIGNA Medication Guide.

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T-AM7-1131488

TASIGNA® (nilotinib) Capsules for oral use Initial U.S. Approval: 2007 BRIEF SUMMARY: Please see package insert for full prescribing information. WARNING: QT PROLONGATION AND SUDDEN DEATHS • Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.15). • Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2). • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8). • Avoid food 2 hours before and 1 hour after taking the dose (5.9). 1 INDICATIONS AND USAGE 1.1 Newly Diagnosed Ph+ CML-CP Tasigna (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates [see Clinical Studies (14.1) in the full prescribing information]. 1.2 Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [see Clinical Studies (14.2) in the full prescribing information]. 4 CONTRAINDICATIONS Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning]. 5 WARNINGS AND PRECAUTIONS 5.1 Myelosuppression Treatment with Tasigna can cause Grade 3/4 thrombocytopenia, neutropenia and anemia. Perform complete blood counts every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction [see Dosage and Administration (2.2) in the full prescribing information]. 5.2 QT Prolongation Tasigna has been shown to prolong cardiac ventricular repolarization as measured by the QT interval on the surface ECG in a concentration-dependent manner [see Adverse Reactions (6.1), Clinical Pharmacology (12.6) in the full prescribing information]. Prolongation of the QT interval can result in a type of ventricular tachycardia called torsade de pointes, which may result in syncope, seizure, and/or death. ECGs should be performed at baseline, 7 days after initiation of Tasigna, and periodically as clinically indicated and following dose adjustments [see Warnings and Precautions (5.15)]. Tasigna should not be used in patients who have hypokalemia, hypomagnesemia or long QT syndrome. Before initiating Tasigna and periodically, test electrolyte, calcium and magnesium blood levels. Hypokalemia or hypomagnesemia must be corrected prior to initiating Tasigna and these electrolytes should be monitored periodically during therapy [see Warnings and Precautions (5.15)]. Significant prolongation of the QT interval may occur when Tasigna is inappropriately taken with food and/or strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT. Therefore, coadministration with food must be avoided and concomitant use with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT should be avoided [see Warnings and Precautions (5.8, 5.9)]. The presence of hypokalemia and hypomagnesemia may further prolong the QT interval [see Warnings and Precautions (5.7, 5.15)]. 5.3 Sudden Deaths Sudden deaths have been reported in 0.3% of patients with CML treated with nilotinib in clinical studies of 5,661 patients. The relative early occurrence of some of these deaths relative to the initiation of nilotinib suggests the possibility that ventricular repolarization abnormalities may have contributed to their occurrence. 5.4 Cardiac and Arterial Vascular Occlusive Events Cardiovascular events, including arterial vascular occlusive events, were reported in a randomized, clinical trial in newly diagnosed CML patients and observed in the postmarketing reports of patients receiving nilotinib therapy. With a median time on therapy of 60 months in the clinical trial, cardiovascular events, including arterial vascular occlusive events, occurred in 9.3% and 15.2% of patients in the Tasigna 300 and 400 mg bid arms, respectively, and in 3.2% in the imatinib arm. These included cases of cardiovascular events including ischemic heart disease-related cardiac events (5.0% and 9.4% in the Tasigna 300 mg and 400 mg bid arms respectively, and 2.5% in the imatinib arm), peripheral arterial occlusive disease (3.6% and 2.9% in the Tasigna 300 mg and 400 mg bid arms respectively, and 0% in the imatinib arm), and ischemic cerebrovascular events (1.4% and 3.2% in the Tasigna 300 mg and 400 mg bid arms respectively, and 0.7% in the imatinib arm). If acute signs or symptoms of cardiovascular events occur, advise patients to seek immediate medical attention. The cardiovascular status of patients should be evaluated and cardiovascular risk factors should be monitored and actively managed during Tasigna therapy according to standard guidelines [see Dosage and Administration (2.2) in the full prescribing information].

5.5 Pancreatitis and Elevated Serum Lipase Tasigna can cause increases in serum lipase. Patients with a previous history of pancreatitis may be at greater risk of elevated serum lipase. If lipase elevations are accompanied by abdominal symptoms, interrupt dosing and consider appropriate diagnostics to exclude pancreatitis. Test serum lipase levels monthly or as clinically indicated. 5.6 Hepatotoxicity Tasigna may result in hepatotoxicity as measured by elevations in bilirubin, AST/ALT, and alkaline phosphatase. Monitor hepatic function tests monthly or as clinically indicated [see Warnings and Precautions (5.15)]. 5.7 Electrolyte Abnormalities The use of Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating Tasigna and during therapy. Monitor these electrolytes periodically during therapy [see Warnings and Precautions (5.15)]. 5.8 Drug Interactions Avoid administration of Tasigna with agents that may increase nilotinib exposure (e.g., strong CYP3A4 inhibitors) or anti-arrhythmic drugs (including, but not limited to amiodarone, disopyramide, procainamide, quinidine and sotalol) and other drugs that may prolong QT interval (including, but not limited to chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin and pimozide). Should treatment with any of these agents be required, interrupt therapy with Tasigna. If interruption of treatment with Tasigna is not possible, patients who require treatment with a drug that prolongs QT or strongly inhibits CYP3A4 should be closely monitored for prolongation of the QT interval [see Boxed Warning, Dosage and Administration (2.2), Drug Interactions (7.2) in the full prescribing information]. 5.9 Food Effects The bioavailability of nilotinib is increased with food, thus Tasigna must not be taken with food. No food should be consumed for at least 2 hours before and for at least 1 hour after the dose is taken. Also avoid grapefruit products and other foods that are known to inhibit CYP3A4 [see Boxed Warning, Drug Interactions (7.2) and Clinical Pharmacology (12.3) in the full prescribing information] . 5.10 Hepatic Impairment Nilotinib exposure is increased in patients with impaired hepatic function. Use a lower starting dose for patients with mild to severe hepatic impairment (at baseline) and monitor the QT interval frequently [see Dosage and Administration (2.2) and Use in Specific Populations (8.7) in the full prescribing information]. 5.11 Tumor Lysis Syndrome Tumor lysis syndrome cases have been reported in Tasigna treated patients with resistant or intolerant CML. Malignant disease progression, high WBC counts and/or dehydration were present in the majority of these cases. Due to potential for tumor lysis syndrome, maintain adequate hydration and correct uric acid levels prior to initiating therapy with Tasigna. 5.12 Hemorrhage In a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase comparing Tasigna and imatinib, Grade 3 or 4 hemorrhage occurred in 1.1% of patients in the Tasigna 300 mg bid arm, in 1.8% patients in the Tasigna 400 mg bid arm, and 0.4% of patients in the imatinib arm. GI hemorrhage occurred in 2.9% and 5.1% of patients in the Tasigna 300 mg bid and 400 mg bid arms and in 1.4% of patients in the imatinib arm, respectively. Grade 3 or 4 events occurred in 0.7% and 1.4% of patients in the Tasigna 300 mg bid and 400 mg bid arms, respectively, and in no patients in the imatinib arm. 5.13 Total Gastrectomy Since the exposure of nilotinib is reduced in patients with total gastrectomy, perform more frequent monitoring of these patients. Consider dose increase or alternative therapy in patients with total gastrectomy [see Clinical Pharmacology (12.3) in the full prescribing information]. 5.14 Lactose Since the capsules contain lactose, Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing products, or of glucose-galactose malabsorption. 5.15 Monitoring Laboratory Tests Complete blood counts should be performed every 2 weeks for the first 2 months and then monthly thereafter. Perform chemistry panels, including electrolytes, calcium, magnesium, liver enzymes, lipid profile, and glucose prior to therapy and periodically. ECGs should be obtained at baseline, 7 days after initiation and periodically thereafter, as well as following dose adjustments [see Warnings and Precautions (5.2)]. Monitor lipid profiles and glucose periodically during the first year of Tasigna therapy and at least yearly during chronic therapy. Should treatment with any HMG-CoA reductase inhibitor (a lipid lowering agent) be needed to treat lipid elevations, evaluate the potential for a drugdrug interaction before initiating therapy as certain HMG-CoA reductase inhibitors are metabolized by the CYP3A4 pathway [see Drug Interactions (7.1) in the full prescribing information]. Assess glucose levels before initiating treatment with Tasigna and monitor during treatment as clinically indicated. If test results warrant therapy, physician should follow their local standards of practice and treatment guidelines. 5.16 Embryo-Fetal Toxicity There are no adequate and well controlled studies of Tasigna in pregnant women. However, Tasigna may cause fetal harm when administered to a pregnant woman. Nilotinib caused embryo-fetal toxicities in animals at maternal exposures that were lower than the expected human exposure at the recommended doses of nilotinib. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should avoid becoming pregnant while taking Tasigna [see Use in Specific Populations (8.1) in the full prescribing information].

5.17 Fluid Retention In the randomized trial in patients with newly diagnosed Ph+ CML in chronic phase, severe (Grade 3 or 4) fluid retention occurred in 3.9% and 2.9% of patients receiving Tasigna 300 mg bid and 400 mg bid, respectively, and in 2.5% of patients receiving imatinib. Effusions (including pleural effusion, pericardial effusion, ascites) or pulmonary edema, were observed in 2.2% and 1.1% of patients receiving Tasigna 300 mg bid and 400 mg bid, respectively, and in 2.1% of patients receiving imatinib. Effusions were severe (Grade 3 or 4) in 0.7% and 0.4% of patients receiving Tasigna 300 mg bid and 400 mg bid, respectively, and in no patients receiving imatinib. Similar events were also observed in postmarketing reports. Monitor patients for signs of severe fluid retention (e.g., unexpected rapid weight gain or swelling) and for symptoms of respiratory or cardiac compromise (e.g., shortness of breath) during Tasigna treatment; evaluate etiology and treat patients accordingly. 6 ADVERSE REACTIONS The following serious adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of the package insert [see Boxed Warning, Warnings and Precautions (5)]. • • • • • • • • •

Myelosuppression [see Warnings and Precautions (5.1)] QT Prolongation [see Boxed Warning, Warnings and Precautions (5.2)] Sudden Deaths [see Boxed Warning, Warnings and Precautions (5.3)] Cardiac and Arterial Vascular Occlusive Events [see Warnings and Precautions (5.4)] Pancreatitis and Elevated Serum Lipase [see Warnings and Precautions (5.5)] Hepatotoxicity [see Warnings and Precautions (5.6)] Electrolyte Abnormalities [see Boxed Warning, Warnings and Precautions (5.7)] Hemorrhage [see Warnings and Precautions (5.12)] Fluid Retention [see Warnings and Precautions (5.17)]

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Patients with Newly Diagnosed Ph+ CML-CP The data below reflect exposure to Tasigna from a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice-daily (n=279). The median time on treatment in the nilotinib 300 mg twice-daily group was 61 months (range 0.1 to 71 months). The median actual dose intensity was 593 mg/day in the nilotinib 300 mg twice-daily group. The most common (>10%) non-hematologic adverse drug reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain. Constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly (≤10% and >5%) and have been of mild to moderate severity, manageable and generally did not require dose reduction. Increase in QTcF >60 msec from baseline was observed in 1 patient (0.4%) in the 300 mg twice-daily treatment group. No patient had an absolute QTcF of >500 msec while on study drug. The most common hematologic adverse drug reactions (all grades) were myelosuppression including: thrombocytopenia (18%), neutropenia (15%) and anemia (8%). See Table 7 for Grade 3/4 laboratory abnormalities. Discontinuation due to adverse reactions, regardless of relationship to study drug, was observed in 10% of patients. In Patients with Resistant or Intolerant Ph + CML-CP and CML-AP In the single open-label multicenter clinical trial, a total of 458 patients with Ph+ CML-CP and CML-AP resistant to or intolerant to at least one prior therapy including imatinib were treated (CML-CP=321; CML-AP=137) at the recommended dose of 400 mg twice-daily. The median duration of exposure in days for CML-CP and CML-AP patients is 561 (range 1 to 1096) and 264 (range 2 to 1160), respectively. The median dose intensity for patients with CML-CP and CML-AP is 789 mg/day (range 151 to 1110) and 780 mg/day (range 150 to 1149), respectively and corresponded to the planned 400 mg twice-daily dosing. The median cumulative duration in days of dose interruptions for the CML-CP patients was 20 (range 1 to 345), and the median duration in days of dose interruptions for the CML-AP patients was 23 (range 1 to 234). In patients with CML-CP, the most commonly reported non-hematologic adverse drug reactions (≥10%) were rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting and myalgia. The common serious drug-related adverse reactions (≥1% and <10%) were thrombocytopenia, neutropenia and anemia. In patients with CML-AP, the most commonly reported non-hematologic adverse drug reactions (≥10%) were rash, pruritus and fatigue. The common serious adverse drug reactions (≥1% and <10%) were thrombocytopenia, neutropenia, febrile neutropenia, pneumonia, leukopenia, intracranial hemorrhage, elevated lipase and pyrexia.

Sudden deaths and QT prolongation were reported. The maximum mean QTcF change from baseline at steady-state was 10 msec. Increase in QTcF >60 msec from baseline was observed in 4.1% of the patients and QTcF of >500 msec was observed in 4 patients (<1%) [see Boxed Warning, Warnings and Precautions (5.2, 5.3), Clinical Pharmacology (12.6) in the full prescribing information] . Discontinuation due to adverse drug reactions was observed in 16% of CML-CP and 10% of CML-AP patients.

Most Frequently Reported Adverse Reactions Tables 5 and 6 show the percentage of patients experiencing non-hematologic adverse reactions (excluding laboratory abnormalities) regardless of relationship to study drug. Adverse reactions reported in greater than 10% of patients who received at least 1 dose of Tasigna are listed. Table 5: Most Frequently Reported Non-hematologic Adverse Reactions (Regardless of Relationship to Study Drug) in Patients with Newly Diagnosed Ph+ CML-CP (≥10% in Tasigna 300 mg Twice-Daily or Imatinib 400 mg Once-Daily Groups) 60-Month Analysisa Patients with Newly Diagnosed Ph+ CML-CP TASIGNA Imatinib TASIGNA Imatinib 300 mg 400 mg 300 mg 400 mg twiceoncetwiceoncedaily daily daily daily N=279 N=280 N=279 N=280 Body System and Preferred Term All Grades (%) CTC Gradesb 3/4 (%) Skin and Rash 38 19 <1 2 subcutaneous Pruritus 21 7 <1 0 tissue disorders Alopecia 13 7 0 0 Dry skin 12 6 0 0 Gastrointestinal Nausea 22 41 2 2 disorders Constipation 20 8 <1 0 Diarrhea 19 46 1 4 Vomiting 15 27 <1 <1 Abdominal pain upper 18 14 1 <1 Abdominal pain 15 12 2 0 Dyspepsia 10 12 0 0 Nervous system Headache 32 23 3 <1 disorders Dizziness 12 11 <1 <1 General Fatigue 23 20 1 1 disorders and Pyrexia 14 13 <1 0 administration Asthenia 14 12 <1 0 site conditions Peripheral edema 9 20 <1 0 Face edema <1 14 0 <1 Musculoskeletal Myalgia 19 19 <1 <1 and connective Arthralgia 22 17 <1 <1 tissue disorders Muscle spasms 12 34 0 1 Pain in extremity 15 16 <1 <1 Back pain 19 17 1 1 Respiratory, thoracic Cough 17 13 0 0 and mediastinal Oropharyngeal pain 12 6 0 0 disorders Dyspnea 11 6 2 <1 Infections and Nasopharyngitis 27 21 0 0 infestations Upper respiratory tract infection 17 14 <1 0 Influenza 13 9 0 0 Gastroenteritis 7 10 0 <1 Eye disorders Eyelid edema 1 19 0 <1 Periorbital edema <1 15 0 0 Psychiatric disorders Insomnia 11 9 0 0 Vascular disorder Hypertension 10 4 1 <1 a Excluding laboratory abnormalities b NCI Common Terminology Criteria for Adverse Events, Version 3.0

Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna 400 mg Twice-Daily (Regardless of Relationship to Study Drug) (≥10% in any Group) 24-Month Analysisa

Body System and Preferred Term

CML-CP

CML-AP

N=321

N=137

Table 7: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory Abnormalities Patient Population Resistant or Intolerant Ph+ Newly Diagnosed Ph+ CML-CP

All Grades (%)

CTC Gradesb 3/4 (%)

All Grades (%)

CTC Gradesb 3/4 (%)

Skin and subcutaneous tissue disorders

Rash Pruritus Night sweat Alopecia

36 32 12 11

2 <1 <1 0

29 20 27 12

0 0 0 0

Gastrointestinal disorders

Nausea Constipation Diarrhea Vomiting Abdominal pain Abdominal pain upper Dyspepsia

37 26 28 29 15 14 10

1 <1 3 <1 2 <1 <1

22 19 24 13 16 12 4

<1 0 2 0 3 <1 0

Nervous system disorders

Headache

General disorders and administration site conditions

Fatigue Pyrexia Asthenia Peripheral edema

32 22 16 15

3 <1 0 <1

23 28 14 12

<1 2 1 0

Musculoskeletal and connective tissue disorders

Myalgia Arthralgia Muscle spasms Bone pain Pain in extremity Back pain Musculoskeletal pain

19 26 13 14 20 17 11

2 2 <1 <1 2 2 <1

16 16 15 15 18 15 12

<1 0 0 2 1 <1 1

Respiratory, thoracic and mediastinal disorders

Cough Dyspnea Oropharyngeal pain

27 15 11

<1 2 0

18 9 7

0 2 0

Infections and infestations

Nasopharyngitis Upper respiratory tract infection

Metabolism and nutrition disorders

Decreased appetitec

Psychiatric disorders

Insomnia

Vascular disorders

Hypertension

Excluding laboratory abnormalities NCI Common Terminology Criteria for Adverse Events, Version 3.0 c Also includes preferred term anorexia a

Laboratory Abnormalities Table 7 shows the percentage of patients experiencing treatment-emergent Grade 3/4 laboratory abnormalities in patients who received at least one dose of Tasigna. Table 7: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory Abnormalities Patient Population Resistant or Intolerant Ph+ Newly Diagnosed Ph+ CML-CP CML-CP CML-AP TASIGNA Imatinib TASIGNA TASIGNA 300 mg 400 mg 400 mg 400 mg twice-daily once-daily twice-daily twice-daily N=279 N=280 N=321 N=137 (%) (%) (%) (%) Hematologic Parameters Thrombocytopenia 10 9 301 423 Neutropenia 12 22 312 424 Anemia 4 6 11 27 Biochemistry Parameters Elevated lipase 9 4 18 18 Hyperglycemia 7 <1 12 6 Hypophosphatemia 8 10 17 15 Elevated bilirubin (total) 4 <1 7 9 Elevated SGPT (ALT) 4 3 4 4 Hyperkalemia 2 1 6 4 Hyponatremia 1 <1 7 7 (continued)

Biochemistry Parameters Hypokalemia Elevated SGOT (AST) Decreased albumin Hypocalcemia Elevated alkaline phosphatase Elevated creatinine

CML-CP

CML-AP

TASIGNA 300 mg twice-daily N=279 (%)

Imatinib 400 mg once-daily N=280 (%)

TASIGNA 400 mg twice-daily N=321 (%)

TASIGNA 400 mg twice-daily N=137 (%)

<1 1 0 <1 0 0

2 1 <1 <1 <1 <1

2 3 4 2 <1 <1

9 2 3 5 1 <1

*NCI Common Terminology Criteria for Adverse Events, version 3.0 1 CML-CP: Thrombocytopenia: 12% were Grade 3, 18% were Grade 4 2 CML-CP: Neutropenia: 16% were Grade 3, 15% were Grade 4 3 CML-AP: Thrombocytopenia: 11% were Grade 3, 32% were Grade 4 4 CML-AP: Neutropenia: 16% were Grade 3, 26% were Grade 4 Elevated total cholesterol (all grades) occurred in 28% (Tasigna 300 mg bid) and 4% (imatinib). Elevated triglycerides (all grades) occurred in12% and 8% of patients in the Tasigna and imatinib arms, respectively. Hyperglycemia (all grades) occurred in 50% and 31% of patients in the Tasigna and imatinib arms, respectively. Most common biochemistry laboratory abnormalities (all grades) were alanine aminotransferase increased (72%), blood bilirubin increased (59%), aspartate aminotransferase increased (47%), lipase increased (28%), blood glucose increased (50%), blood cholesterol increased (28%), and blood triglyceride increased (12%). 6.2 Additional Data from Clinical Trials The following adverse drug reactions were reported in patients in the Tasigna clinical studies at the recommended doses. These adverse drug reactions are ranked under a heading of frequency, the most frequent first using the following convention: common (≥1% and <10%), uncommon (≥0.1% and <1%), and unknown frequency (single events). For laboratory abnormalities, very common events (≥10%), which were not included in Tables 5 and 6, are also reported. These adverse reactions are included based on clinical relevance and ranked in order of decreasing seriousness within each category, obtained from 2 clinical studies: 1. Newly diagnosed Ph+ CML-CP 60 month analysis and, 2. Resistant or intolerant Ph+ CML-CP and CMP-AP 24 months’ analysis. Infections and Infestations: Common: folliculitis. Uncommon: pneumonia, bronchitis, urinary tract infection, candidiasis (including oral candidiasis). Unknown frequency: sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis. Neoplasms Benign, Malignant, and Unspecified: Common: skin papilloma. Unknown frequency: oral papilloma, paraproteinemia. Blood and Lymphatic System Disorders: Common: leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia. Unknown frequency: thrombocythemia, leukocytosis. Immune System Disorders: Unknown frequency: hypersensitivity. Endocrine Disorders: Uncommon: hyperthyroidism, hypothyroidism. Unknown frequency: hyperparathyroidism secondary, thyroiditis. Metabolism and Nutrition Disorders: Very Common: hypophosphatemia. Common: electrolyte imbalance (including hypomagnesemia, hyperkalemia, hypokalemia, hyponatremia, hypocalcemia, hypercalcemia, hyperphosphatemia), diabetes mellitus, hyperglycemia, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia. Uncommon: gout, dehydration, increased appetite. Unknown frequency: hyperuricemia, hypoglycemia. Psychiatric Disorders: Common: depression, anxiety. Unknown frequency: disorientation, confusional state, amnesia, dysphoria. Nervous System Disorders: Common: peripheral neuropathy, hypoesthesia, paresthesia. Uncommon: intracranial hemorrhage, ischemic stroke, transient ischemic attack, cerebral infarction, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperesthesia. Unknown frequency: basilar artery stenosis, brain edema, optic neuritis, lethargy, dysesthesia, restless legs syndrome. Eye Disorders: Common: eye hemorrhage, eye pruritus, conjunctivitis, dry eye (including xerophthalmia). Uncommon: vision impairment, vision blurred, visual acuity reduced, photopsia, hyperemia (scleral, conjunctival, ocular), eye irritation, conjunctival hemorrhage. Unknown frequency: papilloedema, diplopia, photophobia, eye swelling, blepharitis, eye pain, chorioretinopathy, conjunctivitis allergic, ocular surface disease. Ear and Labyrinth Disorders: Common: vertigo. Unknown frequency: hearing impaired, ear pain, tinnitus. Cardiac Disorders: Common: angina pectoris, arrhythmia (including atrioventricular block, cardiac flutter, extrasystoles, atrial fibrillation, tachycardia, bradycardia), palpitations, electrocardiogram QT prolonged. Uncommon: cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur,

coronary artery stenosis, myocardial ischemia, pericardial effusion, cyanosis. Unknown frequency: ventricular dysfunction, pericarditis, ejection fraction decrease. Vascular Disorders: Common: flushing. Uncommon: hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, arterial stenosis limb, hematoma, arteriosclerosis. Unknown frequency: shock hemorrhagic, hypotension, thrombosis, peripheral artery stenosis. Respiratory, Thoracic and Mediastinal Disorders: Common: dyspnea exertional, epistaxis, dysphonia. Uncommon: pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation. Unknown frequency: pulmonary hypertension, wheezing. Gastrointestinal Disorders: Common: pancreatitis, abdominal discomfort, abdominal distension, dysgeusia, flatulence. Uncommon: gastrointestinal hemorrhage, melena, mouth ulceration, gastroesophageal reflux, stomatitis, esophageal pain, dry mouth, gastritis, sensitivity of teeth. Unknown frequency: gastrointestinal ulcer perforation, retroperitoneal hemorrhage, hematemesis, gastric ulcer, esophagitis ulcerative, subileus, enterocolitis, hemorrhoids, hiatus hernia, rectal hemorrhage, gingivitis. Hepatobiliary Disorders: Very Common: hyperbilirubinemia. Common: hepatic function abnormal. Uncommon: hepatotoxicity, toxic hepatitis, jaundice. Unknown frequency: cholestasis, hepatomegaly. Skin and Subcutaneous Tissue Disorders: Common: eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform). Uncommon: exfoliative rash, drug eruption, pain of skin, ecchymosis. Unknown frequency: psoriasis, erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysesthesia syndrome, petechiae, photosensitivity, blister, dermal cyst, sebaceous hyperplasia, skin atrophy, skin discoloration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis. Musculoskeletal and Connective Tissue Disorders: Common: bone pain, musculoskeletal chest pain, musculoskeletal pain, back pain, neck pain, flank pain, muscular weakness. Uncommon: musculoskeletal stiffness, joint swelling. Unknown frequency: arthritis. Renal and Urinary Disorders: Common: pollakiuria. Uncommon: dysuria, micturition urgency, nocturia. Unknown frequency: renal failure, hematuria, urinary incontinence, chromaturia.

Reproductive System and Breast Disorders: Uncommon: breast pain, gynecomastia, erectile dysfunction. Unknown frequency: breast induration, menorrhagia, nipple swelling. General Disorders and Administration Site Conditions: Common: pyrexia, chest pain (including noncardiac chest pain), pain, chest discomfort, malaise. Uncommon: gravitational edema, influenza-like illness, chills, feeling body temperature change (including feeling hot, feeling cold). Unknown frequency: localized edema. Investigations: Very Common: alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, lipoprotein cholesterol (including very low density and high density) increased, total cholesterol increased, blood triglycerides increased. Common: hemoglobin decreased, blood amylase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, blood alkaline phosphatase increased, weight decreased, weight increased, globulins decreased. Uncommon: blood lactate dehydrogenase increased, blood urea increased. Unknown frequency: troponin increased, blood bilirubin unconjugated increased, insulin C-peptide decreased, blood parathyroid hormone increased. 10 OVERDOSAGE Overdose with nilotinib has been reported, where an unspecified number of Tasigna capsules were ingested in combination with alcohol and other drugs. Events included neutropenia, vomiting, and drowsiness. In the event of overdose, the patient should be observed and appropriate supportive treatment given. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Revised: January 2015 © Novartis T2015-143 October 2015

NEWS | MEDIAPLANET | 25

Overcoming Leukemia at Age 2 Charles Esten, who plays Deacon Claybourne on "Nashville," still remembers the devastating moment that changed his role as a parent. By Liane Bonin Starr

PHOTO: Leukemia & Lymphoma Society

ddie, Charles Esten’s then twoand-a-half-year-old daughter, hadn’t seemed herself after the removal of a small growth on her leg. Charles and his wife Patty were determined to find out why. “She was pale, grumpy and these little black spots emerged on her legs, which we would later find out were peticiae, or tiny little spots of bleeding on the skin caused by little or no platelets,” Esten recalls. When their surgeon could find nothing wrong, they went to their pediatrician. “Within minutes of a blood test, we were sent to CedarsSinai Hospital.”

Faith in numbers

It was there that the Estens first learned that leukemia could be the cause of their daughter’s symptoms. Still, that didn’t make the diagnosis—acute lymphoblastic leukemia—any easier to bear. “The doctor mentioned the 85 percent survival rate, which was different than when I was a kid and leukemia was a death sentence,” Esten says. “But there was also the 15 percent, and it was the biggest 15 percent I’d ever considered in my life.” The good news is that Addie was in the majority; she is now a healthy 16-year-old with few, if any, memories of her two-year course of chemotherapy. In the years since

Addie’s diagnosis, the survival rates for children with leukemia diagnoses have soared above 90 percent. “They’re still making great advances,” Esten says. “But it’s not good enough.” Looking at all blood cancers combined, onethird of patients don’t survive five years past diagnosis despite strides in survival rates.

Walking on

That’s just one reason why the Estens are committed to working with The Leukemia & Lymphoma Society (LLS). Last year, Esten was

... she is now a healthy 16-year-old with few, if any, memories of her two-year course of chemotherapy. named the Honorary Chair for the 2015 National Light the Night Walk, an event held in almost 200 cities across the country. Esten, wife Patty and Addie will be carrying a lantern, a white light representing a patient in remission, this year as well.

“We walk with Team Addie,” Esten says. “Every year, I can see Addie get more involved and engaged, and it is not just something her mom and I are doing. This is her cause now, too. It could be very easy for her to step away, but she’s seen the work LLS does.”

Today Addie only needs to have her blood tested once a year to rule out a recurrence. The Estens, who have two older children as well as Addie, are grateful. “There are doctors and nurses and researchers whom I’ve never met, and fundraisers I will never know who made Addie’s chance of surviving 85 percent instead of 20 percent,” Esten says. “We were surrounded by friends and family and prayers, and that was huge, but just as huge was the community that has spent its time fighting this and that we are now trying to be a part of.” n

26 | FUTUREOFPERSONALHEALTH.COM | INSPIRATION

PHOTO: Kirk McKoy/Los Angeles Times/Contour by Getty Images

Cindy Crawford’s Personal Campaign Against Blood Cancer

After losing her brother to blood cancer, the legendary model strove to make a difference for other patients. Years later, she’s still passionately urging for bone marrow donor registration. By Kristen Castillo

indy Crawford is a world-famous supermodel and entrepreneur, with a beauty product line and a home furnishings business. Despite her busy schedule, she makes time for another personal passion: advocating for blood cancer awareness and bone marrow donation, a commitment that started years ago.

Lifelong meaning “My younger brother Jeff was diagnosed with leukemia when he was only 2,” she says. “I was eight. Sadly, he passed away two years later, after chemotherapy and radiation therapy.” Part of the family’s healing was to give back to others. Crawford’s mother encouraged her daughter and other family members to raise money for the Leukemia

Society of America. Crawford has been raising money and awareness throughout her career, and is still involved with the American Family Children’s Hospital in Madison, Wisconsin, where Jeff was treated. “I have seen how bone marrow transplant is a powerful and effective tool in the fight against blood cancers,” says Crawford, underscoring that not every per-

son who needs a bone marrow transplant has a match from a family member. “The more people who register for bone marrow donation, the more chances some of these patients have for a match.” Impact and honor While Jeff’s death was always tough on Crawford, it wasn’t until she had her own family (she has two children with her restau-

rateur husband, Rande Gerber) that she realized the impact of a child’s death. “When I became a mother myself, I began to understand what that must have been like for my parents,” she says. “He was so brave and courageous in his fight against leukemia and I channeled his energy into the things I was trying to conquer,” Crawford says. “Being able to be involved in helping fight blood cancers is a way for me to honor him.” Donors make the difference Every three minutes, someone in the United States is diagnosed with blood cancer, such as leukemia, lymphoma or myeloma. Every 10 minutes, someone dies from one of those respective cancers. “Joining the bone marrow donor registry is the first big way to help,” says Katharina Harf, the co-founder of Delete Blood Cancer DKMS, the world’s largest network of donor centers. Crawford’s advocacy includes working with Delete Blood Cancer, which has registered nearly six million donors and provided over 53,000 patients with a second chance at life. Every year, nearly 14,000 people rely on the national registry and groups like Delete Blood Cancer for life saving bone marrow matches to treat blood cancers, as well as illnesses like sickle cell anemia and aplasic anemia. “Every new person on registry brings hope to patients and increases their chances of finding a matching donor,” says Harf, explaining that registering is as simple as swabbing a would-be donor’s cheek. “Many people don’t know how about the crucial need for more donors, or how bone marrow donation really works. When we get the chance to explain this, most people register on the spot.” n

INSIGHT | FUTUREOFPERSONALHEALTH.COM | 27

PHOTO: Delete Blood Cancer

Transplanting Awareness for Bone Marrow Donors

What do leukemia, sickle cell anemia and MDS all have in common? These very different diseases can all be treated with a bone marrow transplant.

hile the list of blood cancers and disorders that bone marrow transplants can help eradicate continues to grow, the positive is that there is a direct way we can help. The challenge? Most of us don’t understand how. Myths matter Misconceptions about the need and the bone marrow donation process abound, but here are the facts. Every 35 seconds, someone around the world is diagnosed with a blood cancer. In the U.S. alone, this figure is every three minutes. Even more alarming

than these statistics is the fact that blood cancers represent only a fraction of the variety of blood disorders—like different types of anemia and immune deficiency disorders, for example—for which a bone marrow transplant is the closest hope for a cure. With only about 30 percent of people who need a transplant able to find a matching donor in their family, the vast majority of patients will hope and search urgently for an unrelated donor match within our databases. The search for a matching donor is far from easy. Without going into the science of it, the search is comparable to finding a needle in a haystack, rendering it ex-

tremely difficult to find a match, especially outside of one’s family.

An air of mystery, fueled by the misconceptions surrounding the process, has consistently shrouded bone marrow donation.

In the know Everyone should be able to find a matching donor. One of the largest obstacles to this vision is the lack of awareness and understanding of the need for donors and the donation process. An air of mystery, fueled by the misconceptions surrounding the process, has consistently shrouded bone marrow donation. One key fact to highlight here is that there are two methods of donation, both simple outpatient procedures after which the donor’s bone marrow regenerates within just a few weeks.

Bone marrow donation is a living donation. It is easier than you think, and there is no cost for the donor. Essentially, becoming a bone marrow donor is one of the simplest ways to dramatically and directly affect another person’s life. If we can educate and register new potential donors, we can raise the funds to continue covering the costs of registering, typing and processing new potential donors. From registering as a potential donor to volunteering or helping raise money, you can help! n By Desirée Chavis, Delete Blood Cancer DKMS

28 | FUTUREOFPERSONALHEALTH.COM

| INSIGHT

MEDIAPLANET

DOCTOR’S VISIT

Why Is Early Detection Crucial to Managing Multiple Myeloma? Dr. Naveen Bangia, the director of scientific affairs for The Binding Site, goes in-depth on the big question surrounding one of the most difficult-to-pin-down diseases rooted in the blood. Why is it important to diagnose multiple myeloma early?

Changing the Conversation for Blood Cancer Dr. Lee Greenberger from The Leukemia & Lymphoma society discusses the latest treatment options available for individuals with blood cancers.

By Meghan Catucci

If you go to your primary care physician and tell her that you’re tired, or your bones hurt, chances are she will tell you to get some more rest or exercise and may do some basic blood work. Fatigue and bone pain are common symptoms that may be due to any one of a number of causes.

haracterized by their location in the blood or lymphatic system, blood cancers include leukemia, myeloma and lymphoma. There are 162,000 new cases of blood cancer a year in the U.S.

Multiple myeloma is a blood cancer that can cause symptoms such as fatigue, bone pain or kidney problems. Over 50 percent of myeloma patients go to their primary care physician with vague symptoms. Often, these patients are not diagnosed for more than six months, allowing the cancer to damage bones and kidneys. Detecting myeloma earlier means fewer patients with extensive damage to their bones and kidneys, and longer survival.

How we’re treating Some modern treatments for these cancers, such as cytotoxic drugs, monoclonal drugs and radiation, have been around for decades and can still be very effective. Bone marrow transplants are also a common treatment option. Newer options include precision medicine, tailoring medical treatments to the individual’s specific tumor cells and, most recently, immunotherapy. “Immunotherapy is a type of therapy that activates the immune system one way or another,” says Dr. Lee Greenberger, the chief scientific officer

The tests recommended for detection of myeloma are Serum Protein Electrophoresis (SPE or SPEP), Serum Immunofixation and Freelite. These three tests together will detect 99 percent of myeloma cases. With earlier detection, patients can be monitored or treated more quickly to improve their quality of life (fewer bone and kidney problems) and increase their chances of long-term survival.

for The Leukemia & Lymphoma Society. “This therapy, by either genetic engineering or using antibodies to ultimately activate the immune system, has produced very dramatic results in certain blood cancers and is being expanded out across many different types of blood cancers, including also being deployed to solid tumors.” Gaining credibility One factor that makes immunotherapy so exciting, Dr. Greenberger adds, is its potential. “One reason why we have good confidence in this therapy is because it is now being used by multiple laboratories for clinical sites across the country,” Greenberger continues. “It’s always important for a scientist’s approach to validate the results in somebody’s hands, in a completely independent manner. And it has been done for this therapy.” n

30 | FUTUREOFPERSONALHEALTH.COM | NEWS

MEDIAPLANET

Improving Quality of Life for Multiple Myeloma Patients The Food and Drug Administration recently approved several new drugs some say can revolutionize the treatment of multiple myeloma and, in particular, patients facing a relapse. By Roberta Codemo

ccording to Dr. C. Ola Landgren, the chief of the myeloma service division of hematologic oncology at Memorial Sloan-Kettering Cancer Center, we have come a very, very long step forward in the past 15 years. Today, he explains, there are approximately 10 drugs available in the fight against multiple myeloma—compared to the one or two we had 15 to 20 years ago. How we’re fighting The number of new drugs available—monoclonal antibodies, proteasome inhibitors and immunomodulatory agents—are doubling and tripling survival rates. “This gives patients hope,” chimes in Dr. Joseph Mikhael, associate professor of medicine at Mayo Clinic and spokesperson for the American Society of Hematology. We have yet to develop a cure for multiple myeloma, a rare cancer that affects plasma cells normally found in the bone marrow. Plasma cells produce antibodies called immunoglobulins that help fight infections and other diseases. When plasma cells become malignant, the cells produce a tumor called a plasmacytoma, which normally develops in a bone. Persons with more than one plasmacytoma have multiple myeloma. Are you at risk? About 25,000 new cases are diagnosed each year, and the aver-

this January, the FDA approved a new indication for Carfilzomib, making it the only approved therapy for relapsed multiple myeloma, with proven efficacy as a single agent, doublet and triplet combination. Two new monoclonal antibodies, Daratumumab and Elotuzumab, are the first FDA-approved drugs that engage the immune system and destroy the tumors. Immunomodulatory drugs are also proving effective against multiple myeloma.

age age of onset is 70. It is more prevalent in African-Americans. Over 95,000 people in the U.S. are living with, or in remission from myeloma. There were an estimated 11,000 deaths in 2015. The disease produces proteins that are detectable in blood and urine while the patient is asymptomatic. “A very small percentage develops multiple myeloma,” says Dr. Landgren. “We want to prevent it before it happens.” The disease primarily affects the blood,

bones and kidneys and, once it does, is “difficult to treat,” confirms Dr. Mikhael. “There is no known cause,” Dr. Landgren adds. Research suggests that environmental factors, such as exposure to pesticides, may play a role, and that genetic factors may trigger the development of the disease. Vigilant treatment It’s important to initiate treatment at the right time. Early in-

tervention may delay or prevent progression of the disease. Says Landgren: “We want to catch it before it goes out of control.” New treatment options are enhancing the quality of life for patients, who are able to live normal lives. “When we talk about quality of life, we look at how well we manage the side effects. It’s a subjective measurement,” Mikhael explains. “Proteasome inhibitors are a huge step forward.” Late

Charting progress “Every patient will have a relapse,” confirms Mikhael. The new drugs show a lot of promise and new drug combinations are being studied that will help patients remain in remission longer with fewer side effects. Some patients are now in remission for a decade or longer, and the average survival rate has increased, from 3 to 4 years, to 9 to 12 years. “It’s important to monitor the treatment response,” Landgren says. If patients have a negative response to treatment, for example, the therapy can be stepped down to a lower intensity. It’s important to maintain drug therapies at a level where the disease doesn’t become active. Science and research must build a thorough understanding of this disease to develop effective drugs. From there, patients will begin to live longer, better lives. “Many still die every day,” Dr. Mikhael says. “We still have a long way to go.” n

32 | FUTUREOFPERSONALHEALTH.COM

| NEWS

Multiple Myeloma Masquerades as Pain and Fatigue

ultiple myeloma is a blood cancer that affects plasma cells, a type of white blood cell. Each year, more than 20,000 Americans are diagnosed with multiple myeloma, but treatment options and detection methods are now better than ever. While multiple myeloma can strike anyone, it is most common in adults over the age of 65, and the risk of developing myeloma increases with age. It is also more common among men and AfricanAmericans. People with a close family member who suffers from multiple myeloma are also at an increased risk for developing it. Symptoms It can be difficult to tie specific symptoms to multiple myeloma without ruling out other possible causes. “It can present in many ways, the most common in the form of bone pain or fractures, but it can also be seen with kidney damage, fatigue from a low hemoglobin, or other symptoms like numbness, weakness or even repeated infections,” says Joseph Mikhael, associate dean of the Mayo School of Graduate Medical Education and deputy director for Education at the Mayo Clinic Cancer Center. Fortunately, the tests to detect myeloma, such as the free light chain blood test (Freelite®), are extremely reliable, and early diagnosis improves outcomes. “Almost all patients have the abnormal protein in their blood for months or years,” Mikhael adds. “Catching it early can often prevent the organ damage that the proteins can cause.” A likely candidate for testing would be “someone who develops a bone pain or anemia without any particular cause, or a reduction

The blood cancer multiple myeloma can be easily missed, but new therapies mean it’s becoming easier to treat. By I-Hsien Sherwood

in kidney function without high blood pressure, high blood pressure or diabetes,” says Dr. Robert Kyle, professor of medicine and laboratory medicine at the Mayo Medical School. Often, the signs are subtle. Barb Hansen broke a rib 8 months before her myeloma diagnosis in 2006. “I had x-rays, I wasn’t diagnosed while I was in all this pain, and when I did get the diagnosis it was kind of a shocker,” Hansen says. “I had never heard of myeloma before. Nothing had shown up in my physical.” New treatments Typical treatments include chemotherapy and drugs like proteasome inhibitors, but researchers are identifying new immune therapies, some which can be taken orally, as well as targeted antibody treatments. With the wide choice of therapies, Freelite® and other laboratory tests are useful to evaluate patient progress. “In the past 15 years there’s been a huge improvement in our ability to treat myeloma and to have patients that go into remission and have remissions that last for many years,” says Brian Durie, a doctor specializing in multiple myeloma at CedarsSinai Outpatient Cancer Center in Los Angeles, and Chairman of the International Myeloma Foundation. Hansen was put on the drug lenalidomide after her myeloma diagnosis, followed by a stem cell transplant in 2007. She’s been in remission for over six years. “Stay strong, think positively, learn what you can about the disease, be your own advocate, accept the support that people give you and be encouraged by the research that’s being done and the new drugs that are being developed,” Hansen says. “There is hope.” n

advocacy | MEDIAPLANET | 33

For Kids, Diet After a Diagnosis Is Vital The dangers of childhood obesity range from cardiovascular disease to prediabetes and bone and joint problems.

hese effects are even more threatening for kids who are already sick with a disease like cancer. But what are the effects of childhood obesity on children and adolescents who are already sick with a disease like cancer? Elena J. Ladas, Ph.D., RD, an assistant professor of nutrition in pediatrics in the Institute of Human Nutrition at Columbia University Medical Center, has set out to answer this question, specifically for children and adolescents with acute lymphoblastic leukemia, otherwise referred to as ALL. In the first study of its kind,

Dr. Ladas will research how best to curb childhood obesity during ALL treatment and examine the effects of childhood obesity on both prognosis and recurrence. The study began in January of this year and will continue through December 2019. The role of prevention "ALL is the most common childhood cancer," Dr. Ladas explains. "In fact, a quarter of all pediatric cancers are leukemia. Yet there have been few nutrition studies related to this disease—or in the area of pediatric oncology in general. Even more concerning is the association of obesity and survival of ALL. Children who

are obese throughout therapy have twice the risk of reduced survival. Therapeutic interventions that prevent the development of obesity may have a real impact on improving survival in children with ALL. Survival rates for childhood ALL have increased from below 10 percent to about 90 percent, with two to three year treatment plans. However, treatment comes with side effects, many of which are nutrition related. Approximately 50 percent of children become obese by the end of treatment, and the obesity often persists long after treatment ends. As part of her research, Dr. Ladas will examine the diets of nearly 800

children and adolescents undergoing treatment for ALL. She will start by looking at the amount of sugar in their diets, measured by the glycemic index and glycemic load of the foods that they eat during treatment. Then she will compare the prognosis and reoccurrence rates with different diets. Cancer care revisited "Thanks to a grant from the American Cancer Society, we may finally get a clear understanding of why so many pediatric ALL survivors become obese and how that ultimately impacts their health," says Dr. Ladas. "We’ll be asking questions like:

How does diet change during treatment? Is it a nutrient we should be worried about? Calcium and vitamin D? Patterns of dietary intake?" Until now, modifying the diet and exercise habits of pediatric cancer patients has not been part of the standard of care. Dr. Ladas hopes that this research will begin to change that. "We want to empower both patients and parents," she says. “We want them to know with confidence that the foods they eat may be just as important as the medicines they take." n By Ashley Engelman, American Cancer Society

34 | FUTUREOFPERSONALHEALTH.COM | ADVOCACY

MEDIAPLANET

After the Biggest Victory, Ethan Zohn Passes Hope Following his victory on “Survivor: Africa,” the pro soccer player’s toughest competition became cancer. Here’s his advice for patients and their loved ones.

By Jennifer DeMeritt

has urged other cancer patients to bring all the strength and optimism they can to their battle. “Cancer is as much mental as it is physical,” he says. “One must believe in their course of treatment in addition to taking good care of their body. The negative patients in the chemo suite often seem to do worse in the long run Suiting up or have a more difficult time durBut Zohn is a fighter, so that’s not ing treatment.” what he did. Before his diagnoZohn has been cancer-free since sis, Zohn was a professional soc- 2013, but he’s still advocating for a cer player. Then cure. “You know he found fame what a miracle as the winner looks like to can“One must of “Survivor: Afcer patients? Sucrica,” and levercessful research believe in their aged that fame and new drugs. to start the nonCancer patients course of profit Grassroots are desperate. We Soccer. are literally waittreatment in Zohn is a tering every minute minal optimist, addition to taking of every day for so when he was some life-saving good care of diagnosed with breakthrough.” CD20+ Hodgkin The good news their body.” lymphoma, he is that new treatmustered all that ments are being optimism and developed all the beat cancer— time, and, thanks twice. But he didn’t do it alone. to advances in research, more are “My mom, two brothers, friends on the horizon. But Zohn knows from school, my teammates and that the fight isn’t over. the cancer community reached “There are 14.5 million cancer out and embraced me,” Zohn re- patients and survivors in the U.S. calls. Their support inspired Zohn that can use help. Many of the to go public with his diagnosis. organizations supporting this community are underfunded,” he Becoming a beacon says. “Volunteer efforts are every “I realized that the details of my bit as important as large dollar life had the power to comfort oth- donations. Anyone and everyone ers,” he says. Since then, Zohn truly can me a difference.” n

PHOTO: FRANCINE DEVITA

than Zohn is a survivor in more ways than one. “When I was 14 years old, cancer came into my home and took my father. Then it tried to take me,” says Zohn. “All I wanted to do was to curl up into a ball and hide in my room.”

POLYCYTHEMIA VERA (PV) IS A RARE, CHRONIC BLOOD CANCER Unless you or a loved one has been diagnosed with PV, you may not have heard about it. PV is part of a group of diseases called “myeloproliferative neoplasms” or MPNs. With PV, a person’s body makes too many red blood cells, white blood cells, and platelets. Too many red blood cells can cause the blood to thicken. Thicker blood doesn’t flow normally through arteries and veins.

I S Y O U R P V U N D E R C O N T R O L? Check off the information below that applies to you.

It’s important to keep your PV under control to help reduce the risk of complications such as heart attack or stroke. Regular monitoring and medical care can help detect changes in your condition. Keeping your blood counts—particularly your hematocrit (a measure of red cells in the blood)—at the right levels is an important goal in managing PV. By tracking your symptoms and blood counts, you and your healthcare team can work to control your disease and reduce the risk of complications.

START THE CONVERSATION WITH YOUR HEALTHCARE PROFESSIONAL It is important to tell your Healthcare Professional about any symptoms you have, even if you are not sure they are related to your PV. Talking to your Healthcare Professional about your symptoms helps you both: • Understand how PV is affecting you • Follow how your PV is changing over time

Get more information about PV. Visit PVvoices.com today.

If you checked any of the boxes above, it is important to talk to your Healthcare Professional to understand if your PV is under control.

Advancing therapeutics, Improving lives.

For more than 25 years, Gilead has worked to develop medicines that address areas of unmet medical need for people around the world. Our portfolio of medicines and pipeline of investigational drugs include treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions. Every day we strive to transform and simplify care for people with life-threatening illnesses.

GIlEAD IS cOmmIttED tO tHE DEVElOpmEnt OF nOVEl tHErApIES FOr blOOD cAncErS.