TAP Vol 1 Issue 6

Page 1

Triple–negative breast cancer 10

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NCCN patient guidelines 16

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VOLUME 1, ISSUE 6

Health-care reform 40

NOVEMBER 2010 ASCOPost.com

Editor-in-Chief, James O. Armitage, MD

35th ESMO Congress

‘Made in China’

Erlotinib More Than Doubles Progression-free Survival in Non–Small Cell Lung Cancer By Caroline Helwick

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n the phase III OPTIMAL study, which was conducted in China, first-line single-agent erlotinib (Tarceva) given to patients with advanced non–small cell lung cancer (NSCLC) extended median progression-free survival (PFS) to 13.1 months, a highly significant increase over a PFS of 4.6����������������� ���������������� months with gemcitabine/carboplatin, reported Caicun Zhou, MD, of Tongji University in Shanghai, at the 35th ESMO Congress, held October 8-12 in Milan, Italy.1 The study, which included a population expected to be sensitive to inhibitors of the epidermal growth

Erlotinib in NSCLC ■■ In the phase III OPTIMAL trial, median PFS

was increased from 4.6 months with standard treatment to 13.1 months with single-agent erlotinib.

factor receptor (EGFR), was the first trial to compare erlotinib head-tohead with a platinum doublet regimen. Investigators screened 549 patients with NSCLC for EGFR-activating mutations, requiring that patients have exon 19 deletions or exon 21 point Caicun Zhou, MD mutations, as these genetic variations are associated with particular sensitivity to anti-EGFR agents. They randomly assigned 165 patients to receive erlotinib (150 mg/d) or gemcitabine (1,000 mg/m2) plus carboplatin (AUC 5), which is standard first-line treatment for NSCLC in China.

Consistent Benefit In the intent-to-treat analysis, erlotinib reduced the risk of progression by 84% (P < .0001) over

■■ Erlotinib reduced the risk of progression by 84%, and benefit was consistent across all subgroups.

See page 52

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JCO Spotlight

Two Pivotal Studies Help Fine-tune Use of Panitumumab in Colorectal Cancer By Caroline Helwick

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wo important studies recently published online in the Journal of Clinical Oncology have clarified the role of panitumumab (Vectibix) in metastatic colorectal cancer (mCRC). Panitumumab, a fully human monoclonal antibody against the epidermal growth factor recepJean-Yves Douillard, MD tor (EGFR), was effective in both the first- and second-line settings when combined with chemotherapy in patients with wild-type (WT) KRAS tumors, but not in patients with mutated (MT) KRAS. The findings underscore the importance of KRAS testing in patients with mCRC and tailoring treatment accordingly, as this agent enters the treatment armamentarium. The PRIME study, led by Jean-Yves Douillard, MD, was an international open-label phase III trial in

1,183 mCRC patients with no prior chemotherapy for metastatic disease.1 Patients were randomly assigned to receive FOLFOX4 (infusional fluorouracil [5-FU], leucovorin, and oxaliplatin) every 2 weeks alone or FOLFOX4 plus panitumumab, 6.0 mg/kg, every 2 weeks until disease progression. The study was originally designed to test the treatment effect in all patients, but was amended to compare progression-free survival (PFS), the primary endpoint, and overall survival (OS) according to KRAS status. Patients were followed for a median of 11 to 13 months. Outcomes were prospectively analyzed on an intent-totreat basis by tumor KRAS status, which was available for 93% of the patients. In patients with WT KRAS, median PFS was significantly improved with the addition of panitumumab (Fig. 1), from 8.0 months with FOLFOX4 alone to 9.6 months with the addition of panitumumab (P = .02). A nonsignificant increase in OS was also observed,

By Tony Mok, MD

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hat do a pair of Nike sneakers, a pair of Levi’s jeans, and a global-scale lung cancer trial have in common? They are all either solely or partly produced in China. But while we may be perfectly comfortable in our Nikes and Levi’s, we may not be so at ease with a clinical trial that can change the daily management of lung cancer patients. Thus, it is important to recognize and understand the ability and status of lung cancer clinical research in China.

Clinical Trial Triad Investigator, sponsor, and patient are the three essential participants in any clinical trial, but each has his/her own motivation for participation. The primary objective of the investigator should be scientific advancement. However, the coprimary objective closely linked to scientific advancement is publication in high-impact, peer-review journals. Investigators in academic medicine need to publish in order to sustain their credentials and advance their careers. The same principle applies in China. Until the past decade, Chinese investigators could publish in local journals and still get continued on page 2

Dr. Mok is Professor in the Department of Clinical Oncology, The Chinese University of Hong Kong, China, and is a member of The ASCO Post’s International Editorial Board.

MORE IN THIS ISSUE Oncology Meetings Coverage

35th ESMO Congress �������1, 3, 8, 17, 20 AACR International Conference ����18, 19 2010 Breast Cancer Symposium �����10, 11 Best of ASCO ���������������������������� 33, 35, 38 Direct from ASCO ������������������������������������ 21 Maintenance chemo in NSCLC �������������� 54

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A Harborside Press Publication


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