MESSAGE FROM THE CHAIR
Welcome to this edition of UPdate, the newsletter of the Australian & New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP)! The chaos and excitement of ASCO, with our plenary presentation and our simultaneous NEJM paper, are now well behind us. Don’t be fooled though into thinking that things have quietened down for ANZUP: it might appear that way, but everything is relative! 1. ENZAMET: the action there is by no means finished. Martin Stockler presented some of the hot-off-thepress quality of life data at ESMO in September. This work showed that there were some early impairments in specific aspects of quality of life for me receiving enzalutamide on the trial, but overall we found improvement in deterioration-free survival (defined as the earliest of death, clinical progression, cessation of study treatment, or clinically important worsening from baseline scores in pertinent quality of life subscales). The early impairments due to side effects were insufficient to outweigh the benefits in terms of delay in clinical progression or improved survival. This is important: we need to understand the effects on our patients of introducing treatments earlier (and possibly for much longer) in their treatment course. This work gives us confidence that we are having positive impact in areas important to patient well-being and beyond the main trial endpoints of survival or progression. We are here to improve things for our patients and their families: that’s in our mission, and here is level 1 evidence that we are doing it. There has been widespread uptake of the information out of ENZAMET. People were obviously interested in the main findings, but I think many were surprised that we did not find an overall survival benefit by adding docetaxel to the mix. That’s not to say there isn’t one: we just didn’t detect it at this interim analysis, and there is a benefit in
secondary endpoints such as PSA or clinical progression, so the possibility exists that we might see something in the future. However, one important message from ENZAMET did get out and we think this will alter practice: clinicians in places like the USA that have access to multiple agents should not assume that if A is good, and B is good, then A+B = even better. “It seemed like a good idea” is not good enough for our patients when we have evidence of this quality to suggest otherwise. Hot off the press - this week the US FDA approved the use of enzalutamide for men with metastatic hormonesensitive prostate cancer (mHSPC). And although this is not yet approved in Australia, it’s a great step forward and another option for men in the US with mHSPC. There is far more to come for ENZAMET. We plan to report longer term outcomes, especially for that group of patients who did well on both arms and so were not included in the interim analysis. We want to look further at the effects of the combination with docetaxel. We are planning detailed translational studies, and health economic studies, and no doubt many more riches will fall into our hands from this work.
2. Other current studies: Look around you at the ANZUP portfolio: it is booming! Since the last UPdate we have completed recruitment to UNISoN, TheraP and Pain Free TrusB. Three very important trials that may well change practice in the future. I won’t go into them all (you will read more inside this newsletter), but here’s a taste of what else is on offer: • U NICAB: an opportunity to use cabozantinib for non-clear-cell renal cell carcinoma patients who have received prior immunotherapy (mostly patients previously on UNISoN) – now open. • P hase 3 BEP: an international study that has just ticked over 100 patients recruited. ANZUP UPdate Summer 2019 | 3
