MedicalResearch.com: What are the main findings of the study?
Dr. Basch: The primary clinical finding of this study is that treatment with abiraterone acetate delays the time until pain develops or worsens in men with advanced prostate cancer. Furthermore, abiraterone delays the time until quality of life and functioning deteriorate, compared to placebo. There is also a broader research finding of this study, which is that it is feasible to rigorously study the time until symptom progression in cancer clinical trials, which paves the way for future studies to use a similar approach.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Basch: The high level of patient compliance with symptom reporting was a positive finding – even men with advanced cancer and many symptoms were willing and able to self-report. This is important because a concern sometimes raised by skeptics about this type of study is the risk of missing data. But this study, as well as multiple otter recent studies (such as the pivotal trial for ruxolitinib) show greater than 90% compliance with patient self-reporting.
As far as the clinical benefits, there was a suspicion about pain response from earlier studies and anecdotal reports, but the amount of benefit was not clear. Also, the amount of pain relief from prednisone alone in the control arm was fairly high, showing that prednisone is indeed an active comparator in this population and has pain benefits.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Basch: Understanding the impact of cancer treatments on symptoms and quality of life is essential information for making informed decisions. I would argue that any drug development program that does not rigorously measure symptoms and functioning is omitting key information about the properties of the product. This particular study provides such information about abiraterone acetate, so that men with advanced prostate cancer and their clinicians can make more informed decisions. For men who value the impact of treatment on symptoms, information from this study may be particularly informative.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Basch: Symptoms and quality of life should be measured rigorously in all phase 3 studies including patients with advanced cancers. Leaving out this type of assessment is an omission and leads to an incomplete picture of the properties of a given product under study. Treatment decisions about prostate cancer ideally will include a discussion of the impact of treatment on symptoms.
Additional methodological research is needed about how optimally to assess analgesic use, and how this should figure into the definition of pain response.
Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial
Dr Ethan Basch MD,Karen Autio MD,Charles J Ryan MD,Prof Peter Mulders MD,Neal Shore MD,Thian Kheoh PhD,Prof Karim Fizazi MD,Prof Christopher J Logothetis MD,Dana Rathkopf MD,Prof Matthew R Smith MD,Paul N Mainwaring MD,Yanni Hao PhD,Thomas Griffin MD,Susan Li PhD,Michael L Meyers MD,Arturo Molina MD,Prof Charles Cleeland PhD
The Lancet Oncology – 25 September 2013