Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials

作者：Massari Francesco; Modena Alessandra; Ciccarese Chiara; Pilotto Sara; Maines Francesca; Bracarda Sergio; Sperduti Isabella; Giannarelli Diana; Carlini Paolo; Santini Daniele; Tortora Giampaolo; Porta Camillo; Bria Emilio

来源：Critical Reviews in Oncology/Hematology, 2016, 98: 254-263.

DOI：10.1016/j.critrevonc.2015.11.009

• Prostate cancer
• Chemotherapy
• Hormonal therapy
• Immunotherapy
• Overall survival

We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy.

• 出版日期2016-2