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

Francesco Massari, Alessandra Modena, Chiara Ciccarese, Sara Pilotto, Francesca Maines, S. Bracarda, Isabella Sperduti, Diana Giannarelli, Paolo Carlini, Daniele Santini, G. Tortora, Camillo Porta, Emilio Bria

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)254-263
Number of pages10
JournalCritical Reviews in Oncology/Hematology
Volume98
DOIs
Publication statusPublished - Feb 1 2016

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Geriatrics and Gerontology

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