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- W2271874013 abstract "4551 Background: Sipuleucel-T is an investigational autologous active cellular immunotherapy for the treatment of metastatic castration resistant prostate cancer (CRPC). Reported here is an integrated analysis of the effect of post-randomization docetaxel use on overall survival (OS) and the observed sipuleucel-T survival effect. Methods: OS for 3 randomized, double blind, placebo controlled trials in metastatic CRPC was analyzed using a Cox regression model with treatment, adjusted for baseline PSA and LDH, and stratified by study. Docetaxel use was examined as a dichotomous and a time dependent covariate. Results: The integrated analysis included 737 randomized patients (488 sipuleucel-T: 249 placebo) with median follow-up of 36 months. Sipuleucel-T treatment was associated with a 26.5% reduction in risk of death (HR=0.735, 95% CI:0.613, 0.882, P<0.001). Post-randomization docetaxel use was reported in 363 patients (49%); observed median time to use was 8.4 months. A sipuleucel-T effect was observed in patients with subsequent docetaxel use (HR=0.825, 95% CI:0.619, 1.101) and in patients without (HR=0.693, 95% CI:0.545, 0.880). The sipuleucel-T effect was also significant in an analysis in which patients were censored at the time of docetaxel use (HR=0.714, 95% CI:0.562, 0.908, P=0.006). At baseline, patients who subsequently received docetaxel tended to be younger with greater predicted survival (Halabi 2003), and had lower alkaline phosphatase, fewer bone metastases, greater use of bisphosphonates, and less prior docetaxel use. Patients with subsequent docetaxel use had better OS compared to those without, but when entered as a time-dependent covariate, docetaxel use was not a significant predictor of OS (HR=0.941, P=0.54), and the sipuleucel- T effect remained significant (HR=0.736, 95% CI:0.613, 0.883, P<0.001). Conclusions: A sipuleucel-T treatment effect was observed both in patients who did and did not receive subsequent docetaxel. The overall sipuleucel-T treatment effect remained robust when adjusting for docetaxel use. There was no evidence to suggest that subsequent docetaxel use explains the observed sipuleucel-T effect. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Dendreon Dendreon Dendreon Dendreon" @default.
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- W2271874013 date "2010-05-20" @default.
- W2271874013 modified "2023-10-14" @default.
- W2271874013 title "Persistence of immunotherapy survival effects of sipuleucel-T and relationship to postrandomization docetaxel use in phase III studies." @default.
- W2271874013 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.4551" @default.
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