Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: Experience at Dana Farber and in the PROCEED Registry

Prostate Cancer & Prostatic DiseasesWei XX, Kwak L, Hamid A, et al. | February 11, 2022

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In this study, two datasets were used to analyze metastatic castration-resistant prostate cancer (mCRPC) patients managed with sipuleucel-T who did not immediately start subsequent therapy. Findings revealed delayed PSA response in a subset of patients suggesting delayed clinical activity.

  • Sipuleucel-T has shown survival advantage in phase 3 trials but is employed in few men with mCRPC partially because of low rates of PSA and objective response.

  • Among 1902 men who underwent treatment for mCRPC in PROCEED (an FDA-requested outcomes registry) and 255 patients treated consecutively with sipuleucel-T at Dana-Farber Cancer Institute (DFCI), 171 and 28 patients were included, respectively.

  • All patients exhibited increasing PSA before initiating sipuleucel-T and available post-treatment PSA measurements.

  • Clinical results of interest were: PSA 50 response rate, time to subsequent mCRPC directed therapy, and overall survival (OS).

  • In the PROCEED cohort, 19.9% demonstrated PSA 50 response at a median of 5.5 months (IQR: 3.9–9.5) since the last sipuleucel-T infusion; median time to subsequent mCRPC directed therapy and median OS were 10 months (95% CI: 9–11) and 49 months (95% CI: 43–NR), respectively.

  • In the DFCI cohort, 14.3% demonstrated PSA 50 response at a median of 6.3 months (IQR: 4.7–7.0); median time to subsequent mCRPC directed therapy and median OS were 9 months (95% CI: 9–11) and 60 months (95% CI: 51–74), respectively.

Read the full article on Prostate Cancer & Prostatic Diseases

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