Abstract
PurposeAfrican Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T.Patients and methodsOS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan–Meier and Cox proportional hazard methodologies.ResultsMedian follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68–0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57–0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37–0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48–0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races.ConclusionIn this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.
Highlights
These authors were joint lead authors and contributed as such: Oliver Sartor, Andrew J
The objectives of the analyses presented here are to explore the observations of a difference in survival outcomes between races given the identification of race as an important factor in the multivariate analysis model presented in the primary paper [4], which further describes the outcomes related to the prespecified study objectives of quantifying both the risk of cerebrovascular event (CVE) and survival in all subjects
Most patients were treated in oncology practices (1248, 66%), while 654 (34%) patients were treated in urology practices
Summary
The objectives of the analyses presented here are to explore the observations of a difference in survival outcomes between races given the identification of race as an important factor in the multivariate analysis model presented in the primary paper [4], which further describes the outcomes related to the prespecified study objectives of quantifying both the risk of CVEs and survival in all subjects. OS was measured from the first sipuleucel-T infusion until date of death as reported by site investigator. Patients were followed for ≥3 years, until death or study withdrawal, or study close. In the few cases where death could not be ascertained, the patient was censored at the date of the last site contact. The study explored efficacy in terms of race. As part of an exploratory objective, the number and types of Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the
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