Duke University Medical Center, Durham, NC
Susan Halabi , Sandipan Dutta , Catherine M. Tangen , Mark Rosenthal , Daniel Peter Petrylak , Ian Murchie Thompson Jr., Kim N. Chi , Johann S. De Bono , Abderrahim Fandi , John C. Araujo , Mario A. Eisenberger , Christopher Logothetis , David I. Quinn , Karim Fizazi , Celestia S. Higano , Daniel J. George , Michael J. Morris , Eric Jay Small , Ian Tannock , William Kevin Kelly
Background: Reports have suggested that African-American (AA) men with metastatic castration-resistant prostate cancer (mCRPC) have shorter overall survival (OS) than Caucasian (C) men. Prior reports have been limited by small sample size. The primary goal of this analysis was to compare OS in AA men to Caucasian men treated with docetaxel/prednisone or a docetaxel/prednisone containing regimen. Methods: Individual patient data from 8,871 mCRPC men randomized on nine phase III trials to docetaxel/prednisone (DP) or a DP containing regimen were combined. Race used in the analysis was based on self-report. The primary endpoint is OS, defined as the time between randomization and death or date of last follow-up if patients were alive. The proportional hazards model was used to assess the prognostic importance of race (AA vs. C) adjusting for established risk factors that were common across the trials (age, PSA, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). Results: Of 8,871 patients, 7,528 (85%) were C, 500 (6%) were AA, 424 were Asian (5%) and 419 (4%) had race unspecified. The last two groups were deleted from the analysis leaving 8,452 pts. Median age was 69 years and 94% had performance status 0-1. Median hemoglobin, PSA and alkaline phosphatase were 12.9 g/dL, 86 ng/mL and 139 U/L, respectively. Pattern of metastatic spread were: 72% bone disease with or without lymph nodes, 9% lung disease, 9% liver disease and 7% lymph nodes only. Median OS were 21.0 (95% CI = 19.4-22.5) vs. 21.2 months (95% CI = 20.8-21.7) in AAs and C, respectively. In multivariable analysis adjusting for established risk factors, the pooled hazard ratio (HR) for AAs vs. Caucasians was 0.81 (95% CI = 0.72-0.92, p-value = 0.001) in all patients. Similar results were observed in 4,172 of patients who were treated with DP. Conclusions: We observed a statistically significant increased OS in AA vs. C men with mCRPC who were eligible to be enrolled on these clinical trials. Further understanding the biological variation by race in men with mCRPC treated with DP is warranted.
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