Susan Halabi1, Sandipan Dutta1, Catherine M Tangen2, Mark Rosenthal3, Daniel P Petrylak4, Ian M Thompson5, Kim N Chi6, John C Araujo7, Christopher Logothetis7, David I Quinn8, Karim Fizazi9, Michael J Morris10, Mario A Eisenberger11, Daniel J George1, Johann S De Bono12, Celestia S Higano2, Ian F Tannock13, Eric J Small14, William Kevin Kelly15. 1. 1 Duke University Medical Center, Durham, NC. 2. 2 Fred Hutchinson Cancer Research Center, Seattle, WA. 3. 3 The Royal Melbourne Hospital, Parkville, VIC, Australia. 4. 4 Yale University School of Medicine, New Haven, CT. 5. 5 UT Health Science Center, San Antonio, TX. 6. 6 BC Cancer Agency Vancouver Centre, Vancouver, BC. 7. 7 The University of Texas MD Anderson Cancer Center, Houston, TX. 8. 8 University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA. 9. 9 Gustave Roussy, Villejuif, France. 10. 10 Memorial Sloan Kettering Cancer Center, New York, NY. 11. 11 The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD. 12. 12 The Institute of Cancer Research and The Royal Marsden National Health Service Foundation Trust, Sutton, United Kingdom. 13. 13 Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada. 14. 14 University of California San Francisco, San Francisco, CA. 15. 15 Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA.
Abstract
PURPOSE: Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen. METHODS: Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined. Race was based on self-report. The primary end point was OS. The Cox proportional hazards regression model was used to assess the prognostic importance of race (black v white) adjusted for established risk factors common across the trials (age, prostate-specific antigen, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). RESULTS:Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race. Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men. Despite these differences, the median OS was 21.0 months (95% CI, 19.4 to 22.5 months) versus 21.2 months (95% CI, 20.8 to 21.7 months) in black and white men, respectively. The pooled multivariable hazard ratio of 0.81 (95% CI, 0.72 to 0.91) demonstrates that overall, black men have a statistically significant decreased risk of death compared with white men ( P < .001). CONCLUSION: When adjusted for known prognostic factors, we observed a statistically significant increased OS in black versus white men with mCRPC who were enrolled in these clinical trials. The mechanism for these differences is not known.
RCT Entities:
PURPOSE: Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen. METHODS: Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined. Race was based on self-report. The primary end point was OS. The Cox proportional hazards regression model was used to assess the prognostic importance of race (black v white) adjusted for established risk factors common across the trials (age, prostate-specific antigen, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). RESULTS: Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race. Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men. Despite these differences, the median OS was 21.0 months (95% CI, 19.4 to 22.5 months) versus 21.2 months (95% CI, 20.8 to 21.7 months) in black and white men, respectively. The pooled multivariable hazard ratio of 0.81 (95% CI, 0.72 to 0.91) demonstrates that overall, black men have a statistically significant decreased risk of death compared with white men ( P < .001). CONCLUSION: When adjusted for known prognostic factors, we observed a statistically significant increased OS in black versus white men with mCRPC who were enrolled in these clinical trials. The mechanism for these differences is not known.
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