S Halabi1, S Dutta2, C M Tangen3, M Rosenthal4, D P Petrylak5, I M Thompson6, K N Chi7, J S De Bono8, J C Araujo9, C Logothetis9, M A Eisenberger10, D I Quinn11, K Fizazi12, M J Morris13, C S Higano14, I F Tannock15, E J Small16, W K Kelly17. 1. Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu. 2. Old Dominion University, Norfolk, USA. 3. Fred Hutchinson Cancer Research Center, Seattle, USA. 4. The Royal Melbourne Hospital, Parkville, Australia. 5. Yale School of Medicine, New Haven, USA. 6. Christus San Rosa Hospital Medical Center, San Antonio, USA. 7. British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada. 8. The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK. 9. The University of Texas MD Anderson Cancer Center, Houston, USA. 10. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA. 11. University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA. 12. Gustave Roussy, Villejuif, France. 13. Memorial Sloan Kettering Cancer Center, New York, USA. 14. University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA. 15. Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada. 16. University of California, San Francisco, San Francisco, USA. 17. Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.
Abstract
BACKGROUND: We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen. PATIENTS AND METHODS: Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors. RESULTS: Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively. CONCLUSIONS: We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.
BACKGROUND: We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen. PATIENTS AND METHODS: Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors. RESULTS: Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively. CONCLUSIONS: We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.
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