Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Aug 1;6(8):e2326546.
doi: 10.1001/jamanetworkopen.2023.26546.

Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial

Nicolas Sayegh  1 , Umang Swami  1 , Yeonjung Jo  1 , Georges Gebrael  1 , Benjamin Haaland  1 , Shilpa Gupta  2 , Melissa Plets  3 , Maha H A Hussain  4 , David I Quinn  5 , Primo N Lara Jr  6 , Ian M Thompson Jr  7 , Neeraj Agarwal  1
Affiliations
Clinical Trial

Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial

Nicolas Sayegh et al. JAMA Netw Open. .

Abstract

Importance: Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compared with White patients, possibly because of equitable access to care available in a clinical trial setting.

Objective: To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.

Design, setting, and participants: This secondary analysis of patient-level data of a prospective phase 3 randomized clinical trial included patients with newly diagnosed mCSPC enrolled between March 1, 2013, and July 15, 2017. Analysis was conducted between December 2022 and February 2023.

Interventions: Patients receiving androgen deprivation therapy were randomized (1:1) to receive either orteronel 300 mg orally twice daily (experimental group) or bicalutamide 50 mg orally daily (control group).

Main outcomes and measures: OS, with progression-free survival (PFS) as a secondary end point.

Results: Among 1313 participants, 135 (10%) identified as Black and 1077 (82%) as White, with an equal racial distribution between groups. Black patients were younger (median [IQR] age, 65.8 [60-70] vs 68.4 [62.5-74.1] years; P = .001) and had a higher median (IQR) baseline prostate-specific antigen response rate than White patients (54.7 [19.8-222.0] vs 26.7 [9.2-96.0] ng/mL; P < .001). At a median follow-up of 4.9 years, Black and White patients had similar median PFS (2.3 years; 95% CI, 1.8-1.4 years vs 2.9 years; 95% CI, 2.5-3.3 years; P = .71) and OS (5.5 years; 95% CI, 4.8-NR vs 6.3 years; 95% CI, 5.7-NR; P = .65). The multivariable analysis confirmed similar PFS and OS after adjusting for known prognostic factors. No interaction between race and treatment was observed.

Conclusions and relevance: In this secondary analysis of a randomized clinical trial studying androgen deprivation therapy with first- or second-generation androgen receptor pathway inhibitors, both Black and White patients demonstrated similar OS and PFS. Equitable access to care may reduce historical differences in outcomes between Black and White patients with advanced prostate cancer.

Trial registration: ClinicalTrials.gov Identifier: NCT01809691.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Swami reported receiving consulting fees from Astellas, Exelixis, Seattle Genetics, Imvax, Sanofi, AstraZeneca, and Gilead; he reported receiving grants from Janssen, Exelixis, and Astellas/Seattle Genetics outside the submitted work. Dr Haaland reported full-time employment with Pentara Corporation and consulting fees from National Kidney Foundation Consulting outside the submitted work. Dr Gupta reported receiving consulting fees from Janssen, and consulting fees and grants from Pfizer outside the submitted work. Dr Hussain reported support from Northwestern University for the clinical trial during the conduct of the study. Dr Quinn reported employment with AbbVie outside the submitted work. Dr Agarwal reported receiving grants from Takeda during the conduct of the study; he reported receiving consulting fees from Astellas, Astra Zeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics, and Seattle Genetics. No other disclosures were reported.

Figures

Figure.
Figure.. Kaplan-Meier Estimates of Overall Survival (OS) and Progression-Free Survival (PFS) by Race in the Overall Population
Dashed lines indicate median time participants experienced OS (panel A) or PFS (panel B).
See this image and copyright information in PMC

References

    1. Lillard JW Jr, Moses KA, Mahal BA, George DJ. Racial disparities in Black men with prostate cancer: a literature review. Cancer. 2022;128(21):3787-3795. doi:10.1002/cncr.34433 - DOI - PMC - PubMed
    1. George DJ, Halabi S, Heath EI, et al. . A prospective trial of abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer. Cancer. 2021;127(16):2954-2965. doi:10.1002/cncr.33589 - DOI - PMC - PubMed
    1. Agarwal N, Tangen CM, Hussain MHA, et al. . Orteronel for metastatic hormone-sensitive prostate cancer: a multicenter, randomized, open-label phase III trial (SWOG-1216). J Clin Oncol. 2022;40(28):3301-3309. doi:10.1200/JCO.21.02517 - DOI - PMC - PubMed
    1. Marar M, Long Q, Mamtani R, Narayan V, Vapiwala N, Parikh RB. Outcomes among African American and non-Hispanic White men with metastatic castration-resistant prostate cancer with first-line abiraterone. JAMA Netw Open. 2022;5(1):e2142093. doi:10.1001/jamanetworkopen.2021.42093 - DOI - PMC - PubMed
    1. Smith KER, Brown JT, Wan L, et al. . Clinical outcomes and racial disparities in metastatic hormone-sensitive prostate cancer in the era of novel treatment options. Oncologist. 2021;26(11):956-964. doi:10.1002/onco.13848 - DOI - PMC - PubMed

Publication types

Associated data