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- Title
Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial.
- Authors
Sayegh, Nicolas; Swami, Umang; Jo, Yeonjung; Gebrael, Georges; Haaland, Benjamin; Gupta, Shilpa; Plets, Melissa; Hussain, Maha H. A.; Quinn, David I.; Lara Jr, Primo N.; Thompson Jr, Ian M.; Agarwal, Neeraj
- Abstract
Key Points: Question: Do Black patients with metastatic castration-sensitive prostate cancer have worse outcomes than White patients when treated with systemic androgen deprivation therapy combined with a first- or a second-generation androgen receptor pathway inhibitor? Findings: In this secondary analysis of a randomized phase 3 clinical trial with 1313 patients with metastatic castration-sensitive prostate cancer, there was no statistically significant difference in overall survival and progression-free survival between Black and White patients. Meaning: These results suggest that providing fair and equal access to health care may reduce the disparities in treatment outcomes between Black and White patients with advanced prostate cancer. This secondary analysis of a randomized clinical trial evaluates the association of race with survival among patients with metastatic castration-sensitive prostate cancer. 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
- Subjects
PATIENT aftercare; ANTIANDROGENS; CONFIDENCE intervals; MULTIVARIATE analysis; RACE; METASTASIS; CANCER patients; DESCRIPTIVE statistics; RESEARCH funding; PROGRESSION-free survival; WHITE people; PROSTATE-specific antigen; DATA analysis software; PROSTATE tumors; AFRICAN Americans; ENZYME inhibitors; OVERALL survival; SECONDARY analysis; EVALUATION
- Publication
JAMA Network Open, 2023, Vol 6, Issue 8, pe2326546
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.26546