Outcome of male patients and black patients enrolled in S0221, an intergroup chemotherapy study.
1016 Background: Assessment of the outcome of minority populations within clinical trials may give insight into important tumor and host factors relevant to those populations. Methods: S0221 is a phase III trial of various dose-schedules of doxorubicin, cyclophosphamide and paclitaxel. S0221 allowed enrollment of male patients, and was sufficiently large to enroll significant numbers of minority populations. Here, we report the outcome of male patients and patients of black race. Results: Among 3236 total patients entered on S0221, 23 (0.7%) were male and 378 (12%) were of self-reported black race. Non-significant differences in male/female patients were seen in HER2 positivity (9%/19%), hormone receptor (HR) positivity (100%/66%), lymph node negativity (17%/26%), and treatment completion rate (70%/74%), but men were more often ≥60 years old (48%/21%, p=0.006). Males had significantly worse disease-free survival (DFS), with 5-year DFS 49%/82%; HR=3.16, Log-Rank p=0.0003. Male sex remained an adverse facto...