Patient-reported outcomes from ASCENT-03: sacituzumab govitecan vs chemotherapy in advanced triple-negative breast cancer

BACKGROUND: In the ASCENT-03 study, first-line sacituzumab govitecan (SG) led to a statistically significant progression-free survival improvement vs chemotherapy in participants with metastatic triple-negative breast cancer (mTNBC) who were not candidates for PD-(L)1 inhibitors. We report patient-reported outcomes from ASCENT-03. METHODS: 558 participants were randomized 1:1 to SG or chemotherapy. Participants completed the EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5L, and FACT-GP5 questionnaires. Key secondary endpoints were change from baseline (CFB) at week 25 in physical functioning and time-to-first-meaningful deterioration (TTD) in fatigue. Additional exploratory analyses were performed for other EORTC QLQ-C30 domains and other questionnaires. RESULTS: Least-squares mean CFB at week 25 favored SG for physical functioning (difference, 6.89; 95% CI, 3.50-10.28); TTD in fatigue was similar between treatment groups (hazard ratio, 0.98; 95% CI, 0.80-1.19). Least-squares mean CFB also favored SG for role functioning, global health status/quality of life (QOL), fatigue, pain, and dyspnea and favored chemotherapy for diarrhea. TTD favored SG for dyspnea and chemotherapy for nausea/vomiting and diarrhea. Time-to-first-meaningful improvement favored SG for physical, role, cognitive, and social functioning; fatigue; insomnia; appetite loss; and constipation. Other patient-reported outcomes consistently favored SG. CONCLUSIONS: SG provided meaningful and sustained benefits in QOL vs chemotherapy. Although SG is associated with known increased gastrointestinal side effects, they can be managed and did not adversely affect functioning, long-term QOL, or treatment tolerability. These data complement previous efficacy results and support first-line SG as a new standard of care for patients with mTNBC who are not candidates for PD-(L)1 inhibitors.(ClinicalTrials.gov number, NCT05382299).