Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer

• Published in: European journal of cancer (1990) 2023-01, Vol.178, p.23-33
• Main Authors: Loibl, Sibylle, Loirat, Delphine, Tolaney, Sara M., Punie, Kevin, Oliveira, Mafalda, Rugo, Hope S., Bardia, Aditya, Hurvitz, Sara A., Brufsky, Adam M., Kalinsky, Kevin, Cortés, Javier, O'Shaughnessy, Joyce A., Dieras, Véronique, Carey, Lisa A., Gianni, Luca, Gharaibeh, Mahdi, Preger, Luciana, Phan, See, Chang, Lawrence, Shi, Ling, Piccart, Martine J.
• Format: Article
• Language: English
• Subjects: Adult; Antibodies; Antibody–drug conjugate; Breast cancer; Chemotherapy; Clinical trial; Diarrhea; EORTC QLQ-C30; Fatigue; Fatigue - drug therapy; Gemcitabine; Global health; Health services; Humans; Immunoconjugates - adverse effects; Metastases; Metastasis; Monoclonal antibodies; Pain; Pain - drug therapy; Patients; Phase III; Public health; Quality of Life; Sacituzumab govitecan; Survival; Targeted cancer therapy; Triple Negative Breast Neoplasms - drug therapy; Triple-negative breast neoplasms; Vinorelbine; Vomiting
• ISSN: 0959-8049; 1879-0852; 1879-0852
• DOI: 10.1016/j.ejca.2022.10.003

The antibody–drug conjugate sacituzumab govitecan (SG) prolongs progression-free survival and overall survival in patients with refractory/relapsed metastatic triple-negative breast cancer (mTNBC). Here, we investigated its effect on health-related quality of life (HRQoL). This analysis was based on the open-label phase III ASCENT trial (NCT02574455). Adults with refractory/relapsed mTNBC who had received ≥2 prior systemic therapies (≥1 in the metastatic setting) were randomised 1:1 to SG or treatment of physician's choice (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine). HRQoL was assessed on day 1 of each treatment cycle using the EORTC QLQ-C30. Score changes from baseline were analysed using linear mixed-effect models for repeated measures. Stratified Cox regressions evaluated time to first clinically meaningful change of HRQoL. The analysis population comprised 236 patients randomised to SG and 183 to TPC. For global health status (GHS)/QoL, physical functioning, fatigue, and pain, changes from baseline were superior for SG versus TPC. Compared with TPC, SG was inferior regarding changes from baseline for nausea/vomiting and diarrhoea but non-inferior for other QLQ-C30 domains. Median time to first clinically meaningful worsening was longer for SG than for TPC for physical functioning (22.1 versus 12.1 weeks, P