1553O Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC)

Abstract

The antibody-drug conjugate SG comprises an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker. In the ongoing randomized TROPiCS-02 trial, SG is being evaluated vs single-agent chemotherapy treatment of physician’s choice (TPC) after CDK 4/6 inhibitor, endocrine therapy, and at least 2 chemotherapies in HR+/HER2- MBC setting. Here we assess the impact of SG on HRQoL in TROPiCS-02. Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). HRQoL was assessed at baseline (BL), day 1 of each Tx cycle (CxDx) and at end of treatment visit using the EORTC QLQ-C30. The analysis included all pts with valid HRQoL assessments at BL and ≥1 post-BL visit. Linear mixed-effect models for repeated measures were used to estimate differences in overall least-square mean changes from BL between Tx arms, using on-Tx data up to C11D1 (n ≥25 in both arms). The analysis included 446 pts (236 SG, 210 TPC; median age 56 y). The EORTC QLQ-C30 completion rate was ≥85% up to C13D1 in both Tx arms. Mean HRQoL scores at BL were generally similar for SG and TPC. The SG arm showed a trend of improvement in most HRQoL domains. A significantly greater improvement in physical functioning and dyspnea was observed for SG vs TPC and greater worsening in diarrhea (table).Table: 1553OEORTC QLQ-C30 least-square mean change from baselineSG vs TPC (95% CI)Global health status/QoL2.4 (-0.7, 5.5)FunctioningPhysical3.9 (0.9, 6.9)Role3.1 (-1.2, 7.4)Emotional0.9 (-2.4, 4.3)Cognitive-0.2 (-3.3, 2.9)Social0.8 (-3.2, 4.7)Summary Score0.6 (-1.8, 3.1)SymptomsFatigue-3.3 (-7.1, 0.5)Pain-1.6 (-5.5, 2.3)Nausea/Vomiting1.4 (-0.9, 3.8)Dyspnea-4.3 (-8.5, -0.1)Insomnia-3.7 (-8.1, 0.8)Appetite Loss-3.3 (-7.3, 0.8)Constipation-1.0 (-5.5, 3.4)Diarrhea10.4 (6.3, 14.5)Financial Difficulties0.9 (-2.5, 4.2)Positive value represents improvement for functioning and worsening for symptoms.SG, sacituzumab govitecan; TPC, treatment of physician’s choice. Open table in a new tab SG, sacituzumab govitecan; TPC, treatment of physician’s choice. Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC.