KEY TAKEAWAYS
- A Phase 3 Ascent study aimed to analyze the effect of SG, an antibody-drug conjugate, on health-related quality of life (HRQoL) in patients with refractory/relapsed mTNBC.
- 236 patients were randomized to SG and 183 to the treatment of physician’s choice (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine).
- SG was generally associated with greater global health status (GHS)/QoL improvements, physical functioning, fatigue, and pain than TPC.
- SG was inferior to TPC regarding changes from baseline for nausea/vomiting and diarrhea but non-inferior for other QLQ-C30 domains.
- The median time to first clinically meaningful worsening was longer for SG than for TPC for physical functioning, role functioning, fatigue, and pain.
Sacituzumab Govitecan (SG) is an antibody-drug conjugate that improves PFS and OS in patients with resistant or recurrent metastatic triple-negative breast cancer (mTNBC). In this study, we aimed to assess how it affects health-related quality of life (HRQoL).
The ASCENT experiment, a phase III open-label study, served as the basis for this analysis. Patients with refractory/relapsed mTNBC who had previously been treated with 2 systemic treatments (1 in the metastatic context) were randomly assigned to receive either SG or treatment of physician’s choice (at a rate of 1:1). (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine).
The EORTC QLQ-C30 was used to evaluate HRQoL on day 1 of each treatment cycle. Linear mixed-effect models for repeated assessments were used to examine scores’ differences from the study’s beginning. In addition, the time to the first clinically relevant change in HRQoL was assessed using stratified Cox regressions.
In total, there were 236 patients in the analytic population, with 183 assigned to TPC and the remaining 81 to SG. Changes from baseline were better for SG than TPC regarding GHS/QoL, physical functioning, exhaustion, and pain. Although SG was not worse than TPC across the board on the QLQ-C30, it did perform worse than TPC regarding changes from baseline for nausea/vomiting and diarrhea.
For physical functioning (SG, 22.1 vs. 12.1 weeks, P 0.001), role functioning (11.4 vs. 7.1 weeks, P< 0.001), fatigue (7.7 vs. 6.0 weeks, P <0.05), and pain (21.6 vs. 9.9 weeks, P< 0.001), the median time to first clinically relevant worsening were greater for SG. Overall, SG was connected to more substantial improvements and later deterioration of HRQoL ratings than TPC. This lends credence to SG’s potential as a therapy for mTNBC.
Source:https://pubmed.ncbi.nlm.nih.gov/36379186/
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT02574455/
Loibl, S., Loirat, D., Tolaney, S.M., Punie, K., Oliveira, M., Rugo, H.S., Bardia, A., Hurvitz, S.A., Brufsky, A.M., Kalinsky, K., Cortés, J., O’Shaughnessy, J.A., Dieras, V., Carey, L.A., Gianni, L., Gharaibeh, M., Preger, L., Phan, S., Chang, L. Piccart M, and Shi, L. (2023). Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer. European Journal of Cancer, 178, pp.23–33. doi:https://doi.org/10.1016/j.ejca.2022.10.003.
