Impact of Pembrolizumab Versus Chemotherapy on Health-Related Quality of Life in Patients With Metastatic Triple-Negative Breast Cancer: Results From the Phase 3 Randomized KEYNOTE-119 Study

Mené sur 187 patientes atteintes d'un cancer du sein triple négatif de stade métastatique, cet essai de phase III compare l'intérêt, du point de vue de la qualité de vie, du pembrolizumab et d'une chimiothérapie en fonction de l'expression tumorale de PD-L1

Résumé en anglais

Background: In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary endpoint) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumor PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119.

Methods: Eligible patients were randomized 1:1 to pembrolizumab 200 mg Q3W intravenously for up to 35 cycles or treatment of physician’s choice per local/country guidelines. Prespecified exploratory endpoints were change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterize utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline.

Results: HRQoL analyses included 187 patients with tumor PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, −1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 vs 1.7 months), QLQ-C30 nausea/vomiting (7.7 vs 4.8 months), and QLQ-BR23 systemic therapy side effects (6.1 vs 3.4 months). Minimal treatment differences were observed for other HRQoL endpoints.

Conclusion: HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumor PD-L1 CPS ≥10.