Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer
Mené sur des patientes atteintes d'un cancer du sein triple négatif de stade métastatique surexprimant PD-L1, cet essai de phase III évalue l'intérêt, du point de vue des symptômes et de la qualité de vie déclarée par les patientes, de l'ajout de l'atézolizumab au nab-paclitaxel en traitement de première ligne
Background : Metastatic triple-negative breast cancer (mTNBC) is incurable. A key treatment goal is providing palliation while maintaining patients’ health-related quality of life (HRQoL). IMpassion130 demonstrated progression-free survival benefit with atezolizumab+nab-paclitaxel (A+nP) versus placebo+nab-paclitaxel (Pl+nP) in first-line treatment of patients with mTNBC with PD-L1+ tumors. We report patient-reported outcomes (PROs) data, which capture patient perspectives of treatment. Patients and methods : Patients with untreated advanced or mTNBC received atezolizumab 840 mg or placebo q2w in combination with nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 of each 28-day cycle until progression or intolerance. Patients completed the EORTC QLC-C30 and QLQ-BR23 on day 1 of each cycle, at end of treatment, and q4w during 1 year of follow-up. Time-to-deterioration (TTD) in HRQoL (first ≥ 10-point decrease from baseline lasting 2 cycles) was a secondary endpoint. Exploratory endpoints included TTD in functioning and mean and mean change from baseline scores in HRQoL, functioning, and disease- and treatment-related symptoms. Results : Baseline completion of PROs was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained >80% through cycle 20 in intent-to-treat (ITT) and PD-L1+ patients. No differences between arms in median TTD in PD-L1+ patients were observed for HRQoL (HR, 0.94 [95% CI, 0.69-1.28]) or physical (HR, 1.02 [95% CI, 0.76-1.37]) or role (HR, 0.77 [95% CI, 0.57-1.04]) functioning. Mean baseline scores for A+nP vs Pl+nP for HRQoL (67.5 vs 65.0) and physical (82.8 vs 79.4) and role (73.7 vs 71.7) functioning were comparable between arms and throughout the course of treatment, with no clinically meaningful (≥10-point) changes from baseline until patients discontinued treatment. No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, nausea/vomiting) were observed between arms. Results in ITT patients were similar. Conclusions : A+nP as first-line treatment for mTNBC delayed progression without compromising patients’ day-to-day functioning or HRQoL or worsening treatment symptoms.