Patient-reported outcomes in patients with metastatic non-squamous non-small cell lung cancer from the randomized Phase II PERLA trial comparing first-line chemotherapy plus dostarlimab or pembrolizumab
Mené sur des patients atteints d'un cancer du poumon non à petites cellules non épidermoïde de stade métastatique, cet essai de phase II compare l'intérêt, du point de vue de la préservation de la qualité de vie, du dostarlimab et du pembrolizumab en combinaison avec une chimiothérapie de première ligne
Background: PERLA (NCT04581824) compared efficacy and safety of dostarlimab (DCT) or pembrolizumab (PCT) plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer. Here, we report patient-reported outcomes (PROs; exploratory analysis) from PERLA. Methods: Patients were randomized 1:1 to receive DCT or PCT every 3 weeks (Q3W) for ≤35 cycles [C]. PROs (EORTC QLQ-C30 and QLQ-LC13, PRO-CTCAE, FACT-GP5) were collected at baseline, Q3W until C4, Q9W until C16, Q12W until end of treatment and at 30-day safety follow-up. Change from baseline and time to deterioration (TTD) in QLQ-C30 and QLQ-LC13 were analyzed using longitudinal mixed models and Kaplan–Meier estimators, respectively. Results: The PRO (DCT/PCT) datasets included 102/99 patients for QLQ-C30, 96/90 for QLQ-LC13, 96/88 for PRO-CTCAE, and 95/87 for FACT-GP5. Completion rates were >80% to C4, then decreased in both arms. For QLQ-C30 and QLQ-LC13, most patients reported stable/improved responses at C13 (~9 months on treatment), with similar responses between arms except more patients reported improvements in dyspnea (QLQ-C30: 36.4% vs 13.0%; QLQ-LC13: 40.6% vs 25.0%) and chest pain (QLQ-LC13: 34.4% vs 10.0%) with DCT versus PCT. TTD per QLQ-C30 and QLQ-LC13 were similar between arms, although TTD in dyspnea was longer with DCT versus PCT (QLQ-LC13: 4.24 vs 1.54 months; p=0.0168). Most patients in both arms reported that adverse events occurred occasionally/rarely/never with moderate/mild severity. Overall, patients reported little/no bother from treatment side effects. Conclusions: DCT maintained health-related quality of life similarly to PCT and was well tolerated, supporting the PERLA primary results and dostarlimab use in future regimens.