First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes
Mené sur 719 patients atteints d'un cancer du poumon non à petites cellules de stade métastatique (durée minimale de suivi : 2 ans), cet essai randomisé évalue l'intérêt, du point de vue des symptômes et de la qualité de vie déclarés par les patients, d'une chimiothérapie de première ligne dispensée seule ou en combinaison avec le nivolumab et l'ipilimumab
Background: In CheckMate 9LA (NCT03215706), first-line nivolumab plus ipilimumab with chemotherapy (2 cycles) significantly improved overall survival versus chemotherapy (4 cycles) in patients with metastatic non-small cell lung cancer (mNSCLC) and no known sensitizing EGFR/ALK alterations. We present exploratory patient-reported outcomes (PROs; minimum follow-up, 2 years). Methods: In patients (N = 719) randomized 1:1 to nivolumab plus ipilimumab with chemotherapy or chemotherapy alone, disease-related symptom burden and health-related quality of life (HRQoL) were assessed using the Lung Cancer Symptom Scale (LCSS) and 3-level EQ-5D (EQ-5D-3L). Treatment-phase changes in LCSS average symptom burden index (ASBI), LCSS three-item global index (3-IGI), and EQ-5D-3L visual analog scale (VAS) and utility index (UI) over time were analyzed descriptively and using mixed-effect model repeated measures (MMRM). Time-to-deterioration/improvement analyses were conducted. Results: Treatment-phase PRO questionnaire completion rates were >80%. Mean treatment-phase changes showed no deterioration from baseline in both arms for LCSS ASBI/3-IGI and EQ-5D-3L VAS/UI; however, minimally important differences (MIDs) were not met. MMRM analyses showed overall reduction in symptom burden from baseline for both arms; changes from baseline for LCSS 3-IGI and EQ-5D-3L VAS/UI were numerically improved with nivolumab plus ipilimumab with chemotherapy versus chemotherapy, but MIDs were not met. Nivolumab plus ipilimumab with chemotherapy delayed time-to-definitive-deterioration versus chemotherapy (LCSS ASBI: HR, 0.62 [95% CI, 0.45−0.87]); results were similar across PRO measures. Conclusions: At 2-year minimum follow-up, first-line nivolumab plus ipilimumab with chemotherapy reduced the risk of definitive deterioration in disease-related symptom burden and HRQoL versus chemotherapy and maintained QoL in patients with mNSCLC.