TY - JOUR
TI - First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1
AU - Reck, M.
AU - Ciuleanu, T.-E.
AU - Lee, J.-S.
AU - Schenker, M.
AU - Audigier-Valette, C.
AU - Zurawski, B.
AU - Linardou, H.
AU - Otterson, G.A.
AU - Salman, P.
AU - Nishio, M.
AU - de la Mora Jimenez, E.
AU - Lesniewski-Kmak, K.
AU - Albert, I.
AU - Ahmed, S.
AU - Syrigos, K.
AU - Penrod, J.R.
AU - Yuan, Y.
AU - Blum, S.I.
AU - Nathan, F.E.
AU - Sun, X.
AU - Moreno-Koehler, A.
AU - Taylor, F.
AU - O'Byrne, K.J.
JO - Journal of Thoracic Oncology
PY - 2021
VL - 16
TODO - 4
SP - 665-676
PB - HANLEY & BELFUS-ELSEVIER INC
SN - 1556-0864, 1556-1380
TODO - 10.1016/j.jtho.2020.12.019
TODO - ipilimumab;  nivolumab;  platinum complex;  programmed death 1 ligand 1;  antineoplastic agent;  ipilimumab;  nivolumab;  programmed death 1 ligand 1, Article;  cancer chemotherapy;  cancer staging;  confidence interval;  controlled study;  European Quality of Life 5 Dimensions questionnaire;  hazard ratio;  health status;  human;  Lung Cancer Symptom Scale;  major clinical study;  multiple cycle treatment;  non small cell lung cancer;  overall survival;  patient-reported outcome;  protein expression;  randomized controlled trial;  respiratory tract disease assessment;  symptom;  visual analog scale;  lung tumor;  quality of life;  tumor recurrence, Antineoplastic Combined Chemotherapy Protocols;  B7-H1 Antigen;  Humans;  Ipilimumab;  Lung Neoplasms;  Neoplasm Recurrence, Local;  Nivolumab;  Patient Reported Outcome Measures;  Quality of Life
TODO - Introduction: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% or greater tumor programmed death ligand 1 expression had significantly improved overall survival with nivolumab plus ipilimumab versus chemotherapy. We present the patient-reported outcomes (PROs). Methods: Patients (N = 1189) were randomized to nivolumab plus ipilimumab, nivolumab, or chemotherapy. PROs were exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index, LCSS 3-item global index, EQ-5D visual analog scale (VAS), and EQ-5D utility index were analyzed descriptively. Mixed-effect model repeated measures and time-to-first deterioration and improvement analyses were conducted. Results: PRO completion rates were generally greater than 80%. On-treatment improvements from baseline in LCSS measures of symptom burden and global health status with nivolumab plus ipilimumab generally met or exceeded the minimal important difference (smallest clinically meaningful change) from weeks 24 and 30, respectively; improvements with chemotherapy generally remained below the minimal important difference. Mean on-treatment EQ-5D VAS scores for both treatments approached the U.K. population norm at week 24, remaining so throughout the treatment period. Mixed-effect model repeated measures analyses revealed numerically greater improvements from baseline with nivolumab plus ipilimumab versus chemotherapy across LCSS average symptom burden index and 3-item global index, and EQ-5D VAS and utility index. Nivolumab plus ipilimumab had delayed time-to-first deterioration (hazard ratio [95% confidence interval] 0.74 [0.56 to 0.98]) and a trend for more rapid time-to-first improvement (1.24 [0.98 to 1.59]) versus chemotherapy. Conclusions: Nivolumab plus ipilimumab revealed delayed deterioration and numerical improvement in symptoms and health-related quality of life versus chemotherapy in patients with advanced NSCLC and 1% or greater programmed death ligand 1 expression. © 2021 International Association for the Study of Lung Cancer
ER -