Martin Reck1, Tudor-Eliade Ciuleanu2, Jong-Seok Lee3, Michael Schenker4, Clarisse Audigier-Valette5, Bogdan Zurawski6, Helena Linardou7, Gregory A Otterson8, Pamela Salman9, Makoto Nishio10, Emmanuel de la Mora Jimenez11, Krysztof Lesniewski-Kmak12, István Albert13, Samreen Ahmed14, Konstantinos Syrigos15, John R Penrod16, Yong Yuan16, Steven I Blum16, Faith E Nathan16, Xiaowu Sun17, Alejandro Moreno-Koehler17, Fiona Taylor17, Kenneth John O'Byrne18. 1. LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de. 2. Institutul Oncologic Prof. Dr. Ion Chiricuta and UNF Iulia Hatieganu, Cluj-Napoca, Romania. 3. Seoul National University Bundang Hospital, Seongnam, Republic of Korea. 4. Sf Nectarie Oncology Center, Craiova, Romania. 5. Hôpital Sainte-Musse, Toulon, France. 6. Ambulatorium Chemioterapii, Bydgoszcz, Poland. 7. Metropolitan Hospital, Neo Faliro, Greece. 8. The Ohio State University, Columbus, Ohio. 9. Fundación Arturo López Pérez, Santiago, Chile. 10. The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. 11. Instituto Jalisciense De Cancerología, Guadalajara, Mexico. 12. Oddzial Onkologii I Radioterapii Szpital Morski Im. Pck, Gdynia, Poland. 13. Mátrai Gyógyintézet, Mátraháza, Hungary. 14. University Hospitals of Leicester NHS Trust, Leicester, United Kingdom. 15. Sotiria General Hospital, National and Kaposistrian University of Athens, Athens, Greece. 16. Bristol Myers Squibb, Princeton, New Jersey. 17. Adelphi Values, Boston, Massachusetts. 18. Princess Alexandra Hospital, Woolloongabba, Australia.
Abstract
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), andEQ-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-5DVAS 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.
RCT Entities:
INTRODUCTION: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% or greater tumorprogrammed 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.
Authors: Elaina J Wang; Jia-Shu Chen; Saket Jain; Ramin A Morshed; Alexander F Haddad; Sabraj Gill; Angad S Beniwal; Manish K Aghi Journal: Front Genet Date: 2021-12-17 Impact factor: 4.772