PMID- 36871487 OWN - NLM STAT- MEDLINE DCOM- 20230320 LR - 20230325 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 183 DP - 2023 Apr TI - 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. PG - 174-187 LID - S0959-8049(23)00036-9 [pii] LID - 10.1016/j.ejca.2023.01.015 [doi] AB - 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 and no known sensitising epidermal growth factor receptor/anaplastic lymphoma kinase alterations. We present exploratory patient-reported outcomes (PROs; minimum follow-up, 2 years). METHODS: In patients (N = 719) randomised 1:1 to nivolumab plus ipilimumab with chemotherapy or chemotherapy alone, disease-related symptom burden and health-related quality of life 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 analogue scale (VAS) and utility index (UI) over time were analysed descriptively and using mixed-effect model repeated measures. 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 were not met. Mixed-effect model repeated measures 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 minimally important differences were not met. Nivolumab plus ipilimumab with chemotherapy delayed time-to-definitive-deterioration versus chemotherapy (LCSS ASBI: hazard ratio, 0.62 [95% confidence interval, 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 health-related quality of life versus chemotherapy and maintained QoL in patients with metastatic non-small cell lung cancer. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT03215706. CI - Copyright (c) 2023 The Authors. Published by Elsevier Ltd.. 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LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230128 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 31YO63LBSN (Nivolumab) RN - 0 (Ipilimumab) SB - IM MH - Humans MH - Nivolumab/adverse effects MH - *Carcinoma, Non-Small-Cell Lung/drug therapy/pathology MH - Ipilimumab/adverse effects MH - Quality of Life MH - *Lung Neoplasms/pathology MH - Patient Reported Outcome Measures MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects OTO - NOTNLM OT - CTLA-4 inhibitor OT - Health-related quality of life OT - Immune-checkpoint inhibitors OT - Immunotherapy OT - Non-small cell lung cancer OT - Patient-reported outcomes OT - Programmed death (PD)-1 inhibitor OT - Symptom burden EDAT- 2023/03/06 06:00 MHDA- 2023/03/21 06:00 CRDT- 2023/03/05 18:18 PHST- 2022/10/25 00:00 [received] PHST- 2023/01/10 00:00 [revised] PHST- 2023/01/14 00:00 [accepted] PHST- 2023/03/06 06:00 [pubmed] PHST- 2023/03/21 06:00 [medline] PHST- 2023/03/05 18:18 [entrez] AID - S0959-8049(23)00036-9 [pii] AID - 10.1016/j.ejca.2023.01.015 [doi] PST - ppublish SO - Eur J Cancer. 2023 Apr;183:174-187. doi: 10.1016/j.ejca.2023.01.015. Epub 2023 Jan 28.