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

被引：10

作者：

Reck, Martin ^{[1
]}

Ciuleanu, Tudor-Eliade ^{[2
,3
]}

Cobo, Manuel ^{[4
]}

Schenker, Michael ^{[5
]}

Zurawski, Bogdan ^{[6
]}

Menezes, Juliana ^{[7
]}

Richardet, Eduardo ^{[8
]}

Bennouna, Jaafar ^{[9
,10
]}

Felip, Enriqueta ^{[11
]}

Juan-Vidal, Oscar ^{[12
]}

Alexandru, Aurelia ^{[13
]}

Cheng, Ying ^{[14
]}

Sakai, Hiroshi ^{[15
]}

Paz-Ares, Luis ^{[16
,17
]}

Lu, Shun ^{[18
]}

John, Thomas ^{[19
]}

Sun, Xiaowu ^{[20
]}

Moisei, Aniela ^{[20
]}

Taylor, Fiona ^{[20
]}

Lawrance, Rachael ^{[21
]}

Zhang, Xiaoqing ^{[22
]}

Sylvester, Judi ^{[22
]}

Yuan, Yong ^{[22
]}

Blum, Steven I. ^{[22
]}

Penrod, John R. ^{[22
]}

Carbone, David P. ^{[23
]}

机构：

[1] German Ctr Lung Res, Airway Res Ctr North, Dept Thorac Oncol, LungClin, Wohrendamm 80, D-22927 Grosshansdorf, Germany

[2] Inst Oncol Prof Dr Ion Chiricuta, Dept Oncol, Cluj Napoca, Romania

[3] UMF Iuliu Hatieganu, Cluj Napoca, Romania

[4] Hosp Univ Reg & Virgen de la Victoria, Dept Med Oncol, Unidad Gest Clin Interctr Oncol Med, IBIMA, Malaga, Spain

[5] SF Nectarie Oncol Ctr, Dept Oncol, Craiova, Romania

[6] Ambulatorium Chemioterapii, Dept Clin Oncol, Bydgoszcz, Poland

[7] Hosp Nossa Senhora da Conceicao, Dept Oncol, Porto Alegre, Brazil

[8] Inst Oncol Cordoba, Dept Clin Oncol, Cordoba, Argentina

[9] Univ Hosp Nantes, Dept Thorac Oncol, Nantes, France

[10] INSERM, CRCINA, Nantes, France

[11] Vall dHebron Univ Hosp, Vall dHebron Inst Oncol, Dept Med Oncol, Barcelona, Spain

[12] Hosp Univ La Fe, Dept Med Oncol, Valencia, Spain

[13] Inst Oncol Prof Dr Alexandru Trestioreanu Bucha, Dept Oncol, Bucharest, Romania

[14] Jilin Canc Hosp, Dept Med Oncol, Changchun, Peoples R China

[15] Saitama Canc Ctr, Dept Thorac Oncol, Saitama, Japan

[16] Univ Complutense, Hosp Univ 12 Octubre, Dept Med Oncol, CNIO H12o Lung Canc Clin Res Unit, Madrid, Spain

[17] CiberOnc, Madrid, Spain

[18] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China

[19] Austin Hosp, Dept Med Oncol, Heidelberg, Australia

[20] Adelphi Values, Boston, MA USA

[21] Adelphi Values, Grimshaw Ln, Bollington, Cheshire, England

[22] Bristol Myers Squibb, Princeton, NJ USA

[23] Ohio State Univ, Dept Med Oncol, Comprehens Canc Ctr, Columbus, OH USA

来源：

EUROPEAN JOURNAL OF CANCER | 2023年 / 183卷

关键词：

CTLA-4; inhibitor; Immunotherapy; Patient-reported outcomes; Health-related quality of life; Immune-checkpoint inhibitors; Non-small cell lung cancer; Programmed death (PD)-1 inhibitor; Symptom burden; QUALITY-OF-LIFE; OPEN-LABEL; CLINICAL-TRIALS; NSCLC; MULTICENTER; PEMBROLIZUMAB; PLATINUM;

D O I：

10.1016/j.ejca.2023.01.015

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: In CheckMate 9LA (NCT03215706), first-line nivolumab plus ipili-mumab with chemotherapy (2 cycles) significantly improved overall survival versus chemo-therapy (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 Z 719) randomised 1:1 to nivolumab plus ipilimumab with chemo-therapy 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 mea-sures. 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 chemo-therapy (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 pa-tients with metastatic non-small cell lung cancer.Clinical trial registration: ClinicalTrials.gov Identifier, NCT03215706.2023 Published by Elsevier Ltd.

引用

页码：174 / 187

页数：14

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