@article{4990e452c3c64cf3a35953b43a1063ec,
title = "First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743",
abstract = "Objective: In CheckMate 743 (NCT02899299), nivolumab + ipilimumab significantly prolonged overall survival in patients with unresectable malignant pleural mesothelioma (MPM). We present patient-reported outcomes (PROs). Materials and Methods: Patients (N = 605) were randomized to nivolumab + ipilimumab or chemotherapy. Changes in disease-related symptom burden and health-related quality of life (HRQoL) were evaluated descriptively using the Lung Cancer Symptom Scale (LCSS)-Mesothelioma (Meso) average symptom burden index (ASBI), LCSS-Meso 3-item global index (3-IGI), 3-level EuroQol 5-dimensional (EQ-5D-3L) visual analog score (VAS), and EQ-5D-3L utility index. PROs were assessed at baseline and every 2 (nivolumab + ipilimumab) or 3 weeks (chemotherapy) through 12 weeks, every 6 weeks through 12 months, every 12 weeks thereafter, and at specified follow-ups. Mixed-effect model repeated measures (MMRM) and time to deterioration analyses were conducted. Results: Completion rates were generally >80%. LCSS-Meso ASBI mean changes from baseline trended to improve over time with nivolumab + ipilimumab and deteriorate with chemotherapy, but did not meet clinically important difference thresholds [±10 score change]. EQ-5D-3L VAS mean scores improved over time with nivolumab + ipilimumab; by week 60, patients had scores consistent with United Kingdom normal population values. MMRM analyses favored nivolumab + ipilimumab for all individual symptoms except cough. Nivolumab + ipilimumab delayed time to definitive deterioration in HRQoL (hazard ratio 0.52 [95% confidence interval 0.36–0.74]) and showed a trend in symptom delay versus chemotherapy. Conclusions: Nivolumab + ipilimumab decreased the risk of deterioration in disease-related symptoms and HRQoL versus chemotherapy and maintained QoL in patients with unresectable MPM.",
keywords = "Anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), EQ-5D, Immune checkpoint inhibitors, Immuno-oncology, Immunotherapy, Lung Cancer Symptom Scale, Overall survival, Programmed cell death (PD)-1 inhibitor, Quality of life, Symptom burden",
author = "Arnaud Scherpereel and Scott Antonia and Yolanda Bautista and Francesco Grossi and Dariusz Kowalski and G{\'e}rard Zalcman and Nowak, {Anna K.} and Nobukazu Fujimoto and Solange Peters and Tsao, {Anne S.} and Mansfield, {Aaron S.} and Sanjay Popat and Xiaowu Sun and Rachael Lawrance and Xiaoqing Zhang and Daumont, {Melinda J.} and Bryan Bennett and Mike McKenna and Paul Baas",
note = "Funding Information: Arnaud Scherpereel reports receiving grants/research support for the institution from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Epizyme, MSD, Roche; other fees (honoraria) from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, MSD, and Roche; and other (presenter) from AstraZeneca, Bristol Myers Squibb, MSD, and Roche. Scott Antonia reports receiving personal fees from Bristol Myers Squibb for the submitted work; personal fees from Achilles Therapeutics, Amgen, AstraZeneca, Caris Life Sciences, Celsius Therapeutics, EMD Serono, G1 Therapeutics, GlaxoSmithKline, Glympse, Memgen, Merck & Co Inc, Nektar, RAPT Therapeutics, Samyang, and Venn Therapeutics outside of the submitted work; grants from Cellular Biomedicine Group outside of the submitted work; and non-financial support from Amgen outside of the submitted work. Yolanda Bautista declares no conflicts of interest. Francesco Grossi reports receiving grants from Bristol Myers Squibb; honoraria/personal fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD, Pierre Fabre, Pfizer, Roche, and Takeda. Dariusz Kowalski reports receiving other fees (consultant/advisor) from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Roche/Genentech, and Pfizer. Gerald Zalcman reports receiving grants from Inventiva, Roche-France, and Takeda outside of the submitted work; personal fees from AstraZeneca, Bristol Myers Squibb, Da Volterra, MSD, and Pfizer outside of the submitted work; and non-financial support from AbbVie and Inventiva outside of the submitted work. Anne K. Nowak reports receiving personal fees from Bristol Myers Squibb for the submitted work, and from Atara Biotherapeutics, PharmAbcine, Seagen, and Trizell Ltd outside of the submitted work; grants from AstraZeneca outside of the submitted work; and other fees (consultant) from AstraZeneca and Douglas Pharmaceuticals outside of the submitted work. Nobukazu Fujimoto reports receiving grants, personal fees, and other fees (consultant/advisor) from Bristol Myers Squibb and Ono Pharmaceutical for the submitted work; personal fees from Eli Lilly Japan for the submitted work; grants from MSD outside of the submitted work; and personal fees from Chugai Pharmaceutical and Daiichi Sankyo outside of the submitted work. Solange Peters reports receiving grants for the institution from Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol Myers Squibb, Clovid, Eli Lilly, GlaxoSmithKline, Illumina, Merck Serono, Mirati Therapeutics, MSD, Novartis, Pfizer, Phosplatin Therapeutics, and Roche/Genentech; other fees (consultant/advisor) from AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Biocartis, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, Foundation Medicine, Illumina, IQVIA, Imedex, Incyte, Janssen, Medscape, Merck Serono, Merrimack Pharmaceuticals, MSD, Novartis, OncologyEducation, PER, Pfizer, PharmaMar, Phosplatin Therapeutics, PRIME, Regeneron, RMEI, Roche/Genentech, RTP, Sanofi, Seattle Genetics, and Takeda; and other fees (presenter) from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, ecancer, Eli Lilly, Illumina, Imedex, Medscape, MSD, Novartis, PER, Pfizer, Prime, Roche/Genentech, RTP, Sanofi, and Takeda. Anne S. Tsao reports receiving personal fees from Genentech for the submitted work; personal fees from Ariad, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Merck, Novartis, Roche, Seattle Genetics, Sellas Life Sciences, and Takeda outside of the submitted work; grants from Epizyme, EMD Serono, Millennium Pharmaceuticals, and Polaris outside of the submitted work. Aaron S. Mansfield reports receiving grants from Novartis and Verily outside of the submitted work; and other fees (honoraria, travel) from AbbVie, AstraZeneca, Bristol Myers Squibb, Genentech/Roche, Janssen, and Roche; and is a non-remunerated director for the Mesothelioma Applied Research Foundation. Sanjay Popat reports receiving personal fees from Amgen, AstraZeneca, Bayer, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Guardant Health, Janssen, Merck KGaA, Novartis, Roche, Seattle Genetics, Takeda, and Turning Point Therapeutics outside of the submitted work. Xiaowu Sun reports receiving grants from Bristol Myers Squibb while at Adelphi Values Ltd for statistical support during this study; and reports other (employment) from CVS Health outside of the submitted work. Rachael Lawrance reports receiving grants from Bristol Myers Squibb to her institution (Adelphi Values Ltd) for statistical support. Xiaoqing Zhang, Melinda J. Daumont, and Bryan Bennett are employees of Bristol Myers Squibb. Paul Baas reports receiving grants from AstraZeneca, Bristol Myers Squibb, and MSD outside of the submitted work; and other fees (consultant/advisor) from AstraZeneca, BeiGene, Bristol Myers Squibb, MSD, Roche, and Takeda outside of the submitted work. Mike McKenna is an employee of Health Outcomes Solutions. Publisher Copyright: {\textcopyright} 2022 The Author(s)",
year = "2022",
month = may,
doi = "10.1016/j.lungcan.2022.03.012",
language = "English (US)",
volume = "167",
pages = "8--16",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",
}