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First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743
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Description
In CheckMate 743 (NCT02899299), nivolumab + ipilimumab significantly prolonged overall survival in patients with unresectable malignant pleural mesothelioma (MPM). We present patient-reported outcomes (PROs).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.Completion rates were generally80%. 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.Nivolumab + ipilimumab decreased the risk of deterioration in disease-related symptoms and HRQoL versus chemotherapy and maintained QoL in patients with unresectable MPM.
Journal
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- Lung Cancer
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Lung Cancer 167 8-16, 2022-05-01
Elsevier BV
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Keywords
- Quality of life
- Mesothelioma
- Lung Neoplasms
- 610
- Immune checkpoint inhibitors
- Antineoplastic Combined Chemotherapy Protocols
- Humans
- Overall survival
- Patient Reported Outcome Measures
- Malignant
- Lung Cancer Symptom Scale
- Mesothelioma, Malignant
- EQ-5D
- Immuno-oncology
- Ipilimumab
- Nivolumab
- Programmed cell death (PD)-1 inhibitor
- Quality of Life
- Symptom burden
- Anti-cytotoxic T lymphocyte antigen-4 (CTLA-4)
- Immunotherapy
- Antineoplastic Combined Chemotherapy Protocols/adverse effects; Humans; Ipilimumab/therapeutic use; Lung Neoplasms/diagnosis; Lung Neoplasms/drug therapy; Lung Neoplasms/etiology; Mesothelioma/drug therapy; Mesothelioma, Malignant; Nivolumab/adverse effects; Patient Reported Outcome Measures; Quality of Life; 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
Details 詳細情報について
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- CRID
- 1872553967738986496
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- HANDLE
- 1887/3565034
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- ISSN
- 01695002
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- PubMed
- 35367910
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- Data Source
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- OpenAIRE