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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Embargo End Date
ICR Authors
Authors
Scherpereel, A
Antonia, S
Bautista, Y
Grossi, F
Kowalski, D
Zalcman, G
Nowak, AK
Fujimoto, N
Peters, S
Tsao, AS
Mansfield, AS
Popat, S
Sun, X
Lawrance, R
Zhang, X
Daumont, MJ
Bennett, B
McKenna, M
Baas, P
Antonia, S
Bautista, Y
Grossi, F
Kowalski, D
Zalcman, G
Nowak, AK
Fujimoto, N
Peters, S
Tsao, AS
Mansfield, AS
Popat, S
Sun, X
Lawrance, R
Zhang, X
Daumont, MJ
Bennett, B
McKenna, M
Baas, P
Document Type
Journal Article
Date
2022-05-01
Date Accepted
2022-03-12
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.
Citation
Lung Cancer, 2022, 167 pp. 8 - 16
Source Title
Lung Cancer
Publisher
ELSEVIER IRELAND LTD
ISSN
0169-5002
eISSN
1872-8332
1872-8332
1872-8332