Quality of life with first-line pembrolizumab for PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma : results from the randomised phase III KEYNOTE-062 study
Van Cutsem, E. (University Hospitals Gasthuisberg (Leuven, Bélgica))
Valderrama, A. (Center for Observational and Real-World Evidence, Merck)
Bang, Yung-Jue (Seoul National University College of Medicine)
Fuchs, C. S. (Yale University Cancer Center)
Shitara, Kohei (National Cancer Center Hospital East, Kashiwa, Japan)
Janjigian, Y. Y. (Memorial Sloan Kettering Cancer Center)
Qin, S. (PLA Cancer Centre of Nanjing Bayi Hospital)
Larson, T. G. (Minnesota Oncology Hematology)
Shankaran, V. (Seattle Cancer Care Alliance)
Stein, S. (Yale University Cancer Center)
Norquist, J. M. (Center for Observational and Real-World Evidence, Merck)
Kher, U. (Department of Medical Oncology, Merck)
Shah, S. (Department of Medical Oncology, Merck)
Alsina, Maria (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	In the randomised phase III KEYNOTE-062 study, pembrolizumab was non-inferior to chemotherapy for overall survival in patients with programmed death-ligand 1 (PD-L1)-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (GEJ) cancer. We present findings of prespecified health-related quality-of-life (HRQOL) analyses for pembrolizumab versus chemotherapy in this population. HRQOL, a secondary endpoint, was measured in patients who received ≥1 dose of study treatment and completed ≥1 HRQOL questionnaire [European Organisation for the Research and Treatment of Cancer (EORTC) 30-question quality-of-life (QLQ-C30), EORTC 22-question quality-of-life gastric-cancer-specific module (QLQ-STO22)]. Least squares mean (LSM) change (baseline to week 18) in global health status/quality of life (GHS/QOL; EORTC QLQ-C30) and time to deterioration (TTD) in GHS/QOL, nausea/vomiting and appetite loss scores (EORTC QLQ-C30) and abdominal pain/discomfort scores (EORTC QLQ-STO22) were evaluated. The HRQOL population comprised 495 patients with CPS ≥1 (pembrolizumab, 252; chemotherapy, 243). Compliance rates at week 18 were similar for pembrolizumab and chemotherapy (EORTC QLQ-C30, 87. 9% and 81. 9%; EORTC QLQ-STO22, 87. 9% and 81. 3%, respectively). There was no between-arm difference in LSM score change in GHS/QOL [−0. 16; 95% confidence interval (CI) −5. 01 to 4. 69; P = 0. 948]. The LSM score change for most subscales showed comparable worsening in both arms. TTD for GHS/QOL [hazard ratio (HR), 0. 96; 95% CI, 0. 67-1. 38; P = 0. 826], appetite loss (HR, 0. 83; 95% CI, 0. 58-1. 20; P = 0. 314) and pain (HR, 1. 22; 95% CI, 0. 78-1. 91; P = 0. 381) were similar between arms. Longer TTD was observed for pembrolizumab versus chemotherapy for nausea/vomiting (HR, 0. 61; 95% CI, 0. 44-0. 85; P = 0. 003). HRQOL was maintained with first-line treatment with pembrolizumab in patients with PD-L1-positive advanced gastric/GEJ cancer and was similar between pembrolizumab and chemotherapy in this population.
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Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Gastric cancer ; Gastroesophageal cancer ; Pembrolizumab ; Quality of life ; Patient-reported outcomes
Published in:	ESMO open, Vol. 6 (august 2021) , ISSN 2059-7029

DOI: 10.1016/j.esmoop.2021.100189
PMID: 34371381

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