Quality of life with first-line pembrolizumab for PD-L1epositive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study
Autor: | Van Cutsem, E., Valderrama, A., Bang, Yung-Jue, Fuchs, C. S., Shitara, Kohei, Janjigian, Y. Y., Qin, S., Larson, T. G., Shankaran, V., Stein, S., Norquist, J. M., Kher, U., Shah, S., Alsina, Maria, Universitat Autònoma de Barcelona |
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Přispěvatelé: | Institut Català de la Salut, [Van Cutsem E] Department of Digestive Oncology, University Hospital Gasthuisberg Leuven and KU Leuven, Leuven, Belgium. [Valderrama A] Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, USA. [Bang YJ] Department of Biomedical Research, Seoul National University College of Medicine, Seoul, South Korea. [Fuchs CS] Department of Internal Medicine: Hematology, Medical Oncology, Gastro-oncology, Yale University Cancer Center, Smilow Cancer Hospital, New Haven, USA. [Shitara K] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. [Janjigian YY] Department of Gastrointestinal Oncology, Medicine, Memorial Sloan Kettering Cancer Center, New York, USA. [Alsina M] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, Vall d'Hebron Barcelona Hospital Campus |
Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Cancer Research
Abdominal pain medicine.medical_specialty Nausea medicine.medical_treatment Population Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Pembrolizumab Adenocarcinoma Other subheadings::Other subheadings::/drug therapy [Other subheadings] Antibodies Monoclonal Humanized Gastroenterology Esòfag - Càncer - Tractament B7-H1 Antigen gastroesophageal cancer Quality of life Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans education Original Research Chemotherapy education.field_of_study business.industry gastric cancer Neoplasms::Neoplasms by Histologic Type::Neoplasms Glandular and Epithelial::Carcinoma::Adenocarcinoma [DISEASES] Hazard ratio neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::adenocarcinoma [ENFERMEDADES] social sciences humanities Adenocarcinoma - Tractament Oncology quality of life patient-reported outcomes Vomiting Digestive System::Gastrointestinal Tract::Upper Gastrointestinal Tract::Esophagus::Esophagogastric Junction [ANATOMY] sistema digestivo::tracto gastrointestinal::tracto gastrointestinal superior::esófago::unión esofagogástrica [ANATOMÍA] Esophagogastric Junction pembrolizumab medicine.symptom business |
Zdroj: | ESMO Open Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona Scientia |
Popis: | Background 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. Materials and methods 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. Results 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). Conclusions 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. Highlights • HRQOL was similar between pembrolizumab and chemotherapy in patients with PD-L1-positive advanced gastric/GEJ cancer. • General HRQOL as measured by QLQ-C30 GHS/QOL scores was comparable between treatment arms from baseline to week 18. • The EQ-5D-3L visual analogue scale was also equivalent between arms from baseline to week 18. |
Databáze: | OpenAIRE |
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