Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061
Van Cutsem, Eric (University Hospitals Gasthuisberg (Leuven, Bélgica))
Amonkar, Mayur (Merck & Co., Inc.. Center for Observational and Real World Evidence)
Fuchs, Charles S. (Yale School of Medicine. Yale Cancer Center)
Alsina, Maria (Vall d'Hebron Institut d'Oncologia)
Özgüroğlu, Mustafa (Istanbul University-Cerrahpaşa. Department of Internal Medicine, Medical Oncology, and Clinical Trial Unit)
Bang, Yung-Jue (Seoul National University College of Medicine. Department of Internal Medicine)
Chung, Hyun Cheol (Yonsei University College of Medicine. Department of Medical Oncology)
Muro, Kei (Aichi Cancer Center Hospital)
Goekkurt, Eray (University Cancer Center Hamburg. North-German Trial Center for Innovative Oncology)
Benson, Al B. (Northwestern University. Robert H. Lurie Comprehensive Cancer Center)
Sun, Weijing (University of Kansas. Department of Internal Medicine and Medical Oncology)
Wainberg, Zev A. (David Geffen School of Medicine at UCLA. Department of Medicine and Hematology and Oncology)
Norquist, Josephine M. (Merck & Co., Inc.. Center for Observational and Real World Evidence)
Chen, Xinqun (Merck & Co., Inc.. Department of Medical Oncology)
Shih, Chie-Schin (Merck & Co., Inc.. Department of Medical Oncology)
Shitara, Kohei (National Cancer Center Hospital. Department of Gastrointestinal Oncology)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	In the primary analysis population (i. e. , PD-L1 combined positive score [CPS] ≥ 1) of the phase 3 KEYNOTE-061 study (NCT02370498), pembrolizumab did not significantly prolong overall survival or progression-free survival. Pembrolizumab had a favorable safety profile in the all-patient population. We present results of prespecified health-related quality of life (HRQoL) analyses. HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC QLQ gastric cancer questionnaire (QLQ-STO22), and EuroQol 5-dimension, 3-level questionnaire (EQ-5D-3L). Data were analyzed from patients who received ≥ 1 dose of study treatment and who completed ≥ 1 HRQoL assessment. Key analyses included baseline to week 12 least-squares mean (LSM) change in global health status (GHS)/QoL, functional/symptom subscales, and time to deterioration (TTD; ≥ 10-point decrease from baseline) for specific subscales. The HRQoL population included 371 patients (pembrolizumab, n = 188; paclitaxel, n = 183). Compliance and completion rates for all 3 questionnaires were similar in both groups at baseline and week 12. There was no difference in LSM change between groups (- 3. 54; 95% CI - 8. 92 to 1. 84) in GHS/QoL at week 12. LSM change from baseline to week 12 for most QLQ-C30, QLQ-STO22, and EQ-5D-3L subscales indicated some worsening of QoL in both groups. TTD for GHS/QoL, nausea/vomiting, and appetite loss subscales in QLQ-C30 and the pain subscales in QLQ-STO22 were similar between treatment groups. In this population with advanced gastric and GEJ cancer receiving second-line treatment, HRQoL was similar in patients receiving pembrolizumab and those receiving paclitaxel. ClinicalTrials. gov, NCT02370498. The online version contains supplementary material available at 10. 1007/s10120-021-01200-w.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Estudi clínic ; recerca ; Versió publicada
Matèria:	Pembrolizumab ; Chemotherapy ; Gastric cancer ; HRQoL
Publicat a:	Gastric Cancer, Vol. 24 (august 2021) , p. 1330-1340, ISSN 1436-3305

DOI: 10.1007/s10120-021-01200-w
PMID: 34363528

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