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Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061

 Eric Van Cutsem  ;  Mayur Amonkar  ;  Charles S Fuchs  ;  Maria Alsina  ;  Mustafa Özgüroğlu  ;  Yung-Jue Bang  ;  Hyun Cheol Chung  ;  Kei Muro  ;  Eray Goekkurt  ;  Al B Benson 3rd  ;  Weijing Sun  ;  Zev A Wainberg  ;  Josephine M Norquist  ;  Xinqun Chen  ;  Chie-Schin Shih  ;  Kohei Shitara 
 GASTRIC CANCER, Vol.24(6) : 1330-1340, 2021-11 
Journal Title
Issue Date
Antibodies, Monoclonal, Humanized / administration & dosage ; Antibodies, Monoclonal, Humanized / therapeutic use* ; Antineoplastic Agents, Immunological / administration & dosage ; Antineoplastic Agents, Immunological / therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols ; Belgium ; Esophagogastric Junction* ; Humans ; Neoplasm Metastasis ; Progression-Free Survival ; Quality of Life ; Stomach Neoplasms / drug therapy* ; Stomach Neoplasms / mortality ; Stomach Neoplasms / pathology ; Surveys and Questionnaires
Chemotherapy ; Gastric cancer ; HRQoL ; Pembrolizumab
Background: 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.

Methods: 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.

Results: 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.

Conclusions: In this population with advanced gastric and GEJ cancer receiving second-line treatment, HRQoL was similar in patients receiving pembrolizumab and those receiving paclitaxel.

Clinical trial registry and number: ClinicalTrials.gov, NCT02370498.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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