Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061
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),... Mehr ...
Dokumenttyp: | Artikel |
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Erscheinungsdatum: | 2021 |
Verlag/Hrsg.: |
Springer-Verlag Tokyo
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Schlagwörter: | Antibodies / Monoclonal / Humanized / administration & dosage / Humanized / therapeutic use* / Antineoplastic Agents / Immunological / administration & dosage / 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 |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-28530036 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190695 |
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. ; open