Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061
BackgroundIn 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.MethodsHRQoL 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 E... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2021 |
Reihe/Periodikum: | Gastric Cancer, vol 24, iss 6 |
Verlag/Hrsg.: |
eScholarship
University of California |
Schlagwörter: | Cancer / Clinical Research / Evaluation of treatments and therapeutic interventions / 6.1 Pharmaceuticals / Antibodies / Monoclonal / Humanized / Antineoplastic Agents / Immunological / Antineoplastic Combined Chemotherapy Protocols / Belgium / Esophagogastric Junction / Humans / Neoplasm Metastasis / Progression-Free Survival / Quality of Life / Stomach Neoplasms / Surveys and Questionnaires / Pembrolizumab / Chemotherapy / Gastric cancer / HRQoL / Oncology and Carcinogenesis / Oncology & Carcinogenesis |
Sprache: | unknown |
Permalink: | https://search.fid-benelux.de/Record/base-28526382 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://escholarship.org/uc/item/7w26n99f |
BackgroundIn 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.MethodsHRQoL 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.ResultsThe 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.ConclusionsIn 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 numberClinicalTrials.gov, NCT02370498.