Health-related quality of life with pembrolizumab monotherapy in patients with previously treated advanced microsatellite instability high/mismatch repair deficient endometrial cancer in the KEYNOTE-158 study

O&#39;Malley, DM; Bariani, GM; Cassier, PA; Marabelle, A; Hansen, AR; De Jesus Acosta, A; Miller, WH, Jr; Safra, T; Italiano, A; Mileshkin, L; Amonkar, M; Yao, L; Jin, F; Norwood, K; Maio, M

Author(s): O'Malley, DM; Bariani, GM; Cassier, PA; Marabelle, A; Hansen, AR; De Jesus Acosta, A; Miller, WH, Jr; Safra, T; Italiano, A; Mileshkin, L; Amonkar, M; Yao, L; Jin, F; Norwood, K; Maio, M;
Details: Publication Year 2022-08,Volume 166,Issue #2,Page 245-253
Journal Title: Gynecologic Oncology
Publication Type: Research article
Abstract: OBJECTIVE: Pembrolizumab demonstrated a clinically meaningful objective response rate in patients with previously treated, advanced MSI-H/dMMR endometrial cancer in the multicohort phase 2 KEYNOTE-158 study (ClinicalTrials.gov, NCT02628067). We present health-related quality of life (HRQoL) results for these patients. METHODS: This analysis included patients from cohorts D (endometrial cancer with any MSI status) and K (any MSI-H/dMMR solid tumor except colorectal) who had previously treated, advanced MSI-H/dMMR endometrial cancer. Patients received pembrolizumab 200 mg Q3W for 35 cycles. EORTC QLQ-C30 and EQ-5D-3L questionnaires were administered at baseline, at regular intervals during treatment, and 30 days after treatment discontinuation. Pre-specified exploratory analyses included changes from baseline to week 9 in QLQ-C30 global health status (GHS)/QoL and EQ-5D-3L visual analog scale (VAS) score for all patients and by best overall response. RESULTS: 84 of 90 enrolled patients completed >/=1 HRQoL questionnaire and were included in the analysis. QLQ-C30 and EQ-5D-3L compliance rates were 90% and 94%, respectively, at baseline, and 92% and 93% at week 9. Mean (95% CI) QLQ-C30 GHS/QoL scores improved from baseline to week 9 by 6.08 (0.71-11.46) points in the overall population, with greater improvement in patients who achieved complete or partial response (11.67 [5.33-18.00]-point increase). Mean (95% CI) EQ-5D-3L VAS scores improved by 6.00 (2.25-9.75) points in the overall population and 9.11 (5.24-12.98) points in patients with CR/PR. CONCLUSIONS: Pembrolizumab maintained or improved HRQoL in patients with previously treated, advanced MSI-H/dMMR endometrial cancer, further supporting efficacy and safety results from KEYNOTE-158 and pembrolizumab use in this setting.
Keywords: Antibodies, Monoclonal, Humanized; DNA Mismatch Repair; *Endometrial Neoplasms/drug therapy/genetics; Female; Humans; Microsatellite Instability; *Quality of Life; Advanced endometrial cancer; Health-related quality of life; Microsatellite instability high; Mismatch repair deficiency; Patient-reported outcomes; Pembrolizumab
Department(s): Medical Oncology
PubMed ID: 35835611
Publisher's Version: https://doi.org/10.1016/j.ygyno.2022.06.005
Open Access at Publisher's Site: https://doi.org/10.1016/j.ygyno.2022.06.005
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-02-14 04:06:04

Last Modified: 2025-02-14 04:08:15