Health-related quality of life in patients with advanced endometrial cancer treated with lenvatinib plus pembrolizumab or treatment of physician's choice Journal Article


Authors: Lorusso, D.; Colombo, N.; Herraez, A. C.; Santin, A. D.; Colomba, E.; Miller, D. S.; Fujiwara, K.; Pignata, S.; Baron-Hay, S. E.; Ray-Coquard, I. L.; Shapira-Frommer, R.; Kim, Y. M.; McCormack, M.; Massaad, R.; Nguyen, A. M.; Zhao, Q.; McKenzie, J.; Prabhu, V. S.; Makker, V.
Article Title: Health-related quality of life in patients with advanced endometrial cancer treated with lenvatinib plus pembrolizumab or treatment of physician's choice
Abstract: Purpose: Lenvatinib and pembrolizumab (LEN+PEMBRO) demonstrated clinically meaningful and statistically significant improvements in efficacy versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer (aEC) in the phase 3 Study 309/KEYNOTE-775. Health-related quality-of-life (HRQoL) is reported. Patients and Methods: Patients were randomly assigned to receive LEN+PEMBRO (n = 411; LEN 20 mg/day; PEMBRO 200 mg Q3W) or TPC (n = 416; doxorubicin 60 mg/m2 Q3W or paclitaxel 80 mg/m2 [weekly, 3 weeks on/1 week off]). Impact of treatment on HRQoL assessed by the global health status/quality of life (GHS/QoL) score of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) was a secondary objective; other scales of the Quality-of-Life Questionnaire (QLQ-C30), EORTC QLQ-Endometrial, 24 questions (EORTC QLQ-EN24), and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) were exploratory objectives. HRQoL was assessed on day 1 of each cycle. Completion/compliance, change from baseline, time to first and definitive deterioration were assessed. No multiplicity adjustments were applied for HRQoL endpoints. Results: The latest timepoint at which the predefined rates of completion (≥60%) and compliance (≥80%) were met was week 12. HRQoL at week 12 between treatment groups was generally similar. Time to first deterioration symptom scales favoured LEN+PEMBRO for QLQ-C30 dyspnoea, and QLQ-EN24 for poor body image, tingling/numbness, and hair loss; and TPC was favoured for QLQ-C30 pain, appetite loss, and diarrhoea, and QLQ-EN24 muscular pain. While the QLQ-C30 physical functional scale favoured TPC, other functional scales were generally similar between arms. Time to definitive deterioration favoured LEN+PEMBRO on most scales. Conclusion: HRQoL data from Study 309/KEYNOTE-775, with previously published efficacy and safety results, indicate that LEN+PEMBRO has an overall favourable benefit/risk profile versus TPC for the treatment of patients with aEC. ClinicalTrials.gov: NCT03517449. © 2023 The Authors
Keywords: controlled study; major clinical study; constipation; fatigue; paresthesia; doxorubicin; advanced cancer; diarrhea; side effect; paclitaxel; endometrial cancer; endometrium cancer; quality of life; nausea; vomiting; myalgia; clinical assessment; vagina disease; backache; dyspnea; lymphedema; insomnia; sexual dysfunction; patient compliance; taste disorder; health-related quality of life; patient-reported outcomes; gastrointestinal disease; physical performance; clinical observation; hair loss; global health; patient-reported outcome; skin tingling; urinary tract disease; general condition deterioration; combination drug therapy; lenvatinib; human; female; article; pembrolizumab; pelvic pain; loss of appetite; european organization for research and treatment of cancer quality of life questionnaire core 30; european quality of life 5 dimensions questionnaire; body dissatisfaction
Journal Title: European Journal of Cancer
Volume: 186
ISSN: 0959-8049
Publisher: Elsevier Inc.  
Date Published: 2023-06-01
Start Page: 172
End Page: 184
Language: English
DOI: 10.1016/j.ejca.2023.03.015
PUBMED: 37086595
PROVIDER: scopus
PMCID: PMC11003310
DOI/URL:
Notes: Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed (via CoI statement) and PDF -- Export Date: 1 May 2023 -- Source: Scopus
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  1. Vicky Makker
    265 Makker