Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice

• Published in: European journal of cancer (1990) 2023-06, Vol.186, p.172-184
• Main Authors: Lorusso, Domenica, Colombo, Nicoletta, Herraez, Antonio Casado, Santin, Alessandro D., Colomba, Emeline, Miller, David Scott, Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally E., Ray-Coquard, Isabelle Laure, Shapira-Frommer, Ronnie, Kim, Yong Man, McCormack, Mary, Massaad, Rachid, Nguyen, Allison Martin, Zhao, Qi, McKenzie, Jodi, Prabhu, Vimalanand S., Makker, Vicky
• Format: Article
• Language: English
• Subjects: Endometrial cancer; Endometrial Neoplasms - drug therapy; Female; Health-related quality of life; Humans; Lenvatinib; Pain; Patient-reported outcomes; Pembrolizumab; Physicians; Quality of Life
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2023.03.015

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 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. 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. 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. NCT03517449. •HRQoL was assessed in patients with endometrial cancer in Study 309/KEYNOTE-775.•Week 12 declines from baseline in most scales were similar between treatment arms.•Some differences existed (e.g. diarrhoea favoured TPC, dyspnoea favoured LEN+PEMBRO).•Coupled with efficacy and safety data, the PRO data support use of LEN+PEMBRO in EC.