The efficacy and safety of lenvatinib plus pembrolizumab in vulnerable patients with metastatic or recurrent endometrial cancer: a single institution experience

• Published in: International journal of clinical oncology 2024-12
• Main Authors: Yunokawa, Mayu, Abe, Akiko, Wang, Xiaofei, Toyohara, Yusuke, Nimura, Ryo, Komoto, Takayuki, Misaka, Satoki, Yoshimitsu, Teruyuki, Ikki, Ai, Kamata, Mayumi, Nishino, Shogo, Kanno, Motoko, Fusegi, Atsushi, Netsu, Sachiho, Aoki, Yoichi, Omi, Makiko, Tanigawa, Terumi, Okamoto, Sanshiro, Nomura, Hidetaka, Kanao, Hiroyuki
• Format: Article
• Language: English
• ISSN: 1341-9625; 1437-7772; 1437-7772
• DOI: 10.1007/s10147-024-02667-0

Effective management with second-line therapy with the lenvatinib + pembrolizumab regimen for patients with advanced endometrial cancer is necessary. This retrospective study enrolled patients with endometrial cancer treated with the lenvatinib + pembrolizumab regimen. We evaluated progression-free survival (PFS), overall survival (OS), safety for patients non-eligible for the KEYNOTE775 trial, aged ≥65 years, or with ECOG performance status 1-2. Forty-five patients were analyzed: 21 (47%) were aged ˃ 65 years, 16 (36%) had performance status 1-2, and 15 (33%) were non-eligible for KEYNOTE775 trial participation. Overall, the median PFS was 8.5 months (95% confidence interval [CI] 4.6-12.4), and the median OS was 15.6 months (95% CI 9.4-NA). Median PFS was significantly shorter in patients not eligible for KEYNOTE775 participation and with performance status 1-2. The median OS was significantly shorter in patients with performance status 1-2. Grade ˃3 adverse events (AEs) occurred in 78% of patients who received the lenvatinib + pembrolizumab regimen. AEs resulted in lenvatinib dose reductions in 35 patients (78%) and lenvatinib and pembrolizumab discontinuation in 3 (7%) and 5 (11%), respectively. The median time to the first lenvatinib dose reduction was 1.5 (0.92-2.3) months in all patients and was significantly shorter in patients aged >65 years. The current regimen has favorable efficacy and manageable safety with appropriate dose reduction of lenvatinib in the real world. However, the efficacy may be inferior in patients with performance status 1 or 2, heavily treated patients, and those with organ dysfunction. The current treatment status should reflect real-world data relative to the medical environment and management.