Article Text
Abstract
Introduction Lenvatinib plus pembrolizumab (LP) has been approved for the treatment of advanced or recurrent endometrial cancer, but there have been few reports in clinical practice. We aimed to investigate the efficacy and safety of LP in real clinical practice.
Methods We retrospectively reviewed the medical records regarding patients who received LP for recurrent or advanced endometrial cancer at our hospital from 2018 to 2023. The overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) were evaluated regarding efficacy, and adverse events were evaluated regarding safety.
Results Twenty-eight patients were included. The median age was 59 (31–78) and the median observation period was 9 months (0.7–45). Regarding mismatch repair status, one patient was deficient and 27 patients were proficient. The histologic subtypes were endometrioid G1/2 in eight patients, endometrioid G3 in nine, carcinosarcoma in four, serous in three, mixed in three, and clear cell in one, respectively. The best response was complete response in one patient (4%), partial response in 11 (39%), stable disease in eight (29%), progressive disease in six (21%), not evaluated in two (7%), and the ORR was 43%. The median PFS and OS were 8.0 and 19.6 months, respectively. Adverse events with grade 3 or higher were observed in 17 patients (61%). Five patients (18%) had to discontinue treatment due to toxicities.
Conclusion/Implications LP showed comparable efficacy to the phase III trial in clinical practice, however, it caused serious adverse events that were different from conventional cytotoxic chemotherapies. It was considered important to manage these toxicities.