Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan.
[BACKGROUND] Lenvatinib plus pembrolizumab (LP) therapy has emerged as an effective treatment for patients with advanced or recurrent endometrial cancer.
- p-value P = 0.011
- 95% CI 0.28-0.78
APA
Nagase Y, Nakagawa S, et al. (2025). Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan.. International journal of clinical oncology, 30(11), 2342-2351. https://doi.org/10.1007/s10147-025-02842-x
MLA
Nagase Y, et al.. "Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan.." International journal of clinical oncology, vol. 30, no. 11, 2025, pp. 2342-2351.
PMID
40914783
Abstract
[BACKGROUND] Lenvatinib plus pembrolizumab (LP) therapy has emerged as an effective treatment for patients with advanced or recurrent endometrial cancer. However, limited data are available regarding its outcomes in real-world settings. This study aimed to identify prognostic factors associated with the efficacy of LP therapy.
[METHODS] This multicenter observational study was conducted across 15 institutions in Japan and examined patients with endometrial cancer, including uterine carcinosarcoma, who experienced disease progression after receiving at least one platinum-based chemotherapy, including adjuvant treatment, and subsequently received LP therapy. The prognostic factors for progression-free survival were assessed using a multivariate Cox proportional hazards model.
[RESULTS] A total of 105 patients met the inclusion criteria. Improved progression-free survival was independently associated with performance status of 0 (adjusted hazard ratio [aHR] 0.42, 95% confidence interval [CI] 0.23-0.75), platinum-free interval (PFI) of ≥ 6 months (aHR 0.46, 95% CI 0.28-0.78), histology of grade 1-2 endometrioid carcinoma (aHR 0.52, 95% CI 0.30-0.91), and relative dose intensity during the initial 8 weeks (8w-RDI) of lenvatinib of ≥ 50% (aHR 0.53, 95% CI 0.31-0.91). Patients with PFI of ≥ 6 months also demonstrated improved overall survival (HR 0.44, 95% CI 0.25-0.76) and objective response rate (44.0% versus 20.0%, P = 0.011) compared with those with PFI of < 6 months. Additionally, 8w-RDI of lenvatinib ≥ 50% was associated with improved overall survival (HR 0.53, 95% CI 0.30-0.92) compared to those with < 50%.
[CONCLUSIONS] This study identified several novel prognostic factors for LP therapy. Among them, PFI may inform treatment selection for recurrent endometrial cancer following chemotherapy.
[CLINICAL TRIAL REGISTRATION] University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 000049997.
[METHODS] This multicenter observational study was conducted across 15 institutions in Japan and examined patients with endometrial cancer, including uterine carcinosarcoma, who experienced disease progression after receiving at least one platinum-based chemotherapy, including adjuvant treatment, and subsequently received LP therapy. The prognostic factors for progression-free survival were assessed using a multivariate Cox proportional hazards model.
[RESULTS] A total of 105 patients met the inclusion criteria. Improved progression-free survival was independently associated with performance status of 0 (adjusted hazard ratio [aHR] 0.42, 95% confidence interval [CI] 0.23-0.75), platinum-free interval (PFI) of ≥ 6 months (aHR 0.46, 95% CI 0.28-0.78), histology of grade 1-2 endometrioid carcinoma (aHR 0.52, 95% CI 0.30-0.91), and relative dose intensity during the initial 8 weeks (8w-RDI) of lenvatinib of ≥ 50% (aHR 0.53, 95% CI 0.31-0.91). Patients with PFI of ≥ 6 months also demonstrated improved overall survival (HR 0.44, 95% CI 0.25-0.76) and objective response rate (44.0% versus 20.0%, P = 0.011) compared with those with PFI of < 6 months. Additionally, 8w-RDI of lenvatinib ≥ 50% was associated with improved overall survival (HR 0.53, 95% CI 0.30-0.92) compared to those with < 50%.
[CONCLUSIONS] This study identified several novel prognostic factors for LP therapy. Among them, PFI may inform treatment selection for recurrent endometrial cancer following chemotherapy.
[CLINICAL TRIAL REGISTRATION] University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 000049997.
MeSH Terms
Humans; Female; Endometrial Neoplasms; Phenylurea Compounds; Aged; Middle Aged; Japan; Antibodies, Monoclonal, Humanized; Quinolines; Prognosis; Neoplasm Recurrence, Local; Antineoplastic Combined Chemotherapy Protocols; Aged, 80 and over; Adult; Cohort Studies; Progression-Free Survival