Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia

Aim. To assess the efficacy and safety of lenvatinib plus pembrolizumab for the treatment of mismatch repair-proficient (pMMR) endometrial cancer (EC) in routine clinical practice in Russia.Materials and methods. This multicenter, retrospective, cohort study included 114 patients with recurrent and metastatic EC from 37 cancer centers in Russia treated between December 2020 and November 2024. Patients with histologically verified EC without microsatellite instability were included. The primary endpoint was progression-free survival; the clinical characteristics of the patients were additionally analyzed; the objective response rate and the toxicity profile of therapy were assessed.Results. Median patients’ age was 66.5 (33–83) years. The most common histologic tumor subtype was endometrioid adenocarcinoma (72.8 %); serous adenocarcinoma was diagnosed in 18.4 % of cases, other subtypes – in 8.8 %. The median progression-free survival was 8.15 months (95 % confidence interval 0.4–41.1). Objective response rate was 38.0 %. The median overall survival was not achieved with a median follow-up of 12.23 months. During treatment, dose reduction rate due to adverse events was 50 %. The most frequent adverse events were hypertension (n = 64; 56.1 %), fatigue (n = 45; 39.5 %), and diarrhea (n = 20; 17.5 %).Conclusion. In the conducted study of routine clinical practice in Russian patients with recurrent and metastatic EC without mismatch repair system deficiency (pMMR/MSS), lenvatinib plus pembrolizumab showed good efficacy with a manageable safety profile.

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Journal
Tumors of female reproductive system
Published
2024-12-03
DOI
https://doi.org/10.17650/1994-4098-2024-20-4-111-118
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
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article

Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia

N. E. Musaeva, V. G. Sisakyan, T. A. Makarkina, A. S. Antipin et al.
Tumors of female reproductive system
Cancer Immunotherapy and Biomarkers
article

Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia

N. E. Musaeva, V. G. Sisakyan, T. A. Makarkina, A. S. Antipin, M. R. Mukhitova, E.A. Talalaeva, N. R. Abidova, M. V. Volkonsky, E. B. Shakhnovich, Anna A. Grechkina, A. G. Shishkov, R. S. Zhikhorev, А. А. Rumyantsev, I. Yu. Lots, S. P. Medvedev, A. A. Gofman, T. V. Davydova, Nina Romanova, А. Э. Протасова, A. A. Akopyan, К. С. Титов, V. M. Filippova, S. T. Nazranova, Yu. V. Vasilyeva, A. B. Sunyaykin, M. O. Skorina, А. Yu. Goryainova, T. A. Zhelezkova, D. N. Bubenko, N. M. Chernorubashkina, E. P. Krasnorutskaya, O. N. Aymamedova, F. V. Tsarakhova, I. S. Usoltseva, A. O. Milyukova, Roman A. Skotnikov, Olha Romanchuk, A. N. Letuchikh, M. P. Karpovich, E. E. Tonenkova, Eminat M. Magomedova, A. K. Chebodaev, N. S. Goloschapova, B. V. Gonchikov, D. V. Khodareva, T. V. Krashihina, N. V. Prokudina, P. R. Rabadanova, P. A. Sakulin, A. I. Tabakova, Yu. A. Trushina, Kh. M. Khabrieva
article en

Abstract

Aim. To assess the efficacy and safety of lenvatinib plus pembrolizumab for the treatment of mismatch repair-proficient (pMMR) endometrial cancer (EC) in routine clinical practice in Russia.Materials and methods. This multicenter, retrospective, cohort study included 114 patients with recurrent and metastatic EC from 37 cancer centers in Russia treated between December 2020 and November 2024. Patients with histologically verified EC without microsatellite instability were included. The primary endpoint was progression-free survival; the clinical characteristics of the patients were additionally analyzed; the objective response rate and the toxicity profile of therapy were assessed.Results. Median patients’ age was 66.5 (33–83) years. The most common histologic tumor subtype was endometrioid adenocarcinoma (72.8 %); serous adenocarcinoma was diagnosed in 18.4 % of cases, other subtypes – in 8.8 %. The median progression-free survival was 8.15 months (95 % confidence interval 0.4–41.1). Objective response rate was 38.0 %. The median overall survival was not achieved with a median follow-up of 12.23 months. During treatment, dose reduction rate due to adverse events was 50 %. The most frequent adverse events were hypertension (n = 64; 56.1 %), fatigue (n = 45; 39.5 %), and diarrhea (n = 20; 17.5 %).Conclusion. In the conducted study of routine clinical practice in Russian patients with recurrent and metastatic EC without mismatch repair system deficiency (pMMR/MSS), lenvatinib plus pembrolizumab showed good efficacy with a manageable safety profile.

Tumors of female reproductive systemVol. 20(4)
St Petersburg University (RU), Federal Almazov North-West Medical Research Centre (RU), Moscow Clinical Scientific Center (RU), Nizhny Novgorod Regional Clinical Oncology Center (RU), Ministry of Health of the Russian Federation (RU), Regional Cancer Center (US), City Hospital (GB), Krasnoyarsk Regional Clinical Hospital (RU), Republican Oncological Clinical Dispensary (RU), City Clinical Hospital (RU), State Autonomous Institution of Health Interregional Clinical Diagnostic Center (RU), State Healthcare Institution "Regional Clinical Oncological Dispensary" (RU), Ulyanovsk Regional Oncology Center (RU), Chelyabinsk Regional Clinical Oncology Center (RU), Ministry of Health (JM), Moscow City Oncology Hospital №62 (RU), Avaya (Bermuda) (BM)
Openalex Percentile: Top 57%
Cancer Immunotherapy and Biomarkers
DOIOpen Access PDFOpenAlex
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