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

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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.

About the authors

A. A. Rumyantsev

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia

Author for correspondence.
Email: alexeymma@gmail.com
ORCID iD: 0000-0003-4443-9974

Aleksey Aleksandrovich Rumyantsev 

23 Kashirskoe Shosse, Moscow 115478, Russia 

Russian Federation

A. E. Protasova

Saint Petersburg State University;
V.A. Almazov National Medical Research Center, Ministry of Health of Russia;
AVA-PETER LLC

ORCID iD: 0000-0001-7930-8048

7–9 Universitetskaya Naberezhnaya, Saint Petersburg 199034, Russia;

2 Akkuratova St., Saint Petersburg 197341, Russia;

Build. 2, 4 Ilyushina St., Saint Petersburg 196634, Russia 

Russian Federation

A. A. Grechkina

Primorsky Regional Oncology Center

59 Russkaya St., Vladivostok 690105, Russia

Russian Federation

M. V. Volkonskiy

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0003-4060-5015

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

M. R. Mukhitova

Republican Clinical Oncology Dispensary, Ministry of Health of the Republic of Tatarstan

ORCID iD: 0000-0002-0741-624X

29 Sibirskiy Trakt St., Kazan 420029, Russia 

Russian Federation

O. N. Aymamedova

Lyubertsy Oncology Dispensary

338 Oktyabrskiy Prospect, Lyubertsy 140006, Russia

Russian Federation

A. Yu. Goryainova

Clinical Oncology Dispensary No. 1

ORCID iD: 0000-0001-7127-7945

146 Dimitrova St., Krasnodar 350040, Russia

Russian Federation

A. A. Akopyan

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0002-0893-9034

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

A. A. Gofman

Altai Regional Oncology Dispensary

10k Zmeinogorskiy Trakt St., Barnaul 656045, Russia

Russian Federation

T. A. Zhelezkova

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0001-5049-6559

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

R. S. Zhikhorev

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0003-2281-7380

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

E. P. Krasnorutskaya

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

N. R. Abidova

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0009-0006-8989-0004

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

T. A. Makarkina

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0002-1000-4262

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

V. G. Sisakyan

Novosibirsk Regional Clinical Oncology Center

2 Plakhotnogo St., Novosibirsk 630108, Russia

Russian Federation

M. O. Skorina

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

V. M. Filippova

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0003-1990-175X

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

A. K. Chebodaev

Abakan Interregional Clinical Hospital

57A Chertygasheva St., Abakan 655017, Russia

Russian Federation

N. M. Chernorubashkina

Regional Oncology Center

32 Frunze St., Irkutsk 664035, Russia

Russian Federation

S. P. Medvedev

National Medical Research Center of Treatment and Rehabilitation

3 Ivankovskoe Shosse, Moscow 125367, Russia

Russian Federation

D. N. Bubenko

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

A. S. Antipin

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

ORCID iD: 0000-0003-3147-7023

42 Blyukhera St., Chelyabinsk 454087, Russia

Russian Federation

Yu. V. Vasilyeva

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0001-6394-1578

6 Staropetrovskiy Proezd, Moscow 125130, Russia

Russian Federation

N. S. Goloschapova

Regional Clinical Oncology Hospital

67 Prospekt Oktyabrya, Yaroslavl 150054, Russia

Russian Federation

B. V. Gonchikov

Regional Oncology Center

Россия, 664035 Иркутск, ул. Фрунзе, 32

Russian Federation

T. V. Davydova

Republican Clinical Oncological Dispensary

173 Tsukanova St., Abakan 655009, Russia

Russian Federation

D. V. Khodareva

A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center

16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia

Russian Federation

M. P. Karpovich

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia

Russian Federation

T. V. Krashihina

Multidisciplinary Medical Center “Lyadov Clinics”

21/2 Panfilova St., Khimki 141407, Russia

Russian Federation

I. Yu. Lots

Novosibirsk Regional Clinical Oncology Center

ORCID iD: 0009-0004-0139-4491

2 Plakhotnogo St., Novosibirsk 630108, Russia

Russian Federation

E. M. Magomedova

Republican Oncology Center

24 Gadzhieva St., Makhachkala 367008, Russia

Russian Federation

A. O. Milyukova

Sakhalin Regional Oncology Dispensary

3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia

Russian Federation

S. T. Nazranova

Oncology Dispensary, Ministry of Health of Kabardino-Balkar Republic

23 Lermontova St., Nalchik 360051, Russia

Russian Federation

N. E. Musaeva

A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center

 16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia

Russian Federation

N. V. Prokudina

Regional Clinical Hospital of Kaliningrad Region

74 Klinicheskaya St., Kaliningrad 236016, Russia

Russian Federation

P. R. Rabadanova

Republican Oncology Center

24 Gadzhieva St., Makhachkala 367008, Russia

Russian Federation

N. D. Romanova

National Medical Research Center of Treatment and Rehabilitation

3 Ivankovskoe Shosse, Moscow 125367, Russia

Russian Federation

O. V. Romanchuk

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia

Russian Federation

P. A. Sakulin

National Medical Research Center of Treatment and Rehabilitation

3 Ivankovskoe Shosse, Moscow 125367, Russia

Russian Federation

R. A. Skotnikov

Tula Regional Clinical Oncologic Dispensary

16, Yablochkova St., Tula 300053, Russia

Russian Federation

A. B. Sunyaykin

Sakhalin Regional Oncology Dispensary

3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia

Russian Federation

A. I. Tabakova

Mytishchi City Clinical Hospital

 24 Cominterna St., Mytishchi 141009, Russia

Russian Federation

E. A. Talalaeva

Central City Hospital No. 3

16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia

Russian Federation

K. V. Titov

Moscow Regional Clinical Oncologic Dispensary

6 Karbysheva St., Balashiha 143900, Russia

Russian Federation

E. E. Tonenkova

Nizhny Novgorod Regional Clinical Oncological Dispensary

11/1 Delovaya St., Nizhny Novgorod 603093, Russia

Russian Federation

Yu. A. Trushina

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia

Russian Federation

I. S. Usoltseva

Sakhalin Regional Oncology Dispensary

3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia

Russian Federation

Kh. M. Khabrieva

Republican Oncological Dispensary of the Republic of Ingushetia

5 Chechenskaya St., Nazran 386101, Russia;

Russian Federation

F. V. Tsarakhova

Republican Oncology Dispensary

2 Zortova St., Vladikavkaz 362002, Russia

Russian Federation

E. B. Shakhnovich

City Hospital No. 1

24 Tsiolkovskogo St., Korolev 141070, Russia

Russian Federation

A. P. Shishkov

Central City Hospital No. 3

16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia

Russian Federation

A. N. Letuchikh

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0003-4481-4164

23 Kashirskoe Shosse, Moscow 115478, Russia 

Russian Federation

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