Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia
A. A. Rumyantsev,
A. E. Protasova,
A. A. Grechkina,
M. V. Volkonskiy,
M. R. Mukhitova,
O. N. Aymamedova,
A. Yu. Goryainova,
A. A. Akopyan,
A. A. Gofman,
T. A. Zhelezkova,
R. S. Zhikhorev,
E. P. Krasnorutskaya,
N. R. Abidova,
T. A. Makarkina,
V. G. Sisakyan,
M. O. Skorina,
V. M. Filippova,
A. K. Chebodaev,
N. M. Chernorubashkina,
S. P. Medvedev,
D. N. Bubenko,
A. S. Antipin,
Yu. V. Vasilyeva,
N. S. Goloschapova,
B. V. Gonchikov,
T. V. Davydova,
D. V. Khodareva,
M. P. Karpovich,
T. V. Krashihina,
I. Yu. Lots,
E. M. Magomedova,
A. O. Milyukova,
S. T. Nazranova,
N. E. Musaeva,
N. V. Prokudina,
P. R. Rabadanova,
N. D. Romanova,
O. V. Romanchuk,
P. A. Sakulin,
R. A. Skotnikov,
A. B. Sunyaykin,
A. I. Tabakova,
E. A. Talalaeva,
K. V. Titov,
E. E. Tonenkova,
Yu. A. Trushina,
I. S. Usoltseva,
Kh. M. Khabrieva,
F. V. Tsarakhova,
E. B. Shakhnovich,
A. P. Shishkov,
A. N. Letuchikh https://doi.org/10.17650/1994-4098-2024-20-4-111-118
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.
Supporting agencies: The article was published with the financial support of Eisai Co., Ltd.
About the Authors
A. A. Rumyantsev
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Russian Federation
Aleksey Aleksandrovich Rumyantsev
23 Kashirskoe Shosse, Moscow 115478, Russia
A. E. Protasova
Saint Petersburg State University;
V.A. Almazov National Medical Research Center, Ministry of Health of Russia;
AVA-PETER LLC
Russian Federation
Russian Federation
7–9 Universitetskaya Naberezhnaya, Saint Petersburg 199034, Russia;
2 Akkuratova St., Saint Petersburg 197341, Russia;
Build. 2, 4 Ilyushina St., Saint Petersburg 196634, Russia
A. A. Grechkina
Primorsky Regional Oncology Center
Russian Federation
Russian Federation
59 Russkaya St., Vladivostok 690105, Russia
M. V. Volkonskiy
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
M. R. Mukhitova
Republican Clinical Oncology Dispensary, Ministry of Health of the Republic of Tatarstan
Russian Federation
Russian Federation
29 Sibirskiy Trakt St., Kazan 420029, Russia
O. N. Aymamedova
Lyubertsy Oncology Dispensary
Russian Federation
Russian Federation
338 Oktyabrskiy Prospect, Lyubertsy 140006, Russia
A. Yu. Goryainova
Clinical Oncology Dispensary No. 1
Russian Federation
Russian Federation
146 Dimitrova St., Krasnodar 350040, Russia
A. A. Akopyan
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
A. A. Gofman
Altai Regional Oncology Dispensary
Russian Federation
Russian Federation
10k Zmeinogorskiy Trakt St., Barnaul 656045, Russia
T. A. Zhelezkova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
R. S. Zhikhorev
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
E. P. Krasnorutskaya
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
N. R. Abidova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
T. A. Makarkina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
V. G. Sisakyan
Novosibirsk Regional Clinical Oncology Center
Russian Federation
Russian Federation
2 Plakhotnogo St., Novosibirsk 630108, Russia
M. O. Skorina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
V. M. Filippova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
A. K. Chebodaev
Abakan Interregional Clinical Hospital
Russian Federation
Russian Federation
57A Chertygasheva St., Abakan 655017, Russia
N. M. Chernorubashkina
Regional Oncology Center
Russian Federation
Russian Federation
32 Frunze St., Irkutsk 664035, Russia
S. P. Medvedev
National Medical Research Center of Treatment and Rehabilitation
Russian Federation
Russian Federation
3 Ivankovskoe Shosse, Moscow 125367, Russia
D. N. Bubenko
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
A. S. Antipin
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Russian Federation
Russian Federation
42 Blyukhera St., Chelyabinsk 454087, Russia
Yu. V. Vasilyeva
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130, Russia
N. S. Goloschapova
Regional Clinical Oncology Hospital
Russian Federation
Russian Federation
67 Prospekt Oktyabrya, Yaroslavl 150054, Russia
B. V. Gonchikov
Regional Oncology Center
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
32 Frunze St., Irkutsk 664035, Russia
T. V. Davydova
Republican Clinical Oncological Dispensary
Russian Federation
Russian Federation
173 Tsukanova St., Abakan 655009, Russia
D. V. Khodareva
A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center
Russian Federation
Russian Federation
16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia
M. P. Karpovich
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Russian Federation
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
T. V. Krashihina
Multidisciplinary Medical Center “Lyadov Clinics”
Russian Federation
Russian Federation
21/2 Panfilova St., Khimki 141407, Russia
I. Yu. Lots
Novosibirsk Regional Clinical Oncology Center
Russian Federation
Russian Federation
2 Plakhotnogo St., Novosibirsk 630108, Russia
E. M. Magomedova
Republican Oncology Center
Russian Federation
Russian Federation
24 Gadzhieva St., Makhachkala 367008, Russia
A. O. Milyukova
Sakhalin Regional Oncology Dispensary
Russian Federation
Russian Federation
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
S. T. Nazranova
Oncology Dispensary, Ministry of Health of Kabardino-Balkar Republic
Russian Federation
Russian Federation
23 Lermontova St., Nalchik 360051, Russia
N. E. Musaeva
A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center
Russian Federation
Russian Federation
16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia
N. V. Prokudina
Regional Clinical Hospital of Kaliningrad Region
Russian Federation
Russian Federation
74 Klinicheskaya St., Kaliningrad 236016, Russia
P. R. Rabadanova
Republican Oncology Center
Russian Federation
Russian Federation
24 Gadzhieva St., Makhachkala 367008, Russia
N. D. Romanova
National Medical Research Center of Treatment and Rehabilitation
Russian Federation
Russian Federation
3 Ivankovskoe Shosse, Moscow 125367, Russia
O. V. Romanchuk
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Russian Federation
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
P. A. Sakulin
National Medical Research Center of Treatment and Rehabilitation
Russian Federation
Russian Federation
3 Ivankovskoe Shosse, Moscow 125367, Russia
R. A. Skotnikov
Tula Regional Clinical Oncologic Dispensary
Russian Federation
Russian Federation
16, Yablochkova St., Tula 300053, Russia
A. B. Sunyaykin
Sakhalin Regional Oncology Dispensary
Russian Federation
Russian Federation
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
A. I. Tabakova
Mytishchi City Clinical Hospital
Russian Federation
Russian Federation
24 Cominterna St., Mytishchi 141009, Russia
E. A. Talalaeva
Central City Hospital No. 3
Russian Federation
Russian Federation
16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia
K. V. Titov
Moscow Regional Clinical Oncologic Dispensary
Russian Federation
Russian Federation
6 Karbysheva St., Balashiha 143900, Russia
E. E. Tonenkova
Nizhny Novgorod Regional Clinical Oncological Dispensary
Russian Federation
Russian Federation
11/1 Delovaya St., Nizhny Novgorod 603093, Russia
Yu. A. Trushina
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Russian Federation
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
I. S. Usoltseva
Sakhalin Regional Oncology Dispensary
Russian Federation
Russian Federation
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
Kh. M. Khabrieva
Republican Oncological Dispensary of the Republic of Ingushetia
Russian Federation
Russian Federation
5 Chechenskaya St., Nazran 386101, Russia;
F. V. Tsarakhova
Republican Oncology Dispensary
Russian Federation
Russian Federation
2 Zortova St., Vladikavkaz 362002, Russia
E. B. Shakhnovich
City Hospital No. 1
Russian Federation
Russian Federation
24 Tsiolkovskogo St., Korolev 141070, Russia
A. P. Shishkov
Central City Hospital No. 3
Russian Federation
Russian Federation
16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia
A. N. Letuchikh
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Russian Federation
23 Kashirskoe Shosse, Moscow 115478, Russia
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For citations:
Rumyantsev A.A., Protasova A.E., Grechkina A.A., Volkonskiy M.V., Mukhitova M.R., Aymamedova O.N., Goryainova A.Yu., Akopyan A.A., Gofman A.A., Zhelezkova T.A., Zhikhorev R.S., Krasnorutskaya E.P., Abidova N.R., Makarkina T.A., Sisakyan V.G., Skorina M.O., Filippova V.M., Chebodaev A.K., Chernorubashkina N.M., Medvedev S.P., Bubenko D.N., Antipin A.S., Vasilyeva Yu.V., Goloschapova N.S., Gonchikov B.V., Davydova T.V., Khodareva D.V., Karpovich M.P., Krashihina T.V., Lots I.Yu., Magomedova E.M., Milyukova A.O., Nazranova S.T., Musaeva N.E., Prokudina N.V., Rabadanova P.R., Romanova N.D., Romanchuk O.V., Sakulin P.A., Skotnikov R.A., Sunyaykin A.B., Tabakova A.I., Talalaeva E.A., Titov K.V., Tonenkova E.E., Trushina Yu.A., Usoltseva I.S., Khabrieva Kh.M., Tsarakhova F.V., Shakhnovich E.B., Shishkov A.P., Letuchikh A.N. Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia. Tumors of female reproductive system. 2024;20(4):111-118. (In Russ.) https://doi.org/10.17650/1994-4098-2024-20-4-111-118
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