Efficacy and safety of lenvatinib plus pembrolizumab in patients with endometrial cancer: data from an extended study of routine clinical practice in Russia
- Authors: Rumyantsev A.A.1, Protasova A.E.2,3,4, Grechkina A.A.5, Volkonskiy M.V.6, Mukhitova M.R.7, Aymamedova O.N.8, Goryainova A.Y.9, Akopyan A.A.6, Gofman A.A.10, Zhelezkova T.A.6, Zhikhorev R.S.6, Krasnorutskaya E.P.6, Abidova N.R.6, Makarkina T.A.6, Sisakyan V.G.11, Skorina M.O.6, Filippova V.M.6, Chebodaev A.K.12, Chernorubashkina N.M.13, Medvedev S.P.14, Bubenko D.N.6, Antipin A.S.15, Vasilyeva Y.V.6, Goloschapova N.S.16, Gonchikov B.V.13, Davydova T.V.17, Khodareva D.V.18, Karpovich M.P.19, Krashihina T.V.20, Lots I.Y.11, Magomedova E.M.21, Milyukova A.O.22, Nazranova S.T.23, Musaeva N.E.18, Prokudina N.V.24, Rabadanova P.R.21, Romanova N.D.14, Romanchuk O.V.19, Sakulin P.A.14, Skotnikov R.A.25, Sunyaykin A.B.22, Tabakova A.I.26, Talalaeva E.A.27, Titov K.V.28, Tonenkova E.E.29, Trushina Y.A.19, Usoltseva I.S.22, Khabrieva K.M.30, Tsarakhova F.V.31, Shakhnovich E.B.32, Shishkov A.P.27, Letuchikh A.N.1
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Affiliations:
- N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
- Saint Petersburg State University
- V.A. Almazov National Medical Research Center, Ministry of Health of Russia
- AVA-PETER LLC
- Primorsky Regional Oncology Center
- Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
- Republican Clinical Oncology Dispensary, Ministry of Health of the Republic of Tatarstan
- Lyubertsy Oncology Dispensary
- Clinical Oncology Dispensary No. 1
- Altai Regional Oncology Dispensary
- Novosibirsk Regional Clinical Oncology Center
- Abakan Interregional Clinical Hospital
- Regional Oncology Center
- National Medical Research Center of Treatment and Rehabilitation
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
- Regional Clinical Oncology Hospital
- Republican Clinical Oncological Dispensary
- A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center
- Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
- Multidisciplinary Medical Center “Lyadov Clinics”
- Republican Oncology Center
- Sakhalin Regional Oncology Dispensary
- Oncology Dispensary, Ministry of Health of Kabardino-Balkar Republic
- Regional Clinical Hospital of Kaliningrad Region
- Tula Regional Clinical Oncologic Dispensary
- Mytishchi City Clinical Hospital
- Central City Hospital No. 3
- Moscow Regional Clinical Oncologic Dispensary
- Nizhny Novgorod Regional Clinical Oncological Dispensary
- Republican Oncological Dispensary of the Republic of Ingushetia
- Republican Oncology Dispensary
- City Hospital No. 1
- Issue: Vol 20, No 4 (2024)
- Pages: 111-118
- Section: GYNECOLOGY. ORIGINAL REPORTS
- Published: 03.12.2024
- URL: https://ojrs.abvpress.ru/ojrs/article/view/1324
- DOI: https://doi.org/10.17650/1994-4098-2024-20-4-111-118
- ID: 1324
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Full Text
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 FederationA. 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 FederationA. A. Grechkina
Primorsky Regional Oncology Center
59 Russkaya St., Vladivostok 690105, Russia
Russian FederationM. V. Volkonskiy
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0003-4060-5015
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationM. 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 FederationO. N. Aymamedova
Lyubertsy Oncology Dispensary
338 Oktyabrskiy Prospect, Lyubertsy 140006, Russia
Russian FederationA. Yu. Goryainova
Clinical Oncology Dispensary No. 1
ORCID iD: 0000-0001-7127-7945
146 Dimitrova St., Krasnodar 350040, Russia
Russian FederationA. A. Akopyan
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0002-0893-9034
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationA. A. Gofman
Altai Regional Oncology Dispensary
10k Zmeinogorskiy Trakt St., Barnaul 656045, Russia
Russian FederationT. A. Zhelezkova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0001-5049-6559
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationR. S. Zhikhorev
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0003-2281-7380
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationE. P. Krasnorutskaya
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationN. R. Abidova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0009-0006-8989-0004
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationT. A. Makarkina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0002-1000-4262
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationV. G. Sisakyan
Novosibirsk Regional Clinical Oncology Center
2 Plakhotnogo St., Novosibirsk 630108, Russia
Russian FederationM. O. Skorina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationV. M. Filippova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0003-1990-175X
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationA. K. Chebodaev
Abakan Interregional Clinical Hospital
57A Chertygasheva St., Abakan 655017, Russia
Russian FederationN. M. Chernorubashkina
Regional Oncology Center
32 Frunze St., Irkutsk 664035, Russia
Russian FederationS. P. Medvedev
National Medical Research Center of Treatment and Rehabilitation
3 Ivankovskoe Shosse, Moscow 125367, Russia
Russian FederationD. N. Bubenko
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationA. S. Antipin
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
ORCID iD: 0000-0003-3147-7023
42 Blyukhera St., Chelyabinsk 454087, Russia
Russian FederationYu. V. Vasilyeva
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
ORCID iD: 0000-0001-6394-1578
6 Staropetrovskiy Proezd, Moscow 125130, Russia
Russian FederationN. S. Goloschapova
Regional Clinical Oncology Hospital
67 Prospekt Oktyabrya, Yaroslavl 150054, Russia
Russian FederationB. V. Gonchikov
Regional Oncology Center
Россия, 664035 Иркутск, ул. Фрунзе, 32
Russian FederationT. V. Davydova
Republican Clinical Oncological Dispensary
173 Tsukanova St., Abakan 655009, Russia
Russian FederationD. V. Khodareva
A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center
16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia
Russian FederationM. P. Karpovich
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
Russian FederationT. V. Krashihina
Multidisciplinary Medical Center “Lyadov Clinics”
21/2 Panfilova St., Khimki 141407, Russia
Russian FederationI. Yu. Lots
Novosibirsk Regional Clinical Oncology Center
ORCID iD: 0009-0004-0139-4491
2 Plakhotnogo St., Novosibirsk 630108, Russia
Russian FederationE. M. Magomedova
Republican Oncology Center
24 Gadzhieva St., Makhachkala 367008, Russia
Russian FederationA. O. Milyukova
Sakhalin Regional Oncology Dispensary
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
Russian FederationS. T. Nazranova
Oncology Dispensary, Ministry of Health of Kabardino-Balkar Republic
23 Lermontova St., Nalchik 360051, Russia
Russian FederationN. E. Musaeva
A.I. Kryzhanovsky Krasnoyarsk Regional Oncological Center
16 1-ya Smolenskaya St., Krasnoyarsk 660133, Russia
Russian FederationN. V. Prokudina
Regional Clinical Hospital of Kaliningrad Region
74 Klinicheskaya St., Kaliningrad 236016, Russia
Russian FederationP. R. Rabadanova
Republican Oncology Center
24 Gadzhieva St., Makhachkala 367008, Russia
Russian FederationN. D. Romanova
National Medical Research Center of Treatment and Rehabilitation
3 Ivankovskoe Shosse, Moscow 125367, Russia
Russian FederationO. V. Romanchuk
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
Russian FederationP. A. Sakulin
National Medical Research Center of Treatment and Rehabilitation
3 Ivankovskoe Shosse, Moscow 125367, Russia
Russian FederationR. A. Skotnikov
Tula Regional Clinical Oncologic Dispensary
16, Yablochkova St., Tula 300053, Russia
Russian FederationA. B. Sunyaykin
Sakhalin Regional Oncology Dispensary
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
Russian FederationA. I. Tabakova
Mytishchi City Clinical Hospital
24 Cominterna St., Mytishchi 141009, Russia
Russian FederationE. A. Talalaeva
Central City Hospital No. 3
16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia
Russian FederationK. V. Titov
Moscow Regional Clinical Oncologic Dispensary
6 Karbysheva St., Balashiha 143900, Russia
Russian FederationE. E. Tonenkova
Nizhny Novgorod Regional Clinical Oncological Dispensary
11/1 Delovaya St., Nizhny Novgorod 603093, Russia
Russian FederationYu. A. Trushina
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
8 Sosenskiy Stan St., Kommunarka Settlement, Moscow 108814, Russia
Russian FederationI. S. Usoltseva
Sakhalin Regional Oncology Dispensary
3 Gorkogo St., Yuzhno-Sakhalinsk 693010, Russia
Russian FederationKh. M. Khabrieva
Republican Oncological Dispensary of the Republic of Ingushetia
5 Chechenskaya St., Nazran 386101, Russia;
Russian FederationF. V. Tsarakhova
Republican Oncology Dispensary
2 Zortova St., Vladikavkaz 362002, Russia
Russian FederationE. B. Shakhnovich
City Hospital No. 1
24 Tsiolkovskogo St., Korolev 141070, Russia
Russian FederationA. P. Shishkov
Central City Hospital No. 3
16 Bratyev Bykovykh St., Ekaterinburg 620027, Russia
Russian FederationA. 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 FederationReferences
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