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Efficacy and safety of lenvatinib and pembrolizumab in the treatment of endometrial cancer: data from routine clinical practice in Russia

https://doi.org/10.17650/1994-4098-2023-19-4-104-113

Abstract

Aim. To assess the efficacy and safety of lenvatinib and pembrolizumab for the treatment of mismatch repair-proficient endometrial cancer (EC) in routine clinical practice in Russia.
Materials and methods. This multicenter, retrospective, cohort study included patients with recurrent and metastatic EC from 37 cancer centers in Russia treated between May 2020 and April 2023. Patients with histologically verified EC without microsatellite instability who received ≥1 course of pembrolizumab/lenvatinib therapy were included in the study. 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. The study included 100 patients. Median age was 65 (30–83) years. The most common histologic tumor subtype was endometrioid adenocarcinoma (68 %); serous adenocarcinoma was diagnosed in 22 % of cases, other types of tumor – 10 % of cases. All patients had pMMR/microsatellite-stable tumors. The median progression-free survival was 7.75 months (95 % confidence interval 0.7–33.8), and a partial response to therapy was observed in 24 % of patients. Almost half of the patients (44 %) required dose reduction due to adverse events. The most common adverse events included fatigue (n = 26; 26 %), hypertension (n = 20; 20 %), and hypothyroidism (n = 14; 14 %).
Conclusion. This study confirms the clinical efficacy of lenvatinib and pembrolizumab in patients with recurrent and metastatic EC without mismatch repair system deficiency (pMMR-tumors) in routine clinical practice.

About the Authors

A. A. Rumyantsev
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation

Aleksey Aleksandrovich Rumyantsev

24 Kashirskoe Shosse, Moscow 115522


A. E. Protasova
Saint Petersburg State University; I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia; V.A. Almazov National Medical Research Centre, Ministry of Health of Russia; AVA-PETER LLC
Russian Federation

7–9 Universitetskaya Naberezhnaya, Saint Petersburg 199034;

41 Kirochnaya St., Saint Petersburg 191015;

2 Akkuratova St., Saint Petersburg 197341;

Bld. 2, 4 Ilyushina St., Saint Petersburg 196634


M. Yu. Sheremet
AVA-PETER LLC
Russian Federation

Bld. 2, 4 Ilyushina St., Saint Petersburg 196634


A. Yu. Goryainova
Clinical Oncology Dispensary No. 1, Ministry of Health of Krasnodar Region; Kuban State Medical University
Russian Federation

146 Dimitrova St., Krasnodar 350040;

4 Mitrofana Sedina St., Krasnodar 350063


M. V. Volkonskiy
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


A. G. Kedrova
Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian Federation; Academy of Postgraduate Education, Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian Federation
Russian Federation

28 Orekhovyy Bulvar, Moscow 115682;

91 Volokolamskoe Shosse, Moscow 125371


S. V. Kuzmicheva
Moscow Regional Oncology Dispensary
Russian Federation

6 Karbysheva St., Balashikha 143900


O. N. Aymamedova
Lyubertsy Oncology Dispensary
Russian Federation

338 Oktyabrskiy Prospect, Lyubertsy 140006


Kh. S. Musaeva
Republican Oncology Dispensary, Ministry of Health of Chechen Republic
Russian Federation

81 Leonova St., Grozny 364029


S. M. Soroka
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


O. V. Romanchuk
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation

8 Sosenskiy Stan, Kommunarka, Moscow 108814


V. N. Orlova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


N. G. Graft
A.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation

86 Shosse Enthuziastov, Moscow 111123


M. R. Ibragimova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


Yu. I. Merzlikina
A.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation

86 Shosse Enthuziastov, Moscow 111123


L. V. Stepura
Oncology Dispensary of Shakhty
Russian Federation

153 Shevchenko St., Shakhty 346500


L. B. Tatulova
Mozhaisk Central District Hospital
Russian Federation

1 Ambulatornaya St., Mozhaisk 143200


A. A. Abasova
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation

8 Sosenskiy Stan, Kommunarka, Moscow 108814


A. A. Akopyan
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


E. V. Arsenyeva
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


Yu. V. Vasilyeva
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


A. V. Belonogov
National Medical Research Center, Treatment and Rehabilitation Center, Ministry of Health of Russia
Russian Federation

3 Ivankovskoe Shosse, Moscow 125367


L. V. Krivolapova
B.V. Petrovskiy Russian Research Center of Surgery
Russian Federation

2 Abrikosovskiy Pereulok, GSP-1, Moscow 119435


A. A. Bobryshev
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation

8 Sosenskiy Stan, Kommunarka, Moscow 108814


D. Yu. Vovk
Domodedovo Hospital
Russian Federation

9 Pirogova St., Domodedovo 142005


I. A. Luev
Dr. Laskov’s Clinic
Russian Federation

Bld. 1, 2 Molodogvardeyskaya St., Moscow 121467


N. R. Abidova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


R. S. Zhikhorev
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


T. A. Zhelezkova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


T. T. Grigoryan
S.P. Botkin City Clinical Hospital, Moscow Healthcare Department
Russian Federation

Bld. 28, 5 2-oy Botkinskiy Proezd, Moscow 125284


T. A. Makarkina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


V. A. Ekimov
City Hospital No. 1
Russian Federation

24 Tsiolkovskogo St., Korolev 141070


A. V. Zhizhina
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation

8 Sosenskiy Stan, Kommunarka, Moscow 108814


E. V. Karabina
Tula Regional Oncology Dispensary
Russian Federation

1B Yablochkova St., Tula 300053


O. A. Kuchevskaya
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


V. M. Filippova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


T. A. Linchenko
Regional Clinical Oncology Dispensary
Russian Federation

90 12-go Sentyabrya St., Ulyanovsk 432017


A. A. Lisaeva
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


A. N. Fedorova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


K. S. Maystrenko
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


E. V. Markizova
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation

8 Sosenskiy Stan, Kommunarka, Moscow 108814


E. V. Kogay
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation

24 Kashirskoe Shosse, Moscow 115522


E. P. Krasnorutskaya
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation

6 Staropetrovskiy Proezd, Moscow 125130


M. E. Popova
A.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation

86 Shosse Enthuziastov, Moscow 111123


Yu. Yu. Pchelin
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation

18A Zagorodnoe Shosse, Moscow 117152


R. A. Ryanzhina
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation

68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758


D. B. Sidorov
Moscow Regional Oncology Dispensary
Russian Federation

6 Karbysheva St., Balashikha 143900


E. B. Shakhnovich
City Hospital No. 1
Russian Federation

24 Tsiolkovskogo St., Korolev 141070


S. M. Alekseev
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


M. V. Zinkevich
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


I. O. Belogortsev
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


V. A. Chubenko
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation

68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758


V. M. Moiseenko
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation

68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758


N. Kh. Abduloeva
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation

68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758


A. A. Lebedinets
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


L. V. Strakh
AVA-PETER LLC
Russian Federation

Bld. 2, 4 Ilyushina St., Saint Petersburg 196634


L. K. Semenov
Leningrad Regional Clinical Oncology Dispensary
Russian Federation

37–39 Liteynyy Prospect, Saint Petersburg 191104


M. B. Bolieva
Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia – Alania
Russian Federation

2 Zortova St., Vladikavkaz 362002


F. Z. Aydaeva
Republican Oncology Dispensary, Ministry of Health of Chechen Republic
Russian Federation

81 Leonova St., Grozny 364029


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For citations:

Rumyantsev A.A., Protasova A.E., Sheremet M.Yu., Goryainova A.Yu., Volkonskiy M.V., Kedrova A.G., Kuzmicheva S.V., Aymamedova O.N., Musaeva Kh.S., Soroka S.M., Romanchuk O.V., Orlova V.N., Graft N.G., Ibragimova M.R., Merzlikina Yu.I., Stepura L.V., Tatulova L.B., Abasova A.A., Akopyan A.A., Arsenyeva E.V., Vasilyeva Yu.V., Belonogov A.V., Krivolapova L.V., Bobryshev A.A., Vovk D.Yu., Luev I.A., Abidova N.R., Zhikhorev R.S., Zhelezkova T.A., Grigoryan T.T., Makarkina T.A., Ekimov V.A., Zhizhina A.V., Karabina E.V., Kuchevskaya O.A., Filippova V.M., Linchenko T.A., Lisaeva A.A., Fedorova A.N., Maystrenko K.S., Markizova E.V., Kogay E.V., Krasnorutskaya E.P., Popova M.E., Pchelin Yu.Yu., Ryanzhina R.A., Sidorov D.B., Shakhnovich E.B., Alekseev S.M., Zinkevich M.V., Belogortsev I.O., Chubenko V.A., Moiseenko V.M., Abduloeva N.Kh., Lebedinets A.A., Strakh L.V., Semenov L.K., Bolieva M.B., Aydaeva F.Z. Efficacy and safety of lenvatinib and pembrolizumab in the treatment of endometrial cancer: data from routine clinical practice in Russia. Tumors of female reproductive system. 2023;19(4):104-113. (In Russ.) https://doi.org/10.17650/1994-4098-2023-19-4-104-113

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