The long-term clinical efficacy and safety of lenvatinib plus pembrolizumab in endometrial cancer: data from routine clinical practice in Russia
A. E. Protasova,
A. A. Rumyantsev,
M. Yu. Sheremet,
A. Yu. Goryainova,
M. V. Volkonsky,
A. G. Kedrova,
S. V. Kuzmicheva,
O. N. Aymamedova,
Kh. S. Musaeva,
S. M. Soroka,
O. V. Romanchuk,
V. N. Orlova,
N. G. Graft,
M. R. Ibragimova,
Yu. I. Merzlikina,
L. V. Stepura,
L. B. Tatulova,
A. A. Abasova,
A. A. Akopyan,
E. V. Arsenyeva,
Yu. V. Vasilyeva,
A. V. Belonogov,
L. V. Krivolapova,
A. A. Bobryshev,
D. Yu. Vovk,
I. A. Luev,
N. R. Abidova,
R. S. Zhikhorev,
T. A. Zhelezkova,
T. T. Grigoryan,
T. A. Makarkina,
V. A. Ekimov,
A. V. Zhizhina,
E. V. Karabina,
O. A. Kuchevskaya,
V. M. Filippova,
T. A. Linchenko,
A. A. Lisaeva,
A. N. Fedorova,
K. S. Maystrenko,
E. V. Markizova,
E. V. Kogay,
E. P. Krasnorutskaya,
M. E. Popova,
Yu. Yu. Pchelin,
R. A. Ryanzhina,
D. B. Sidorov,
E. B. Shakhnovich,
S. M. Alekseev,
M. V. Zinkevich,
I. O. Belogortsev,
V. A. Chubenko,
V. M. Moiseenko,
N. Kh. Abduloeva,
A. A. Lebedinets,
L. V. Strakh,
L. K. Semenov,
M. B. Bolieva,
F. Z. Aydaeva https://doi.org/10.17650/1994-4098-2024-20-3-69-77
Abstract
Background. Endometrial cancer (EC) treatment outcomes need to be improved. Immunotargeted therapy lead to long-term and delayed effects compared to chemotherapy. Estimation of long-term efficacy and quality of life are crucial when we are talking about efficacy in whole.
Aim. To evaluate the long-term clinical efficacy of lenvatinib plus pembrolizumab therapy in patients with EC.
Materials and methods. The study included 43 patients with stages I-IV EC with mismatch repair-proficient tumors and treatment duration of more than 9 months. We evaluated median progression-free survival, objective response, duration of treatment depending on the line of therapy, prevalence and type of adverse events, and correction regimens. Results. Lenvatinib plus pembrolizumab treatment was safe and efficacious in recurrent EC. Median of progression-free survival (patients with response or stabilization more than 9 months) is 10.2 months (95 % confidence interval 9.1-13.0), median of follow up is 9.7 (1.4-33.8) months. There were no complete responses, partial response was in 12 (28 %) patients, disease stabilization was in 31 (72 %) patients. Regarding safety, the overall rate of any-grade adverse events was 56.3 %. The most common treatment-related adverse events were fatigue (32.6 %), hypertension (23.3 %), and hypothyroidism (18.6 %). Dose reduction was performed in 22 (51.2 %) patients.
Conclusion. The combination of lenvatinib plus pembrolizumab has long-term efficacy and manageable profile of safety. The presence of a significant pool of patients with durable response allows improving the survival rate of such patients in Russia.
Supporting agencies: This publication has been prepared with the financial support of Eisai. The authors are solely responsible for the content of the publication and editorial decisions
About the Authors
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
Russian Federation
Competing Interests:
Russian Federation
Anna Eduardovna Protasova
7—9 Universitetskaya Naberezhnaya, Saint Petersburg 199034; 2 Akkuratova St., Saint Petersburg 197341; 41 Kirochnaya St., Saint Petersburg 191015
Competing Interests:
The authors declare no conflict of interest
A. A. Rumyantsev
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
24 Kashirskoe Shosse, Moscow 115522
Competing Interests:
The authors declare no conflict of interest
M. Yu. Sheremet
AVA-PETER LLC
Russian Federation
Competing Interests:
Russian Federation
Bld. 2, 4 Ilyushina St., Saint Petersburg 196634
Competing Interests:
The authors declare no conflict of interest
A. Yu. Goryainova
Clinical Oncology Dispensary No. 1, Ministry of Health of Krasnodar Region; Kuban State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
146 Dimitrova St., Krasnodar 350040; Kuban State Medical University, Ministry of Health of Russia
Competing Interests:
The authors declare no conflict of interest
M. V. Volkonsky
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
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
Competing Interests:
Russian Federation
28 Orekhovyy Bulvar, Moscow 115682; 91 Volokolamskoe Shosse, Moscow 125371
Competing Interests:
The authors declare no conflict of interest
S. V. Kuzmicheva
Moscow Regional Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
6 Karbysheva St., Balashikha 143900
Competing Interests:
The authors declare no conflict of interest
O. N. Aymamedova
Lyubertsy Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
338 Oktyabrskiy Prospekt, Lyubertsy 140006
Competing Interests:
The authors declare no conflict of interest
Kh. S. Musaeva
Republican Oncology Dispensary, Ministry of Health of Chechen Republic
Russian Federation
Competing Interests:
Russian Federation
81 Leonova St., Grozny 364029
Competing Interests:
The authors declare no conflict of interest
S. M. Soroka
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
O. V. Romanchuk
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
8 Sosenskiy Stan, Kommunarka, Moscow 108814
Competing Interests:
The authors declare no conflict of interest
V. N. Orlova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
N. G. Graft
А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
86 Shosse Entuziastov, Moscow 111123
Competing Interests:
The authors declare no conflict of interest
M. R. Ibragimova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
Yu. I. Merzlikina
А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
86 Shosse Entuziastov, Moscow 111123
Competing Interests:
The authors declare no conflict of interest
L. V. Stepura
Oncology Dispensary of Shakhty
Russian Federation
Competing Interests:
Russian Federation
153 Shevchenko St., Shakhty 346500
Competing Interests:
The authors declare no conflict of interest
L. B. Tatulova
Mozhaisk Central District Hospital
Russian Federation
Competing Interests:
Russian Federation
1 Ambulatornaya St., Mozhaisk 143200
Competing Interests:
The authors declare no conflict of interest
A. A. Abasova
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
8 Sosenskiy Stan, Kommunarka, Moscow 108814
Competing Interests:
The authors declare no conflict of interest
A. A. Akopyan
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
E. V. Arsenyeva
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
Yu. V. Vasilyeva
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
A. V. Belonogov
National Medical Research Center, Treatment and Rehabilitation Center, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
3 Ivankovskoe Shosse, Moscow 125367
Competing Interests:
The authors declare no conflict of interest
L. V. Krivolapova
B.V. Petrovskiy Russian Research Center of Surgery
Russian Federation
Competing Interests:
Russian Federation
2 Abrikosovskiy Pereulok, GSP-1, Moscow 119435
Competing Interests:
The authors declare no conflict of interest
A. A. Bobryshev
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
8 Sosenskiy Stan, Kommunarka, Moscow 108814
Competing Interests:
The authors declare no conflict of interest
D. Yu. Vovk
Domodedovo Hospital
Russian Federation
Competing Interests:
Russian Federation
9 Pirogova St., Domodedovo 142005
Competing Interests:
The authors declare no conflict of interest
I. A. Luev
Dr. Laskov’s Clinic
Russian Federation
Competing Interests:
Russian Federation
Bld. 1, 2 Molodogvardeyskaya St., Moscow 121467
Competing Interests:
The authors declare no conflict of interest
N. R. Abidova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
R. S. Zhikhorev
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
T. A. Zhelezkova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
T. T. Grigoryan
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
Bld. 28, 5 2-oy Botkinskiy Proezd, Moscow 125284
Competing Interests:
The authors declare no conflict of interest
T. A. Makarkina
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
V. A. Ekimov
City Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
24 Tsiolkovskogo St., Korolev 141070
Competing Interests:
The authors declare no conflict of interest
A. V. Zhizhina
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
8 Sosenskiy Stan, Kommunarka, Moscow 108814
Competing Interests:
The authors declare no conflict of interest
E. V. Karabina
Tula Regional Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
1B Yablochkova St., Tula 300053
Competing Interests:
The authors declare no conflict of interest
O. A. Kuchevskaya
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
V. M. Filippova
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
T. A. Linchenko
Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
90 12-go Sentyabrya St., Ulyanovsk 432017
Competing Interests:
The authors declare no conflict of interest
A. A. Lisaeva
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
A. N. Fedorova
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
K. S. Maystrenko
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
E. V. Markizova
Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
8 Sosenskiy Stan, Kommunarka, Moscow 108814
Competing Interests:
The authors declare no conflict of interest
E. V. Kogay
Saint Petersburg State University
Russian Federation
Competing Interests:
Russian Federation
7—9 Universitetskaya Naberezhnaya, Saint Petersburg 199034
Competing Interests:
The authors declare no conflict of interest
E. P. Krasnorutskaya
Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
6 Staropetrovskiy Proezd, Moscow 125130
Competing Interests:
The authors declare no conflict of interest
M. E. Popova
А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
86 Shosse Entuziastov, Moscow 111123
Competing Interests:
The authors declare no conflict of interest
Yu. Yu. Pchelin
City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
The authors declare no conflict of interest
R. A. Ryanzhina
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation
Competing Interests:
Russian Federation
68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758
Competing Interests:
The authors declare no conflict of interest
D. B. Sidorov
Moscow Regional Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
6 Karbysheva St., Balashikha 143900
Competing Interests:
The authors declare no conflict of interest
E. B. Shakhnovich
City Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
24 Tsiolkovskogo St., Korolev 141070
Competing Interests:
The authors declare no conflict of interest
S. M. Alekseev
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
M. V. Zinkevich
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
I. O. Belogortsev
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
V. A. Chubenko
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation
Competing Interests:
Russian Federation
68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758
Competing Interests:
The authors declare no conflict of interest
V. M. Moiseenko
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation
Competing Interests:
Russian Federation
68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758
Competing Interests:
The authors declare no conflict of interest
N. Kh. Abduloeva
N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
Russian Federation
Competing Interests:
Russian Federation
68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758
Competing Interests:
The authors declare no conflict of interest
A. A. Lebedinets
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
L. V. Strakh
AVA-PETER LLC
Russian Federation
Competing Interests:
Russian Federation
Bld. 2, 4 Ilyushina St., Saint Petersburg 196634
Competing Interests:
The authors declare no conflict of interest
L. K. Semenov
Leningrad Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
37—39 Liteynyy Prospect, Saint Petersburg 191104
Competing Interests:
The authors declare no conflict of interest
M. B. Bolieva
Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia — Alania
Russian Federation
Competing Interests:
Russian Federation
2 Zortova St., Vladikavkaz 362002
Competing Interests:
The authors declare no conflict of interest
F. Z. Aydaeva
Republican Oncology Dispensary, Ministry of Health of Chechen Republic
Russian Federation
Competing Interests:
Russian Federation
81 Leonova St., Grozny 364029
Competing Interests:
The authors declare no conflict of interest
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For citations:
Protasova A.E., Rumyantsev A.A., Sheremet M.Yu., Goryainova A.Yu., Volkonsky 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. The long-term clinical efficacy and safety of lenvatinib plus pembrolizumab in endometrial cancer: data from routine clinical practice in Russia. Tumors of female reproductive system. 2024;20(3):69-77. (In Russ.) https://doi.org/10.17650/1994-4098-2024-20-3-69-77
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