The long-term clinical efficacy and safety of lenvatinib plus pembrolizumab in endometrial cancer: data from routine clinical practice in Russia

A. E. Protasova; Протасова А. Э.; A. A. Rumyantsev; Румянцев А. А.; M. Yu. Sheremet; Шеремет М. Ю.; A. Yu. Goryainova; Горяйнова А. Ю.; M. V. Volkonsky; Волконский М. В.; A. G. Kedrova; Кедрова А. Г.; S. V. Kuzmicheva; Кузьмичева С. В.; O. N. Aymamedova; Аймамедова О. Н.; Kh. S. Musaeva; Мусаева Х. С.; S. M. Soroka; Сорока С. М.; O. V. Romanchuk; Романчук О. В.; V. N. Orlova; Орлова В. Н.; N. G. Graft; Графт Н. Г.; M. R. Ibragimova; Ибрагимова М. Р.; Yu. I. Merzlikina; Мерзликина Ю. И.; L. V. Stepura; Степура Л. В.; L. B. Tatulova; Татулова Л. Б.; A. A. Abasova; Абасова А. А.; A. A. Akopyan; Акопян А. А.; E. V. Arsenyeva; Арсеньева Е. В.; Yu. V. Vasilyeva; Васильева Ю. В.; A. V. Belonogov; Белоногов А. В.; L. V. Krivolapova; Криволапова Л. В.; A. A. Bobryshev; Бобрышев А. А.; D. Yu. Vovk; Вовк Д. Ю.; I. A. Luev; Луев И. А.; N. R. Abidova; Абидова Н. Р.; R. S. Zhikhorev; Жихорев Р. С.; T. A. Zhelezkova; Железкова Т. А.; T. T. Grigoryan; Григорян Т. Т.; T. A. Makarkina; Макаркина Т. А.; V. A. Ekimov; Екимов В. А.; A. V. Zhizhina; Жижина А. В.; E. V. Karabina; Карабина Е. В.; O. A. Kuchevskaya; Кучевская О. А.; V. M. Filippova; Филиппова В. М.; T. A. Linchenko; Линченко Т. А.; A. A. Lisaeva; Лисаева А. А.; A. N. Fedorova; Федорова А. Н.; K. S. Maystrenko; Майстренко К. С.; E. V. Markizova; Маркизова Е. В.; E. V. Kogay; Когай Е. В.; E. P. Krasnorutskaya; Красноруцкая Е. П.; M. E. Popova; Попова М. Е.; Yu. Yu. Pchelin; Пчелин Ю. Ю.; R. A. Ryanzhina; Рянжина Р. А.; D. B. Sidorov; Сидоров Д. Б.; E. B. Shakhnovich; Шахнович Е. Б.; S. M. Alekseev; Алексеев С. М.; M. V. Zinkevich; Зинькевич М. В.; I. O. Belogortsev; Белогорцев И. О.; V. A. Chubenko; Чубенко В. А.; V. M. Moiseenko; Моисеенко В. М.; N. Kh. Abduloeva; Абдулоева Н. Х.; A. A. Lebedinets; Лебединец А. А.; L. V. Strakh; Страх Л. В.; L. K. Semenov; Семенов Л. К.; M. B. Bolieva; Болиева М. Б.; F. Z. Aydaeva; Айдаева Ф. З.

doi:10.17650/1994-4098-2024-20-3-69-77

The long-term clinical efficacy and safety of lenvatinib plus pembrolizumab in endometrial cancer: data from routine clinical practice in Russia

Authors: Protasova A.E.¹^,2^,3, Rumyantsev A.A.⁴, Sheremet M.Y.⁵, Goryainova A.Y.⁶^,7, Volkonsky M.V.⁸, Kedrova A.G.⁹^,10, Kuzmicheva S.V.¹¹, Aymamedova O.N.¹², Musaeva K.S.¹³, Soroka S.M.¹⁴, Romanchuk O.V.¹⁵, Orlova V.N.¹⁶, Graft N.G.¹⁷, Ibragimova M.R.¹⁶, Merzlikina Y.I.¹⁷, Stepura L.V.¹⁸, Tatulova L.B.¹⁹, Abasova A.A.¹⁵, Akopyan A.A.⁸, Arsenyeva E.V.¹⁶, Vasilyeva Y.V.⁸, Belonogov A.V.²⁰, Krivolapova L.V.²¹, Bobryshev A.A.¹⁵, Vovk D.Y.²², Luev I.A.²³, Abidova N.R.⁸, Zhikhorev R.S.⁸, Zhelezkova T.A.⁸, Grigoryan T.T.²⁴, Makarkina T.A.⁸, Ekimov V.A.²⁵, Zhizhina A.V.¹⁵, Karabina E.V.²⁶, Kuchevskaya O.A.¹⁶, Filippova V.M.⁸, Linchenko T.A.²⁷, Lisaeva A.A.¹⁶, Fedorova A.N.¹⁶, Maystrenko K.S.¹⁶, Markizova E.V.¹⁵, Kogay E.V.¹, Krasnorutskaya E.P.⁸, Popova M.E.¹⁷, Pchelin Y.Y.¹⁶, Ryanzhina R.A.²⁸, Sidorov D.B.¹¹, Shakhnovich E.B.²⁵, Alekseev S.M.¹⁴, Zinkevich M.V.¹⁴, Belogortsev I.O.¹⁴, Chubenko V.A.²⁸, Moiseenko V.M.²⁸, Abduloeva N.K.²⁸, Lebedinets A.A.¹⁴, Strakh L.V.⁵, Semenov L.K.¹⁴, Bolieva M.B.²⁹, Aydaeva F.Z.¹³
Affiliations:
1. Saint Petersburg State University
2. I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia
3. V.A. Almazov National Medical Research Centre, Ministry of Health of Russia
4. N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
5. AVA-PETER LLC
6. Clinical Oncology Dispensary No. 1, Ministry of Health of Krasnodar Region
7. Kuban State Medical University, Ministry of Health of Russia
8. Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
9. Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian Federation
10. Academy of Postgraduate Education, Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian Federation
11. Moscow Regional Oncology Dispensary
12. Lyubertsy Oncology Dispensary
13. Republican Oncology Dispensary, Ministry of Health of Chechen Republic
14. Leningrad Regional Clinical Oncology Dispensary
15. Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
16. City Clinical Oncology Hospital No. 1, Moscow Healthcare Department
17. А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department
18. Oncology Dispensary of Shakhty
19. Mozhaisk Central District Hospital
20. National Medical Research Center, Treatment and Rehabilitation Center, Ministry of Health of Russia
21. B.V. Petrovskiy Russian Research Center of Surgery
22. Domodedovo Hospital
23. Dr. Laskov’s Clinic
24. S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow Healthcare Department
25. City Hospital No. 1
26. Tula Regional Oncology Dispensary
27. Regional Clinical Oncology Dispensary
28. N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)
29. Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia — Alania
Issue: Vol 20, No 3 (2024)
Pages: 69-77
Section: GYNECOLOGY. ORIGINAL REPORTS
Published: 08.11.2024
URL: https://ojrs.abvpress.ru/ojrs/article/view/1278
DOI: https://doi.org/10.17650/1994-4098-2024-20-3-69-77
ID: 1278

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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.

Keywords

immunotargeted therapy, pembrolizumab, lenvatinib, endometrial cancer, real practice

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

Email: protasova1966@yandex.ru
ORCID iD: 0000-0001-7930-8048

Anna Eduardovna Protasova

7—9 Universitetskaya Naberezhnaya, Saint Petersburg 199034; 2 Akkuratova St., Saint Petersburg 197341; 41 Kirochnaya St., Saint Petersburg 191015

Russian Federation

A. A. Rumyantsev

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

Author for correspondence.
ORCID iD: 0000-0003-4443-9974

24 Kashirskoe Shosse, Moscow 115522

Russian Federation

M. Yu. Sheremet

AVA-PETER LLC

ORCID iD: 0009-0008-4392-0700

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

Russian Federation

A. Yu. Goryainova

Clinical Oncology Dispensary No. 1, Ministry of Health of Krasnodar Region; Kuban State Medical University, Ministry of Health of Russia

ORCID iD: 0000-0001-7127-7945

146 Dimitrova St., Krasnodar 350040; Kuban State Medical University, Ministry of Health of Russia

Russian Federation

M. V. Volkonsky

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0003-4060-5015

6 Staropetrovskiy Proezd, Moscow 125130

Russian Federation

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

ORCID iD: 0000-0003-1031-9376

28 Orekhovyy Bulvar, Moscow 115682; 91 Volokolamskoe Shosse, Moscow 125371

Russian Federation

S. V. Kuzmicheva

Moscow Regional Oncology Dispensary

6 Karbysheva St., Balashikha 143900

Russian Federation

O. N. Aymamedova

Lyubertsy Oncology Dispensary

338 Oktyabrskiy Prospekt, Lyubertsy 140006

Russian Federation

Kh. S. Musaeva

Republican Oncology Dispensary, Ministry of Health of Chechen Republic

81 Leonova St., Grozny 364029

Russian Federation

S. M. Soroka

Leningrad Regional Clinical Oncology Dispensary

ORCID iD: 0009-0001-4758-0757

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

O. V. Romanchuk

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan, Kommunarka, Moscow 108814

Russian Federation

V. N. Orlova

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

N. G. Graft

А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department

86 Shosse Entuziastov, Moscow 111123

Russian Federation

M. R. Ibragimova

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

Yu. I. Merzlikina

А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department

86 Shosse Entuziastov, Moscow 111123

Russian Federation

L. V. Stepura

Oncology Dispensary of Shakhty

ORCID iD: 0000-0002-1008-6085

153 Shevchenko St., Shakhty 346500

Russian Federation

L. B. Tatulova

Mozhaisk Central District Hospital

1 Ambulatornaya St., Mozhaisk 143200

Russian Federation

A. A. Abasova

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan, Kommunarka, Moscow 108814

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

Russian Federation

E. V. Arsenyeva

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

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

Russian Federation

A. V. Belonogov

National Medical Research Center, Treatment and Rehabilitation Center, Ministry of Health of Russia

3 Ivankovskoe Shosse, Moscow 125367

Russian Federation

L. V. Krivolapova

B.V. Petrovskiy Russian Research Center of Surgery

2 Abrikosovskiy Pereulok, GSP-1, Moscow 119435

Russian Federation

A. A. Bobryshev

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan, Kommunarka, Moscow 108814

Russian Federation

D. Yu. Vovk

Domodedovo Hospital

9 Pirogova St., Domodedovo 142005

Russian Federation

I. A. Luev

Dr. Laskov’s Clinic

ORCID iD: 0000-0002-7694-0862

Bld. 1, 2 Molodogvardeyskaya St., Moscow 121467

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

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

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

Russian Federation

T. T. Grigoryan

S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow Healthcare Department

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

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

Russian Federation

V. A. Ekimov

City Hospital No. 1

24 Tsiolkovskogo St., Korolev 141070

Russian Federation

A. V. Zhizhina

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan, Kommunarka, Moscow 108814

Russian Federation

E. V. Karabina

Tula Regional Oncology Dispensary

ORCID iD: 0000-0001-6062-5318

1B Yablochkova St., Tula 300053

Russian Federation

O. A. Kuchevskaya

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

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

Russian Federation

T. A. Linchenko

Regional Clinical Oncology Dispensary

90 12-go Sentyabrya St., Ulyanovsk 432017

Russian Federation

A. A. Lisaeva

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

A. N. Fedorova

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

K. S. Maystrenko

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

E. V. Markizova

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

8 Sosenskiy Stan, Kommunarka, Moscow 108814

Russian Federation

E. V. Kogay

Saint Petersburg State University

ORCID iD: 0009-0002-0391-8514

7—9 Universitetskaya Naberezhnaya, Saint Petersburg 199034

Russian Federation

E. P. Krasnorutskaya

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

6 Staropetrovskiy Proezd, Moscow 125130

Russian Federation

M. E. Popova

А.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department

86 Shosse Entuziastov, Moscow 111123

Russian Federation

Yu. Yu. Pchelin

City Clinical Oncology Hospital No. 1, Moscow Healthcare Department

18A Zagorodnoe Shosse, Moscow 117152

Russian Federation

R. A. Ryanzhina

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

ORCID iD: 0009-0002-9370-3866

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

Russian Federation

D. B. Sidorov

Moscow Regional Oncology Dispensary

6 Karbysheva St., Balashikha 143900

Russian Federation

E. B. Shakhnovich

City Hospital No. 1

24 Tsiolkovskogo St., Korolev 141070

Russian Federation

S. M. Alekseev

Leningrad Regional Clinical Oncology Dispensary

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

M. V. Zinkevich

Leningrad Regional Clinical Oncology Dispensary

ORCID iD: 0009-0005-9106-955X

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

I. O. Belogortsev

Leningrad Regional Clinical Oncology Dispensary

ORCID iD: 0009-0005-7328-8222

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

V. A. Chubenko

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

ORCID iD: 0000-0001-6644-6687

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

Russian Federation

V. M. Moiseenko

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

ORCID iD: 0000-0002-2246-0441

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

Russian Federation

N. Kh. Abduloeva

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

ORCID iD: 0000-0001-5236-0241

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

Russian Federation

A. A. Lebedinets

Leningrad Regional Clinical Oncology Dispensary

ORCID iD: 0009-0002-0240-6656

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

L. V. Strakh

AVA-PETER LLC

ORCID iD: 0000-0001-5943-1081

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

Russian Federation

L. K. Semenov

Leningrad Regional Clinical Oncology Dispensary

37—39 Liteynyy Prospect, Saint Petersburg 191104

Russian Federation

M. B. Bolieva

Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia — Alania

2 Zortova St., Vladikavkaz 362002

Russian Federation

F. Z. Aydaeva

Republican Oncology Dispensary, Ministry of Health of Chechen Republic

81 Leonova St., Grozny 364029

Russian Federation

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