Email this article The combination of lenvatinib and pembrolizumab in the treatment of patients with metastatic kidney cancer and factors of poor prognosis: experience of clinics in Moscow: A prospective observational study
- Authors: Pokataev I.A.1, Stroyakovskiy D.L.2, Fedyanin M.Y.3,4,5, Zhukova L.G.6, Stativko O.A.1, Andreyashkina I.I.6, Volkova M.I.1,7, Volkonskiy M.V.2, Polshina N.I.6, Kotova E.V.5, Kravchuk D.A.4, Bystrov A.A.2, Antonova T.G.1, Lyadova M.A.1,8, Kuzmina E.S.1, Parts S.A.1, Salpagarov M.K.6, Galkin V.N.1, Klimov A.V.3
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Affiliations:
- Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
- Moscow City Oncology Hospital №62
- Blokhin National Medical Research Center of Oncology
- Moscow Multidisciplinary Clinical Center “Kommunarka”
- Pirogov National Medical and Surgical Center
- Loginov Moscow Clinical Scientific Center
- Russian Medical Academy of Continuous Professional Education
- Novokuznetsk State Institute for Further Training of Physicians – Branch Campus of the Federal State Budgetary Educational Institution of Further Professional Education «Russian Medical Academy of Continuous Professional Education» of the Ministry of Healthcare of the Russian Federation
- Issue: Vol 26, No 3 (2024)
- Pages: 367-373
- Section: Articles
- URL: https://bakhtiniada.ru/1815-1434/article/view/275833
- DOI: https://doi.org/10.26442/18151434.2024.3.202977
- ID: 275833
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Abstract
Background. Combination therapy is the standard of care for intermediate and poor prognosis metastatic renal cell carcinoma. In the IMDC prognostic classification, tumor stage and histological type are not considered due to the lack of independent impact on overall survival. The CLEAR study demonstrated the efficacy of lenvatinib and pembrolizumab combination in long-term treatment outcomes, including overall survival in poor prognosis compared to sunitinib. The KEYNOTE-B61 study demonstrated high efficacy of this combination in patients with non-clear cell renal cell carcinoma.
Aim. To evaluate the efficacy of the combination of lenvatinib and pembrolizumab in patients with high tumor burden and non-clear cell histotypes.
Materials and methods. This prospective observational study included 54 patients with metastatic renal cell carcinoma who received a combination of lenvatinib and pemrolizumab in the first line between 2022 and May 2024 in oncology clinics of the Moscow Department of Health. Clear cell histotype was represented in 79.6% of cases, 14.8% had papillary cancer, and 5.6% of patients had chromophobe cancer. The primary endpoint was the objective response rate.
Results. The objective response was assessed in 50 patients. The objective response rate was 38%, including 2% complete response according to RECIST 1.1, disease progression was in 8% of patients. The median depth of response was -25% (from -100% to +28). The median time to response was 12.4 weeks (1.1–38.3).
Conclusion. The efficacy of the combination of lenvatinib and pembrolizumab in real-life clinical practice outside the inclusion criteria of the CLEAR study is clinically significant and allows us to expect improvement even in patients with a large volume of metastatic process and non-clear cell histotype, but the expected benefit in patients with unsatisfactory somatic status remains disputed.
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##article.viewOnOriginalSite##About the authors
Ilya A. Pokataev
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0000-0001-9864-3837
D. Sci. (Med.)
Russian Federation, MoscowDaniil L. Stroyakovskiy
Moscow City Oncology Hospital №62
Email: ipokataev@gmail.com
ORCID iD: 0000-0003-1973-1092
Cand. Sci. (Med.)
Russian Federation, MoscowMikhail Y. Fedyanin
Blokhin National Medical Research Center of Oncology; Moscow Multidisciplinary Clinical Center “Kommunarka”; Pirogov National Medical and Surgical Center
Email: ipokataev@gmail.com
ORCID iD: 0000-0001-5615-7806
D. Sci. (Med.), Moscow Multidisciplinary Clinical Center “Kommunarka”, Blokhin National Medical Research Center of Oncology, Pirogov National Medical and Surgical Center
Russian Federation, Moscow; Moscow; MoscowLiudmila G. Zhukova
Loginov Moscow Clinical Scientific Center
Email: ipokataev@gmail.com
ORCID iD: 0000-0003-4848-6938
D. Sci. (Med.), Corr. Memb. RAS
Russian Federation, MoscowOlesia A. Stativko
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0009-0002-1084-1551
SPIN-code: 3627-0262
Head of the Chemotherapy Department
Russian Federation, MoscowIrina I. Andreyashkina
Loginov Moscow Clinical Scientific Center
Email: ipokataev@gmail.com
ORCID iD: 0000-0003-2646-499X
D. Sci. (Med.)
Russian Federation, MoscowMaria I. Volkova
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department; Russian Medical Academy of Continuous Professional Education
Email: ipokataev@gmail.com
ORCID iD: 0000-0001-7754-6624
D. Sci. (Med.), Prof., Moscow State Budgetary Healthcare Institution "Oncological Center No. 1 of Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department", Russian Medical Academy of Continuous Professional Education
Russian Federation, Moscow; MoscowMikhail V. Volkonskiy
Moscow City Oncology Hospital №62
Email: ipokataev@gmail.com
ORCID iD: 0000-0003-4060-5015
Cand. Sci. (Biol.)
Russian Federation, MoscowNatalya I. Polshina
Loginov Moscow Clinical Scientific Center
Email: ipokataev@gmail.com
ORCID iD: 0000-0001-5417-0425
oncologist
Russian Federation, MoscowEkaterina V. Kotova
Pirogov National Medical and Surgical Center
Email: ipokataev@gmail.com
ORCID iD: 0009-0003-2140-352X
Resident
Russian Federation, MoscowDarya A. Kravchuk
Moscow Multidisciplinary Clinical Center “Kommunarka”
Email: ipokataev@gmail.com
ORCID iD: 0000-0002-8780-6159
oncologist
Russian Federation, MoscowAlexandr A. Bystrov
Moscow City Oncology Hospital №62
Email: ipokataev@gmail.com
Cand. Sci. (Med.)
Russian Federation, MoscowTatiana G. Antonova
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0009-0007-6646-7454
Head of the Day Hospital for Antitumor and Drug Therapy Department
Russian Federation, MoscowMarina A. Lyadova
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department; Novokuznetsk State Institute for Further Training of Physicians – Branch Campus of the Federal State Budgetary Educational Institution of Further Professional Education «Russian Medical Academy of Continuous Professional Education» of the Ministry of Healthcare of the Russian Federation
Email: ipokataev@gmail.com
ORCID iD: 0000-0002-9558-5579
Cand. Sci. (Med.), Moscow State Budgetary Healthcare Institution "Oncological Center No. 1 of Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department", Novokuznetsk State Institute for Further Training of Physicians – Branch Campus of the Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
Russian Federation, Moscow; NovokuznetskEvgeniya S. Kuzmina
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0009-0007-2856-5176
SPIN-code: 9668-5733
oncologist, Department Head
Russian Federation, MoscowSergey A. Parts
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0009-0003-9954-4584
Cand. Sci. (Med.)
Russian Federation, MoscowMagomet Kh. Salpagarov
Loginov Moscow Clinical Scientific Center
Email: ipokataev@gmail.com
ORCID iD: 0009-0002-1562-8944
Head of the Oncourology Department
Russian Federation, MoscowVsevolod N. Galkin
Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
Email: ipokataev@gmail.com
ORCID iD: 0000-0002-6619-6179
D. Sci. (Med.), Prof.
Russian Federation, MoscowAlexey V. Klimov
Blokhin National Medical Research Center of Oncology
Author for correspondence.
Email: ipokataev@gmail.com
ORCID iD: 0000-0003-0727-2976
Senior Res. Officer
Russian Federation, MoscowReferences
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