Efficacy of the combination of lenvatinib with pembrolizumab in patients with advanced renal cell carcinoma

被引：0

作者：

Volkova, M., I ^{[1
,2
]}

Kalpinskiy, A. S. ^{[3
]}

Goncharova, O. A. ^{[4
]}

Menshikov, K. V. ^{[5
,6
]}

Stativko, O. A. ^{[1
]}

Karabina, E. V. ^{[7
]}

Dergunov, A. S. ^{[8
]}

Polshina, N. I. ^{[9
]}

Aleksandrova, E. N. ^{[10
]}

Lebedinets, A. A. ^{[11
]}

Panov, A. K. ^{[12
]}

Sultanbaev, A. V. ^{[5
]}

Usynin, E. A. ^{[13
]}

Volkonsky, M. V. ^{[14
]}

Mikhalyuk, V. V. ^{[15
]}

Zukov, R. A. ^{[16
,17
]}

Anzhiganova, Yu. V. ^{[16
,17
]}

Gusniev, M. A. ^{[18
]}

Igumnova, E. N. ^{[19
]}

Kuzmicheva, S. V. ^{[20
]}

Pokataev, I. A. ^{[1
]}

Olshanskaya, A. S. ^{[1
]}

Pervakova, N. I. ^{[21
]}

Parsadanova, E. L. ^{[22
]}

Sannikova, T. A. ^{[23
]}

Bystrov, A. A. ^{[14
]}

Dubovichenko, D. M. ^{[24
]}

Mukhitova, M. R. ^{[25
]}

Chubenko, V. A. ^{[26
]}

Shkret, K. A. ^{[27
]}

Gorshenina, M. N. ^{[28
]}

Semenov, A. V. ^{[29
]}

Davlatova, M. K. ^{[25
]}

Kosareva, A. E. ^{[19
,30
]}

Lutoshkina, O. A.

Maslova, O. A. ^{[20
]}

Makhnutina, M. V. ^{[31
]}

Mishina, A. V. ^{[32
]}

Murzalina, M. Zh. ^{[33
]}

Podyacheva, O. A. ^{[34
]}

Kalinin, S. A. ^{[35
]}

Mailyan, O. A. ^{[3
]}

Safarova, A. R. ^{[25
]}

Semenova, K. O. ^{[36
]}

Strokova, M. A. ^{[37
]}

Urashkina, E. Yu. ^{[36
]}

Shmygina, O. S. ^{[38
]}

Novikova, O. Yu. ^{[39
]}

机构：

[1] Moscow Healthcare Dept, City Clin Oncol Hosp 1, 18A Zagorodnoe Shosse, Moscow 117152, Russia

[2] Minist Hlth Russia, Russian Med Acad Continuing Profess Educ, Build 1, 2-1 Barrikadnaya St, Moscow 125993, Russia

[3] Minist Hlth Russia, PA Hertzen Moscow Oncol Res Inst, Branch Natl Med Res Radiol Ctr, 3 2nd Botkinskiy Proezd, Moscow 125284, Russia

[4] Minist Hlth Krasnodar Reg, Clin Oncol Dispensary 1, 146 Dimitrova St, Krasnodar 350040, Russia

[5] Minist Hlth Republ Bashkortostan, Republican Clin Oncol Dispensary, 73-1 Oktyabrya Prospekt, Ufa 450054, Russia

[6] Bashkir State Med Univ, Minist Hlth Russia, 3 Lenina St, Ufa 450008, Russia

[7] Tula Reg Clin Oncol Dispensary, 60 Kaluzhskoe Shosse, Tula 300024, Russia

[8] Tver Reg Clin Oncol Dispensary, 57-37 15 let Oktyabrya, Tver 170008, Russia

[9] Moscow Healthcare Dept, AS Loginov Moscow Clin Sci Ctr, 86 Shosse Entuziastov, Moscow 111123, Russia

[10] Yakutsk Republican Oncol Dispensary, 89-5 Petra Alekseeva, Yakutsk 677005, Russia

[11] Leningrad Reg Clin Hosp, Lit A,Build 1,45 Prospekt Lunacharskogo, St Petersburg 194291, Russia

[12] MS Rappoport Kuzbass Clin Oncol Dispensary, 25 Kutuzova St, Novokuznetsk 654041, Russia

[13] Russian Acad Sci, Tomsk Natl Res Med Ctr, 10 Naberezhnaya Reki Ushaiki St, Tomsk 634050, Russia

[14] Moscow Healthcare Dept, Moscow City Oncol Hosp 62, 27 Istra, Moscow 143515, Russia

[15] Nizhnevartovsk Canc Dispensary, 9A Sportivnaya St, Nizhnevartovsk 628615, Russia

[16] VF Voino Yasenetsky Krasnoyarsk State Med Univ, Minist Hlth Russia, 1 Partizana Zheleznyaka St, Krasnoyarsk 660022, Russia

[17] AI Kryzhanovsky Krasnoyarsk Reg Clin Oncol Dispens, 16 1st Smolenskaya St, Krasnoyarsk 660133, Russia

[18] Republican Oncol Ctr, 24 Gaydara Gadzhieva St, Makhachkala 367008, Russia

[19] Perm Reg Oncol Dispensary, 15 Baumana St, Perm 614066, Russia

[20] Moscow Reg Oncol Dispensary, 6 Karbysheva St, Balashikha 143900, Russia

[21] MS Rappoport Kuzbass Clin Oncol Dispensary, 35 Volgogradskaya St, Kemerovo 650036, Russia

[22] Sakhalin Reg Oncol Dispensary, 3 Gorkogo St, Yuzhno Sakhalinsk 693010, Russia

[23] Perm Krai Clin Hosp, 85 Pushkina St, Perm 614990, Russia

[24] Arkhangelsk Clin Oncol Dispensary, Build 1, 145 Proezd Obvodnyy Kanal, Arkhangelsk 163045, Russia

[25] Minist Hlth Republ Tatarstan, Prof MZ Sigal Republican Clin Oncol Dispensary, 29 Sibirskiy Trakt, Kazan 420029, Russia

[26] NP Napalkov St Petersburg Clin Sci & Pract Ctr Spe, Lit A,68A Leningradskaya St, St Petersburg 197758, Russia

[27] Cent City Clin Hosp 24, 16 Rizhskiy Pereulok, Ekaterinburg 620085, Russia

[28] Republican Clin Oncol Dispensary, 22 Osipenko St, Yoshkar Ola 424037, Russia

[29] Ivanovo Reg Oncol Dispensary, 5 Lyubimova St, Ivanovo 153040, Russia

[30] Multidisciplinary Clin Med Ctr Med City, 32 Barnaulskaya St, Tyumen 625041, Russia

[31] Samara Reg Clin Oncol Dispensary, 50 Solnechnaya St, Samara 443031, Russia

[32] Sverdlovsk Reg Oncol Dispensary, 29 Soboleva St, Ekaterinburg 620036, Russia

[33] Orenburg Reg Clin Oncol Dispensary, 11 Prospekt Gagarina, Orenburg 460021, Russia

[34] Reg Clin Oncol Dispensary, 90 12 Sentyabrya St, Ulyanovsk 432017, Russia

[35] NI Pirogov Russian Natl Res Med Univ, Minist Hlth Russia, 1 Ostrovityanova St, Moscow 117513, Russia

[36] Chelyabinsk Reg Clin Ctr Oncol & Nucl Med, 42 Blyukhera St, Chelyabinsk 454087, Russia

[37] VM Efetov Crimean Republican Oncol Clin Dispensary, 49A Bespalova St, Simferopol 295023, Russia

[38] Med Ctr Lotus, 4 Engelsa St, Chelyabinsk 454080, Russia

[39] Reg Clin Ctr Oncol, 164 Voronezhskoe Shosse, Khabarovsk 680042, Russia

来源：

ONKOUROLOGIYA | 2024年 / 20卷 / 03期

关键词：

advanced renal cell carcinoma; lenvatinib; pembrolizumab; survival; objective response; safety; CRITERIA; THERAPY;

D O I：

10.17650/1726-9776-2024-20-3-33-48

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective: to re-evaluate the efficacy and safety of lenvatinib with pembrolizumab in unselected Russian renal cell carcinoma (RCC) patients, included in the phase IV study, in a median follow-up extended to 17.1 months. The primary end point was progression-free survival (PFS), secondary end points were overall survival (OS), objective response rate (ORR) and duration of response (DOR), disease control rate (DCR) and its duration, as well as safety. Materials and methods. The study included medical data of 165 patients with verified advanced RCC who received lenvatinib with pembrolizumab in 36 centers of the Russian Federation from 05.02.2018 to 25.07.2024. The median age was 60 (20-76) years, the male to female ratio was 2.3:1. The majority of patients had Karnofsky performance status >= 80 % (74.6 %), clear cell RCC (93.3 %) without sarcomatoid differentiation (93.3 %), metachronous metastases (50.9 %) localized in >1 organ (75.2 %), were nephrectomized (63.0 %) and did not receive antitumor therapy (91.0 %). At the time of lenvatinib with pembrolizumab therapy start 40 patients (24.2 %) were classified into International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) favorable prognostic group, 92 (55.8 %) in the intermediate prognostic group, and 33 (20.0 %) in the poor prognostic group. The median follow-up was 17.1 (1.5-72.9) months. Results. The median PFS achieved 24.0 (18.7-29.3) months, 17-month PFS- 60.5%. The median OS was 48.9 (18.5- 79.2) months, 17-month OS - 76.1 %. Objective response was registered in 46.0 % of patients including 2.4 % complete responders; the DCR was 92.1 %. The median DOR was 16.6 (2.1-72.9) months, duration of disease control - 14.3 (2.1-72.9) months. Confirmed dynamics of change in the sum of tumor foci diameters was recorded in 152 patients, while the median change was -25 % (from -100 % to +29 %). Any decrease in the sum of tumor foci diameters occurred in 69.1 % of cases. The incidence of any adverse events (AE) was 78.2 %, severe AE - 24.2 %, and serious AE - 9.7 %. Immune-mediated AEs developed in 17.0 % of cases and AE grades 3-4 in 6.7 % of cases. Mortality from AEs was 1.2 %. Conclusion. Compared with the registration study, in real-world clinical practice in patients with advanced RCC the lenvatinib with pembrolizumab provides a lower ORR with comparable PFS and OS rates and demonstrates a satisfactory safety profile.

引用

页数：170

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