Efficacy and safety of cabozantinib in metastatic renal cell carcinoma patients: Russian multicenter observational study

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Abstract

Purpose: an assessment of efficacy and safety of cabozantinib in unselected patients with metastatic renal cell carcinoma in the first and subsequent lines of therapy.

Materials and methods. Russian multicenter observational study included 92 consecutive patients with morphologically verified metastatic renal cell carcinoma treated with cabozantinib (60 mg/d) in 16 Russian centers. Median age of the patients was 56 (19-79) years, a male-to-female ratio - 3:1. At the start of cabozantinib therapy 27.2 % of patients had ECOG PS 2. Most common histological type of kidney cancer was clear-cell RCC (90.2 %). Most patients were diagnosed with synchronous (71.7 %) multiple metastases (60.9 %). Previous nephrectomy was performed in 87.0 % of cases. Prognosis according to International Metastatic Renal Cancer Database Consortium (IMDC) score was assessed as favorable in 5.4 %, intermediate - in 58.7 % and poor - in 35.9 % patients. Cabozantinib as the first-line therapy was administered in 9 (9.8 %), following 1-5 lines of systemic treatment - in 83 (90.2 %) cases. Median follow-up was 11 (2.3-44.5) months.

Results. In patients, receiving cabozantinib as the first-line therapy, objective response rate was 66.7 %, tumor control was reached in 100 % of cases. Median time to the objective response was 2.6 (1.9-3.6) months, median objective response duration - 13.2 (6.2-21.5) months. Median progression-free survival (PFS) and overall survival (OS) were not reached, 6- and 12-months PFS was 77.8 % and 77.8 %, 6- and 12-months OS - 88.9 % and 88.9 % respectively. Cabozantinib as the second and subsequent lines of therapy provided objective response rate of 34.9 %, tumor control rate - 97.6     %. Median time to the objective response was 2.5 (1.8-4.1) months, median objective response duration - 12.6 (5.5-27.3) months. Median PFS was not reached (6- and 12-months PFS - 92.5 % and 73.1 % respectively), median OS was 32.6      months (6- and 12-months OS - 97.4 % and 80.8 % respectively). Any adverse events (AE) developed in 88.8 %, AE grade III-IV - in 32.6 % of cases. Most frequent AE grade III-IV included arterial hypertension (18.5 %), diarrhea (6.5 %) and palmar-plantar erythrodysesthesia (6.5 %). Unacceptable toxicity demanded treatment cancellation in 2.2 %, therapy interruption - in 16.3 % and dose reduction - in 30.4 % of patients.

Conclusion. Cabozantinib as the first and subsequent lines of therapy for metastatic renal cell carcinoma patients in the real world practice demonstrated high efficacy and better tolerability comparing with population assigned for cabozantinib monotherapy in the randomized phase II-III trials.

About the authors

M. I. Volkova

City Clinical Oncological Hospital No. 1, Moscow Healthcare Department; A.I. Savitskiy Department of Oncology and Palliative Medicine, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia

Author for correspondence.
Email: mivolkova@rambler.ru
ORCID iD: 0000-0001-7754-6624

Mariya I. Volkova.

18 A Zagorodnoe Shosse, Moscow 117152; Build. 1, 2/1 Barrikadnaya St., Moscow 125993

Russian Federation

A. S. Kalpinskiy

P.A. Hertzen Moscow Oncology Research Institute — branch of the National Medical Research Radiological Center, Ministry of Health of Russia

ORCID iD: 0000-0002-2209-3020

3 2nd Botkinskiy Proezd, Moscow 125284

Russian Federation

K. V. Men'shikov

Republican Clinical Oncological Dispensary, Bashkortostan Ministry of Health

73/1 Oktyabrya Prospekt, Ufa 450054

Russian Federation

L. V. Gorbuleva

V.M. Efetov Crimean Republican Oncological Clinical Dispensary

49A Bespalova St., Simferopol, Republic of Crimea 295023

Russian Federation

O. I. Evsyukova

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

ORCID iD: 0000-0002-3016-6357

23 Kashirskoe Shosse, Moscow 115478

Russian Federation

V. R. Meltonyan

N.P. Napalkov Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

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

Russian Federation

S. V. Mishugin

D.D. Pletnyov City Clinical Hospital, Moscow Healthcare Department

32 11th Parkovaya St., Moscow 105077

Russian Federation

M. R. Maturov

D.D. Pletnyov City Clinical Hospital, Moscow Healthcare Department

32 11th Parkovaya St., Moscow 105077

Russian Federation

A. S. Ol'shanskaya

City Clinical Oncological Hospital No. 1, Moscow Healthcare Department (Center for Outpatient Oncological Help of North-Eastern Administrative District)

ORCID iD: 0000-0003-0389-564X

Build. 4, 26 Durova St., Moscow 129090

Russian Federation

D. Yu. Shemetov

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

42 Blyukhera St., Chelyabinsk 454087

Russian Federation

T. A. Sannikova

Perm Regional Oncological Dispensary

15 Baumana St., Perm 614066

Russian Federation

M. V. Makhnutina

Samara Regional Clinical Oncological Dispensary

50 Solnechnaya St., Samara 443031

Russian Federation

M. A. Filip'eva

Samara Regional Clinical Oncological Dispensary

50 Solnechnaya St., Samara 443031

Russian Federation

E. A. Gaysina

Multi-Profile Consulting-Diagnostic Center

117 Mel'nikayte St., Tumen 625026

Russian Federation

E. G. Ovchinnikova

Nizhny Novgorod Regional Clinical Oncology Dispensary

11/1 Delovaya St., Nizhny Novgorod 603163

Russian Federation

V. B. Matveev

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

ORCID iD: 0000-0001-7748-9527

23 Kashirskoe Shosse, Moscow 115478

Russian Federation

B. Ya. Alekseev

P.A. Hertzen Moscow Oncology Research Institute — branch of the National Medical Research Radiological Center, Ministry of Health of Russia; Medical Institute of Continuing Education, Russian Biotechnological University

ORCID iD: 0000-0002-3398-4128

3 2nd Botkinskiy Proezd, Moscow 125284; 11 Volokolamskoe Shosse, Moscow 125080

Russian Federation

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