Efficiency and safety of the everolimus in patients with the generalized renal cell carcinoma (multicentral observational study)

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Abstract

Objective – to evaluate efficacy and safety of everolimus in Russian population of unselected patients with advanced renal cell carcinoma progressing after at least 1 line of anti-angiogenic targeted therapy.

Materials and methods. In observational multicenter study CRAD001LRU03 from 17.01.2012 to 31.03.2015 in 43 centers 226 patients with advanced renal cell carcinoma with documented progression on the background or after at least 1 line of anti-angiogenic targeted therapy were included. The survey was conducted on all patients according to the practice, everolimus therapy was administered in accordance with instructions to the drug.

Results. Objective response rate was 10 %, tumor control was achieved on 69.2 % of patients. Progression-free survival median – 7.8 months. Adverse events occurred in 44.7 % of patients, reached the III–IV severity of 9.3 %, were the reason for the cancellation of everolimus therapy in 2.2 % of cases. The most frequent complications of treatment were pneumonitis (n = 5 (2.2 %)) and anemia (n = 3 (1.3 %)).

Conclusion. The observational study confirms efficacy and favorable safety profile of everolimus mTOR inhibitor in the Russian unselected patients with advanced renal cell carcinoma with progression or intolerable toxicity against background of anti-angiogenic therapy.

About the authors

M. I. Volkova

N.N. Blokhin Russian Cancer Research Center; 23 Kashirskoe Shosse, Moscow, 115478, Russia

Author for correspondence.
Email: mivolkova@rambler.ru
Russian Federation

D. A. Nosov

N.N. Blokhin Russian Cancer Research Center; 23 Kashirskoe Shosse, Moscow, 115478, Russia

Russian Federation

V. A. Chernyaev

N.N. Blokhin Russian Cancer Research Center; 23 Kashirskoe Shosse, Moscow, 115478, Russia

Russian Federation

E. A. Voroshilova

N.N. Blokhin Russian Cancer Research Center; 23 Kashirskoe Shosse, Moscow, 115478, Russia

Russian Federation

M. S. Sayapina

N.N. Blokhin Russian Cancer Research Center; 23 Kashirskoe Shosse, Moscow, 115478, Russia

Russian Federation

G. P. Kolesnikov

Outpatient Department of the Moscow Municipal Oncological Hospital № 62 of Moscow Healthcare Department; 6 Staropetrovskiy Proezd, Moscow, 125130, Russia

Russian Federation

R. V. Leonenkov

St. Petersburg Clinical Research and Practical Center of Specialized Types of Medical Care (Oncologic); 68a Leningradskaya St., township Pesochnyy, Saint Petersburg, 197758, Russia

Russian Federation

D. A. Khvorostenko

Leningrad Regional Oncology Dispensary; 37 Liteynyy Prospekt, Saint Petersburg, 191014, Russia

Russian Federation

P. S. Borisov

City Clinical Oncology Dispensary; 3/5 Second Berezovaya Avenue, Saint Petersburg, 197022, Russia

Russian Federation

M. U. Shushakov

Municipal Polyclinic № 11, filial № 4; 5 Novatorov St., Moscow, 119421, Russia

Russian Federation

N. V. Kirdakova

Clinical Oncology Dispensary № 1 of Moscow Healthcare Department; 17/1 Baumanskaya St., Moscow, 105005, Russia

Russian Federation

B. Ya. Alekseev

P.A. Herzen Moscow Oncology Research Institute Ministry of Health of Russia; 3nd Botkinskiy Passage, Moscow, 125284, Russia

Russian Federation

M. G. Matyash

Novartis, Department of the Oncological Agents; Moscow, Russia

Russian Federation

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