Open AccessEfficacy and safety of lenvatinib in combination with everolimus in metastatic renal cell carcinoma resistant to antiangiogenic targeted therapy: Russian multicenter observational study ROSLERCM
Author(s) -
Maria Volkova,
Ahmed Abdelgafur,
М. Т. Айвазов,
З. В. Амоев,
К. Г. Бабина,
Pavel Borisov,
А. А. Воронцова,
И. В. Евстигнеева,
О. И. Евсюкова,
О В Железин,
А. С. Калпинский,
Е. В. Карабина,
Н. В. Кирдакова,
Г. П. Колесников,
Е. С. Кузьмина,
D.Kh. Latipova Latipova,
Р. В. Леоненков,
М. Р. Матуров,
А. В. Меских,
С. В. Мишугин,
Е. Г. Овчинникова,
А. С. Ольшанская,
S.A. Protsenko Protsenko,
Т. Ю. Семиглазова,
Р. В. Смирнов,
Е. А. Усынин,
М. М. Фаэль,
Elena M Cherniakova,
И. Э. Шумская
Publication year - 2019
Publication title -
onkourologiâ
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.125
H-Index - 4
eISSN - 1996-1812
pISSN - 1726-9776
DOI - 10.17650/1726-9776-2019-15-3-56-69
Subject(s) - medicine , everolimus , renal cell carcinoma , lenvatinib , adverse effect , kidney cancer , oncology , targeted therapy , combination therapy , urology , cancer , surgery , thyroid cancer
Objective: an assessment of efficacy and safety of lenvatinib in combination with everolimus in unselected patients with metastatic renal cell carcinoma (mRCC) progressed during or following ≥1 line of antiangiogenic targeted therapy. Material. Russian multicenter observational study ROSLERCM included 73 consecutive patients with morphologically verified mRCC progressed during or following ≥1 line of antiangiogenic targeted therapy, treated with lenvatinib (18 mg/d) and everolimus (5 mg/d) in 20 Russian centers. Median age of the patients was 59 (23–73) years, a male-to-female ratio – 3:1. Most common histological type of kidney cancer was clear-cell RCC (71 (95.8 %)). More than 2 lines of previous therapy were administered in 45 (61.6 %) cases. Most patients were diagnosed with multiple metastases (71 (97.3 %)) in >1 site (61 (83.6 %)). Nephrectomy was performed in 87.7 % (64/73) of cases. At the combined therapy start ECOG PS 2–4 was registered in 16 (20.5 %), poor prognosis according to IMDC score – in 33 (45.2 %) patients. Median follow-up was 9.7 (1–26) months. Results. Median progression-free survival achieved 16.9 (95 % confidence intervals (CI) 12.1–20.6), overall survival – 20.8 (95 % CI 15.7–25.9) months. Objective response rate was 11 % (8/73); tumor control was reached in 93.2 % (68/73) of cases. Median objective response duration was 10.5 (4.3–16.8) months, tumor control duration – 10.0 (2.5–17.5) months. Any adverse events developed in 83.6 % (61/73), adverse events grade III–V – in 23.3 % (17/73) of cases. Most frequent AE grade III–IV were diarrhea (10 (13.6 %)) and arterial hypertension (6 (8.2 %)). Unacceptable toxicity demanded treatment cancellation in 4.2 % (3/73), therapy interruption – in 30.1 % (22/73) and dose reduction – in 32.9 % (24/73) of patients. Conclusion. Unselected mRCC patients administered with combined targeted therapy in the real world practice were registered with similar survival, lower objective response rate, and better tolerability comparing with population assigned for lenvatinib plus everolimus in the randomized phase II trial.