Abstract
644 Background: 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. Methods: Russian multicenter observational study 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 treatment 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: 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. Median progression-free survival (PFS) achieved 16.9 (95% confidence intervals (CI): 12.1-20.6), overall survival (OS) – 20.8 (95% CI: 15.7-25.9) months. Any adverse events (AE) developed in 83.6% (61/73), AE grade 3-5 - in 23.3% (17/73) of cases. Most frequent AE grade 3-4 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. Conclusions: unselected mRCC patients administered with combined targeted therapy in the real world practice were registered with lower objective response rate, similar survival and better tolerability comparing with population assigned for lenvatinib plus everolimus in the randomized phase II trial.
Highlights
Survival risk factors in patients with refractory metastatic renal cell carcinoma (mRCC) treated with lenvatinib combined with everolimus
Motzer R.J., Hutson T.E., Glen H. et al Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial
Summary
Группа прогноза IMDC: IMDC prognostic group: хороший favorable промежуточный intermediate плохой poor. Результаты При медиане наблюдения 9,7 мес (1–26 мес) лечение продолжают 35 (47,9 %), завершили терапию 38 (52,1 %) из 73 пациентов. Причинами прекращения лечения послужили: прогрессирование в 21 (28,8 %), смерть – в 14 (19,2 %), непереносимая токсичность – в 3 (4,1 %) случаях. Медиана продолжительности завершенной комбинированной таргетной терапии у 38 больных равнялась 7,4 мес (1,0–22,2 мес), медиана количества завершенных циклов терапии – 7. Медиана длительности терапии во всей группе исследования достигла 10,0 мес (1+ – 30,5+ мес), медиана циклов лечения – 9 (0–27). Ответ на лечение оценен у всех пациентов. По критериям RECIST максимальный ответ расценен как частичный в 8 (11,0 %), стабилизация – в 60 (82,2 %), прогрессирование – в 5 (6,8 %) случаях; полных эффектов не зарегистрировано. Медиана времени до развития максимального ответа составила 2 мес (1–4 мес).
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