Efficacy and safety of lenvatinib in combination with everolimus in metastatic renal cell carcinoma resistant to antiangiogenic targeted therapy: Russian multicenter observational study ROSLERCM
| Autor: | M. I. Volkova, A. M. Abdelgafur, M. T. Aivazov, Z. V. Amoev, K. G. Babina, P. S. Borisov, A. A. Vorontsovа, I. V. Evstigneeva, O. I. Evsyukova, O. V. Zhelezin, A. S. Kalpinsky, E. V. Karabina, N. V. Kirdakova, G. P. Kolesnikov, E. S. Kuzmina, D. Kh. Latipova, R. V. Leonenkov, M. R. Maturov, A. V. Meskikh, S. V. Mishugin, E. G. Ovchinnikova, A. S. Olshanskaya, S. A. Protsenko, T. Yu. Semiglazova, R. V. Smirnov, E. A. Usynin, M. M. Fael, E. M. Cherniakova, I. E. Shumskaya |
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| Jazyk: | ruština |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Urology medicine.medical_treatment Population Gastroenterology metastatic renal cell carcinoma 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Renal cell carcinoma Internal medicine medicine Radiology Nuclear Medicine and imaging education Adverse effect 030304 developmental biology 2nd line therapy 0303 health sciences education.field_of_study Everolimus business.industry medicine.disease Nephrectomy Oncology chemistry Tolerability Nephrology lenvatinib in combination with everolimus 030220 oncology & carcinogenesis Medicine Surgery Lenvatinib business Kidney cancer medicine.drug |
| Zdroj: | Onkourologiâ, Vol 15, Iss 3, Pp 56-69 (2019) |
| ISSN: | 1996-1812 1726-9776 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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