TY - JOUR
T1 - Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma
T2 - Real-World Data From an Italian Managed Access Program
AU - Procopio, Giuseppe
AU - Prisciandaro, Michele
AU - Iacovelli, Roberto
AU - Cortesi, Enrico
AU - Fornarini, Giuseppe
AU - Facchini, Gaetano
AU - Cartenì, Giacomo
AU - Sabbatini, Roberto
AU - Del Bene, Gabriella
AU - Galli, Luca
AU - Caserta, Claudia
AU - Multari, Andrea Giovanni
AU - Bregni, Marco
AU - Massari, Francesco
AU - Buti, Sebastiano
AU - De Giorgi, Ugo
AU - Zustovich, Fable
AU - Milella, Michele
AU - Calabrò, Fabio
AU - Mancini, Maria Laura
AU - Tortora, Giampaolo
AU - Vernieri, Claudio
AU - Santini, Daniele
AU - Sorarù, Mariella
AU - Ricotta, Riccardo
AU - Masini, Cristina
AU - Tucci, Marcello
AU - Fedeli, Stefano Luzi
AU - Ortega, Cinzia
AU - Mecozzi, Antonella
AU - Ratta, Raffaele
AU - Sternberg, Cora N.
AU - Verzoni, Elena
PY - 2018/8/1
Y1 - 2018/8/1
N2 - The aim of this analysis was to evaluate the safety and activity of cabozantinib in a large unselected population of patients with metastatic renal-cell carcinoma (mRCC) progressing after prior treatments. Our data showed that cabozantinib is effective in a large unselected population of mRCC patients treated in everyday clinical practice. Cabozantinib was also safe and its toxicity profile was feasible and manageable. Background: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. Methods: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016. Patients with mRCC with disease that progressed after one or more prior systemic treatment were evaluated. Cabozantinib 60 mg was administered orally once daily. Doses were reduced to 40 mg or 20 mg in patients experiencing grade 3 or intolerable grade 2 adverse events (AEs). Results: Data from 96 patients were evaluated. Cabozantinib was administered as second-line therapy in 28 patients (29%) and as third-line therapy in 18 patients (19%), while the remaining 50 patients (52%) received cabozantinib in further treatment lines. Sixty-six patients began therapy with the full dose of 60 mg. Because of poor performance status, 29 patients began therapy with a reduced dose of 40 mg and 1 patient with 20 mg. At the time of our analysis, grade 3/4 AEs were observed in 35 patients (36%). Only 5 patients discontinued treatment as a result of AEs. Partial response was observed in 35 patients (36%), whereas 33 (34%) had stable disease and 28 (30%) progressive disease. Median progression-free survival was 8.0 months. Conclusion: Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
AB - The aim of this analysis was to evaluate the safety and activity of cabozantinib in a large unselected population of patients with metastatic renal-cell carcinoma (mRCC) progressing after prior treatments. Our data showed that cabozantinib is effective in a large unselected population of mRCC patients treated in everyday clinical practice. Cabozantinib was also safe and its toxicity profile was feasible and manageable. Background: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. Methods: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016. Patients with mRCC with disease that progressed after one or more prior systemic treatment were evaluated. Cabozantinib 60 mg was administered orally once daily. Doses were reduced to 40 mg or 20 mg in patients experiencing grade 3 or intolerable grade 2 adverse events (AEs). Results: Data from 96 patients were evaluated. Cabozantinib was administered as second-line therapy in 28 patients (29%) and as third-line therapy in 18 patients (19%), while the remaining 50 patients (52%) received cabozantinib in further treatment lines. Sixty-six patients began therapy with the full dose of 60 mg. Because of poor performance status, 29 patients began therapy with a reduced dose of 40 mg and 1 patient with 20 mg. At the time of our analysis, grade 3/4 AEs were observed in 35 patients (36%). Only 5 patients discontinued treatment as a result of AEs. Partial response was observed in 35 patients (36%), whereas 33 (34%) had stable disease and 28 (30%) progressive disease. Median progression-free survival was 8.0 months. Conclusion: Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
KW - c-Met
KW - Metastatic renal cell carcinoma
KW - METEOR study
KW - Targeted therapy
KW - VEGF inhibitor
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UR - http://www.scopus.com/inward/citedby.url?scp=85046658578&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2018.03.014
DO - 10.1016/j.clgc.2018.03.014
M3 - Article
C2 - 29753637
AN - SCOPUS:85046658578
VL - 16
SP - e945-e951
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
SN - 1558-7673
IS - 4
ER -