Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program

Giuseppe Procopio, Michele Prisciandaro, Roberto Iacovelli, Enrico Cortesi, Giuseppe Fornarini, Gaetano Facchini, Giacomo Cartenì, Roberto Sabbatini, Gabriella Del Bene, Luca Galli, Claudia Caserta, Andrea Giovanni Multari, Marco Bregni, Francesco Massari, Sebastiano Buti, Ugo De Giorgi, Fable Zustovich, Michele Milella, Fabio Calabrò, Maria Laura ManciniGiampaolo Tortora, Claudio Vernieri, Daniele Santini, Mariella Sorarù, Riccardo Ricotta, Cristina Masini, Marcello Tucci, Stefano Luzi Fedeli, Cinzia Ortega, Antonella Mecozzi, Raffaele Ratta, Cora N. Sternberg, Elena Verzoni

Research output: Contribution to journalArticle

Abstract

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.
Original languageEnglish
Pages (from-to)e945-e951
JournalClinical Genitourinary Cancer
Volume16
Issue number4
DOIs
Publication statusPublished - Aug 1 2018

Fingerprint

Renal Cell Carcinoma
Safety
Therapeutics
cabozantinib
Population
Disease-Free Survival

Keywords

  • c-Met, Metastatic renal cell carcinoma, METEOR study, Targeted therapy, VEGF inhibitor

Cite this

Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program. / Procopio, Giuseppe; Prisciandaro, Michele; Iacovelli, Roberto; Cortesi, Enrico; Fornarini, Giuseppe; Facchini, Gaetano; Cartenì, Giacomo; Sabbatini, Roberto; Del Bene, Gabriella; Galli, Luca; Caserta, Claudia; Multari, Andrea Giovanni; Bregni, Marco; Massari, Francesco; Buti, Sebastiano; De Giorgi, Ugo; Zustovich, Fable; Milella, Michele; Calabrò, Fabio; Mancini, Maria Laura; Tortora, Giampaolo; Vernieri, Claudio; Santini, Daniele; Sorarù, Mariella; Ricotta, Riccardo; Masini, Cristina; Tucci, Marcello; Fedeli, Stefano Luzi; Ortega, Cinzia; Mecozzi, Antonella; Ratta, Raffaele; Sternberg, Cora N.; Verzoni, Elena.

In: Clinical Genitourinary Cancer, Vol. 16, No. 4, 01.08.2018, p. e945-e951.

Research output: Contribution to journalArticle

Procopio, G, Prisciandaro, M, Iacovelli, R, Cortesi, E, Fornarini, G, Facchini, G, Cartenì, G, Sabbatini, R, Del Bene, G, Galli, L, Caserta, C, Multari, AG, Bregni, M, Massari, F, Buti, S, De Giorgi, U, Zustovich, F, Milella, M, Calabrò, F, Mancini, ML, Tortora, G, Vernieri, C, Santini, D, Sorarù, M, Ricotta, R, Masini, C, Tucci, M, Fedeli, SL, Ortega, C, Mecozzi, A, Ratta, R, Sternberg, CN & Verzoni, E 2018, 'Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program', Clinical Genitourinary Cancer, vol. 16, no. 4, pp. e945-e951. https://doi.org/10.1016/j.clgc.2018.03.014
Procopio, Giuseppe ; Prisciandaro, Michele ; Iacovelli, Roberto ; Cortesi, Enrico ; Fornarini, Giuseppe ; Facchini, Gaetano ; Cartenì, Giacomo ; Sabbatini, Roberto ; Del Bene, Gabriella ; Galli, Luca ; Caserta, Claudia ; Multari, Andrea Giovanni ; Bregni, Marco ; Massari, Francesco ; Buti, Sebastiano ; De Giorgi, Ugo ; Zustovich, Fable ; Milella, Michele ; Calabrò, Fabio ; Mancini, Maria Laura ; Tortora, Giampaolo ; Vernieri, Claudio ; Santini, Daniele ; Sorarù, Mariella ; Ricotta, Riccardo ; Masini, Cristina ; Tucci, Marcello ; Fedeli, Stefano Luzi ; Ortega, Cinzia ; Mecozzi, Antonella ; Ratta, Raffaele ; Sternberg, Cora N. ; Verzoni, Elena. / Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program. In: Clinical Genitourinary Cancer. 2018 ; Vol. 16, No. 4. pp. e945-e951.
@article{897f5ade53a648568eddb078835ac3b9,
title = "Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program",
abstract = "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.",
keywords = "c-Met, Metastatic renal cell carcinoma, METEOR study, Targeted therapy, VEGF inhibitor",
author = "Giuseppe Procopio and Michele Prisciandaro and Roberto Iacovelli and Enrico Cortesi and Giuseppe Fornarini and Gaetano Facchini and Giacomo Carten{\`i} and Roberto Sabbatini and {Del Bene}, Gabriella and Luca Galli and Claudia Caserta and Multari, {Andrea Giovanni} and Marco Bregni and Francesco Massari and Sebastiano Buti and {De Giorgi}, Ugo and Fable Zustovich and Michele Milella and Fabio Calabr{\`o} and Mancini, {Maria Laura} and Giampaolo Tortora and Claudio Vernieri and Daniele Santini and Mariella Sorar{\`u} and Riccardo Ricotta and Cristina Masini and Marcello Tucci and Fedeli, {Stefano Luzi} and Cinzia Ortega and Antonella Mecozzi and Raffaele Ratta and Sternberg, {Cora N.} and Elena Verzoni",
year = "2018",
month = "8",
day = "1",
doi = "10.1016/j.clgc.2018.03.014",
language = "English",
volume = "16",
pages = "e945--e951",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
publisher = "Elsevier Inc.",
number = "4",

}

TY - JOUR

T1 - Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: 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, Metastatic renal cell carcinoma, METEOR study, Targeted therapy, VEGF inhibitor

U2 - 10.1016/j.clgc.2018.03.014

DO - 10.1016/j.clgc.2018.03.014

M3 - Article

VL - 16

SP - e945-e951

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

SN - 1558-7673

IS - 4

ER -