Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors

Matteo Santoni; Daniel Y Heng; Sergio Bracarda; Giuseppe Procopio; Michele Milella; Camillo Porta; Marc R Matrana; Giacomo Cartenì; Simon J Crabb; Ugo De Giorgi; Umberto Basso; Cristina Masini; Fabio Calabrò; Maria Giuseppa Vitale; Daniele Santini; Francesco Massari; Luca Galli; Giuseppe Fornarini; Riccardo Ricotta; Sebastiano Buti; Paolo Zucali; Orazio Caffo; Franco Morelli; Francesco Carrozza; Angelo Martignetti; Alain Gelibter; Roberto Iacovelli; Alessandra Mosca; Francesco Atzori; Nuno Vau; Lorena Incorvaia; Cinzia Ortega; Marina Scarpelli; Antonio Lopez-Beltran; Liang Cheng; Vittorio Paolucci; Jeffrey Graham; Erin Pierce; Sarah Scagliarini; Pierangela Sepe; Elena Verzoni; Sara Merler; Mimma Rizzo; Giulia Sorgentoni; Alessandro Conti; Francesco Piva; Alessia Cimadamore; Rodolfo Montironi; Nicola Battelli

doi:10.3390/cancers12010084

Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors

Matteo Santoni, Daniel Y Heng, Sergio Bracarda, Giuseppe Procopio, Michele Milella, Camillo Porta, Marc R Matrana, Giacomo Cartenì, Simon J Crabb, Ugo De Giorgi, Umberto Basso, Cristina Masini, Fabio Calabrò, Maria Giuseppa Vitale, Daniele Santini, Francesco Massari, Luca Galli, Giuseppe Fornarini, Riccardo Ricotta, Sebastiano ButiPaolo Zucali, Orazio Caffo, Franco Morelli, Francesco Carrozza, Angelo Martignetti, Alain Gelibter, Roberto Iacovelli, Alessandra Mosca, Francesco Atzori, Nuno Vau, Lorena Incorvaia, Cinzia Ortega, Marina Scarpelli, Antonio Lopez-Beltran, Liang Cheng, Vittorio Paolucci, Jeffrey Graham, Erin Pierce, Sarah Scagliarini, Pierangela Sepe, Elena Verzoni, Sara Merler, Mimma Rizzo, Giulia Sorgentoni, Alessandro Conti, Francesco Piva, Alessia Cimadamore, Rodolfo Montironi, Nicola Battelli

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Abstract

Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51-10.88) and 11.57 months (95% CI 10.90-not reached (NR)) as second-line and 11.38 months (95% CI 5.79-NR) and NR (95% CI 11.51-NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib-nivolumab and 25.64 months and NR with nivolumab-cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39; 95% CI 1.24-4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04-2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33; 95%CI, 1.16-4.69, p = 0.018) and Hb levels (HR = 3.12; 95%CI 1.18-8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72; 95%CI 1.04-7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.

Original language	English
Article number	E84
Pages (from-to)	1-13
Number of pages	13
Journal	Cancers
Volume	12
Issue number	1
DOIs	https://doi.org/10.3390/cancers12010084
Publication status	Published - Dec 30 2019

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10.3390/cancers12010084

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Santoni, M., Heng, D. Y., Bracarda, S., Procopio, G., Milella, M., Porta, C., Matrana, M. R., Cartenì, G., Crabb, S. J., De Giorgi, U., Basso, U., Masini, C., Calabrò, F., Vitale, M. G., Santini, D., Massari, F., Galli, L., Fornarini, G., Ricotta, R., ... Battelli, N. (2019). Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors. Cancers, 12(1), 1-13. [E84]. https://doi.org/10.3390/cancers12010084

Santoni, M, Heng, DY, Bracarda, S, Procopio, G, Milella, M, Porta, C, Matrana, MR, Cartenì, G, Crabb, SJ, De Giorgi, U , Basso, U , Masini, C, Calabrò, F, Vitale, MG, Santini, D, Massari, F, Galli, L, Fornarini, G, Ricotta, R, Buti, S, Zucali, P, Caffo, O, Morelli, F, Carrozza, F, Martignetti, A, Gelibter, A, Iacovelli, R, Mosca, A, Atzori, F, Vau, N, Incorvaia, L, Ortega, C, Scarpelli, M, Lopez-Beltran, A, Cheng, L, Paolucci, V, Graham, J, Pierce, E, Scagliarini, S, Sepe, P, Verzoni, E, Merler, S, Rizzo, M, Sorgentoni, G, Conti, A, Piva, F, Cimadamore, A, Montironi, R & Battelli, N 2019, 'Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors', Cancers, vol. 12, no. 1, E84, pp. 1-13. https://doi.org/10.3390/cancers12010084

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title = "Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors",

abstract = "Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51-10.88) and 11.57 months (95% CI 10.90-not reached (NR)) as second-line and 11.38 months (95% CI 5.79-NR) and NR (95% CI 11.51-NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib-nivolumab and 25.64 months and NR with nivolumab-cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39; 95% CI 1.24-4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04-2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33; 95%CI, 1.16-4.69, p = 0.018) and Hb levels (HR = 3.12; 95%CI 1.18-8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72; 95%CI 1.04-7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.",

author = "Matteo Santoni and Heng, {Daniel Y} and Sergio Bracarda and Giuseppe Procopio and Michele Milella and Camillo Porta and Matrana, {Marc R} and Giacomo Carten{\`i} and Crabb, {Simon J} and {De Giorgi}, Ugo and Umberto Basso and Cristina Masini and Fabio Calabr{\`o} and Vitale, {Maria Giuseppa} and Daniele Santini and Francesco Massari and Luca Galli and Giuseppe Fornarini and Riccardo Ricotta and Sebastiano Buti and Paolo Zucali and Orazio Caffo and Franco Morelli and Francesco Carrozza and Angelo Martignetti and Alain Gelibter and Roberto Iacovelli and Alessandra Mosca and Francesco Atzori and Nuno Vau and Lorena Incorvaia and Cinzia Ortega and Marina Scarpelli and Antonio Lopez-Beltran and Liang Cheng and Vittorio Paolucci and Jeffrey Graham and Erin Pierce and Sarah Scagliarini and Pierangela Sepe and Elena Verzoni and Sara Merler and Mimma Rizzo and Giulia Sorgentoni and Alessandro Conti and Francesco Piva and Alessia Cimadamore and Rodolfo Montironi and Nicola Battelli",

year = "2019",

month = dec,

day = "30",

doi = "10.3390/cancers12010084",

language = "English",

volume = "12",

pages = "1--13",

journal = "Cancers",

issn = "2072-6694",

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number = "1",

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TY - JOUR

T1 - Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors

AU - Santoni, Matteo

AU - Heng, Daniel Y

AU - Bracarda, Sergio

AU - Procopio, Giuseppe

AU - Milella, Michele

AU - Porta, Camillo

AU - Matrana, Marc R

AU - Cartenì, Giacomo

AU - Crabb, Simon J

AU - De Giorgi, Ugo

AU - Basso, Umberto

AU - Masini, Cristina

AU - Calabrò, Fabio

AU - Vitale, Maria Giuseppa

AU - Santini, Daniele

AU - Massari, Francesco

AU - Galli, Luca

AU - Fornarini, Giuseppe

AU - Ricotta, Riccardo

AU - Buti, Sebastiano

AU - Zucali, Paolo

AU - Caffo, Orazio

AU - Morelli, Franco

AU - Carrozza, Francesco

AU - Martignetti, Angelo

AU - Gelibter, Alain

AU - Iacovelli, Roberto

AU - Mosca, Alessandra

AU - Atzori, Francesco

AU - Vau, Nuno

AU - Incorvaia, Lorena

AU - Ortega, Cinzia

AU - Scarpelli, Marina

AU - Lopez-Beltran, Antonio

AU - Cheng, Liang

AU - Paolucci, Vittorio

AU - Graham, Jeffrey

AU - Pierce, Erin

AU - Scagliarini, Sarah

AU - Sepe, Pierangela

AU - Verzoni, Elena

AU - Merler, Sara

AU - Rizzo, Mimma

AU - Sorgentoni, Giulia

AU - Conti, Alessandro

AU - Piva, Francesco

AU - Cimadamore, Alessia

AU - Montironi, Rodolfo

AU - Battelli, Nicola

PY - 2019/12/30

Y1 - 2019/12/30

N2 - Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51-10.88) and 11.57 months (95% CI 10.90-not reached (NR)) as second-line and 11.38 months (95% CI 5.79-NR) and NR (95% CI 11.51-NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib-nivolumab and 25.64 months and NR with nivolumab-cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39; 95% CI 1.24-4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04-2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33; 95%CI, 1.16-4.69, p = 0.018) and Hb levels (HR = 3.12; 95%CI 1.18-8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72; 95%CI 1.04-7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.

AB - Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51-10.88) and 11.57 months (95% CI 10.90-not reached (NR)) as second-line and 11.38 months (95% CI 5.79-NR) and NR (95% CI 11.51-NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib-nivolumab and 25.64 months and NR with nivolumab-cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39; 95% CI 1.24-4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04-2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33; 95%CI, 1.16-4.69, p = 0.018) and Hb levels (HR = 3.12; 95%CI 1.18-8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72; 95%CI 1.04-7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.

U2 - 10.3390/cancers12010084

DO - 10.3390/cancers12010084

M3 - Article

VL - 12

SP - 1

EP - 13

JO - Cancers

JF - Cancers

SN - 2072-6694

IS - 1

M1 - E84

ER -

Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors

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