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

Research output: Contribution to journalArticle

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 languageEnglish
Article number84
JournalCancers
Volume12
Issue number1
DOIs
Publication statusPublished - Jan 2020

Fingerprint

Renal Cell Carcinoma
Survival
Disease-Free Survival
Hemoglobins
Multivariate Analysis
Proportional Hazards Models
Therapeutics
Retrospective Studies
cabozantinib
Databases

Keywords

  • Cabozantinib
  • Nivolumab
  • Prognosis
  • Real-world data
  • Renal cell carcinoma
  • Targeted therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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

In: Cancers, Vol. 12, No. 1, 84, 01.2020.

Research output: Contribution to journalArticle

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 2020, '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, 84. https://doi.org/10.3390/cancers12010084
Santoni, Matteo ; Heng, Daniel Y. ; Bracarda, Sergio ; Procopio, Giuseppe ; Milella, Michele ; Porta, Camillo ; Matrana, Marc R. ; Cartenì, Giacomo ; Crabb, Simon J. ; De Giorgi, Ugo ; Basso, Umberto ; Masini, Cristina ; Calabrò, Fabio ; Vitale, Maria Giuseppa ; Santini, Daniele ; Massari, Francesco ; Galli, Luca ; Fornarini, Giuseppe ; Ricotta, Riccardo ; Buti, Sebastiano ; Zucali, Paolo ; Caffo, Orazio ; Morelli, Franco ; Carrozza, Francesco ; Martignetti, Angelo ; Gelibter, Alain ; Iacovelli, Roberto ; Mosca, Alessandra ; Atzori, Francesco ; Vau, Nuno ; Incorvaia, Lorena ; Ortega, Cinzia ; Scarpelli, Marina ; Lopez-Beltran, Antonio ; Cheng, Liang ; Paolucci, Vittorio ; Graham, Jeffrey ; Pierce, Erin ; Scagliarini, Sarah ; Sepe, Pierangela ; Verzoni, Elena ; Merler, Sara ; Rizzo, Mimma ; Sorgentoni, Giulia ; Conti, Alessandro ; Piva, Francesco ; Cimadamore, Alessia ; Montironi, Rodolfo ; Battelli, Nicola. / Real-world data on cabozantinib in previously treated patients with metastatic renal cell carcinoma : Focus on sequences and prognostic factors. In: Cancers. 2020 ; Vol. 12, No. 1.
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T1 - Real-world data on cabozantinib in previously treated patients with metastatic renal cell carcinoma

T2 - 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 - 2020/1

Y1 - 2020/1

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.

KW - Cabozantinib

KW - Nivolumab

KW - Prognosis

KW - Real-world data

KW - Renal cell carcinoma

KW - Targeted therapy

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