Safety and Efficacy of Cabozantinib for Metastatic Nonclear Renal Cell Carcinoma: Real-world Data From an Italian Managed Access Program

Michele Prisciandaro, Raffaele Ratta, Francesco Massari, Giuseppe Fornarini, Salvatore Caponnetto, Roberto Iacovelli, Ugo De Giorgi, Gaetano Facchini, Sarah Scagliarini, Roberto Sabbatini, Claudia Caserta, Giorgia Peverelli, Alessia Mennitto, Elena Verzoni, Giuseppe Procopio

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: The activity of cabozantinib in nonclear cell histologies has not been evaluated. MATERIALS AND METHODS: Data were collected across 24 Italian hospitals. Patients were aged 18 years and older with advanced nonclear cell renal cell carcinoma (RCC), with an Eastern Cooperative Oncology Group Performance Status 0 to 2, who had relapsed after previous systemic treatments for metastatic disease. Cabozantinib was administered orally at 60 mg once a day in 28 days cycles. Dose reductions to 40 or 20 mg were made due to toxicity. Adverse events (AEs) were monitored using CTCAE version 4.0. RESULTS: Seventeen patients were enrolled. Three (18%) patients were diagnosed type I papillary RCC, 9 (53%) type II papillary, 3 (18%) chromophobe, and 2 (11%) with Bellini duct carcinoma. In total, 11 patients started with 60 mg. Six patients started a lower dose of 40 mg. Median progression-free survival was 7.83 months (0.4 to 13.4 mo), while median overall survival was not reached but 1-year overall survival was about 60%. Six patients (35%) experienced a partial response to treatment and 6 patients (35%) showed a stable disease. In the remaining 5 (30%), we observed a progressive disease. Grade 3 and 4 AEs were observed in 41% of patients. Among 20 patients, only 1 (6%) discontinued treatment due to AEs. Asthenia (41%), diarrhea (35%), aminotransferase increasing (35%), mucosal inflammation (35%), hand and foot syndrome (24%), and hypothyroidism (24%) were the most frequently AEs. CONCLUSIONS: Our data showed that, cabozantinib is a active and feasible treatment in patient with nonclear cell RCC.

Original languageEnglish
Pages (from-to)42-45
Number of pages4
JournalAmerican Journal of Clinical Oncology
Volume42
Issue number1
DOIs
Publication statusPublished - Jan 1 2019

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Renal Cell Carcinoma
Safety
cabozantinib
Hand-Foot Syndrome
Asthenia
Survival
Therapeutics
Hypothyroidism
Transaminases
Disease-Free Survival
Diarrhea
Histology
Inflammation
Carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Safety and Efficacy of Cabozantinib for Metastatic Nonclear Renal Cell Carcinoma : Real-world Data From an Italian Managed Access Program. / Prisciandaro, Michele; Ratta, Raffaele; Massari, Francesco; Fornarini, Giuseppe; Caponnetto, Salvatore; Iacovelli, Roberto; De Giorgi, Ugo; Facchini, Gaetano; Scagliarini, Sarah; Sabbatini, Roberto; Caserta, Claudia; Peverelli, Giorgia; Mennitto, Alessia; Verzoni, Elena; Procopio, Giuseppe.

In: American Journal of Clinical Oncology, Vol. 42, No. 1, 01.01.2019, p. 42-45.

Research output: Contribution to journalArticle

Prisciandaro, Michele ; Ratta, Raffaele ; Massari, Francesco ; Fornarini, Giuseppe ; Caponnetto, Salvatore ; Iacovelli, Roberto ; De Giorgi, Ugo ; Facchini, Gaetano ; Scagliarini, Sarah ; Sabbatini, Roberto ; Caserta, Claudia ; Peverelli, Giorgia ; Mennitto, Alessia ; Verzoni, Elena ; Procopio, Giuseppe. / Safety and Efficacy of Cabozantinib for Metastatic Nonclear Renal Cell Carcinoma : Real-world Data From an Italian Managed Access Program. In: American Journal of Clinical Oncology. 2019 ; Vol. 42, No. 1. pp. 42-45.
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T1 - Safety and Efficacy of Cabozantinib for Metastatic Nonclear Renal Cell Carcinoma

T2 - Real-world Data From an Italian Managed Access Program

AU - Prisciandaro, Michele

AU - Ratta, Raffaele

AU - Massari, Francesco

AU - Fornarini, Giuseppe

AU - Caponnetto, Salvatore

AU - Iacovelli, Roberto

AU - De Giorgi, Ugo

AU - Facchini, Gaetano

AU - Scagliarini, Sarah

AU - Sabbatini, Roberto

AU - Caserta, Claudia

AU - Peverelli, Giorgia

AU - Mennitto, Alessia

AU - Verzoni, Elena

AU - Procopio, Giuseppe

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N2 - OBJECTIVE: The activity of cabozantinib in nonclear cell histologies has not been evaluated. MATERIALS AND METHODS: Data were collected across 24 Italian hospitals. Patients were aged 18 years and older with advanced nonclear cell renal cell carcinoma (RCC), with an Eastern Cooperative Oncology Group Performance Status 0 to 2, who had relapsed after previous systemic treatments for metastatic disease. Cabozantinib was administered orally at 60 mg once a day in 28 days cycles. Dose reductions to 40 or 20 mg were made due to toxicity. Adverse events (AEs) were monitored using CTCAE version 4.0. RESULTS: Seventeen patients were enrolled. Three (18%) patients were diagnosed type I papillary RCC, 9 (53%) type II papillary, 3 (18%) chromophobe, and 2 (11%) with Bellini duct carcinoma. In total, 11 patients started with 60 mg. Six patients started a lower dose of 40 mg. Median progression-free survival was 7.83 months (0.4 to 13.4 mo), while median overall survival was not reached but 1-year overall survival was about 60%. Six patients (35%) experienced a partial response to treatment and 6 patients (35%) showed a stable disease. In the remaining 5 (30%), we observed a progressive disease. Grade 3 and 4 AEs were observed in 41% of patients. Among 20 patients, only 1 (6%) discontinued treatment due to AEs. Asthenia (41%), diarrhea (35%), aminotransferase increasing (35%), mucosal inflammation (35%), hand and foot syndrome (24%), and hypothyroidism (24%) were the most frequently AEs. CONCLUSIONS: Our data showed that, cabozantinib is a active and feasible treatment in patient with nonclear cell RCC.

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