Alessandro Granito1, Sara Marinelli2, Eleonora Terzi2, Fabio Piscaglia2, Matteo Renzulli3, Laura Venerandi2, Francesca Benevento2, Luigi Bolondi2. 1. Department of Medical and Surgical Sciences, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: alessandro.granito@unibo.it. 2. Department of Medical and Surgical Sciences, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. 3. Radiology Unit, Department of Digestive Diseases and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna, Italy.
Abstract
BACKGROUND: No standard second-line treatments are available for hepatocellular carcinoma patients who fail sorafenib therapy. We assessed the safety and efficacy of metronomic capecitabine after first-line sorafenib failure. METHODS: Retrospective analysis of consecutive hepatocellular carcinoma patients receiving metronomic capecitabine between January 2012 and November 2014. The primary end-point was safety, secondary end-point was efficacy, including time-to-progression and overall survival. RESULTS: Twenty-six patients (80% Child-Pugh A, 80% Barcelona Clinic Liver Cancer stage C) received metronomic capecitabine (500 mg/bid). Median treatment duration was 3.2 months (range 0.6-31). Fourteen (53%) patients experienced at least one adverse event. The most frequent drug-related adverse events were bilirubin elevation (23%), fatigue (15%), anaemia (11%), lymphoedema (11%), and hand-foot syndrome (7.6%). Treatment was interrupted in 19 (73%) for disease progression, in 4 (15%) for liver deterioration, and in 1 (3.8%) for adverse event. Disease control was achieved in 6 (23%) patients. Median time-to-progression was 4 months (95% confidence interval 3.2-4.7). Median overall survival was 8 months (95% confidence interval 3.7-12.3). CONCLUSIONS: Metronomic capecitabine was well tolerated in hepatocellular carcinoma patients who had been treated with sorafenib. Preliminary data show potential anti-tumour activity with long-lasting disease control in a subgroup of patients that warrants further evaluation in a phase III study.
BACKGROUND: No standard second-line treatments are available for hepatocellular carcinomapatients who fail sorafenib therapy. We assessed the safety and efficacy of metronomic capecitabine after first-line sorafenib failure. METHODS: Retrospective analysis of consecutive hepatocellular carcinomapatients receiving metronomic capecitabine between January 2012 and November 2014. The primary end-point was safety, secondary end-point was efficacy, including time-to-progression and overall survival. RESULTS: Twenty-six patients (80% Child-Pugh A, 80% Barcelona Clinic Liver Cancer stage C) received metronomic capecitabine (500 mg/bid). Median treatment duration was 3.2 months (range 0.6-31). Fourteen (53%) patients experienced at least one adverse event. The most frequent drug-related adverse events were bilirubin elevation (23%), fatigue (15%), anaemia (11%), lymphoedema (11%), and hand-foot syndrome (7.6%). Treatment was interrupted in 19 (73%) for disease progression, in 4 (15%) for liver deterioration, and in 1 (3.8%) for adverse event. Disease control was achieved in 6 (23%) patients. Median time-to-progression was 4 months (95% confidence interval 3.2-4.7). Median overall survival was 8 months (95% confidence interval 3.7-12.3). CONCLUSIONS: Metronomic capecitabine was well tolerated in hepatocellular carcinomapatients who had been treated with sorafenib. Preliminary data show potential anti-tumour activity with long-lasting disease control in a subgroup of patients that warrants further evaluation in a phase III study.
Authors: Giovanni Brandi; Michela Venturi; Stefania De Lorenzo; Francesca Garuti; Giorgio Frega; Andrea Palloni; Ingrid Garajovà; Francesca Abbati; Gioconda Saccoccio; Rita Golfieri; Maria Abbondanza Pantaleo; Maria Aurelia Barbera Journal: Cancer Commun (Lond) Date: 2018-06-26
Authors: Franco Trevisani; Giovanni Brandi; Francesca Garuti; Maria Aurelia Barbera; Raffaella Tortora; Andrea Casadei Gardini; Alessandro Granito; Francesco Tovoli; Stefania De Lorenzo; Andrea Lorenzo Inghilesi; Francesco Giuseppe Foschi; Mauro Bernardi; Fabio Marra; Rodolfo Sacco; Giovan Giuseppe Di Costanzo Journal: J Cancer Res Clin Oncol Date: 2017-12-16 Impact factor: 4.322
Authors: Matteo Ravaioli; Alessandro Cucchetti; Antonio Daniele Pinna; Vanessa De Pace; Flavia Neri; Maria Aurelia Barbera; Lorenzo Maroni; Giorgio Frega; Andrea Palloni; Stefania De Lorenzo; Maria Cristina Ripoli; Maria Abbondanza Pantaleo; Matteo Cescon; Massimo Del Gaudio; Giovanni Brandi Journal: Sci Rep Date: 2017-09-12 Impact factor: 4.379