title: Metronomic capecitabine versus best supportive care as second-line treatment in hepatocellular carcinoma: a retrospective study.
abstract: Preliminary studies suggest that capecitabine may be safe and effective in HCC patients. The aim of this study was to retrospectively evaluate the safety and efficacy of metronomic capecitabine as second-line treatment. This multicentric study retrospectively analyzed data of HCC patients unresponsive or intolerant to sorafenib treatment with metronomic capecitabine or best supportive care (BSC).Median progression free survival was 3.1 months in patients treated with capecitabine (95%CI: 2.7-3.5). Median overall survival was 12.0 months (95% CI: 10.7-15.8) in patients receiving capecitabine, while 9.0 months (95% CI: 6.5-13.9) in patients receiving BSC. The result of univariate unweighted Cox regression model shows a 46% reduction in death risk for patients on capecitabine (95%CI: 0.357-0.829; p  =0.005) compared to patients receiving BSC alone. After weighting for potential confounders, death risk remained essentially unaltered (45%; 95%CI: 0.354-0.883; p = 0.013). Metronomic capecitabine seems a safe second-line treatment for HCC patients in terms of management of adverse events, showing a potential anti-tumour activity which needs further evaluation in phase III studies.
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Casadei Gardini
authors.affiliation: Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Flavia
authors.initials: F
authors.lastname: Foca
authors.affiliation: Department of Medical Oncology, University of Cagliari, Cagliari, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Scartozzi
authors.affiliation: Department of Medical Oncology, National Cancer Institute "Giovanni Paolo II", Bari, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Silvestris
authors.affiliation: Department of Medical Oncology, Rimini Hospital, Rimini, Italy.
authors.forename: Emiliano
authors.initials: E
authors.lastname: Tamburini
authors.affiliation: Department of Medical Oncology, University of Cagliari, Cagliari, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Faloppi
authors.affiliation: Department of Medical Oncology, National Cancer Institute "Giovanni Paolo II", Bari, Italy.
authors.forename: Oronzo
authors.initials: O
authors.lastname: Brunetti
authors.affiliation: Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Britt
authors.initials: B
authors.lastname: Rudnas
authors.affiliation: Department of Onco-Ematology Medical Oncology, S.G. Moscati Hospital, Taranto, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Valgiusti
authors.affiliation: Biosciences Laboratory, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Marisi
authors.affiliation: Department of Internal Medicine, Ospedale per gli Infermi, Faenza, Italy.
authors.forename: Francesco Giuseppe
authors.initials: FG
authors.lastname: Foschi
authors.affiliation: Department of General Surgery, Morgagni-Pierantoni Hospital, Forlì, Italy.|Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ercolani
authors.affiliation: Department of Medical Oncology, Rimini Hospital, Rimini, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Tassinari
authors.affiliation: Department of Hematology and Oncology, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Giovanni Luca
authors.initials: GL
authors.lastname: Frassineti
mesh_terms: D059250:Administration, Metronomic; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D019233:Retreatment; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000069287:Capecitabine