Article first published online: 30 NOV 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 54, Issue 6, pages 2055–2063, December 2011
How to Cite
Iavarone, M., Cabibbo, G., Piscaglia, F., Zavaglia, C., Grieco, A., Villa, E., Cammà, C., Colombo, M. and on behalf of the SOFIA (SOraFenib Italian Assessment) study group (2011), Field-practice study of sorafenib therapy for hepatocellular carcinoma: A prospective multicenter study in Italy. Hepatology, 54: 2055–2063. doi: 10.1002/hep.24644
Potential conflict of interest: Fabio Piscaglia receives consulting and speaking support from Bayer and Bracco. Massimo Colombo has received grant and research support from Schering-Plough, Roche, Bristol-Myers Squibb, Gilead, and Bayer and is on the Advisory Boards of Schering-Plough, Roche, Novartis, Vertex, Bristol-Myers Squibb, Gilead, Bayer, and Tibotec. He also receives speaking and teaching support from Schering-Plough, Roche, Novartis, Vertex, Bristol-Myers Squibb, Gilead, and Bayer. The other authors have nothing to report. Travel support provided by Gilead (M. I.) and Bayer (G. C.).
SOFIA study group: Milan1—Massimo Iavarone, Angelo Sangiovanni, Sara Vavassori, Raffaella Romeo, and Massimo Colombo; Palermo2,3—Giuseppe Cabibbo, Vito Di Marco, Calogero Cammà, and Antonio Craxì; Bologna4—Alberto Borghi, Alessandro Granito, Fabio Piscaglia, and Luigi Bolondi; Milan5—Claudio Zavaglia, Aldo Airoldi, and Giovambattista Pinzello; Rome6—Marco Biolato, Simona Racco, Maurizio Pompili, and Antonio Grieco; Modena7—Barbara Lei, Nicola De Maria, and Erica Villa.
- Issue published online: 30 NOV 2011
- Article first published online: 30 NOV 2011
- Accepted manuscript online: 2 SEP 2011 09:29AM EST
- Manuscript Accepted: 3 AUG 2011
- Manuscript Received: 29 JUN 2011
A multicenter randomized controlled trial established sorafenib as a standard of care for patients with advanced hepatocellular carcinoma (HCC). Because the study was prematurely interrupted due to survival benefits in the sorafenib arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice. Starting in 2008, all clinically compensated patients with advanced HCC and those with an intermediate HCC who were unfit or failed to respond to ablative therapies were consecutively evaluated in six liver centers in Italy, for tolerability as well as radiologic and survival response to 800-mg/d sorafenib therapy. Treatment was down-dosed or interrupted according to drug label. Two hundred ninety-six patients (88% Child-Pugh A, 75% Barcelona Clinic Liver Cancer [BCLC]-C, and 25% BCLC-B) received sorafenib for 3.8 months (95% CI 3.3-4.4). Two hundred sixty-nine (91%) patients experienced at least one adverse event (AE), whereas 161 (54%) had to reduce dosing. Treatment was interrupted in 103 (44%) for disease progression, in 95 (40%) for an AE, and in 38 (16%) for liver deterioration. The median survival was 10.5 months in the overall cohort, 8.4 months in BCLC-C versus 20.6 months in BCLC-B patients (P < 0.0001), and 21.6 months in the 77 patients treated for >70% of the time with a half dose versus 9.6 months in the 219 patients treated for >70% of the time with a full dose. At month 2 of treatment, the overall radiologic response was 8%. Eastern Cooperative Oncology Group performance status, macrovascular invasion, extrahepatic spread of the tumor, radiologic response at month 2, and sorafenib dosing were independent predictors of shortened survival. Conclusion: Overall, safety, effectiveness, and generalizability of sorafenib therapy in HCC was validated in field practice. The effectiveness of half-dosed sorafenib may have implications for tailored therapy. (HEPATOLOGY 2011)