P-111 - Final results of the GIDEON (Global Investigational of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) study according to patient...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Cancer Aetiology, Epidemiology, Prevention
Presenter T. Zolfino
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors T. Zolfino1, V. Lorusso2, S. D'Angelo3, D. Sansonno4, A. Benedetti5, V. Montesarchio6, A. Attili7, A. Buonadonna8, S. Barni9, A. Gasbarrini10, M. Pirisi11, U. Cillo12, E. Villa13, P. Giovanis14, G. Pinotti15, G. Raimondo16, C. Erminero17, M. De Giorgio18, D. Germano19, G. Montalto20, S. Marenco21
  • 1AO G. Brotzu, Cagliari/IT
  • 2Oncologic Institute Vito Fazzi Hospital, Lecce/IT
  • 3AO San Giuseppe Moscati, Avellino/IT
  • 4AOU Policlinico Consorziale di Bari G. Bacelli, Bari/IT
  • 5AOU Ospedali Riuniti - PO Umberto I, Ancona/IT
  • 6AORN AO dei Colli Monaldi-Cotugno CTO, Napoli/IT
  • 7Azienda Policlinico Umberto I, Roma/IT
  • 8Istituto Nazionale Tumori, Aviano/IT
  • 9AO Ospedale Treviglio-Caravaggio, Treviglio/IT
  • 10Policlinico Universitario A. Gemelli - UCSC, Roma/IT
  • 11AOU Maggiore della Carità, Novara/IT
  • 12AOU di Padova, Padova/IT
  • 13AOU Policlinico, Modena/IT
  • 14Azienda U.L.S.S. n. 9 di Treviso, Treviso/IT
  • 15Ospedale di Circolo e Fondazione Macchi, Varese/IT
  • 16AOU Policlinico G. Martino, Messina/IT
  • 17Bayer, Milano/IT
  • 18AO Papa Giovanni XXIII, Bergamo/IT
  • 19A.O. G.Rummo, Benevento/IT
  • 20AOUP Paolo Giaccone, Palermo/IT
  • 21IRCCS AUO S. Martino, Genova/IT

Abstract

Introduction

Sorafenib is the only targeted agent indicated for the treatment of hepatocellular carcinoma (HCC). The global, prospective, non-interventional GIDEON study enrolled over 3200 patients (pts) with unresectable HCC (uHCC) treated with sorafenib in real-life clinical practice conditions. The primary objective of the study was to evaluate the safety of sorafenib in HCC patients in clinical practice. Secondary objective was efficacy. We report the final analysis of the Italian subgroup of patients according to etiology.

Methods

Patients with uHCC for whom the decision to administer sorafenib was taken were eligible for enrollment. Disease and patient characteristics were assessed at baseline. Sorafenib dose, adverse events (AEs) and disease assessments were reported at follow-up.

Results

Of 278 pts enrolled in Italy, 274 were evaluable for efficacy and 271 for safety analysis. The median age was 70 years (range: 44-90), 227 pts (83%) were male, 266 pts (97%) Caucasian and disease stage was BCLC-B in 87(32%) and BCLC-C in 142(52%) pts. The etiology of the underlying liver disease was recorded as hepatitis B (hep-B) in 58(21%) pts, hep B only in 39(14%) pts, hepatitis C (hep-C) in 157(57%), hep-C only in 119(43%) pts, alcohol use in 112(41%) pts and nonalcoholic steatohepatitis (NASH) in 7(2.6%) pts.

Overall adverse events were slightly more frequent in pts with hep-B (88%) than those with hep-C (75%) or alcohol use (75%). The type and incidence of AEs were consistent among all subgroups, the most frequent being gastrointestinal (diarrhea/ascites), dermatologic (hand-foot skin reaction/rash) and fatigue. There were no new unexpected AEs.

Median OS in days (months) in pts with hep-B, hep-C, alcohol use, NASH, hep-B only and hep-C only were 351(11.5), 617(20.5), 402(13.1), 211(6.9), 351(11.5) and 633(20.7) respectively.

Conclusion

The most frequent etiology was hep-C followed by alcohol use and hep-B. Safety was consistent with the known profile of sorafenib. Overall survival was longer in the subgroup of hep-C pts than in the other etiology subgroups. This has also been reported in previous analyses.

Table: P-111