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EASL
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196 PROGRAMME AND ABSTRACTSAND ABSTRACTS GENEVA, SWITZERLANDA, SWITZERLAND EASL HCC SUMMITHCC SUMMIT 197
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FEBRUARY 13 - 16, 2014Y 13 - 16, 2014
FEBRUAR
Poster Board Number C1
FINAL ANALYSIS OF EFFICACY AND SAFETY
IN EUROPEAN PATIENTS TREATED WITH
SORAFENIB FOR LESS THAN OR GREATER
THAN 28 WEEKS IN THE GIDEON STUDY

Adina E. Criotoru , Vlad Ratziu , Per I. Stal , Jean-Pierre Bronowicki , Results: Overall, 1113 patients from 22 European countries were evaluable. The
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György M. Bodoky , Bruno Daniele , Christos Papandreou , Juan Turnes , median age was 66 years (range 15–94 years) and 83.3% were male. The duration of
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Phillipe Mathurin , Michael Cox , Fatima Serejo 11 treatment (DoT) was ≤28 weeks in 66.7% of patients and >28 weeks in 33.3%. Baseline
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1 Department of Medical Oncology, Fundeni Clinical Institute, Bucharest, Romania, characteristics were similar with the exception that patients treated for >28 weeks tended
2 Service d’Hépato-Gastroentérologie, Université Pierre et Marie Curie and Hospital Pitié to have a better ECOG performance status (0–1) (91.4% vs 81.2%) and a lower proportion
Salpêtrière, Paris, France, Department of Gastroenterology and Hepatology, Karolinska of Child-Pugh B status (11.3% vs 24.1%) than patients treated for ≤28 weeks. The median
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University Hospital, Stockholm, Sweden, Department of Hepatogastroenterology, Centre time from diagnosis to the start of sorafenib treatment was greater in patients with DoT
Hospitalier Universitaire de Nancy, Université Henri Poincaré–Nancy, Vandoeuvre- >28 weeks (4.8 months) compared with ≤28 weeks (2.9 months). The majority of patients
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lès-Nancy, France, Department of Oncology, St László Teaching Hospital, Budapest, received the recommended daily dose of sorafenib (800 mg). The incidence of drug-
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Hungary, Department of Oncology, G. Rummo Hospital, Benevento, Italy, Department related AEs was greater in patients with a DoT >28 weeks compared with ≤28 weeks
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of Medical Oncology, University Hospital of Larissa, Larissa, Greece, Gastroenterology (78.2% vs 64.2%); however, the incidences of serious AEs (SAEs), drug-related SAEs
Department, Hospital de Montecelo, Complejo Hospitalario de Pontevedra, Pontevedra, and AEs resulting in permanent discontinuation of sorafenib were lower in patients with
Spain, Services des Maladies de l’Appareil Digestif, Hôpital Claude Huriez, Lille, a DoT >28 weeks. Median OS was longer in patients with DoT >28 weeks (23.8 months)
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France, Bayer Healthcare, Basel, Switzerland, Center of Gastroenterology, Liver Unit, compared with patients with DoT ≤28 weeks (5.8 months).
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Hospital de Santa Maria, Faculty of Medicine, Lisbon, Portugal
Conclusions: The safety of sorafenib in European GIDEON uHCC patients appears to
Corresponding author’s e-mail: mark@cancercom.co.uk be consistent with the published safety data. OS was longer in patients with a DoT >28
weeks, which was probably related to the better baseline condition of these patients prior
to the start of treatment.
Introduction: The global, international, non-interventional GIDEON (Global Investigation Disclosure of Interest: A. Criotoru; J.-P. Bronowicki: received consulting, lecture fees
CLINICAL POSTER ABSTRACTS unresectable (u) HCC in real-life clinical practice. We report the final analysis of safety and received consulting fees from Bayer/Onyx Pharmaceuticals, B. Daniele; J. Turnes; P. CLINICAL POSTER ABSTRACTS
of therapeutic decisions in hepatocellular carcinoma [HCC] and of its treatment with
and research support from Bayer/Onyx Pharmaceuticals, V. Ratziu; P. Stal; G. Bodoky:
sorafeNib) study investigated the safety and efficacy of sorafenib in >3200 patients with
Mathurin: received consulting and lecture fees from Bayer/Onyx Pharmaceuticals, M. Cox:
efficacy in European GIDEON patients according to duration of sorafenib treatment: ≤28
received compensated employment from Bayer
weeks or >28 weeks.
Aims: The primary study endpoint was to evaluate the safety of sorafenib. Secondary
endpoints included overall survival (OS) and time to progression (TTP). Patient
demographics, disease characteristics and treatment history were recorded at enrolment.
Sorafenib dose, concomitant medications, performance status, liver function, adverse
events (AEs) and efficacy were recorded at follow-up visits.