Page 341 - ebook HCC

GENEVA, SWITZERLANDA, SWITZERLAND
PROGRAMME
EASL HCC SUMMITHCC SUMMIT
338 PROGRAMME AND ABSTRACTSAND ABSTRACTS GENEV EASL 339
338
339
FEBRUARY 13 - 16, 2014Y 13 - 16, 2014
FEBRUAR
Poster Board Number C94
FINAL ANALYSIS OF EUROPEAN SUBSET Results: 1113 pts in European countries were evaluable for safety. Overall, the incidence
OF GIDEON (GLOBAL INVESTIGATION OF of AEs and drug-related (DR) AEs was similar across CP subgroups, although serious AEs
(SAEs) were more common in CP-B than CP-A pts. The rate of DRAEs (event per patient-
THERAPEUTIC DECISIONS IN HEPATOCELLULAR year) was comparable for CP-A and CP-B pts. The average daily Sor dose was similar;
CARCINOMA AND OF ITS TREATMENT WITH duration of treatment was longer in CP-A (Table). In the intent-to-treat population (n=1115),
median overall survival (OS) (months [95% CI]) was longer in CP-A (15.0[13.3-17.1]) than
SORAFENIB [SOR]) IN SOR-TREATED PATIENTS CP-B pts (4.9[4.0-6.2]).Median OS was shorter in pts with a higher CP-B score: 7 (6.1[4.0-
(PTS): CLINICAL FINDINGS IN PTS WITH LIVER 10.0]); 8 (8.4 [3.1-9.0]); 9 (3.1 [2.2-4.3]).
DYSFUNCTION Conclusion: Sor safety and dosing during treatment seem to be consistent across pts
irrespective of liver function. Pts with CP-B disease may have a higher rate of serious
AEs. As anticipated, CP status is a strong prognostic factor for OS in uHCC pts.
Jean-Pierre Bronowicki , Philippe Mathurin , Fatima Serejo ,
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Per I. Stal , Juan T. Vazquez , Vlad Ratziu , György M. Bodoky , Adina E. Croitoru ,
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Bruno Daniele , Marc Fellous , Christos Papandreou 11
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1 INSERM Unité 954, Centre Hospitalier Universitaire de Nancy, Université Henri
Poincaré–Nancy, Vandoeuvre-lès-Nancy, Services des Maladies de l’Appareil
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Digestif, Hôpital Claude Huriez, Lille, France, Center of Gastroenterology, Liver
Unit, Hospital de Santa Maria, Faculty of Medicine, Lisbon, Portugal, Department of
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Gastroenterology and Hepatology, Karolinska University Hospital, and Department of
Medicine – Huddinge, Karolinska Institutet, Stockholm, Sweden, Gastroenterology
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Department, Hospital de Montecelo, Complejo Hospitalario de Pontevedra, Pontevedra,
Spain, Université Pierre et Marie Curie and Hospital Pitié Salpêtrière, Paris, France,
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7 Department of Oncology, St László Teaching Hospital, Budapest, Hungary, FUNDENI
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Clinical Institute, Bucharest, Romania, Department of Medical Oncology, G. Rummo
Hospital, Benevento, Italy, Bayer HealthCare Pharmaceuticals, Basel, Switzerland,
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11 Department of Medical Oncology, University Hospital of Larissa, Larissa, Greece
CLINICAL POSTER ABSTRACTS Aims: GIDEON is a prospective, non-interventional study, completion of which provides CLINICAL POSTER ABSTRACTS
Corresponding author’s e-mail: jp.bronowicki@chu-nancy.fr
a global database of >3200 Sor-treated unresectable HCC (uHCC) pts, allowing for
evaluation of a pt population with broad baseline characteristics, including Child-Pugh
(CP) B pts with more advanced liver dysfunction. The results for the European pt subset
are presented.
Methodology: Data were collected in pts for whom a decision to treat with Sor had been
made in clinical practice. Adverse events (AEs), dosing, and outcomes data were collected
during follow-up.