Download the ESMO 2012 Abstract Book - Oxford Journals
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Annals of Oncology<br />
Conclusions: QOL in <strong>the</strong> studied patient population was negatively affected by<br />
fatigue and anorexia, and was improved by good response probably through<br />
decreased pain.<br />
Disclosure: Y. Ohashi: I have an advisory relationship and research funding to<br />
disclose. Name of Entity: Taiho Pharmaceutical Co. Ltd. T. Ioka: I have an advisory<br />
relationship and research funding to disclose. Name of Entity: Taiho Pharmaceutical<br />
Co. Ltd. T. Okusaka: I have an advisory relationship and research funding to disclose.<br />
Name of Entity: Taiho Pharmaceutical Co. Ltd<br />
776TiP GAMMA (GEMCITABINE AND AMG 479 FOR METASTATIC<br />
ADENOCARCINOMA OF THE PANCREAS): A PHASE 3,<br />
MULTICENTER, RANDOMIZED, DOUBLE-BLIND,<br />
PLACEBO-CONTROLLED TRIAL OF GANITUMAB PLUS<br />
GEMCITABINE (G) OR PLACEBO PLUS G AS FIRST-LINE<br />
THERAPY FOR METASTATIC PANCREATIC CANCER<br />
<strong>Abstract</strong> withdrawn in exceptional circumstances.<br />
777TiP SECOND INTERIM ANALYSIS OF THE GLOBAL<br />
INVESTIGATION OF THERAPEUTIC DECISIONS IN<br />
HEPATOCELLULAR CARCINOMA AND OF ITS TREATMENT<br />
WITH SORAFENIB (GIDEON) STUDY ACCORDING TO<br />
DISEASE STAGE<br />
B. Daniele 1 , J. Turnes 2 , G. Bodoky 3 , C. Papandreou 4 , A. Hubert 5 , P. Stål 6 ,<br />
V.A. Gorbunova 7 , F. Serejo 8 , A. Croitoru 9 , P. Mathurin 10<br />
1 Medical Oncology Unit, G. Rummo Hospital, Benevento, ITALY,<br />
2 Gastroenterology Department, Hospital de Montecelo, Pontevedra, SPAIN,<br />
3 Department of Oncology, St László Hospital, Budapest, HUNGARY,<br />
4 Department of Medical Oncology, University Hospital of Larissa, Larissa,<br />
GREECE, 5 Gastrointestinal Cancer Center, Sharett Institute of Oncology,<br />
Jerusalem, ISRAEL, 6 Department of Gastroenterology and Hepatology,<br />
Karolinska University Hospital, Stockholm, SWEDEN, 7 Russian Scientific<br />
Research Oncology Centre, N. N. Blokhin Russian Cancer Research Center,<br />
Moscow, RUSSIAN FEDERATION, 8 Center of Gastroenterology, Liver Unit,<br />
Hospital de Santa Maria, Faculty of Medicine, Lisbon, PORTUGAL, 9 Hepatic<br />
Fundeni, FUNDENI Clinical Institute, Bucharest, ROMANIA, 10 Service Des<br />
Maladies De L’appareil Digestif, Hôpital Claude Huriez, Lille, FRANCE<br />
Background: GIDEON (NCT00812175) is an ongoing, global, prospective,<br />
non-interventional study of patients with unresectable hepatocellular carcinoma<br />
(HCC) receiving sorafenib (Nexavar®) in real-life practice. The aim is to evaluate<br />
sorafenib safety and efficacy in diverse settings and patient groups. The second<br />
interim analysis was triggered when ∼1500 patients had been treated for ≥ 4 months.<br />
We describe sorafenib use in Europe according to disease stage.<br />
Methods: Patient/disease characteristics (including Barcelona Clinic Liver Cancer<br />
[BCLC], tumour node metastases [TNM], Cancer for <strong>the</strong> Liver Italian Programme<br />
[CLIP]) and treatment history were recorded at enrolment; sorafenib dose,<br />
concomitant medications, performance status, liver function, adverse events (AEs)<br />
and efficacy are recorded at follow-up visits.<br />
Results: Of 1571 patients in <strong>the</strong> safety population, 588 are in Europe (see table). The<br />
majority of patients were BCLC-C (52.9%), TNM III (40.3%) or CLIP 1/2 (26.0%/<br />
25.9%), although sorafenib was also used in patients with early, intermediate and<br />
end-stage disease. Generally, AEs and serious AEs (SAEs) increased with advancing<br />
disease (AEs: 66.0%, 87.4%, 85.5%, 89.7%; SAEs: 22.6%, 37.8%, 38.3%, 58.6%; for<br />
BCLC-A, B, C and D; respectively), whereas sorafenib-related AEs and SAEs were<br />
comparable across BCLC groups (AEs: 60.4%, 74.1%, 68.5%, 41.4%; SAEs: 7.5%,<br />
15.4%, 10.3%, 10.3%; for BCLC-A, B, C and D; respectively). Evaluation will<br />
continue with more mature data.<br />
Medical oncologist<br />
(n = 189)<br />
Hepatologist/<br />
GI specialist<br />
(n = 332)<br />
EU total<br />
(n = 588)<br />
BCLC stage at study entry, % of n<br />
A 6.9 8.7 9.0<br />
B 19.6 27.7 24.3<br />
C 59.3 50.6 52.9<br />
D 3.2 5.4 4.9<br />
NE/missing 11.1 7.5 8.8<br />
TNM stage at study entry, % of n<br />
I 3.2 10.5 8.8<br />
II 8.5 12.3 10.2<br />
III 39.2 41.9 40.3<br />
IV 40.2 19.9 26.9<br />
NE/missing 9.0 15.4 13.8<br />
Child-Pugh score at start<br />
of sorafenib <strong>the</strong>rapy, % of n<br />
A 68.3 64.8 66.3<br />
B 13.8 26.8 21.6<br />
C 1.1 1.8 1.5<br />
NE/missing 16.9 6.6 10.5<br />
CLIP score at start of sorafenib <strong>the</strong>rapy, % of n<br />
0 14.8 8.4 11.9<br />
1 24.3 26.5 26.0<br />
2 24.3 26.5 25.9<br />
3 5.8 15.7 11.4<br />
4–6 4.2 11.4 8.7<br />
NE/missing 26.5 11.4 16.2<br />
NE, not evaluable<br />
Conclusions: These data reflect real-world sorafenib given to a broad range of<br />
patients, indicating a similar safety profile across <strong>the</strong> different disease stages.<br />
Evaluation is ongoing, with more mature data expected from <strong>the</strong> final analysis.<br />
Disclosure: B. Daniele: Dr B. Daniele has participated in advisory boards and<br />
received lecture fees from Bayer. J. Turnes: Dr J Turnes has participated in advisory<br />
boards for Roche Pharma. C. Papandreou: Prof. C Papandreou has participated in<br />
advisory boards for Bayer, Sanofi Aventis, Novartis, Bristol Meyers Squibb and<br />
Janssen. P. Stål: Prof. Stål has advised and received a grant from Bayer. A. Croitoru:<br />
Dr A Croitoru has consulted for and received an investigator fee from Bayer. P:<br />
Mathurin: Dr. P . Mathurin was paid speaking at symposia for Roche,<br />
Schering-Plough, Gilead Sciences, Bristol-Myers Squibb, Janssen-Cilag and Bayer<br />
Healthcare pharmaceutical companies. He is an investigator for Roche,<br />
Schering-Plough, Bristol-Myers Squibb, Gilead Sciences, Vertex pharmaceuticals<br />
Janssen-Cilag, Boeringher, Novartis and Bayer Healthcare companies. He is a<br />
member of <strong>the</strong> French boards of experts in Hepatology for Roche Schering-Plough,<br />
Gilead Sciences, Bayer Healthcare and Bristol-Myers Squibb pharmaceutical<br />
companies. He is consulting for <strong>the</strong> Gilead Sciences, Bristol-Myers Squibb, Bayer<br />
Healthcare and Vertex pharmaceutical Companies. All o<strong>the</strong>r authors have declared<br />
no conflicts of interest.<br />
778TiP INTERIM ANALYSIS OF OVERALL SURVIVAL PER<br />
SUBGROUPS IN THE PROSPECTIVE,<br />
NON-INTERVENTIONAL INSIGHT STUDY IN PATIENTS WITH<br />
HEPATOCELLULAR CARCINOMA TREATED WITH<br />
SORAFENIB<br />
T. Ganten 1 , E. Schott 2 , P. Galle 3 , T. Göhler 4 , P. Malfer<strong>the</strong>iner 5 , R. Stauber 6 ,<br />
R. Buder 7 , K. Achilles 8 , G. Gerken 9<br />
1 Medizinische Klinik, Gastroenterologie, Hepatologie und Infektiologie,<br />
Universitätsklinik Heidelberg, Heidelberg, GERMANY, 2 Medizinische Klinik,<br />
Hepatologie und Gastroenterologie, Charité- Campus Virchow Klinikum, Berlin,<br />
GERMANY, 3 I. Medizinische Klinik und Poliklinik, Universitätsmedizin der<br />
Johannes Gutenberg-Universität Mainz, Mainz, GERMANY, 4 Onkologische<br />
Praxis, Dresden, GERMANY, 5 Universitätsklinik für Gastroenterologie,<br />
Hepatologie und Infektiologie, Otto-von-Guericke Universität Magdeburg,<br />
Magdeburg, GERMANY, 6 Karl-Franzens-Universität Graz, Abteilung Innere<br />
Medizin, Gastroenterologie und Hepatologie, Graz, AUSTRIA, 7 Abteilung Innere<br />
Medizin, Konventspital Barmherzige Brüder, Linz, AUSTRIA, 8 Bayer HealthCare,<br />
Leverkusen, GERMANY, 9 Abteilung Gastroenterologie und Hepatologie,<br />
Universitätsklinik Essen, Essen, GERMANY<br />
Background: The efficacy of Sorafenib in patients (pts) with hepatocellular<br />
carcinoma (HCC) has been proven in randomized, controlled trials. INSIGHT is a<br />
Volume 23 | Supplement 9 | September <strong>2012</strong> doi:10.1093/annonc/mds398 | ix255