Z Gastroenterol 2017; 55(08): e57-e299
DOI: 10.1055/s-0037-1604771
Kurzvorträge
Ösophagus und Magen
Karzinogenese und Therapieoptionen bei Ösophagus- und Magenkarzinom: Freitag, 15 September 2017, 11:40 – 13:00, Florenz/Forschungsforum 3
Georg Thieme Verlag KG Stuttgart · New York

Perioperative chemotherapy with docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) versus epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/ECX) for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma (FLOT4-AIO): A multicenter, randomized phase 3 trial

T Götze
1   Krankenhaus Nordwest Frankfurt, Institute of Clinical Cancer Research, Frankfurt, Deutschland
,
N Homann
2   Klinikum Wolfsburg, Department of Internal Medicine, Wolfsburg, Deutschland
,
H Schmalenberg
3   Krankenhaus Dresden-Friedrichstadt, IV. Medizinische Klinik, Dresden, Deutschland
,
HG Kopp
4   University Hospital Tübingen, Medical Center II, Tübingen, Deutschland
,
GM Haag
5   University Hospital, Heidelberg, Department of Medical Oncology, Heidelberg, Deutschland
,
K Luley
6   UKSH Campus Luebeck, Department of Internal Medicine, Lübeck, Deutschland
,
W Schmiegel
7   Ruhr-University Bochum, Department of Internal Medicine, Bochum, Deutschland
,
G Folprecht
8   University Hospital Carl Gustav Carus Dresden, Department of Internal Medicine, Dresden, Deutschland
,
S Probst
9   Klinikum Bielefeld, Department of Medical Oncology, Bielefeld, Deutschland
,
N Prasnikar
10   Asklepios Klinik Altona, Department of Internal Medicine, Hamburg, Deutschland
,
P Thuss-Patience
11   Charité Universitätsmedizin Berlin, Department of Internal Medicine, Berlin, Deutschland
,
W Fischbach
12   Klinikum Aschaffenburg, Department of Internal Medicine, Aschaffenburg, Deutschland
,
J Trojan
13   University Hospital Frankfurt, Department of Gastroenterology and Hepatology, Frankfurt, Deutschland
,
M Koenigsmann
14   Onkologisches Ambulanzzentrum, Onkolgie, Hannover, Deutschland
,
C Pauligk
1   Krankenhaus Nordwest Frankfurt, Institute of Clinical Cancer Research, Frankfurt, Deutschland
,
T Kraus
15   Krankenhaus Nordwest Frankfurt, Department of Surgery, Frankfurt, Deutschland
,
A Battmann
16   Krankenhaus Nordwest Frankfurt, Institute for Pathology, Frankfurt, Deutschland
,
A Paul
17   University Hospital Essen, Department of Surgery, Essen, Deutschland
,
S Mönig
18   Hôpitaux Universitaires de Genève, Service de Chirurgie viscéral, Genf, Schweiz
,
WO Bechstein
19   Universitätsklinikum Frankfurt, Klinik für Allgemein- und Viszeralchirurgie, Frankfurt, Deutschland
,
T Gaiser
20   Universitätsmedizin Mannheim, Pathologisches Institut, Mannheim, Deutschland
,
A Tannapfel
21   Ruhr-Universität Bochum, Institut für Pathologie, Bochum, Deutschland
,
E Jäger
15   Krankenhaus Nordwest Frankfurt, Department of Surgery, Frankfurt, Deutschland
,
M Schuler
22   University Hospital Essen, Department of Medical Oncology, Essen, Deutschland
,
U Lindig
23   Uniklinikum Jena, Department of Internal Medicine II, Jena, Deutschland
,
M Pohl
7   Ruhr-University Bochum, Department of Internal Medicine, Bochum, Deutschland
,
S Kasper
22   University Hospital Essen, Department of Medical Oncology, Essen, Deutschland
,
RD Hofheinz
24   University Medical Center Mannheim, Mannheim, Deutschland
,
SE Al-Batran
1   Krankenhaus Nordwest Frankfurt, Institute of Clinical Cancer Research, Frankfurt, Deutschland
› Institutsangaben
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Publikationsverlauf

Publikationsdatum:
02. August 2017 (online)

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Background:

The MAGIC trial established perioperative (periop) epirubicin, cisplatin, and 5-FU (ECF) as a standard treatment for patients (pts) with operable esophagogastric cancer, but survival continues to remain poor. FLOT4 (NCT01216644) is a multicenter, randomized, investigator-initiated, phase 3 trial. It compares the docetaxel-based triplet FLOT with the anthracycline-based triplet ECF/ECX as a periop treatment for pts with resectable gastric or GEJ adenocarcinoma.

Methods:

Eligible pts of stage ≥cT2 and/or cN+ were randomized to either 3 preoperative and 3 post-operative 3-week cycles of ECF/ECX (epirubicin 50 mg/m2, cisplatin 60 mg/m2, both d1, and 5-FU 200 mg/m2 as continuous infusion or capecitabine 1250 mg/m2 orally d1 – 21) or 4 pre-operative and 4 post-operative 2-week cycles of FLOT (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and 5-FU 2600 mg/m2 as 24-hour infusion, all d1). The primary endpoint was overall survival (OS; 80% power; HR of 0.76; 2-sided log-rank test at 5% type I error). Funded by Deutsche Krebshilfe.

Results:

Between Aug 2010 and Feb 2015, 716 pts (360 ECF/ECX; 356 FLOT) were randomly allocated. Baseline characteristics were similar between arms (overall, male 74%; median age 62; cT3/T4 81%; cN+ 80%; GEJ 56%). 91% and 37% of pts with ECF/ECX and 90% and 50% with FLOT completed planned pre-operative and post-operative cycles, respectively. Median follow-up was 43 mon. 369 pts died (203 ECF/ECX; 166 FLOT). FLOT improved OS (mOS, 35 mon with ECX/ECF vs. 50 mon with FLOT; HR 0.77 [0.63 – 0.94]; p = 0.012). 3y OS rate was 48% with ECF/ECX and 57% with FLOT. FLOT also improved PFS (mPFS, 18 mon with ECX/ECF vs. 30 mon with FLOT; HR 0.75 [0.62 – 0.91]; p = 0.004). Periop complications were 50% with ECF/ECX and 51% with FLOT. 30- and 90-day mortality was 3% and 8% with ECF/ECX and 2% and 5% with FLOT. There was more G3/4 nausea and vomiting with ECF/ECX and more G3/4 neutropenia with FLOT.

Conclusion:

Periop FLOT improved outcome in patients with resectable gastric and GEJ cancer compared to periop ECF/ECX and is new standard therapy in this setting.