FLOT4 is the first study to show improvement of outcome over another well-established bimodality therapy in patients with esophagogastric cancer. To consolidate initial results, we performed multivariate, subgroup and sensitivity analyses.
In the FLOT4, pts with resectable gastric or GEJ adenocarcinoma of stage ≥cT2 and/or cN + (n=716) were randomized to either 3 pre-operative and 3 post-operative 3-week cycles of ECF/ECX (epirubicin 50 mg/m2 i.v., cisplatin 60 mg/m2 i.v., both on day 1, and 5-FU 200 mg/m2 as continuous i.v. infusion or capecitabine 1250 mg/m2 orally on days 1 to 21) or 4 pre-operative and 4 post-operative 2-week cycles of FLOT (docetaxel 50 mg/m2 i.v., oxaliplatin 85 mg/m2 i.v., leucovorin 200 mg/m2 i.v., and 5-FU 2600 mg/m2 as 24-hour i.v, infusion, all on day 1). The primary endpoint was overall survival.
Compared to ECF, FLOT was associated with less progressive disease cases during/after preoperative therapy (1% vs. 5%; p
Updated analysis confirmed the superiority of FLOT. Pts derived benefit from FLOT even if they were old ( > =70), had small tumors, a nodal negative status, or a signet cell component. The presence of one of these factors should no longer be a reason for not considering perioperative therapy in daily practice.
Clinical trial identification
Legal entity responsible for the study
Krankenhaus Nordwest GmbH
Deutsche Krebshilfe, Sanofi
S-E. Al-Batran: Advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma Speaker: Roche, Celgene, Lilly, Nordic Pharma Research grants: Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly. N. Homann: Consulting or Advisory Role: Sanofi, Roche, Amgen, Cellgene, Lilly. H. Schmalenberg: Consulting or Advisory Role: Lilly, Baxalter; Research Funding: Sanofi; Travel, Accomodations, expenses: Merck. G.M. Haag: Consulting or Advisory Role: Sanofi, Roche, Taiho, Lilly, Pfizer, Nordic; Research Funding: Taiho, Nordic; Travel, Accomodations, expenses: Amgen, Ipsen, Celgene. K. Luley: Travel, accomodations, expenses: Ipsen, Novartis, Sanofi. P. Thuss-Patience: Consulting or Advisory Role: Roche, Lilly, BMS, MSD, Nordic, Pfizer; Research Funding: Novartis; Travel, Accomodations, expenses: Roche, Merck, Teva. M. Koenigsmann: Honoraria: Novartis, Celgene; Consulting or Advisory Role: Novartis, Celgene; Travel, Accomodations, expenses: Novartis. M. Pohl: Research Funding: Amgen, Baxalta, Celgene, Lilly. T. Goetze: Honoraria: MSD, Celgene Advisory board: BMS, Baxalta- Shire. M. Schuler: Honoraria: AstraZeneca, Alexion, Boehringer Ingelheim, Celgene, Lilly, MSD, Novartis, Roche; Consulting or Advisory Role: AstraZeneca, Boehringer Ingelheim, Celgene, Lilly, Novartis, Roche; Research Funding: Boehringer Ingelheim, BMS, Novartis. All other authors have declared no conflicts of interest.