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Gastrointestinal tumours, non-colorectal 1

2275 - Docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) for resectable esophagogastric cancer: updated results from multicenter, randomized phase 3 FLOT4-AIO trial (German Gastric Group at AIO)

Date

08 Sep 2017

Session

Gastrointestinal tumours, non-colorectal 1

Presenters

Salah-Eddin Al-Batran

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

S. Al-Batran1, C. Pauligk2, N. Homann3, H. Schmalenberg4, H. Kopp5, G.M. Haag6, K. Luley7, G. Folprecht8, S. Probst9, P. Thuss-Patience10, J. Trojan11, M. Koenigsmann12, U. Lindig13, M. Pohl14, S. Kasper15, M. Möhler16, T. Goetze1, M. Schuler17, E. Jaeger18, R.D. Hofheinz19

Author affiliations

  • 1 Institute Of Clinical Cancer Research (ikf), Uct-university Cancer Center, Krankenhaus Nordwest, 60488 - Frankfurt/DE
  • 2 Institute Of Clinical Cancer Research (ikf), Uct-university Cancer Center, Krankenhaus Nordwest, Frankfurt/DE
  • 3 Department Of Internal Medicine Ii, Klinikum Wolfsburg, 38440 - Wolfsburg/DE
  • 4 Iv. Medizinische Klinik, Städtisches Krankenhaus Dresden, Dresden/DE
  • 5 Medical Center Ii, Universitätsklinikum Tübingen Medizinische Universitätsklinik, 72076 - Tübingen/DE
  • 6 Department Of Medical Oncology, Nationales Zentrum für Tumorerkrankungen (NCT), 69120 - Heidelberg/DE
  • 7 Med. Klinik I, University SH.-Lübeck, 23538 - Lübeck/DE
  • 8 University Cancer Center, Medical Dept. I  , University Hospital Carl Gustav Carus, Dresden  , 01129   - Dresden/DE
  • 9 Klinik Für Hämatologie Und Onkologie, Klinikum Bielefeld, Bielefeld/DE
  • 10 Department Of Hematology, Oncology, And Tumor Immunology, Charité University Medicine Berlin, Campus Virchow-Klinikum, 13353 - Berlin/DE
  • 11 Department Of Gastroenterology And Hepatology, University Hospital Frankfurt, Frankfurt/DE
  • 12 Mediprojekt, Onkologisches Ambulanzzentrum OAZ, 30171 - Hannover/DE
  • 13 Klinik Für Innere Medizin Ii, University Hospital Jena, Friedrich-Schiller-University, 7740 - Jena/DE
  • 14 Medical Clinic, Ruhr University Bochum Medizinische Universitätsklinik, 44892 - Bochum/DE
  • 15 Westdeutsches Tumorzentrum, University Hospital Essen, 45122 - Essen/DE
  • 16 I. Med. Klinik Und Poliklinik, Johannes Gutenberg University, 55122 - Mainz/DE
  • 17 Department Of Medical Oncology, West German Cancer Center, University Hospital Essen, 45122 - Essen/DE
  • 18 Department Of Medical Oncology, Krankenhaus Nordwest, 60488 - Frankfurt/DE
  • 19 Iii. Medizinische Klinik, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
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Abstract 2275

Background

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.

Methods

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.

Results

Compared to ECF, FLOT was associated with less progressive disease cases during/after preoperative therapy (1% vs. 5%; p 

Conclusions

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

FLOT4: NCT01216644

Legal entity responsible for the study

Krankenhaus Nordwest GmbH

Funding

Deutsche Krebshilfe, Sanofi

Disclosure

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.

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