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Annals of Oncology Advance Access originally published online on July 31, 2008
Annals of Oncology 2008 19(11):1882-1887; doi:10.1093/annonc/mdn403
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie

S.-E. Al-Batran1,*, J. T. Hartmann2, R. Hofheinz3, N. Homann4, V. Rethwisch5, S. Probst6, J. Stoehlmacher7, M. R. Clemens8, R. Mahlberg8, M. Fritz9, G. Seipelt10, M. Sievert11, C. Pauligk1, A. Atmaca1 and E. Jäger1

1 Klinik für Onkologie und Hämatologie, Krankenhaus Nordwest, Frankfurt
2 Department of Medical Oncology, Hematology, Immunology, Rheumatology and Pulmology South West Cancer Center, Eberhard-Karls-University, Tuebingen
3 Department of Medicine III, Universitätsklinikum Mannheim
4 Department of Medicine I, University of Lübeck
5 Department of Hematology and Oncology, Katholisches Krankenhaus, Hagen
6 Department of Hematology and Oncology, Städtische Kliniken, Bielefeld
7 Department of Internal Medicine I, Universitätsklinikum Carl Gustav Carus, Dresden
8 Department of Medicine I, Mutterhaus der Borromäerinnen, Trier
9 Krankenhaus Bad Cannstatt, Stuttgart
10 Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Bad Soden
11 Medical Oncology, Sanofi Aventis Deutschland GmbH, Berlin, Germany

* Correspondence to: Dr S.-E. Al-Batran, Klinik für Onkologie und Hämatologie, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488 Frankfurt am Main, Germany. Tel: +496976013788; Fax: +496976013655; E-mail: albatran{at}aol.com

Background: The combination of docetaxel (Taxotere), cisplatin, and fluorouracil improved efficacy in gastric cancer, but was associated with substantial toxicity. This study was designed to incorporate docetaxel into a tolerable biweekly (once every 2 weeks) oxaliplatin-based chemotherapy regimen.

Patients and methods: Patients with measurable, metastatic adenocarcinoma of the stomach or esophagogastric junction and no prior chemotherapy received oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and fluorouracil 2600 mg/m2 as a 24-h infusion in combination with docetaxel 50 mg/m2 (FLOT) on day 1 every 2 weeks. Prophylactic growth factors were not administered.

Results: Fifty-nine patients were enrolled; 54 received treatment. Patients had a median age of 60 years (range 29–76) and most (93%) of them had metastatic disease. Objective responses were observed in 57.7% of patients with a median time to treatment response of 1.54 months. Median progression-free survival (PFS) and overall survival were 5.2 and 11.1 months, respectively. Twenty-five percent of patients experienced prolonged (>12 months) PFS. Frequent (>10%) grade 3 or 4 toxic effects included neutropenia in 26 (48.1%), leukopenia in 15 (27.8%), diarrhea in 8 (14.8%), and fatigue in 6 (11.1%) patients. Complicated neutropenia was observed in two (3.8%) patients, only.

Conclusions: Biweekly FLOT is active and has a favorable safety profile.

Key words: docetaxel, esophageal, FLOT, gastric, oxaliplatin

Received for publication February 26, 2008. Revision received May 2, 2008. Accepted for publication May 15, 2008.


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