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
Identifieur interne : 001092 ( Main/Exploration ); précédent : 001091; suivant : 001093Biweekly 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
Auteurs : S.-E. Al-Batran ; J. T. Hartmann ; R. Hofheinz ; N. Homann ; V. Rethwisch ; S. Probst ; J. Stoehlmacher ; M. R. Clemens ; R. Mahlberg ; M. Fritz [Allemagne] ; G. Seipelt ; M. Sievert [Allemagne] ; C. Pauligk ; A. Atmaca ; E. JgerSource :
- Annals of Oncology [ 0923-7534 ] ; 2008-07-31.
Abstract
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 2976) 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.
Url:
DOI: 10.1093/annonc/mdn403
Affiliations:
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Al-Batran</name><affiliation></affiliation><affiliation><wicri:noCountry code="no comma">E-mail: albatran@aol.com</wicri:noCountry></affiliation></author><author><name sortKey="Hartmann, J T" sort="Hartmann, J T" uniqKey="Hartmann J" first="J. T." last="Hartmann">J. T. Hartmann</name><affiliation><wicri:noCountry code="subField">Tuebingen</wicri:noCountry></affiliation></author><author><name sortKey="Hofheinz, R" sort="Hofheinz, R" uniqKey="Hofheinz R" first="R." last="Hofheinz">R. Hofheinz</name><affiliation><wicri:noCountry code="subField">Mannheim</wicri:noCountry></affiliation></author><author><name sortKey="Homann, N" sort="Homann, N" uniqKey="Homann N" first="N." last="Homann">N. Homann</name><affiliation><wicri:noCountry code="subField">Lbeck</wicri:noCountry></affiliation></author><author><name sortKey="Rethwisch, V" sort="Rethwisch, V" uniqKey="Rethwisch V" first="V." last="Rethwisch">V. Rethwisch</name><affiliation><wicri:noCountry code="subField">Hagen</wicri:noCountry></affiliation></author><author><name sortKey="Probst, S" sort="Probst, S" uniqKey="Probst S" first="S." last="Probst">S. Probst</name><affiliation><wicri:noCountry code="subField">Bielefeld</wicri:noCountry></affiliation></author><author><name sortKey="Stoehlmacher, J" sort="Stoehlmacher, J" uniqKey="Stoehlmacher J" first="J." last="Stoehlmacher">J. Stoehlmacher</name><affiliation><wicri:noCountry code="subField">Dresden</wicri:noCountry></affiliation></author><author><name sortKey="Clemens, M R" sort="Clemens, M R" uniqKey="Clemens M" first="M. R." last="Clemens">M. R. Clemens</name><affiliation><wicri:noCountry code="subField">Trier</wicri:noCountry></affiliation></author><author><name sortKey="Mahlberg, R" sort="Mahlberg, R" uniqKey="Mahlberg R" first="R." last="Mahlberg">R. Mahlberg</name><affiliation><wicri:noCountry code="subField">Trier</wicri:noCountry></affiliation></author><author><name sortKey="Fritz, M" sort="Fritz, M" uniqKey="Fritz M" first="M." last="Fritz">M. Fritz</name><affiliation wicri:level="3"><country>Allemagne</country><placeName><settlement type="city">Stuttgart</settlement><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Stuttgart</region></placeName><wicri:orgArea>Krankenhaus Bad Cannstatt</wicri:orgArea></affiliation></author><author><name sortKey="Seipelt, G" sort="Seipelt, G" uniqKey="Seipelt G" first="G." last="Seipelt">G. Seipelt</name><affiliation><wicri:noCountry code="subField">Soden</wicri:noCountry></affiliation></author><author><name sortKey="Sievert, M" sort="Sievert, M" uniqKey="Sievert M" first="M." last="Sievert">M. Sievert</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medical Oncology, Sanofi Aventis Deutschland GmbH, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Pauligk, C" sort="Pauligk, C" uniqKey="Pauligk C" first="C." last="Pauligk">C. Pauligk</name><affiliation><wicri:noCountry code="subField">Frankfurt</wicri:noCountry></affiliation></author><author><name sortKey="Atmaca, A" sort="Atmaca, A" uniqKey="Atmaca A" first="A." last="Atmaca">A. Atmaca</name><affiliation><wicri:noCountry code="subField">Frankfurt</wicri:noCountry></affiliation></author><author><name sortKey="Jger, E" sort="Jger, E" uniqKey="Jger E" first="E." last="Jger">E. Jger</name><affiliation><wicri:noCountry code="subField">Frankfurt</wicri:noCountry></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2008-07-31">2008-07-31</date><biblScope unit="volume">19</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1882">1882</biblScope><biblScope unit="page" to="1887">1887</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">DD9BE3406436815243DA8F1A3BC8720CC5B4E0E0</idno><idno type="DOI">10.1093/annonc/mdn403</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">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 2976) 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.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bade-Wurtemberg</li><li>Berlin</li><li>District de Stuttgart</li></region><settlement><li>Berlin</li><li>Stuttgart</li></settlement></list><tree><noCountry><name sortKey="Al Batran, S E" sort="Al Batran, S E" uniqKey="Al Batran S" first="S.-E." last="Al-Batran">S.-E. Al-Batran</name><name sortKey="Atmaca, A" sort="Atmaca, A" uniqKey="Atmaca A" first="A." last="Atmaca">A. Atmaca</name><name sortKey="Clemens, M R" sort="Clemens, M R" uniqKey="Clemens M" first="M. R." last="Clemens">M. R. Clemens</name><name sortKey="Hartmann, J T" sort="Hartmann, J T" uniqKey="Hartmann J" first="J. T." last="Hartmann">J. T. Hartmann</name><name sortKey="Hofheinz, R" sort="Hofheinz, R" uniqKey="Hofheinz R" first="R." last="Hofheinz">R. Hofheinz</name><name sortKey="Homann, N" sort="Homann, N" uniqKey="Homann N" first="N." last="Homann">N. Homann</name><name sortKey="Jger, E" sort="Jger, E" uniqKey="Jger E" first="E." last="Jger">E. Jger</name><name sortKey="Mahlberg, R" sort="Mahlberg, R" uniqKey="Mahlberg R" first="R." last="Mahlberg">R. Mahlberg</name><name sortKey="Pauligk, C" sort="Pauligk, C" uniqKey="Pauligk C" first="C." last="Pauligk">C. Pauligk</name><name sortKey="Probst, S" sort="Probst, S" uniqKey="Probst S" first="S." last="Probst">S. Probst</name><name sortKey="Rethwisch, V" sort="Rethwisch, V" uniqKey="Rethwisch V" first="V." last="Rethwisch">V. Rethwisch</name><name sortKey="Seipelt, G" sort="Seipelt, G" uniqKey="Seipelt G" first="G." last="Seipelt">G. Seipelt</name><name sortKey="Stoehlmacher, J" sort="Stoehlmacher, J" uniqKey="Stoehlmacher J" first="J." last="Stoehlmacher">J. Stoehlmacher</name></noCountry><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Fritz, M" sort="Fritz, M" uniqKey="Fritz M" first="M." last="Fritz">M. Fritz</name></region><name sortKey="Sievert, M" sort="Sievert, M" uniqKey="Sievert M" first="M." last="Sievert">M. Sievert</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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