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P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck Cancer: A Phase 2 Trial

P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck... Objective: The purpose of this phase 2 trial was to investigate for the first time the efficacy and toxic effects of oxaliplatin combined with folinic acid (FA) and 5-fluorouracil (5-FU) in patients with recurrent squamous cell carcinoma of the head and neck in advanced stage of disease. Design: Thirty-six patients with recurrent/metastatic disease with a median age of 59 years were enrolled. Patients received oxaliplatin (85 mg/m2) and FA (200 mg/m2), followed by 5-FU (2000 mg/m2) as 24-hour continuous infusion on day 1 and 15 in a 4-week cycle. On days 8 and 22, FA (200 mg/m2) and 5-FU (2000 mg/m2) were administered without oxaliplatin, followed by 2 weeks without cytotoxic treatment. Results: Toxic effects, survival, and response were assessable in 33 of 36 patients. The overall response was 60.6%, with 7 (21.2%) complete responders and 13 (39.4%) partial responders. Eight patients (24.2%) showed stable disease and 5 (15.2%) progressed. The median time to progression was 8.1 month (range, 2-14 months), and median overall survival was 10.8 months (range, 5-16 months). The 1-year-survival rate was 43.2%. Hematological toxic effects were low, but mild paresthesias occurred in all patients who received more then 3 cycles of cytotoxic therapy, and dose reduction was necessary in 2 patients due to grade 3 diarrhea. Conclusions: In this small phase 2 study, the combination of oxaliplatin, FA, and 5-FU demonstrated, relative to the standard regimen of cisplatin and 5-FU, a high antitumoral activity in previously treated squamous cell cancer of the head and neck with a favorable toxicity profile. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Otolaryngology - Head & Neck Surgery American Medical Association

P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck Cancer: A Phase 2 Trial

P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck Cancer: A Phase 2 Trial

Abstract

Objective: The purpose of this phase 2 trial was to investigate for the first time the efficacy and toxic effects of oxaliplatin combined with folinic acid (FA) and 5-fluorouracil (5-FU) in patients with recurrent squamous cell carcinoma of the head and neck in advanced stage of disease. Design: Thirty-six patients with recurrent/metastatic disease with a median age of 59 years were enrolled. Patients received oxaliplatin (85 mg/m2) and FA (200 mg/m2), followed by 5-FU (2000 mg/m2) as 24-hour...
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Publisher
American Medical Association
Copyright
Copyright © 2006 American Medical Association. All Rights Reserved.
ISSN
0886-4470
eISSN
1538-361X
DOI
10.1001/archotol.132.8.869-b
Publisher site
See Article on Publisher Site

Abstract

Objective: The purpose of this phase 2 trial was to investigate for the first time the efficacy and toxic effects of oxaliplatin combined with folinic acid (FA) and 5-fluorouracil (5-FU) in patients with recurrent squamous cell carcinoma of the head and neck in advanced stage of disease. Design: Thirty-six patients with recurrent/metastatic disease with a median age of 59 years were enrolled. Patients received oxaliplatin (85 mg/m2) and FA (200 mg/m2), followed by 5-FU (2000 mg/m2) as 24-hour continuous infusion on day 1 and 15 in a 4-week cycle. On days 8 and 22, FA (200 mg/m2) and 5-FU (2000 mg/m2) were administered without oxaliplatin, followed by 2 weeks without cytotoxic treatment. Results: Toxic effects, survival, and response were assessable in 33 of 36 patients. The overall response was 60.6%, with 7 (21.2%) complete responders and 13 (39.4%) partial responders. Eight patients (24.2%) showed stable disease and 5 (15.2%) progressed. The median time to progression was 8.1 month (range, 2-14 months), and median overall survival was 10.8 months (range, 5-16 months). The 1-year-survival rate was 43.2%. Hematological toxic effects were low, but mild paresthesias occurred in all patients who received more then 3 cycles of cytotoxic therapy, and dose reduction was necessary in 2 patients due to grade 3 diarrhea. Conclusions: In this small phase 2 study, the combination of oxaliplatin, FA, and 5-FU demonstrated, relative to the standard regimen of cisplatin and 5-FU, a high antitumoral activity in previously treated squamous cell cancer of the head and neck with a favorable toxicity profile.

Journal

Archives of Otolaryngology - Head & Neck SurgeryAmerican Medical Association

Published: Aug 1, 2006

Keywords: fluorouracil,head and neck cancer,leucovorin,oxaliplatin

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