Optimisation of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of hydroxyurea, leucovorin, 5-FU and cisplatin (HLFP regimen) for metastatic oesophageal cancer.

Abstract

To improve the efficacy and tolerance of the 5-fluorouracil (5-FU)/cisplatin combination in metastatic esophageal cancer, we designed a new therapeutic schedule, the HLFP regimen. 42 patients with metastatic oesophageal adenocarcinoma (n=10) or squamous cell carcinoma (n=32) were prospectively enrolled in the study. All had bidimensionally measurable disease. The HLFP regimen consisted of twice-monthly oral administration of hydroxyurea 1 g/m(2) on days 0, 1 and 2; a 2-h infusion of leucovorin 200 mg/m(2) and a bolus of 5-FU 400 mg/m(2) followed by a 22-h infusion of 5-FU 600 mg/m(2) on days 1 and 2; and, every two cycles, 80 mg/m(2) cisplatin on day 3. Relief of dysphagia and other symptoms were monitored, together with body weight changes. Major objective responses were observed in 24 patients (57%, 95% Confidence Interval (CI): 42-72%), including four complete responses (10%). The median progression-free survival and overall survival times were 8 and 12.7 months, respectively. Weight gain was observed in 48% of patients, and dysphagia improved in 76%. Grade 3-4 toxicity occurred in 40% of patients, with grade 4 neutropenia in 12% and grade 3 thrombocytopenia, vomiting and diarrhoea in 7-9% of patients. There were no treatment-related deaths. These results suggest that the HLFP regimen is an active and well-tolerated chemotherapy for metastatic oesophageal carcinoma.

• Authors: J Taïeb, P Artru, B Baujat, M Mabro, E Carola, F Maindrault, C Tournigand, M Krulik, C Louvet, A de Gramont
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 38 Issue 5 Pg. 661-6 (Mar 2002) ISSN: 0959-8049 [Print] England
• PMID: 11916548 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Cisplatin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, secondary)
• Adult
• Aged
• Analysis of Variance
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, secondary)
• Cisplatin (administration & dosage)
• Deglutition Disorders (drug therapy)
• Disease-Free Survival
• Esophageal Neoplasms (pathology)
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Multivariate Analysis
• Prospective Studies
• Survival Rate
• Treatment Outcome
• Weight Gain (drug effects)