Docetaxel, cisplatin and 5-fluorouracil in patients with locally advanced unresectable head and neck cancer: a phase I-II feasibility study.

Abstract

PURPOSE:

To determine the safety profile and activity of the combination of docetaxel, cisplatin and 5-fluorouracil (5-FU) in chemotherapy-naive patients with squamous cell carcinoma of the head and neck (SCCHN).

PATIENTS AND METHODS:

Patients with locally advanced unresectable SCCHN were treated with docetaxel and cisplatin both as a 1-h infusion on day 1 followed by a continuous infusion of 5-FU for 5 days. Cycles were planned every 3 weeks up to four cycles, whereafter the patients were treated with locoregional radiotherapy. Two dose levels were studied. Doses in level I were 75 mg/m(2) of docetaxel, 75 mg/m(2) of cisplatin and 750 mg/m(2)/day of 5-FU; in level II the cisplatin dose was escalated to 100 mg/m(2). Following chemotherapy, all patients were to receive curative radiotherapy according to the standards in the different institutions.

RESULTS:

Twenty-five patients were treated at dose level I with 86 cycles (median four; range one to four), and 23 at dose level II with 84 cycles (median four; range two to four). The median relative dose intensity was 0.99 (range 0.86-1.04) at level I and 0.94 (range 0.79-1.02) at level II. The response rate in the intention-to-treat population was 64% [95% confidence interval (CI) 42.5% to 82%] in level I and 78.3% (95% CI 56.3% to 92.5%) in level II; all were partial responses. The maximum tolerated dose was reached at level II with renal toxicity, nausea, stomatitis and thrombocytopenia as principal dose-limiting toxicities. The median survival of the 48 patients was 18.5 months. The survival at 12, 18, 24 and 30 months was 69, 54, 41 and 31%, respectively.

CONCLUSIONS:

The combination of docetaxel, cisplatin and 5-FU associated with prophylactic ciprofloxacin is feasible and active in patients with SCCHN. Dose level I is recommended for phase III testing.

• Authors: D Schrijvers, C Van Herpen, J Kerger, E Joosens, C Van Laer, A Awada, D Van den Weyngaert, H Nguyen, C Le Bouder, J A Castelijns, J Kaanders, P De Mulder, J B Vermorken
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 15 Issue 4 Pg. 638-45 (Apr 2004) ISSN: 0923-7534 [Print] England
• PMID: 15033673 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents
• Taxoids
• Docetaxel
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cisplatin (administration & dosage, adverse effects)
• Docetaxel
• Feasibility Studies
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Head and Neck Neoplasms (drug therapy, mortality, pathology)
• Humans
• Male
• Middle Aged
• Nausea (chemically induced)
• Neoplasm Staging
• Neoplasms, Squamous Cell (drug therapy, mortality, pathology)
• Stomatitis (chemically induced)
• Survival Analysis
• Survival Rate
• Taxoids (administration & dosage, adverse effects)
• Thrombocytopenia (chemically induced)
• Treatment Outcome