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Annals of Oncology 15:638-645, 2004
© 2004 European Society for Medical Oncology

Original Paper

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

Received 17 June 2003; revised 27 December 2003; accepted 31 December 2003

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/m2 of docetaxel, 75 mg/m2 of cisplatin and 750 mg/m2/day of 5-FU; in level II the cisplatin dose was escalated to 100 mg/m2. 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.

D. Schrijvers1, C. Van Herpen2, J. Kerger3, E. Joosens4, C. Van Laer1, A. Awada3, D. Van den Weyngaert4, H. Nguyen3, C. Le Bouder5, J. A. Castelijns6, J. Kaanders2, P. De Mulder2 and J. B. Vermorken1,*

1 University Hospital Antwerp, Edegem, Belgium; 2 University Medical Center, Nijmegen, The Netherlands; 3 Institut Jules Bordet, Brussels Belgium; 4 Algemeen Ziekenhuis Middelheim, Antwerp, Belgium; 5 Aventis, Pharma, France, Paris; 6 Free University Medical Center, Amsterdam, The Netherlands

Key words: cisplatin, combination chemotherapy, docetaxel, 5-FU, head and neck cancer, phase I-II


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