Annals of Oncology 5:533-537, 1994
© 1994 European Society for Medical Oncology
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Docetaxel (Taxotere®): An active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck
1Centre Léon Bérard Lyon, France
2Rotterdam Cancer Institute Rotterdam
3 St Radboud Ziekenhuis, Nijmegen, The Netherlands
4 Klinikum rechts der Isar, München, Germany
5Institut Jules Bordet Brussels, Belgium
6 EORTC NDDO, Amsterdam, The Netherlands
7 Rhône Poulenc Rorer, Antony, France
8 Western Infirmary, Glasgow, U.K.
Correspondence to: Gilles Catimel, M.D., Dépt de Médecine, Centre Léon Bérard 28, rue Laennec F-69373Lyon,Cédex08 France
BACKGROUND: Docetaxel (Taxotere®) is a new cytotoxic agent acting as a promotor of tubulin polymerisation with broad spectrum antitumor activity in preclinical testing. Phase I clinical trials have shown promising activity of docetaxel in patients with breast, ovarian and lung carcinomas. The objective of this open multicentre phase II study was to determine the efficacy and tolerability of this agent in patients with head and neck cancer.
PATIENTS AND METHODS: Patients with proven advanced and/ or recurrent squamous cell carcinoma of the head and neck without prior chemotherapy for advanced disease were eligible for this trial. Docetaxel was given at a dose of 100 mg/ m2 as a 1 hour infusion every 3 weeks. Dose reductions were performed according to hematological and non-hematologi-cal toxicities. No pre-medication was given to prevent hyper-sensitivity reactions.
RESULTS: Fourty-three patients entered this trial: 39 patients were evaluable for toxicity and 37 patients were evalu-able for response. Sixty-five percent of the patients had loco-regional disease, 28% had metastatic disease, and 7% had both. Twenty-five percent of the patients had previously received neo-adjuvant cisplatin-based chemotherapy. A total of 166 docetaxel courses were administered. The most frequent side-effects associated with docetaxel were alopecia (90% of the patients), asthenia (69% of the patients) and short lasting neutropenia (grade 3–4 neutropenia in 61% of the courses). Fifty-four percent of the patients experienced skin toxicity, 23% experienced hypersensitivity reaction, and 31% developed peripheral edema. Ten partial and 2 complete responses were observed, yielding a response rate of 32% (95% confidence interval 17%–47%).
CONCLUSION: Docetaxel is an active drug in patients with advanced squamous cell carcinoma of the head and neck.
head and neck cancer, docetaxel, phase II trial
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