A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck

Summary Background Gemcitabine is a new pyrimidine antimetabolite with novel metabolic properties and mechanism of action. Phase I clinical trials have demonstrated acceptable toxicity and promising antitumor activity. The objectives of this open multicenter phase II trial were to determine the efficacy and toxicity of this agent in patients with advanced head and neck cancer. Patients and methods Sixty-one patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with Gemcitabine as a weekly 30 minutes i.v. administration for 3 consecutive weeks followed by one week rest. The Gemcitabine starting dose was 800 mg/m2/week in 47 patients (a majority being pre-treated with chemotherapy) and was later increased to 1250 mg/m2 in 14 chemotherapy-naive patients. Dose adjustements were based on hematologic and non-hematologic toxicities. Results Seven partial responses were observed among 54 evaluable patients, yielding a response rate of 13% (95% confidence interval: 4%–22%). The incidence of hematologic toxicity was low, with grade 3–4 neutropenia in less than 10% of the courses. Fifty-three percent of the patients experienced an increase in liver enzymes, mainly grade 1 or 2. Fatigue was reported by 39% of the patients, frequently associated with flu-like symptoms. Conclusion Gemcitabine is a drug with documented antitumor activity in patients with advanced squamous cell carcinoma of the head and neck.