Objective: The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status ≥60% were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/ m2 and epirubicin 20 mg/m2, on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study. Results: The current study was intended to treat 43 patients butclosed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87%) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70% (range, 60-90%). There was one clinical response (7%) and another three (20%) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47%), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable. Conclusions: In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy naïve patients or in combination with newer agents.
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