Induction paclitaxel in previously untreated, resectable, advanced squamous cell carcinomas of head and neck

BACKGROUND Previous Phase II trials evaluating paclitaxel as a single agent have produced objective response rates of 38–40%. However, in these studies patients had recurrent disease and had received previous treatment with chemotherapy, radiation, surgery, or some combination of the same. To the authors' knowledge, the study reported here is the first to examine the role of paclitaxel in affecting objective antitumor response, as a single agent, in a previously untreated patient population. METHODS Patients with untreated, resectable, advanced squamous cell carcinoma of the head and neck were eligible for this Phase II trial. The treatment plan included paclitaxel 250 mg/m2 administered by 24‐hour intravenous infusion every 21 days for a total of 3 courses and primary prophylaxis with colony stimulating factor during each course of chemotherapy. Surgical resection was performed after recovery from the final course of chemotherapy. After adequate wound healing, patients received external beam radiotherapy (median dose to primary site, 55.8 Gray [Gy]; median dose to neck sites, 50.4 Gy). RESULTS Forty‐five patients were registered. Thirty‐eight patients completed the planned chemotherapy, 41 patients underwent surgical resection, and 37 patients completed the intended radiotherapy. The objective response rate was 50% (10% complete response; 40% partial response). Severe or life‐threatening (Grade 3 or higher) granulocytopenia or thrombocytopenia occurred in 78% and 27% of patients, respectively. Two patients died of sepsis. Seventy‐one percent, 67%, and 91% of patients were free of local, lymph node, and distant recurrence, respectively, with a median follow‐up of 37 months. The 4‐year overall survival and disease‐related survival rates were 44.4% and 52.9%, respectively. CONCLUSION The authors conclude that paclitaxel is an active agent in patients with advanced head and neck carcinoma. However, the overall disease control, achieved by using paclitaxel as induction therapy, did not appear to be better than that achieved with standard treatment methods. Combined modality regimens with concurrent chemotherapy and radiotherapy have demonstrated more promise. Cancer 2000;89:2587–96. © 2000 American Cancer Society. Induction paclitaxel (250 mg/m2, 24‐hour infusion, every 21 days) for 3 courses produces a 50% objective response rate (10% complete response; 40% partial response) in patients with previously untreated resectable advanced squamous cell carcinomas of