Taxane‐based chemoirradiation for organ preservation with locally advanced head and neck cancer: Results of a phase II multi‐institutional trial

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Abstract
Background. The optimal drug schedule and sequencing of chemotherapy and radiation for organ preservation in head and neck cancer has yet to be determined. We undertook a phase II trial of a taxane‐based induction chemotherapy (ICT) followed by a taxane‐based concurrent chemoradiation (CCR) regimen in patients with resectable stage III or IV disease to determine the feasibility, toxicity, and overall efficacy. Methods. Forty‐four patients with laryngeal or tongue base carcinomas were enrolled. All patients received 3 cycles of chemotherapy with paclitaxel 175 mg/m2 and carboplatin AUC (area under the curve) 6–7.5 over 30 minutes on days 1, 22, and 43. Responding patients went on to receive radiation (70 Gy/7 weeks) with cisplatin 75 mg/m2 IV on days 1, 22, and 43 and weekly paclitaxel 30 mg/m2 IV (n = 22). Because of hematologic toxicity, the concurrent regimen was changed to weekly carboplatin AUC 1 plus weekly paclitaxel 30 mg/m2 (n = 22). Results. Twenty‐three patients with stage III and 21 patients with stage IV disease were enrolled. Median follow‐up was 3.7 years. Acute toxicity of concurrent cisplatin and paclitaxel was excessive, with significant hematologic toxicity and 2 toxic deaths. Acute toxicities of concurrent carboplatin and paclitaxel were tolerable. No patients required permanent percutaneous gastrostomy tubes. The organ preservation rate was 83% (toxic deaths considered failures). Of 42 evaluable patients, 20 patients had complete responses (48%), 17 partial responses (41%), 3 minor responses (11%), 1 stable disease (2%), and 1 progressive disease (2%). Two‐year local control, relapse‐free survival, and overall survival were 82%, 77%, and 71%, respectively. Conclusion. There were no significant differences in relapse‐free survival or organ preservation rates between concurrent regimens. Platinum and paclitaxel‐based CCR is feasible after ICT and provides a high rate of organ preservation. Substitution of concurrent cisplatin to weekly carboplatin with paclitaxel and radiation has an improved toxicity profile. The ease of administration and low toxicity make this a regimen that is practical for use in the community setting. © 2007 Wiley Periodicals, Inc. Head Neck, 2007

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