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

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/m ² 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.