ORIGINAL ARTICLE TAXANE-BASED CHEMOIRRADIATION FOR ORGAN PRESERVATION WITH LOCALLYADVANCED HEAD AND NECK CANCER: RESULTS OF A PHASE II MULTI-INSTITUTIONAL TRIAL Anthony J. Cmelak, MD, 1 Barbara A. Murphy, MD, 2 Brian Burkey, MD, 3 Stacy Douglas, RN, 2 Yu Shyr, PhD, 4 James Netterville, MD 3 1 Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee 37232. E-mail: anthony.cmelak@vanderbilt.edu 2 Department ofMedical Oncology, Vanderbilt University Medical Center, Nashville, Tennessee 37232 3 Department ofOtolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee 37232 4 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee 37232 Accepted 10 July 2006 Published online 24 January 2007 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hed.20522 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 deter- mine 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/m 2 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/m 2 IV on days 1, 22, and 43 and weekly paclitaxel 30 mg/m 2 IV (n ¼ 22). Because of hematologic toxicity, the concurrent regimen was changed to weekly carbo- platin AUC 1 plus weekly paclitaxel 30 mg/m 2 (n ¼ 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 ex- cessive, with significant hematologic toxicity and 2 toxic deaths. Acute toxicities of concurrent carboplatin and paclitaxel were tol- erable. No patients required permanent percutaneous gastros- tomy 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 dis- ease (2%). Two-year local control, relapse-free survival, and over- all 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 adminis- tration and low toxicity make this a regimen that is practical for use in the community setting. V V C 2007 Wiley Periodicals, Inc. Head Neck 29: 315–324, 2007 Keywords: taxane; chemoradiation; larynx; oropharynx The majority of patients with squamous cell car- cinomas of the head and neck (SCCHN) region present with locally advanced (American Joint Correspondence to: A. J. Cmelak Dr. Cmelak has disclosed that he has received honoraria from Bristol- Myers Squibb and Ortho-Biotec. Dr. Murphy has disclosed that she has received an honorarium from Bristol-Myers Squibb. V V C 2007 Wiley Periodicals, Inc. Taxane-Based Chemoradiotherapy HEAD & NECK—DOI 10.1002/hed April 2007 315