Final report of a pilot trial of accelerated radiotherapy plus concurrent 96-hour infusional paclitaxel for locally advanced head and neck cancer.

Recent data show that accelerated radiotherapy (XRT) improves local-regional control (LRC) over standard-fractionation XRT. Concurrent chemoradiotherapy improves LRC and survival over XRT alone. This study assesses the feasibility, toxicity, and preliminary efficacy of concurrent 96-hour paclitaxel infusion with accelerated XRT. Eligible patients had stage IV squamous cell carcinoma of the head and neck, exclusive of nasopharynx cancer. Tumor had to be considered technically unresectable after evaluation by our multidisciplinary head/neck tumor board. XRT was given continuous course using an accelerated regimen with twice a day fractionation for the cone down (70-72 Gy/6 weeks). Chemotherapy consisted of 2 cycles of paclitaxel via 96-hour infusion during weeks 1 and 5 of XRT. The first 10 patients received doses of 40-120 mg/m2/cycle, and the subsequent 13 patients received 100 mg/m2/cycle. Twenty-three patients were studied. Median follow-up was 20.4 months (44.4 months for the 10 long-term survivors). Most (19/23) patients had reversible grade 3 acute mucositis. Median treatment time was 44 days, and all but 1 patient received both cycles of paclitaxel at their planned dose. The 3- and 4-year actuarial survival was 37%. Three- and 4-year LRC was 50%. Four patients (18%) developed distant metastases. Two patients (9%) developed severe esophageal strictures requiring permanent gastrostomy/tracheostomy, and 2 patients developed other late grade 3+ toxicities. Accelerated XRT plus concurrent 96-hour infusional paclitaxel as given in this study has intense but acceptable toxicity and is feasible. LRC and survival compare favorably with other aggressive regimens for this poor-prognosis population. Further study of accelerated XRT with concurrent chemotherapy is indicated.