Long-term outcomes with concurrent carboplatin, paclitaxel, and radiation therapy in locally advanced, inoperable head and neck cancer
6032 Background: Our goal was to evaluate long-term outcomes of patients with squamous cell carcinoma of the head and neck (SCCHN) treated with carboplatin, paclitaxel, and radiotherapy. Methods: We conducted a phase II trial in inoperable patients with locally advanced SCCHN. Carboplatin 100 mg/m2 and paclitaxel 40 mg/m2 were administered intravenously once a week during external beam radiotherapy (once daily, 180 cGy/fraction) for 6–7 weeks. Interstitial brachytherapy was used as a boost in selected patients with primary malignancies of the oral cavity and the oropharynx. Results: 55 patients were enrolled. 52 patients (95%) had stage IV and 51 (93%) had technically unresectable disease; 62% had an oropharyngeal primary site. 21 patients underwent brachytherapy boost. Grade 3 or 4 mucositis occurred in 30% of patients. One death occurred during treatment; it was related to complications of gastrostomy tube (G-tube) placement. Forty of 50 evaluable patients (80%) had an objective response, with a complete response rate of 52%. With a median follow-up of 69 months years for surviving patients, the 5-year progression-free survival (PFS) was 36% and the 5-year overall survival (OS) was 35%. Two of the 18 long-term survivors of >50 months were G-tube feeding dependent. Patients undergoing brachytherapy boost (n=21) had similar outcomes compared with the rest of the patients. In multivariate analysis, baseline hemoglobin levels and N stage were predictive of survival. Conclusion: Treatment with concurrent carboplatin, paclitaxel and radiation is safe and offers curative potential for poor prognosis patients with locally advanced SCCHN. No significant financial relationships to disclose.