[Simultaneous radiochemotherapy with taxol/carboplatin in advanced operable head-neck tumors. Preliminary results].

BACKGROUND: The purpose of simultaneous chemoradiotherapy is to increase local-regional control and to decrease the incidence of distant metastases. Regimens containing cisplatin/5-FU chemotherapy are widely accepted as standard treatment in advanced head and neck cancer. Most studies reported promising response and survival data, but also severe mucosal toxicity. In recent years the newly developed drug Taxol demonstrated interesting activity in head and neck cancer as a single agent and as well in combination drug regimens. In the present outpatient phase-II trial we investigated the combination of Taxol/carboplatin with 40 Gy radiotherapy in a neoadjuvant setting of operable Stage-III/IV squamous cell carcinoma of the oral cavity and oropharynx. PATIENTS AND METHODS: Twelve patients were enrolled in this ongoing trial with a projected number of 30 patients and received 5 cycles of weekly Taxol (40 mg/m2) and carboplatin (AUC 1.5) with conventional radiotherapy (40 Gy). Within 3 to 4 weeks after chemoradiotherapy resection of the primary tumor and the regional neck nodes was performed.
RESULTS: So far 12 patients were evaluable for toxicity and response. Complete response was noted in 8/12 patients (CR 66%). In 6/10 patients (60%) complete pathologic response was documented in the resection specimens.
CONCLUSION: Our preliminary results demonstrated excellent clinical and pathological response rates of concurrent Taxol/carboplatin and radiotherapy as preoperative treatment modality in advanced oral and oropharyngeal cancer.