Pilot study of concurrent chemotherapy and radiotherapy for stage IV nasopharyngeal cancer.

Nasopharyngeal carcinoma (NPC) is a more radio- and chemosensitive tumor than all other head and neck cancers. Between September 1991 and December 1992, a total of 19 patients (13 men and six women; median age, 44 years) with AJCC stage IV NPC were entered into a pilot study of concurrent chemoradiotherapy. Pathology showed either poorly differentiated epidermoid carcinoma or undifferentiated carcinoma. Radiotherapy was delivered using a telecobalt unit and 10-MV x-rays and by conventional fractionation (1.8-2.0 Gy/fraction, 5 fractions/week). The total doses delivered were 70-75 Gy to the primary tumor and neck positive region, and 50-55 Gy to the neck negative area. Chemotherapy with cisplatin (10 mg/m2/day, days 1-5) and 5-fluorouracil (500 mg/m2/day, continuously infused for 5 days) was administered concurrently during weeks 1 and 5 of radiotherapy. The major toxicities were mucositis (42% had grade III and 58% grade II) and leukopenia (nadir white blood cells <3,000/mm3 in eight of 19). Although four patients required a delay in their second cycle of concurrent chemotherapy or had their radiotherapy interrupted for 1 week, all 19 patients completed the planned treatment and achieved a 100% complete response rate. After a median follow-up period of 42 months, one patient suffered from neck recurrence plus distant metastasis, and three patients developed distant metastases alone. The 3-year overall and disease-free survival rates are 89.5% and 83.3%, respectively. Our data indicated that concurrent chemoradiotherapy for advanced NPC is both feasible and effective, with acceptable toxicities. A phase III randomized trial to compare the efficacy of concurrent chemoradiotherapy and radiotherapy alone deserves to be studied further.