Phase II study: concurrent chemo-radiotherapy in advanced nasopharyngeal carcinoma.

This prospective clinical trial was conducted in previously untreated patients with stage IV nasopharyngeal carcinoma (TNM classification), who received concurrent chemo-radiotherapy regimen of cisplatin and radiation, followed by adjuvant chemotherapy consisting of 5FU and cisplatin. The aim was to improve both disease free survival and overall survival. From July 1991 to June 1993, 28 patients with stage IV (T1-4N2-3 M0) squamous cell carcinoma or undifferentiated cell carcinoma of the nasopharynx were treated at the Pramongkutklao Hospital with radical radiotherapy and concurrent chemotherapy using cisplatin 100 mg/m2 on day 1 and 22 of radiotherapy. Adjuvant chemotherapy consisted of cisplatin 100 mg/m2 day 1 and 5FU 800 mg/m2 continuous intravenous infusion 24 hours for day 1-4 and repeated every 4 weeks, for 4 courses. All twenty eight cases had documented stage IV without distant metastases. 11/28 and 16/28 had T4 and N3 disease respectively. The initial response to concurrent chemo-radiotherapy was 100 per cent (27 CR, and 1 PR). With a median follow-up period of 58 months, the 2-year and 4-year survival rates were 85 per cent and 78 per cent respectively. Concurrent chemo-radiotherapy and adjuvant chemotherapy was well tolerated and without significant acute or chronic toxic effect, only a few patients had grade 3 and 4 mucositis and hematologic toxicity. At median time to follow-up of 58 months, seven patients developed loco-regional recurrence and two had distant metastases at the time of analysis. The results of this prospective study demonstrated that concurrent chemo-radiotherapy could induce a durable complete remission in a high proportion of patients with poor-prognosis stage IV nasopharyngeal carcinoma, resulting in an improved overall 2 and 4-year survival when compared to historical control of radiation therapy alone.