Alternating chemo-radiotherapy with cisplatin and 5-fluorouracil plus bleomycin by continuous infusion for locally advanced undifferentiated carcinoma nasopharyngeal type.

UNLABELLED: More than 80% of undifferentiated carcinoma nasopharyngeal type patients with N3 disease (AJC-UICC 1987) will die with or from distant metastases within 3 years after the first symptom. From February 1986 to November 1987 30 consecutive patients with very advanced local disease were entered in a programme with chemotherapy-radiotherapy (CT-RT) alternation after a thorough work-up to eliminate the possibility of distant metastases. PROTOCOL: two cycles of cisplatin 100 mg/m2 day 1, bleomycin 15 mg intravenously day 1 and 16 mg/m2 per day by continuous infusion days 1-5; 5-fluorouracil (5-FU) 650 mg/m2 per day by continuous infusion days 1-5 4 weeks apart. This was followed by two series of high-energy radiotherapy, 35 Gy/3.5 weeks, with a third chemotherapy cycle in between. 27 men and 3 women were treated, the median age was 37 years (range 17-71) and the mean WHO performance status was 1 (range 0-3). TNM classification: 15 T4, 9 T3, 6 T2, 28 N3 and 2 N2c. 18 patients had nodes larger than 8 cm and 24 had bulky bilateral cervical nodes. Toxicity for this protocol was moderate, nausea and vomiting being the main side-effects. Results after two CT cycles were 3 complete responses (CR; 10%), 22 partial responses (PR; 73%), 2 disease stabilizations, 2 progressions, and 1 patient inevaluable. Of the 30 patients, 27 patients completed the CT-RT protocol, 2 patients died before radiotherapy and 1 refused treatment after 2 days on protocol. 25 patients were in CR 3 months after the end of radiotherapy. As of August 1991, with a median follow-up of 55 months (range 43-63), there are 17 patients alive, 2 of them with active disease and 15 are NED (2 after salvage therapy).