Phase II trial of chemotherapy with 5-fluorouracil, bleomycin, epirubicin,and cisplatin for patients with locally advanced, metastatic, or recurrentundifferentiated carcinoma of the nasopharyngeal type

BACKGROUND. The aim of this study was to evaluate the toxicity and efficacy of the combination of 5-fluorouracil, bleomycin, epirubicin, and cisplatin (FBEC) in the treatment of patients with undifferentiated carcinoma of nas opharyngeal type (UCNT). The study included patients with metastatic or rec urrent disease (Group A) and previously untreated patients with locally adv anced nonmetastatic disease (T greater than or equal to 3 or any T, N great er than or equal to 2, M0 according to 1987 criteria of the International U nion Against Cancer and the American Joint Committee on Cancer (Group B). METHODS. From January 1992 to November 1996, 49 patients with histologicall y proven UCNT were treated with intravenous (i.v.) 5-fluorouracil (700 mg/m 2/day by continuous infusion for 4 days), epirubicin (70 mg/m(2) i.v. on Da y 1), Bleomycin (10 mg i.v. bolus on Day 1 followed by 12 mg/m2/day by cont inuous infusion for 4 days), and cisplatin (100 mg/m(2) on Day 5); this reg imen was repeated every 21 days. Six cycles were given to Group A (26 patie nts), with bleomycin omitted during the last 3 cycles. In Group B (23 patie nts), only 3 cycles were given, followed by conventional radiotherapy (70 g ray for 7 weeks). RESULTS. Of the 26 patients entered in Group A, 23 were evaluable for respo nse. Nine complete responses (CRs) and 9 partial responses (PRs) were asses sed, for a 78% objective response rate (ORR) (95% CI: 56-92). Three patient s are alive with no evidence of disease after 43, 61, and 73 months, respec tively. These patients achieved a CR with chemotherapy followed by consolid ating radiotherapy to their target lesions. In Group B, the ORR was 91.5%, with 5 CRs (22%) and 16 PRs (69.5%) assessed in the 23 patients. Three mont hs after the end of radiotherapy, the ORR was 87% (20 patients). After a me dian follow-up of 51 months (range, 24-67 months), 15 patients (65%) are al ive without evidence of disease. Forty percent of cycles (51% in Group A, 2 5% in Group B) resulted in Grade 4 neutropenia, with fever and/or sepsis in 9.5%. Mucositis was seen in 42% of pretreated patients. There were 3 treat ment-related deaths (2 from complications of infection and 1 bleomycin fibr osis at a total dose of 160 mg/m(2)), all of them in Group A. CONCLUSIONS. The FBEC regimen has good activity, with durable responses in patients with locally advanced, metastatic, or recurrent UCNT. This regimen is safe for patients with locally advanced disease, but close follow-up an d supportive measures are needed when it is used to treat those with metast atic or recurrent disease. Cancer 1999;86:1101-8. (C) 1999 American Cancer Society.