A PHASE-II STUDY OF OUTPATIENT CHEMOTHERAPY WITH CISPLATIN, 5-FLUOROURACIL, AND LEUCOVORIN IN NASOPHARYNGEAL CARCINOMA

Background. Systemic disease progression occurs in the majority of pat ients with locally advanced nasopharyngeal carcinoma (NPC). Although a variety of chemotherapeutic drugs have had tumoricidal activity, the roles of chemotherapy and optimal regimens must be further defined. Ba sed on high response rates of Cisplatin, 5-Fluororacil and Leucovorin (PFL) in patients with advanced squamous cell cancers of the head and neck, we tested a new outpatient PFL chemotherapy program in patients with advanced NPC. Methods. Patients with NPC and 1) previously untrea ted, locally advanced disease; 2) local regional recurrence (LR) after radiotherapy; or 3) metastatic disease were eligible for study. Cispl atin 20 mg/m(2)/d, 5-FU 800 mg/m(2)/d and Leucovorin 90 mg/m(2)/d were administered simultaneously by continuous 96-hour intravenous infusio n every three weeks. Patients were evaluated for response, survival, a nd toxicity. Results. Thirty-five patients were studied. The response rates of PFL therapy were 100% (15% complete response [CR], 85% partia l response [PR]) in 20 patients with locally advanced or locally recur rent disease, and 80% (13.3% CR, 67.7% PR) in 15 patients with metasta tic disease. The overall median survival was 20 months after therapy ( range, 2-21). The median survival rate for previously untreated, local ly advanced patients was not reached. The median survival rate for pre viously treated, local recurrence was 34 months and for metastatic pat ients was 14 months. Mucositis and leukopenia were the dose-limiting t oxicities (20-23%, grade III) and occurred more frequently in patients previously irradiated. No treatment-related deaths occurred. Conclusi ons. Outpatient PFL chemotherapy is active, safe, and convenient for a dvanced stage nasopharyngeal carcinoma patients, and the overall toxic ities are tolerable.