Metastatic nasopharyngeal carcinoma outcomes in patients on cisplatin with nolatrexed or 5-fluorouracil.

Background: Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China. In this study, we compared the clinical efficacy and toxicity of cisplatin with nolatrexed (LP) or 5-fluorouracil (FP) for NPC. Patients and Methods: 33 patients with metastatic NPC were randomized to the LP and FP regimens. The LP regimen consisted of continuous intravenous infusions of 740 mg/m(2) nolatrexed on days 1-5 and 25 mg/m(2) intravenous cisplatin on days 2-4. The FP regimen consisted of continuous intravenous infusions of 600 mg/m(2) 5-fluorouracil on days 1-5 and 25 mg/m(2) intravenous cisplatin on days 2-4. Cycles were repeated every 3 weeks until disease progression or completion of a total of 6 courses. Results: There were no significant differences in the response rates (RR), disease control rates (DCR), times to progression (UP), and median survival times (MST) between the regimens. The toxicities of the two regimens were mostly grade I/II, but the stomatitis incidence in the patients on the LP regimen was significantly lower than that on the FP regimen. Conclusions: The efficacy of the LP regimen was similar to that of the FP regimen. The LP regimen had lower toxicity.