Activity of paclitaxel by three-hour infusion in Asian patients with metastatic undifferentiated nasopharyngeal cancer

Background: Despite its moderate anti-tumour activity in head and neck cancers there have been no reports on the activity of paclitaxel in patients with nasopharyngeal cancer, a highly chemosensitive tumour. A phase II study was thus initiated to determine the objective response rate and toxicity of paclitaxel in patients with previously untreated metastatic nasopharyngeal cancer. Patients and methods: Twenty-four patients with previously untreated measurable metastatic nasopharyngeal carcinoma were accrued, one of them ineligible because of concomitant beta-blocker usage. Male,female ratio was 19:5, with a median age of 46 years. All had previously received radiotherapy but were chemotherapy-naive. The great majority (20 of 24) had undifferentiated carcinoma. Paclitaxel (Anzatax, Faulding Pharmaceuticals) 175 mg/m(2) was given intravenously over three hours every 21 days after premedication with oral dexamethasone and intravenous diphenhydramine and cimetidine. Results: There were five (21.7%) partial responses while eight patients remained stable. Median response duration was 7.5 months and median survival was 12 months. The main toxicity was haematological, with grade 1-2 neutropenia in 19% and grade 3-4 neutropenia in 4.5% of cycles. Three cycles were complicated by grade 3-4 anaemia and one patient required a blood. transfusion. No thrombocytopenia was seen. Peripheral neuropathy was frequent (20 of 23 patients) but mild. Alopecia was complete in 14 patients. There were no cardiac toxicity or hypersensitivity reactions. Conclusions: Paclitaxel is well tolerated even in previously irradiated patients with metastatic nasopharyngeal cancer. Single-agent activity was 22% and its inclusion into combination chemotherapy regimens should be studied.