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-naïve. The great majority (20 of 24) had undifferentiated carcinoma. Paclitaxel (Anzatax, Faulding Pharmaceuticals) 175 mg/m2 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.