Phase II trial of a paclitaxel and carboplatin combination in Asian patients with metastatic nasopharyngeal carcinoma

Purpose: An earlier phase II trial of paclitaxel in patients with metastati c nasopharyngeal carcinoma (NPC) demonstrated a response rate of 22%. Hence we proceeded to study the combination of paclitaxel and carboplatin in the se patients. Patients and methods: The 21-day regimen was as follows: i.v. paclitaxel 17 5 mg/m(2) over three hours preceded by standard premedications, followed by i.v. carboplatin dosed at AUC of six infused over one hour. Only chemother apy-naive patients with histological diagnoses of undifferentiated carcinom a of the nasopharynx, systemic metastases and radiologically measurable les ions were eligible. Results: Thirty-two patients were accrued to this study. Twenty patients (6 2%) had at least two sites of metastasis. The main grade 3-4 toxicity was n eutropenia (31%). Nine patients (28%) developed neutropenic sepsis, which c aused the demise of one of them. Twenty-four patients (75%) responded to tr eatment, with one (3%) attaining a complete response. The median time to pr ogression of disease was seven months and the median survival was 12 months . At one year, 52% of the patients were alive. Conclusions: The combination of paclitaxel and carboplatin is an active reg imen in NPC. Its convenience of administration and good tolerability make i t an attractive alternative regimen to consider for patients with metastati c disease.