A phase II study of paclitaxel plus cisplatin chemotherapy in an unfavourable group of patients with cancer of unknown primary site

Objective: We evaluated the efficacy and toxicity of combined paclitaxel and cisplatin chemotherapy in patients with cancer of unknown primary site (CUP). Efficacy was evaluated in terms of response rate, progression-free survival and overall survival. Methods: Thirty-seven patients with CUP were enrolled between January 2001 and September 2003 at Korea Cancer Center Hospital. The patients received 21-day cycles of paclitaxel (175 mg/m(2) i.v.) with cisplatin (60 mg/m(2) i.v.) given on the first day. Results: Of the 37 patients, 31 had adenocarcinoma subtypes. The overall response rate of 26 patients with measurable lesions was 42% [95% confidence interval (Cl) 23-61%]. Stable disease was seen in six patients and progressive disease in nine. Median time to progression was 4 months (95% Cl 1.3-6.8). Median overall survival was 11 months (95% Cl 8.3-13.5). The major toxicities were neuropathy and neutropenia. Grade 4 neutropenia occurred in 10 patients, but febrile neutropenia was seen in four. Conclusions: This combined paclitaxel and cisplatin regimen was well tolerated with an encouraging level of effectiveness for patients with CUP.