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 chemo-therapy 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 pacli-taxel (175 mg/m2 i.v.) with cisplatin (60 mg/m2 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 (CI) 23–61%]. Stable diseasewas seen in six patients and progressive disease in nine.Median time to progressionwas 4months (95%CI 1.3–6.8). Median overall survival was 11months (95%CI 8.3–13.5). Themajor 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. Key words: carcinoma of unknown primary site (CUP) – cisplatin – paclitaxe