Paclitaxel, cisplatin and gemcitabine in treatment of carcinomas of unknown primary site, a phase II study.

Background: The present study was conducted to evaluate the efficacy and toxicity of a combination of paclitaxel, cisplatin and gemcitabine in patients with carcinoma of unknown primary site (CUP).

Patients And Methods: Patients with CUP, ECOG performance status 0-1 and age between 18 and 65 years old were treated with paclitaxel 175 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1 and gemcitabine 1000 mg/m(2) day 1 and 8 in a three-week schedule.

Results: Ninety-eight patients were enrolled between 1998 and 2008. Ninety-one patients had target lesions according to the RECIST guidelines. The overall response rate was 42.9% (39 patients), including five complete responses (5.5%) and 34 partial responses (37.4%). The median survival time was 10.7 months, and the survival rates at one and two years were 42% and 14%, respectively. The most frequent grade 3 or more adverse events were neutropenia and thrombocytopenia. There were 3 treatment-related deaths.

Conclusions: Combination of paclitaxel, cisplatin and gemcitabine is an active regimen in patients with CUP with response and survival rates at least similar to other platinum- and taxane-containing regimens. The treatment was well tolerated by most patients although neutropenia and thrombocytopenia were relatively common. The present regimen represents an attractive regimen in younger CUP patients with a good performance status.