Treatment of unresectable or metastatic gallbladder cancer with single-agent gemcitabine or in combination with cisplatin.

4211 Background: Gallbladder carcinomas (GC) are often diagnosed at an advanced/metastatic stage amenable only to palliative surgery. Published data on palliative CT for GC are quite scarce and frequently, erroneously mixed with others biliary tract cancers, their median survival is only around 8 to 12 weeks. Results of chemotherapy for advanced GC are extremely poor with traditional treatment based on 5-FU.,Since 1997 we have been studying the effect of gemcitabine. We retrospectively reviewed data of two different protocol treatments, we made possible. In both trials pts had similar characteristics, they all pts had measurable locally or metastatic GC with histological or cytological proof, no prior chemotherapy or radiotherapy. The main endpoint was RR and secondary endpoints were treatment toxicity and overall survival. We reviewed pts data and outcomes. In first trial 26 pts with advanced GC were treated with GEM 1000 mg/m i.v. for 30 minutes weekly for 3 weeks out of every 4 until disease progression and/or toxicity. In second cohort, 44 pts received Gem 1200 mg/m and Cis 35 mg/m on d1and 8, every 21d for a total of 6 courses. RR was evaluated by abdominal CT scan. Pts were treated on an outpatient basis.,Twenty-five pts and 42 pts were, evaluated for response. There were 0/4 CRs and 9/16 PRs for gem vs gem + cispl. All pts were evaluated for toxicity. Four and 1 died due to disease progression, one pt. died due to renal toxicity in the arm gem +cispl. In one pt occurred hepatotoxicity grade 4 in arm gem alone. The main grade 3 hematology toxicities included thrombocytopenia (0% vs 2%), neutropenia (3.8% vs 23%) and anemia (3.8% vs 14%) in the group gem vs gem + cispl. Median survival time was 8.7 mos. vs 7 mos. for the entire population, 14.1 mos. vs 9 mos. for responders, and 6.1 mos. vs. 5 mos. for non-responders.,GEM is active against advanced, unresectable recurrent and/or metastatic GC with a good tolerability. The low toxicity profile of GEM should be considered when a treatment choice is to be made for a patient with advanced GC. GEM combined cisplatin, resulting in an increased frequency and severity of side effects and not improved rates responses in comparison with gem alone No significant financial relationships to disclose.