Summary

Background: Due to the high mortality rates from gallbladder carcinoma in Chile, we conducted a phase II trial to test the efficacy and safety of gemcitabine in patients with locally advanced or metastatic gallbladder carcinoma. Patients and methods: From January 1998 to February 2000, 26 patients with metastatic or unresectable gallbladder carcinoma and no prior chemotherapy received gemcitabine 1000 mg/m2 over 30 minutes weekly for three weeks followed by a week of rest. Results: Patients received a median of 4.2 cycles (range 1-10). Out of the 25 patients whose response could be eval-uated, 9 went into partial remission, an overall response rate of 36 % (95 % confidence interval (95 % Cl): 17.1 % to 57.9%). In six (25.0%>) patients, the cancer remained stable, and in 10 (40%) it progressed. Median survival time was 30 weeks (range 7- 80+). Hematological toxicities were mild, with no cases of febrile neutropenia or hemorrhage. However, four and one patient(s) had grades 1-2 and 3-4 neutropenia, respectively, and two patients had grade 2 thrombocytopenia. Nine patients experienced grade 1-2 nausea/vomiting, but were able to continue treatment. There were no toxic deaths. Conclusions: In this phase II trial, gemcitabine is an active chemotherapy in metastatic or inoperable gallbladder carcino-ma, with a manageable toxicity profile. Key words: gallbladder cancer, gemcitabine, phase I