A phase II study of gemcitabine in gallbladder carcinoma.

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 1,000 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 evaluated, 9 went into partial remission, an overall response rate of 36% (95% confidence interval (95% CI): 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 carcinoma, with a manageable toxicity profile.