A phase II study of gemcitabine in gallbladder carcinoma

Background: Due to the high mortality rates from gallbladder carcinoma in C hile, we conducted a phase II trial to test the efficacy and safety of gemc itabine in patients with locally advanced or metastatic gallbladder carcino ma. Patients and methods:From January 1998 to February 2000, 26 patients with m etastatic or unresectable gallbladder carcinoma and no prior chemotherapy r eceived gemcitabine 1000 mg/m(2) over 30 minutes weekly for three weeks fol lowed 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 remissio n, 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+). Hem atological toxicities were mild, with no cases of febrile neutropenia or he morrhage. However, four and one patient(s) had grades 1-2 and 3-4 neutropen ia, respectively, and two patients had grade 2 thrombocytopenia. Nine patie nts experienced grade 1-2 nausea/vomiting, but were able to continue treatm ent. 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 toxici ty profile.