A phase II study of gemcitabine in gallbladder carcinoma

Background:Due to the high mortality rates from gallbladdercarcinoma in Chile, we conducted a phase II trial to test the efficacyand safety of gemcitabine in patients with locally advanced ormetastatic gallbladder carcinoma. Patients and methods:From January 1998 to February 2000, 26 patients with metastatic orunresectable gallbladder carcinoma and no prior chemotherapy receivedgemcitabine 1000 mg/m² over 30 minutes weekly for three weeksfollowed by a week of rest. Results:Patients received amedian of 4.2 cycles (range 1–10). Out of the 25 patients whoseresponse could be evaluated, 9 went into partial remission, an overallresponse rate of 36% (95% confidence interval (95%CI): 17.1% to 57.9%). In six (25.0%) patients, thecancer remained stable, and in 10 (40%) it progressed. Mediansurvival time was 30 weeks (range 7 – 80+). Hematologicaltoxicities were mild, with no cases of febrile neutropenia orhemorrhage. However, four and one patient(s) had grades 1–2 and3–4 neutropenia, respectively, and two patients had grade 2thrombocytopenia. Nine patients experienced grade 1–2nausea/vomiting, but were able to continue treatment. There were notoxic deaths. Conclusions:In this phase II trial,gemcitabine is an active chemotherapy in metastatic or inoperablegallbladder carcinoma, with a manageable toxicity profile.