The team conducted a phase II trial to test the efficacy and safety of gemcitabine in patients with locally advanced or metastatic gallbladder carcinoma.
They reported the findings in the latest issue of the Annals of Oncology.
From January 1998 to February 2000, 26 patients with metastatic or unresectable gallbladder carcinoma and no prior chemotherapy were enrolled in the study.
Each received gemcitabine 1000 mg/m2 over 30 minutes weekly for 3 weeks, followed by a week of rest. The patients received a median of 4.2 cycles.
Out of the 25 patients whose response could be evaluated, 9 went into partial remission, an overall response rate of 36%.
|36% of patients responded to gemcitabine.
| Annals of Oncology |
In 6 (25%) patients, the cancer remained stable, and in 10 (40%) it progressed.
Median survival time was found to be 30 weeks.
Hematological toxicities were mild, with no cases of febrile neutropenia or hemorrhage.
However, 4 and 1 patient(s) had grades 1-2 and 3-4 neutropenia, respectively, and 2 patients had grade 2 thrombocytopenia.
The researchers found that 9 patients experienced grade 1-2 nausea/vomiting, but were able to continue treatment.
There were no toxic deaths.
J. O. Gallardo, of the Universidad de Chile, concluded on behalf of the group, "In this phase II trial, gemcitabine is an active chemotherapy in metastatic or inoperable gallbladder carcinoma, with a manageable toxicity profile."