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A phase II study of gemcitabine and carboplatin combination chemotherapy in gallbladder carcinoma.

BACKGROUND
Patients with carcinoma of the gallbladder have advanced, unresectable tumor at the time of presentation and face a dismal prognosis in the absence of a standard palliative chemotherapy regimen. This study was undertaken to evaluate the efficacy and safety of combined chemotherapy of gemcitabine and carboplatin in 20 patients with advanced gallbladder carcinoma.


METHODS
The criteria of eligibility included chemonaive patients with unresectable gallbladder cancer, bidimensionally measurable disease, Zubrod's performance status < or = 2, and adequate major organ function. The patients received gemcitabine (1000 mg/m2) on days 1 and 8, and carboplatin (target AUC of 5.0 mg/ml) on day 1, in a 21-day cycle. CT was used for response assessment.


RESULTS
In this group of 20 patients with advanced gallbladder carcinoma 6 were men and 14 women, with a median age of 55 years. The stage of the tumor at presentation was IVB in 14 patients (70%), IVA in 3 (15%) and III in 3 (15%). Four patients (21%) achieved a complete response, and 3 (15.7%), a partial response; an overall response rate was 36.7%. The median time to progression of the tumor was 33.8 weeks, and 1-year survival rate of the patients was 43.3%. Anemia of WHO grade III or IV was seen in 2 patients (10%) and 1 patient (5%), respectively. Grade III neutropenia and thrombocytopenia were observed in 2 patients (10%) and 1 patient (5%), respectively.


CONCLUSION
With mild toxicity, combined chemotherapy of gemcitabine and carboplatin is effective in the treatment of advanced gallbladder carcinoma.