Purpose: The prognosis of patients with biliary tree carcinomas is very poor. The diagnosis often occurs at an advanced stage, when curative resection is not possible. We combined gemcitabine and docetaxel to optimize the palliative therapy for patients with gallbladder, biliary, and cholangio-carcinomas on an outpatient basis.
Patients and methods: Patients with histologically proven biliary tree carcinomas and a WHO performance status <2 received gemcitabine 1000 mg/m2 followed by docetaxel 35 mg/m2 weekly for 3 weeks followed by I week of rest.
Results: Forty-three patients, 14 males/29 females, with an average age of 63.3 years (range, 41 to 78) have been enrolled since 1998; 37 have completed treatment. So far, 168 cycles (range, 1 to 16) have been administered. All 43 patients were included in the response and toxicity assessments. There are no complete remissions; however, 4 (9.3%) patients achieved partial remission, 1 (2.3%) had a minimal remission, and 24 (55.8%) reached disease stabilization for a median period of 5.2 months. Fourteen (32.6%) patients progressed. The median overall survival rate is currently 11.0 months. Grade 3 hematologic toxicities were infrequent, and there were no grade 4 hematologic toxicities. Grade 3 leukopenia was reported in 4 (9.3%) patients, grade 3 thrombozytopenia in 1 (2.3%) patient, and grade 3 anemia in 1 (2.3%) patient. Twenty-eight (65.1%) patients had grade 3/4 alopecia, 8 (18.6%) had nausea/vomiting, and 2 (4.6%) had mucositis.
Conclusion: The combination of gemcitabine/docetaxel is an effective and well tolerated therapy for patients with advanced or metastatic gallbladder, biliary, and cholangio-carcinomas.