Annals of Oncology 12:183-186, 2001
© 2001 European Society for Medical Oncology
research-article |
Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer
1Division of Oncology, Department of internal Medicine I, Vienna University Medical School Vienna
2Department of Surgery, Wr. Neustadt General Hospital Wr. Neustadt
3Department of Surgery, Stockerau General Hospital Stockerau
4Department of Internal Medicine, Kirchdorf General Hospital Kirchdorf a d.Krems, Austria
Division of Oncology Department of Internal Medicine I Vienna University Medical School Waehringer Guertel 18–20 1090 Vienna Austriawerner.scheithauer{at}akh-wien.ac.at
BACKGROUND:: Patients with advanced biliary tract carcinoma face a dismal prognosis as no effective palliative therapy has been defined. The aim of the present phase II investigation was to evaluate the therapeutic efficacy and tolerance of a two-weekly high-dose gemcitabine regimen in this patient population.
PATIENTS AND METHODS:: Thirty-two consecutive patients with locally unresectable or metastatic biliary tract cancer were enrolled in this multicenter phase II trial. Treatment consisted of genicitabine 2200 mg/m2 given as a 30-mm intravenous infusion every two weeks for a duration of six months unless there was prior evidence of progressive disease.
RESULTS:: Results: After a median number of 12 treatment courses, 7 of 32 (22%) patients had a partial response that lasted for a median duration of 6.0 months (range 3.5–10.0). Fourteen additional patients (44%) had stable disease, whereas eleven patients (34%) progressed despite therapy. The median time to progression was 5.6 months (range 1.8–13.0); median survival time was 11.5 months (range 3.0–24.0), and the probability of surviving beyond 12 months was 44%. The tolerance of treat ment was remarkable with only two patients each experiencing grade 3 leukocytopenia. granulocytopenia and/or thrombocytopenia, and one patient had grade 3 anaemia. Similarly. nonhaematologic side effects were infrequent, and generally mild to moderate.
CONCLUSIONS:: Two-weekly high-dose gemcitabine seems to represent a potentially effective, safe and well-tolerated regimen for the palliative treatment of patients with advanced biliary tract cancer.
biliary tract cancer, chemotherapy, gemcitabine
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