Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer

被引:164
作者
Penz, M
Kornek, GV
Raderer, M
Ulrich-Pur, H
Fiebiger, W
Lenauer, A
Depisch, D
Krauss, G
Schneeweiss, B
Scheithauer, W
机构
[1] Univ Vienna, Sch Med, Dept Internal Med 1, Div Oncol, A-1090 Vienna, Austria
[2] Stockerau Gen Hosp, Dept Surg, Stockerau, Austria
[3] Wr Neustadt Gen Hosp, Dept Surg, Neustadt, Germany
[4] Kirchdorf Gen Hosp, Dept Internal Med, Kirchdorf Krems, Austria
关键词
biliary tract cancer; chemotherapy; gemcitabine;
D O I
10.1023/A:1008352123009
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 gemcitabine 2200 mg/m(2) given as a 30-min intravenous infusion every two weeks for a duration of six months unless there was prior evidence of progressive disease. 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 treatment 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.
引用
收藏
页码:183 / 186
页数:4
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