Gemcitabine for the treatment of advanced biliary tract carcinomas: Evaluation of two different dose regimens
Gemcitabine for the treatment of advanced biliary tract carcinomas: Evaluation of two different dose regimens
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DOI：
10.1159/000027027
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发表时间：
1999-12-01
期刊：
影响因子：
0.3
通讯作者：
Scheithauer, W
中科院分区：
文献类型：
--
作者：
Valencak, J;Kornek, GV;Scheithauer, W
背景资料：对于预后特别差的不可切除的胆道癌患者，目前还没有标准疗法。鉴于迫切需要确定更好的治疗方法，以及吉西他滨在该疾病中治疗潜力的相互矛盾的数据，我们使用这种新型抗代谢药的2种不同剂量方案进行了2次连续临床研究。患者和方法：本研究纳入了38例局部不可切除或转移性胆道癌患者; 24例患者在第1、8和15天接受吉西他滨1，200 mg/m2治疗，在下一个周期应用前休息2周（A组）。第二组14例患者接受吉西他滨治疗，剂量增加至2,200 mg/m2，每2周一次（B组）。在两个治疗组中，除非先前有进展性疾病的证据，否则化疗将持续6个月。结果如下：在A组中，4/24例患者（17%; 95%置信区间CI 5-37%）部分缓解（PR），另外8例患者（33%）病情稳定（SD），12例患者（50%）在治疗期间进展。中位生存期为6.8（范围：2-14）个月，中位进展时间为3.5（范围：1-10.5）个月。在B组中，4/14例患者达到PR（29%; 95% CI 8-58%），5例显示SD（36%），而其余5例患者疾病进展;中位生存时间为10.5（范围3.3-16+）个月，中位至进展时间为4.8（范围1.8 - 10.5）个月。两个治疗组的毒性通常为轻度，仅少数患者发生WHO 3级血液毒性和/或轻度胃肠道症状或疲乏。结论：我们的数据表明，吉西他滨治疗晚期胆道癌是可行的，可以安全地进行本研究中使用的两种剂量方案。在第二组患者（B组）中获得的治疗结果令人鼓舞，并促使我们进一步研究每周一次的高剂量吉西他滨方案。
Background: There is no standard therapy for the treatment of patients with nonresectable biliary tract carcinomas who face a particularly dismal prognosis. In view of the urgent need to define better treatments and of the conflicting data on the therapeutic potential of gemcitabine in this disease, we have performed 2 consecutive clinical investigations using 2 different dose schedules of this novel antimetabolite. Patients and Methods: 38 patients with locally nonresectable or metastatic biliary tract cancer were enrolled in this study; 24 patients were treated with gemcitabine 1,200 mg/m(2) on days 1, 8, and 15 with 2 weeks rest before application of the next cycle (group A). A second cohort of 14 patients received gemcitabine at an increased dose level of 2,200 mg/m(2) every 2 weeks (group B). in both treatment groups, chemotherapy was to he continued for 6 months unless there was prior evidence of progressive disease. Results: In group A, 4/24 patients (17%; 95% confidence interval CI 5-37%) had a partial response (PR), 8 additional patients (33%) had stable disease (SD) and 12 patients (50%) progressed during treatment. The median survival was 6.8 (range, 2-14) months, with the median time to progression being 3.5 (range 1-10.5) months. In group B, 4/14 patients achieved a PR (29%; 95% CI 8-58%), 5 showed SD (36%), while the remaining 5 patients had progressive disease;; A median survival time of 10.5 (range 3.3-16+) months was obtained, and the median time to progression was 4.8 (range, 1.8 to 10.5) months. Toxicity was generally mild in both treatment groups with only a few patients experiencing WHO grade 3 haematotoxicity and/or mild gastrointestinal symptoms or fatigue. Conclusions: Our data suggest that treatment of advanced biliary tract cancer with gemcitabine is feasible and can be safely performed with both dose regimens used in this study. The therapeutic results that were achieved in the second cohort of patients (group B) are encouraging, and have stimulated us to further investigate the hi-weekly high-dose gemcitabine regimen.