Phase I trial of gemcitabine in patients with advanced pancreatic cancer.
Phase I trial of gemcitabine in patients with advanced pancreatic cancer.
复制标题
吉西他滨治疗晚期胰腺癌的 I 期试验。
DOI：
10.1093/jjco/hye003
复制
发表时间：
2001
影响因子：
2.4
通讯作者：
Y. Maru
中科院分区：
文献类型：
--
作者：
S. Okada;H. Ueno;T. Okusaka;M. Ikeda;J. Furuse;Y. Maru
背景
吉西他滨是目前在胰腺癌中测试的最有前途的新药。本研究旨在确认吉西他滨1000 mg/m2每周给药方案在日本晚期胰腺癌患者中的耐受性。
方法
主要终点是评估剂量限制性毒性的频率。吉西他滨1000 mg/m2每周给药30分钟以上，分为两种方案：吉西他滨x3，每4周一次（方案1）和吉西他滨x7，随后停药1周，然后吉西他滨x3，每4周一次（方案2）。每个方案至少有3名患者进入，另外3名患者在存在剂量限制性毒性的情况下接受治疗。
结果
11名Karnofsky体力状态良好（≥ 80分）且有远处转移的未接受过化疗的患者进入本试验。在给药方案1中，在3例患者中未观察到剂量限制性毒性。在给药方案2中，8例入组患者中有6例完成了剂量限制性毒性评价，2例患者在该给药方案中显示剂量限制性毒性; 1例患者发生4级白细胞减少症和4级中性粒细胞减少症，另1例患者发生4级中性粒细胞减少症和3级GOT/GPT升高。2例患者（18%）显示部分缓解，7例可评价患者中的2例（29%）也实现了临床获益缓解。
结论
日本晚期胰腺癌患者可以耐受吉西他滨1000 mg/m2每周给药7次，然后休息一周，此后每4周一次给药3次。
BACKGROUND
Gemcitabine is the most promising new agent currently being tested in pancreatic cancer. The present study was conducted to confirm the tolerability of a weekly schedule of gemcitabine at a dose of 1000 mg/m2 in Japanese patients with advanced pancreatic cancer.
METHODS
The primary end-point was to evaluate the frequency of dose-limiting toxicity. Gemcitabine 1000 mg/m2 was administered over 30 min weekly in two schedules: gemcitabine x3 every 4 weeks (Schedule 1) and gemcitabine x7 followed by a week of rest and then gemcitabine x3 every 4 weeks thereafter (Schedule 2). At least three patients entered each schedule and three additional patients were treated in the presence of dose-limiting toxicity.
RESULTS
Eleven chemo-naive patients with a good Karnofsky performance status of > or =80 points and distant metastasis were entered into this trial. In Schedule 1, no dose-limiting toxicity was observed in the three patients. In Schedule 2, the evaluation of dose-limiting toxicity was complete in six of the eight enrolled patients and two patients showed dose-limiting toxicity in this Schedule; one patient experienced both grade 4 leukocytopenia and grade 4 neutropenia, and both grade 4 neutropenia and grade 3 GOT/GPT increased in another patient. Two patients (18%) showed a partial response and a clinical benefit response was also achieved in two (29%) of the seven evaluable patients.
CONCLUSION
Gemcitabine 1000 mg/m2 weekly x7 followed by a week of rest and weekly x3 every 4 weeks thereafter may be tolerated in Japanese patients with advanced pancreatic cancer.
影响因子：
3
作者：
Ali, S;Aranha, O;Philip, PA
通讯作者：
Philip, PA
影响因子：
45.3
作者：
ABBRUZZESE, JL;GRUNEWALD, R;PLUNKETT, W
通讯作者：
PLUNKETT, W