A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer.
A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer.
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DOI：
10.1038/sj.bjc.6601736
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发表时间：
2004-04-19
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
本研究的主要目的是确定吉西他滨和顺铂联合治疗不可切除的胆囊癌患者的缓解率。次要目的是评价毒性、疾病进展时间和总生存期。本研究入组了经组织学证实的、不可切除的二维可测量胆囊癌的化疗患者。所有患者均要求祖布罗德体能状态为2.2，既往未接受过放疗，并且主要器官功能充足。患者在第1天和第8天接受吉西他滨（1000 mg m−2静脉注射，持续30-60分钟），在第1天接受顺铂（70 mg m−2静脉注射，持续2小时），每21天一次。每隔一个化疗周期后通过CT扫描进行反应评估。共有30例患者符合疗效和毒性分析的条件。有4例（13.3%）完全缓解者，7例（23.3%）部分缓解者，7例（23.3%）疾病稳定，4例（13.2%）患者显示疾病进展。中位至进展时间为18周（95%置信区间（CI）14-24周），中位缓解持续时间为13.5周（范围5.5-104周）。中位总生存期为20周（95%CI 14-31周），1年生存率为18.6%。WHO 3级或4级贫血分别见于7例（23.3%）和4例（13.3%）患者。5例（16.6%）患者分别发生3级或4级中性粒细胞减少，3例（10%）和2例（6.6%）患者分别发生3级或4级血小板减少。目前的研究表明，吉西他滨/顺铂联合治疗晚期不可切除的胆囊癌具有良好的耐受性和活性。
The primary objective of this study was to determine the response rates of the gemcitabine and cisplatin combination in unresectable gall bladder cancer patients. The secondary objectives were to evaluate the toxicity, time to progressive disease, and overall survival. Chemonaïve patients with histologically proven, unresectable bidimensionally measurable gall bladder cancer were enrolled into this study. All patients were required to have a Zubrod's performance status ⩽2, no prior radiotherapy, and adequate major organ function. Patients received gemcitabine (1000 mg m−2 intravenously over 30–60 min) on days 1 and 8, and cisplatin (70 mg m−2 intravenously over 2 h) on day 1, every 21 days. Response assessment was done by a CT scan after every other cycle of chemotherapy. In all, 30 patients were eligible for efficacy and toxicity analysis. There were four (13.3%) complete responders, seven (23.3%) partial responders, and seven (23.3%) with stable disease, with four (13.2%) patients showing disease progression. The median time to progression was 18 weeks (95% confidence interval (CI) 14–24 weeks), and the median duration of response was 13.5 weeks (range 5.5–104 weeks). The median overall survival was 20 weeks (95% CI 14–31 weeks), with 1-year survival rate of 18.6%. WHO grade 3 or 4 anaemia was seen in seven (23.3%) and four (13.3%) patients, respectively. Five (16.6%) patients each experienced grade 3 or 4 neutropenia, and grade 3 or 4 thrombocytopenia was seen in three (10%) and two (6.6%) patients, respectively. The present study shows that gemcitabine/cisplatin combination is well tolerated and active in advanced unresectable gall bladder cancer.
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影响因子：
0.3
作者：
Valencak, J;Kornek, GV;Scheithauer, W
通讯作者：
Scheithauer, W
影响因子：
6.2
作者：
Takada, T;Amano, H;Nakayama, T
通讯作者：
Nakayama, T
影响因子：
2.3
作者：
Verderame, F;Mandina, P;Di Leo, R
通讯作者：
Di Leo, R
影响因子：
4
作者：
Scheithauer, W
通讯作者：
Scheithauer, W
影响因子：
4
作者：
Doval, DC;Sekhon, JS;Awasthy, BS
通讯作者：
Awasthy, BS