A combination of gemcitabine and 5-fluorouracil in advanced pancreatic cancer, a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).
A combination of gemcitabine and 5-fluorouracil in advanced pancreatic cancer, a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).
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吉西他滨和5-氟尿嘧啶在晚期胰腺癌中的结合，这是意大利群体研究消化道癌研究（GISCAD）的一份报告。
DOI：
10.1038/sj.bjc.6690568
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发表时间：
1999-07
影响因子：
8.8
通讯作者：
Catalano, G
中科院分区：
文献类型：
--
作者：
Cascinu, S;Silva, RR;Barni, S;Labianca, R;Frontini, L;Piazza, E;Pancera, G;Giordani, P;Giuliodori, L;Pessi, MA;Fusco, V;Luporini, G;Cellerino, R;Catalano, G
在一项随机临床试验中，吉西他滨（GEM）在晚期胰腺癌患者中的疗效优于5 - 氟尿嘧啶（5 - FU）。吉西他滨和5 - 氟尿嘧啶作用机制不同，从理论上讲，两者联合可能会产生更高的活性。为了测试这种联合用药的活性和可行性，意大利消化道癌症研究小组（GISCAD）于1996年11月启动了一项多机构的II期研究。本研究的主要目的是根据缓解率和临床获益来确定其活性，次要目的是评估毒性。按照最佳的两阶段II期设计，招募了54名患者。用药方案为：吉西他滨1000毫克/平方米，静脉注射（i.v.），5 - 氟尿嘧啶600毫克/平方米，静脉推注，每4周中的3周每周给药一次。所有54名患者都有症状（疼痛、体重减轻、消化不良）。28名患者（51%）获得了临床获益（95%置信区间（CI）为38% - 64%）。2名患者达到部分缓解，34名患者病情稳定。所有患者的中位生存期为7个月。副作用轻微：未记录到胃肠道或血液学3 - 4级毒性（世界卫生组织标准）。我们仅观察到6例2级（世界卫生组织标准）白细胞减少和7例血小板减少。尽管本研究的非随机设计在解释这些数据时需谨慎，但考虑到毒性发生率低以及在临床获益方面取得的良好结果，测试5 - 氟尿嘧啶（持续输注）与吉西他滨联合的更积极的用药方案可能是值得的。©1999癌症研究运动
In a randomized clinical trial, gemcitabine (GEM) was more effective than 5-fluorouracil (5-FU) in advanced pancreatic cancer patients. GEM and 5-FU have different mechanisms of action and their combination, from a theoretical point of view, could result in a higher activity. To test activity and feasibility of such a combination, a multi-institutional phase II study was initiated in November 1996 by the Italian Group for the study of Digestive Tract Cancer (GISCAD). Primary objectives of this study were to determine the activity in terms of response rate and clinical benefit, while the secondary objective was toxicity. According to the optimal two-stage phase II design, 54 patients were enrolled. Schedule was: GEM 1000 mg m−2 intravenous (i.v.), and 5-FU 600 mg m−2 bolus i.v. weekly for 3 weeks out of every 4. All the 54 patients were symptomatic (pain, weight loss, dyspepsia). A clinical benefit was obtained in 28 patients (51%) (95% confidence interval (CI) 38–64%). Two patients achieved a partial response and 34 a stable disease. Median survival for all the patients was 7 months. Side-effects were mild: no gastrointestinal or haematological grade 3–4 toxicity (WHO) were recorded. We observed only six episodes of grade 2 (WHO) leukopenia and seven episodes of thrombocytopenia. Although the non-randomized design of this study suggests caution in the interpretation of these data, in consideration of the low incidence of toxicity and the favourable results obtained in terms of clinical benefit, it may be worthwhile to test more active schedules of 5-FU (continuous infusion) in combination with gemcitabine. © 1999 Cancer Research Campaign
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