DIFLUORODEOXYCYTIDINE (DFDC) - GEMCITABINE - A PHASE-I STUDY
DIFLUORODEOXYCYTIDINE (DFDC) - GEMCITABINE - A PHASE-I STUDY
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DOI：
10.1007/bf00877241
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发表时间：
1992-08-01
影响因子：
3.4
通讯作者：
BAKER, L
中科院分区：
文献类型：
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作者：
POPLIN, EA;CORBETT, T;BAKER, L
二氟脱氧胞苷（dFdC）在临床前模型中表现出广谱活性。在50名合格和可评价的患者中进行了一项每周两次注射的I期研究。29名患者接受了30分钟输注给药，剂量为5-90 Mg/M2，22名患者接受了5分钟推注给药，剂量为30-150 Mg/M2。主要剂量限制性毒性为骨髓抑制和流感样炎症。血小板减少症是剂量限制性的，输注时间表为75 Mg/M2，5分钟时间表为150 Mg/M2。许多患者在注射当天出现流感样症状，包括发热、寒战和不适。1例肾细胞癌患者获得部分缓解。对药物疗效和时间依赖性的评估仍在继续。
Difluorodeoxycytidine (dFdC) demonstrated broad spectrum activity in preclinical models. A phase 1 study utilizing twice weekly injections was conducted in 50 eligible and evaluable patients. Twenty-nine patients received drug by 30 minute infusion at doses of 5-90 Mg/M2 and 22, by 5 minute bolus at 30-150 Mg/M2. The primary dose limiting toxicities were marrow suppression and flu-like symptomatology. Thrombocytopenia was dose limiting at 75 Mg/M2 on the infusion schedule and 150 Mg/M2 on the 5 minute schedule. Flu-like symptoms with fever, rigors and malaise occurred the day of injection in many patients. One patient with renal cell carcinoma attained a partial response. Evaluation of the drug's efficacy and schedule dependency continue.