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Treatment of advanced hepatocellular carcinoma with biweekly high-dose gemcitabine.

机译:每两周一次大剂量吉西他滨治疗晚期肝细胞癌。

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INTRODUCTION: Until today, an optimal palliative treatment regimen has not been defined for patients with advanced hepatocellular carcinoma. Since the novel cytidine analog gemcitabine has shown strong antitumor effects in vitro in a human hepatoma cell line and its therapeutic potential seems well established in several different tumors including gastrointestinal adenocarcinomas, the present phase II trial using a dose-intensified biweekly administration schedule was initiated. PATIENTS AND METHODS: 17 patients with histologically confirmed unresectable advanced or metastatic hepatoma were treated with gemcitabine 2,200 mg/m(2) given as a 30-min intravenous infusion on days 1 and 15. Treatment courses were repeated every 4 weeks. RESULTS: All patients were evaluable for response and toxicity assessment. No objective response was achieved, stable disease occurred in 8 patients (47%), and 9 progressed while on chemotherapy. The median time to progression was 4 months (range 1.5-14 months), and the median survival time was 8.5 months (range 2.5-16.0+ months). Treatment was well tolerated with mild or moderate leukopenia, thrombocytopenia and anemia representing the most common side effects. Gastrointestinal and other subjective toxicities were infrequent and also generally mild. CONCLUSIONS: In view of the disappointing treatment results, gemcitabine using this particular dose regimen should not be considered for further investigation in patients with advanced hepatocellular carcinoma. Copyright 2001 S. Karger AG, Basel.
机译:引言:直到今天,对于晚期肝细胞癌患者仍未确定最佳的姑息治疗方案。由于新型胞苷类似物吉西他滨在人肝癌细胞系中已显示出强大的体外抗肿瘤作用,并且其治疗潜力在包括胃肠道腺癌在内的多种不同肿瘤中似乎都已确立,因此开始了本期II期试验,采用剂量增强的双周给药方案。患者与方法:17例经组织学证实为不可切除的晚期或转移性肝癌患者,在第1天和第15天以30分钟静脉输注吉西他滨2200 mg / m(2)进行治疗。治疗过程每4周重复一次。结果:所有患者均可评估反应和毒性评估。没有达到客观的反应,有8名患者(47%)出现了稳定的疾病,有9名在化疗期间进展。中位进展时间为4个月(范围1.5-14个月),中位生存时间为8.5个月(范围2.5-16.0 +个月)。轻度或中度白细胞减少,血小板减少和贫血代表了最常见的副作用,治疗耐受性良好。胃肠道和其他主观毒性很少见,一般也较轻。结论:鉴于令人失望的治疗结果,吉西他滨在晚期肝细胞癌患者中不应考虑采用这种特殊剂量方案进行进一步研究。版权所有2001 S. Karger AG,巴塞尔。

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