低剂量持续静脉滴注吉西他滨一线治疗晚期肝细胞癌的临床研究

PhaseⅡtrial of prolonged infusion of low-dose Gemcitabine in advanced hepatocellular carcinoma first line treatment

目的评价低剂量吉西他滨持续6 h静脉滴注联合奥沙利铂顺铂一线治疗晚期肝细胞癌的疗效和安全性。方法 13例经病理和/或影像学+血清甲胎蛋白确诊的、未经化疗的晚期肝细胞癌患者,采用吉西他滨250 mg/m2持续静脉滴注6 h,第1、8天;奥沙利铂130 mg/m2,第1天,每3周为1疗程,连续使用2疗程以上。结果 13例患者中12例可评价疗效,所有患者可评价不良反应。完全缓解率0%,部分缓解率0%,疾病控制率83.3%,中位治疗至进展时间为4.2个月,中位生存时间为7.3个月,1年生存率33.3%。Ⅲ～Ⅳ度白细胞减少发生率为7.7%(1/13),Ⅲ～Ⅳ度血小板减少发生率为15.4%(2/13),生活质量的改善率为58.3%。结论低剂量吉西他滨持续6 h静脉滴注联合奥沙利铂一线治疗晚期肝细胞癌疾病控制率高,生活质量改善明显、不良反应轻。

【Objective】 To evaluate the efficacy and safety in first line treatment of 6-hour continuous infusion of low dose of Gemcitabine plus Oxaliplatin for patients with advanced hepatocellular carcinoma.【Methods】 Thirteen advanced hepatocellular carcinoma patients diagnosed by pathology and/or imaging plus serum AFP concentration without chemotherapy before were enrolled.All of them received 6-hour continuous infusion of Gemcitabine 250 mg/m2 on day 1 and 8 plus Oxaliplatin 130 mg/m2 on day 1 every 3 weeks for more than 2 cycles.【Results】 All 13 patients were evaluated for toxicity and 12 for response.The overall disease stable rate was 83.3%,completed and partial response rates were 0.The median time to progression was 4.2 months,median overall survival was 7.3 months,1 year survival rate was 33.3%.The incidence of gradeⅢ-Ⅳ neutropenia and thrombocytopenia were 7.7% and 15.4%,respectively.Improvement rate of life quality was 58.3%.【Conclusion】 Six-hour prolonged infusion of low dose Gemcitabine combined with Oxaliplatin is a relatively safe and effective regimen for patients with advanced hepatocellular carcinoma.