吉西他滨联合5-氟尿嘧啶和四氢叶酸治疗晚期胰腺癌的临床研究

Gemcitabine Plus the Combination of 5-fluorouracil and Folinic Acid in the Patients with Advanced Pancreatic Adenocarcinoma

目的 评价 5 氟尿嘧啶和四氢叶酸联合化疗与加用吉西他滨后治疗晚期胰腺癌的疗效和不良反应 ;以及 5 氟尿嘧啶药物代谢动力学指标的改变。方法 43例晚期胰腺癌患者分为实验组 ( 2 2例 )和对照组 ( 2 1例 )。实验组 :吉西他滨 10 0 0mg/m2 ,第 1,8,16天静脉滴注 ,5 氟尿嘧啶 40 0mg/m2 和四氢叶酸 10 0mg/m2 于第 1～ 5天静脉滴注 ;对照组 :5 氟尿嘧啶 40 0mg/m2 和四氢叶酸 10 0mg/m2 在第 1～ 5天静脉滴注 ,均以每 4周为 1疗程 ,持续 4个疗程。结果 实验组完全缓解 (CR) 1例 ( 4 .5 %) ,部分缓解 (PR) 6例 ( 2 7.3 %) ,临床受益反应率 (CBR)为 68.2 %;对照组无CR ,PR3例 ( 14 .3 %) ,CBR有效率 3 3 .3 %。实验组出现不良反应的数量和严重程度较对照组提高且差异具有显著性。实验组 5 氟尿嘧啶血浆药物浓度、血浆峰值提高 ,血浆半衰期延长。结论 吉西他滨与 5 FU、四氢叶酸联合应用治疗晚期胰腺癌有一定的客观疗效 ,可明显改善患者的生存质量 ,但不良反应也随之提高。上述变化与吉西他滨改变 5

Objective To compare the efficacy,clinical benefit response and toxicity of gemcitabine plus the combination of 5 fluorouracil and folinic acid with that of the chemotherapy of 5 fluorouracil and folinic acid(FA) in patients with advanced pancreatic adenocarcinoma.In the same time ,we investigated whether gemcitabine affects 5 FU pharmaxokinetics. Methods 43 untreated patients were collected and divided into two groups:the experimental group received chemotherapy with gemcitabine(1 000 mg/m 2 in a intravenous on days 1,8 and 16,plus folinic acid (100mg/m 2) and 5-FU(400 mg/m 2) administered by a i.v. infusion on days 1～5; the control groups received FA (100 mg/m 2) and 5 FU (400 mg/m 2) administered in the same way.The cycles were repested every 4 weeks.Results In experimental group and control group,CR 4.5% and 0%,PR27.3% and 14.3%,PR+CR 31.8% and 14.3% were observed.Positive CBR was 68.2% in experimental group and 33.3% in control group.There was a significant increase in systemic(5 FU) exposure and toxicity in the FUFA plus gemcitabine group. Conclusion Gemcitabine combined with 5 fluorouracil and folinic acid can lead to a moderate objective response rate, and significantly improve the quality of life in patients with advanced pancreatic adenocarcinoma. Gemcitabine enhanced systemic exposure to 5 FU in cancer patients.