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洛铂联合5-氟尿嘧啶与亚叶酸钙治疗晚期食管癌的Ⅱ期临床研究 被引量:18

Phase Ⅱ trail of Lobaplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus
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摘要 目的:评价洛铂联合5-FU与亚叶酸钙治疗晚期食管癌患者的疗效及安全性。方法:对40例未经化疗的晚期食管癌患者。给予以下方案化疗:洛铂50mg,静脉滴注,2h;亚叶酸钙200mg/m2,静脉滴注,2h,d1~d3;5-FU400mg/m2,静脉推注,d1~d3;5-FU600mg/m2,持续静脉滴注,22h,d1~d3。每21d重复。完成2个周期后行疗效评价。结果:可评价疗效病例37例,其中CR1例,PR16例,SD15例,PD5例,总有效率为45.9%(17/37)(95%CI为30%~63%),其中初治患者的总体疗效为68.2%(15/22),复治患者中总体疗效为13.3%(2/15);中位疾病进展时间为6个月。主要不良反应为骨髓抑制,其中白细胞下降Ⅲ,Ⅳ度为21.1%,血红蛋白下降Ⅲ,Ⅳ度为10.0%,血小板下降Ⅲ度为3.3%,未发现Ⅳ度反应。结论:该联合方案显示明显的抗肿瘤作用,与其他含铂方案相比,洛铂不良反应相对较轻,耐受性好。 OBJECTIVE: To evaluate the efficacy and tolerability of the combination of lobaplatin, fluorouracil and leucovorin to patients with advanced carcinoma of the esophagus. METHODS: 40 patients with advanced carcinoma of the esophagus were enrolled. All patients had measurable lesions and never had any chemotherapy and radiotherapy before. Patients received lobaplatin 50 mg,as a 2 h infusion on day 1; Leucovion (200 mg/m^2) followed by fiuorouracil bolus (400 mg/m^2) and 22 h continuous infusion fluorouracil (600 mg/m2) was administered on day 1, 2 and 3. Treatment was repeated every 21 days. More than 2 cycles were given for each patient. Efficacy was evaluated after 2 cycles. RESULTS: There were 37 cases can be assessed. 1patient achieved CR, 16 patients achieved PR, 15 SD and 5 PD. Overall response rate (ORR) was 45.9% (17/37) (95% confidence interval , 30% - 63%) and the response rate for chemotherapy naive and pretreated patients were 68.2%(15/22) and 13.3%(2/15), respectively. Median time to progress is 6 months. The maior toxicity noted was myelotoxisity. The rate of grade Ⅲ, Ⅳ of neutropenia is 21.1%, thrombocytopenia is 3.3% and anemia is 10.0%. CONCLUSIONS: Comparing with other regimens involves cisplatin, the combination of Lobaplatin, leucovorin and fluorouracil shows significant antitumor activity and a favorable toxicity profile in patients with advanced carcinoma of the esophagus.
出处 《中华肿瘤防治杂志》 CAS 2007年第1期64-66,共3页 Chinese Journal of Cancer Prevention and Treatment
关键词 食管肿瘤/药物疗法 洛铂/治疗应用 5-氟脲嘧啶/治疗应用 亚叶酸钙/治疗应用 药物疗法 多剂联用 Esophagus neoplasms/drug therapy Lobaplatin/therapeutic use fluorouracil/therapeutic use leucovorin/therapeutic use drug therapy, combination therapy with multi-agents
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参考文献4

  • 1McKeage M J.Lobaplatin..a new antitumour platinum drug[J].Expert Opin Investig Drugs,2001,10(1):119-128.
  • 2Therasse P,Arbuek S G,Eisenhauer E A,et al.New guidelines to evaluate the response to treatment in solid tumors[J].Journal of the National Cancer Institute,2000,92 (3):205 -216.
  • 3孙燕,周际昌.临床肿瘤内科手册[M].4版.北京:人民卫生出版社,2003:97
  • 4Mauer M A,Kraut E H,Krauss S A,et al.Phase Ⅱ trial of oxaliplatin,leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus[J].Annals of Oncology,2005,16(8):1320-1325.

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