伊利替康联合5-氟脲嘧啶及亚叶酸钙方案治疗难治性或复发性食管胃癌的II期研究
发布于 2004-06-18 · 浏览 1093 · IP 江苏江苏
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文题：Phase II study of irinotecan and 5-fluorouracil/leucovorin in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma
作者：L. Assersohn, G. Brown, D. Cunningham, et al.
杂志全名：Annals of Oncology
年份，卷（期）， 起止页码：2004,15: 64–69,
英文摘要：
Background: The purpose of this study was to assess the efficacy and toxicity of irinotecan and 5-fluorouracil (5-FU) in primary refractory or relapsed locally advanced or metastatic oesophagogastric (O-G) carcinoma.
Patients and methods: Patients with documented progression on or within 3 months of chemotherapy were recruited between July 2000 and May 2002. Irinotecan (180 mg/m2) was given with 5-FU (400 mg/m2 bolus) and leucovorin (folinic acid) (125 mg/m2) followed by 5-FU (1200 mg/m2 infusion over 48 h) every 2 weeks.
Response confirmed by computed tomography was assessed at 12 and 24 weeks.
Results: Thirty-eight of 40 registered patients (95%) were assessable. Median follow-up was 9.3 months and median age was 59.0 years. Thirty-three patients (86.8%) had metastatic disease and 37 patients (97.4%) had previously received platinum-based chemotherapy. Overall response rate was 29% (95% confidence interval (15.4% to 45.9%) while an additional 34% had stable disease. Improvement in tumour-related symptoms included dysphagia 78.6%, reflux 60.0%, pain 54.5%, anorexia 64.3% and weight loss 72.7%. Grade 3/4 toxicities were anaemia 13.2%, neutropenia 26.4%, febrile neutropenia 5.2%, stomatitis 2.6%, nausea and vomiting
13.2% and diarrhoea 7.9%. Median failure-free survival was 3.7 months and median overall survival was 6.4 months.
Conclusion: 5-FU/irinotecan is a valuable regimen for second-line treatment in 5-FU/platinum-resistant O-G carcinoma.
Key words: advanced, cancer, gastric, irinotecan, oesophageal, second-line
中文摘要：
伊利替康联合5-氟脲嘧啶及亚叶酸钙方案治疗难治性或复发性食管胃癌的II期研究
背景：本研究的目的是评价伊利替康联合5-氟脲嘧啶（亚叶酸钙）治疗难治性、局部进展或转移性食管胃癌的疗效及不良反应。
资料和方法：本研究收集自2000年7月至2002年5月间入组的前次化疗3个月内证实为复发的食管胃癌患者共40例。治疗方法为伊利替康180mg/m2，亚叶酸钙125mg/m2，5-FU 400mg/m2静脉推注，续以1200mg/m2，48小时维持泵入，第1天给药，每2周重复。化疗12－24周以CT检查评价疗效。
结果：在入组的40例中有38例（95%）可以评价疗效。中位持续时间9.3个月，中位年龄为59岁。其中33例（86.8%）为转移性食管胃癌，37例(97.4%)曾经接受过铂类为基础的化疗。总有效率为29% (95% CI为15.4%―45.9%)，另外有34% 的病例达到稳定（SD）。肿瘤相关症状的改善包括吞咽困难 78.6%，胃食管反流60.0%，疼痛 54.5%，食欲减退 64.3% 以及消瘦 72.7%。WHO 3/4级毒性反应包括贫血13.2%，中性粒细胞减少26.4%，中性粒细胞减少性发热5.2%， 粘膜炎2.6%，恶心呕吐反应13.2% 以及腹泻7.9%。中位无复发生存期为3.7个月，中位总生存期为6.4个月。
结论：对于铂类方案治疗进展的食管胃癌，伊利替康联合5-氟脲嘧啶（亚叶酸钙）方案是有效的二线治疗方案。
关键词：进展的，癌症，胃的，伊利替康，食管的，二线
作者：L. Assersohn, G. Brown, D. Cunningham, et al.
杂志全名：Annals of Oncology
年份，卷（期）， 起止页码：2004,15: 64–69,
英文摘要：
Background: The purpose of this study was to assess the efficacy and toxicity of irinotecan and 5-fluorouracil (5-FU) in primary refractory or relapsed locally advanced or metastatic oesophagogastric (O-G) carcinoma.
Patients and methods: Patients with documented progression on or within 3 months of chemotherapy were recruited between July 2000 and May 2002. Irinotecan (180 mg/m2) was given with 5-FU (400 mg/m2 bolus) and leucovorin (folinic acid) (125 mg/m2) followed by 5-FU (1200 mg/m2 infusion over 48 h) every 2 weeks.
Response confirmed by computed tomography was assessed at 12 and 24 weeks.
Results: Thirty-eight of 40 registered patients (95%) were assessable. Median follow-up was 9.3 months and median age was 59.0 years. Thirty-three patients (86.8%) had metastatic disease and 37 patients (97.4%) had previously received platinum-based chemotherapy. Overall response rate was 29% (95% confidence interval (15.4% to 45.9%) while an additional 34% had stable disease. Improvement in tumour-related symptoms included dysphagia 78.6%, reflux 60.0%, pain 54.5%, anorexia 64.3% and weight loss 72.7%. Grade 3/4 toxicities were anaemia 13.2%, neutropenia 26.4%, febrile neutropenia 5.2%, stomatitis 2.6%, nausea and vomiting
13.2% and diarrhoea 7.9%. Median failure-free survival was 3.7 months and median overall survival was 6.4 months.
Conclusion: 5-FU/irinotecan is a valuable regimen for second-line treatment in 5-FU/platinum-resistant O-G carcinoma.
Key words: advanced, cancer, gastric, irinotecan, oesophageal, second-line
中文摘要：
伊利替康联合5-氟脲嘧啶及亚叶酸钙方案治疗难治性或复发性食管胃癌的II期研究
背景：本研究的目的是评价伊利替康联合5-氟脲嘧啶（亚叶酸钙）治疗难治性、局部进展或转移性食管胃癌的疗效及不良反应。
资料和方法：本研究收集自2000年7月至2002年5月间入组的前次化疗3个月内证实为复发的食管胃癌患者共40例。治疗方法为伊利替康180mg/m2，亚叶酸钙125mg/m2，5-FU 400mg/m2静脉推注，续以1200mg/m2，48小时维持泵入，第1天给药，每2周重复。化疗12－24周以CT检查评价疗效。
结果：在入组的40例中有38例（95%）可以评价疗效。中位持续时间9.3个月，中位年龄为59岁。其中33例（86.8%）为转移性食管胃癌，37例(97.4%)曾经接受过铂类为基础的化疗。总有效率为29% (95% CI为15.4%―45.9%)，另外有34% 的病例达到稳定（SD）。肿瘤相关症状的改善包括吞咽困难 78.6%，胃食管反流60.0%，疼痛 54.5%，食欲减退 64.3% 以及消瘦 72.7%。WHO 3/4级毒性反应包括贫血13.2%，中性粒细胞减少26.4%，中性粒细胞减少性发热5.2%， 粘膜炎2.6%，恶心呕吐反应13.2% 以及腹泻7.9%。中位无复发生存期为3.7个月，中位总生存期为6.4个月。
结论：对于铂类方案治疗进展的食管胃癌，伊利替康联合5-氟脲嘧啶（亚叶酸钙）方案是有效的二线治疗方案。
关键词：进展的，癌症，胃的，伊利替康，食管的，二线
最后编辑于 2022-10-09 · 浏览 1093
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