摘要
背景与目的：晚期和（或）转移性结直肠癌是癌症死亡的第二位主要原因。以前治疗晚期大肠癌的标准方案是氟尿嘧啶（5-FU）联合亚叶酸钙（LV），其有效率可达23％左右。20世纪90年代，几个三期临床研究证实了拓扑异构酶Ⅰ抑制剂伊立替康（开普拓，CPT-11）联合FU-LV（FOLFIRI）方案治疗结直肠癌疗效显著。本研究的目的是观察伊立替康联合5-FU和LV组成的二线化疗方案，治疗一线化疗失败后的中国人群中转移性结直肠癌的远期生存情况、临床疗效及安全性。方法：入组患者为转移性结直肠癌经5-FU，LV以及奥沙利铂等药物一线化疗失败后的患者24例，行CPT-11联合5-FU／LV的持续静脉滴注的两周治疗方案，患者至少接受6个疗程以上。按照WHO实体瘤近期客观疗效评定标准进行评价。结果：全组24例均可评价疗效及毒副反应。完全缓解（CR）为0（0／24），部分缓解（PR）5例（5／24），有效率达20％；稳定（SD）17例（17／24），进展（PD）2例（2／24）。中位疾病进展时间6．6个月（6—24个月），中位生存期10．7个月。不良反应主要是恶心呕吐，厌食，白细胞减少，脱发，延迟性腹泻，多为Ⅰ／Ⅱ度。Ⅲ／Ⅳ度不良反应10例，其中腹泻合并白细胞伴发热5例。结论：伊立替康联合5-FU和LV为治疗晚期转移性结直肠癌有效的二线方案，不良反应能控制，可供临床安全使用。
Background and purpose： Advanced and metastatic colorectal cancer is the second leading cause of cancer death. In the past, the standard treatment for patients with advanced CRC was fluorouracil（5-FU） biochemically modulated by leucovorin（LV）, which demonstrated a response rate of about 23% . In 1990s, a number of new treatment options have been available. In particular, one new cytotoxic agent , irinotecan （CPT-11）, which is a specific inhibitor of topoisomerase I, have been proven to have efficacy in the tretment of CRC . Furthermore, several first-line phase Ⅲ trials show a significant improvement in result with the addition of CPT-11 to FU-LV combination therapy （FOLFIRI）. We observed the survival situation, efficacy and safety of irinotecan plus 5-FU/LV after first-line chemotherapy failure for Chinese patients with advanced or/and metastatic colorectal cancer. Methods： Twenty-four patients with metastatic colorectal cancer whose disease had progressed after treatment with first-line oxaliplatin or other chemotherapeutics were included to receive biweekly FOLFIRI regimen （ irinotecan 180mg/m^2 on day 1, with LV 200mg/m^2 adiministrated as a 2-hour infusion before 5-FU 400mg/m^2 administrated as an intravenous bolus injection and FU 2.4g/m^2 as 46-hour infusion immediately after 5-FU bolus ）. All the patients were planned to receive at least 6 cycles of chemotherapy. They were assessed on the basis of WHO evaluation standard of objective therapeutic effect for solid tumor. Results： 24 patients were assessable to observe the efficacy and safety. No case was CR. 5 case were PR, response rate was 20% （5/24）. 17 case were SD , rate was 70% （17/ 24）. 2 case were PD, rate was 8% （2/24）. Median time to progression （TTP） were 6.6 months （6 to 24 months ）, median overall survival was 10.7 months. The majority of adverse reaction were nausea, vomiting, anorexia, diarrhea, leucopenia, alopecie. Most of them were Ⅰ / Ⅱ degree, only 6 cases reached Ⅲ/Ⅳ degree. 3 cases had diarrhea with leucopenia and fever. Conclusions： The biweekly regimen of irinotcan in combination with 5-FU/LV results in significant and clinically meaningful improvement in survival and quality of life among patients with metastatic colorectal cancer. Toxicity is manageable.
出处
《中国癌症杂志》
CAS
CSCD
2006年第8期667-669,共3页
China Oncology
关键词
伊立替康
转移性结直肠癌
化疗
irinotecon
metastatic colorectal cancer
chemotherapy
