摘要
目的探讨不同剂量紫杉醇联合顺铂新辅助化疗对ⅠB2～ⅡB期宫颈癌患者的近期疗效、不良反应及远期疗效。方法选择2002年1月至2005年12月在本院就诊并经组织病理学活检确诊为ⅠB2～ⅡB期宫颈癌,并符合本研究纳入标准的60例患者为研究对象。将其随机分为TP1组(n=30,135mg/m2紫杉醇联合60mg/m2顺铂)与TP2组(n=30,60mg/m2紫杉醇联合60mg/m2顺铂),化疗1～3个疗程;TP1组与TP2组化疗间隔为21d与10d;化疗结束后行宫颈癌根治手术。采用统计学方法分析两组近期疗效、不良反应及远期疗效(1,3,5年生存率)(本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书)。两组患者年龄、宫颈癌临床分期、宫颈癌病理学类型等比较,差异无统计学意义(P>0.05)。结果 TP1组的化疗有效率(RR)为83.3%(25/30),TP2组为80.0%(24/30),两组比较,差异无统计学意义(P>0.05)。TP1组白细胞减少发生率(36.7%,11/30)高于TP2组(13.3%,4/30),且差异有统计学意义(P<0.05)。两组化疗导致的胃肠道反应、神经毒性及脱发等不良反应发生率比较,差异无统计学意义(P>0.05)。两组患者的1年、3年生存率比较,差异无统计学意义(P>0.05);而TP2组患者的5年生存率高于TP1组,且差异有统计学意义(P<0.05)。结论紫杉醇60mg/m2联合顺铂60mg/m2的新辅助化疗方案,对治疗局部ⅠB2～ⅡB期宫颈癌效果较好,但是否值得临床广泛推荐,尚需后续多中心、大样本与随访时间更长的随机对照研究进一步研究证实。
Objective To investigate the curative effects, adverse reactions and forward effects between different dosages paclitaxel of neoadjuvant chemotherapy on locally advanced cervical cancer in stage ⅠB2-ⅡB. Methods From January 2002 to December 2005,a total of 60 patients with locally advanced cervical cancer in stage ⅠB2-ⅡB were treated with strategies for deference dosages of taxol plus cisplatin （60 mg/m2） for 1 to 3 courses：Taxol 135 mg/m2,21 days interval were used in 30 patients（TP1 group）, and taxol 60 mg/m2,10 days interval were used in 30 patients（TP2 group）. The curative effects, adverse reactions and forward effect,and one-year, three-year, five-year survival rates between two groups were analysis by statistical methods. Informed consent was obtained from all participants. There had no significance difference between two groups among age, cervical cancer staging, and pathological types of cervical cancer,etc. （P0.05）. Results There had no significance difference between TP1 group[83.3%（25/30）] and TP2 group[80.0%（24/30）] in response rate（RR）, respectively（P0.05）.Toxicities including gastroenteric, neurotoxicity and alopecia reactions were similar between two groups（P0.05）, however, toxicities of leucopenia was more common in TP1 group（36.7%,11/30） than that in TP2 group（13.3%,4/30）, there had no significance difference（P0.05）. Subjects in TP2 group and TP1 group whose survival rate of one-year, three-year had no statistically significant（P0.05）,while the five-year survival rates were higher in TP2 group than those in TP1 group （P0.05）. Conclusions Taxol （60 mg/m2） plus Cisplatin（60 mg/m2） for 1 to 3 courses with 10 days interval is worth to be recommended in locally advanced cervical cancer.
出处
《中华妇幼临床医学杂志（电子版）》
CAS
2012年第6期618-621,共4页
Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)
关键词
紫杉醇
顺铂
剂量
宫颈癌
临床分期
新辅助化疗
taxol
cisplatin
dosage
cervical cancer
clinical stage
neoadjuvant chemotherapy
