摘要
目的:探讨人表皮生长因子受体-2(HER-2)阳性转移性乳腺癌患者在一线接受曲妥珠单抗治疗发生疾病进展后,继续使用曲妥珠单抗的疗效及毒副反应。方法:在Medline、Em-base、Cochrane图书馆、临床试验注册库、中国医院数字化图书馆、万方、维普数据库和美国及欧洲临床肿瘤学会历年会议资料中检索有关HER-2阳性转移性乳腺癌患者,在一线使用含曲妥珠单抗治疗方案发生疾病进展后,再应用曲妥珠单抗的随机对照临床试验(RCT),按Meta分析软件(RevMan 4.2)要求处理有关数据。结果:从1999-2010年共有3个临床实验入选,共625例患者,其中试验组304例,对照组321例。一线接受含曲妥珠单抗治疗后发生疾病进展的HER-2阳性转移性乳腺癌,继用曲妥珠单抗与停用曲妥珠单抗相比,客观缓解率差异有统计学意义,OR=1.62(95%CI为1.08~2.44),P=0.02;临床受益反应率OR=1.57(95%CI为0.78~3.14),P=0.20;无进展生存期/总生存期OR=1.02(95%CI为0.67~1.56),P=0.92;3~4级心脏事件发生率OR=2.39(95%CI为0.61~9.41),P=0.21;腹泻发生率OR=1.60(95%CI为1.10~2.32),P=0.01。结论:对于一线接受含曲妥珠单抗方案后发生疾病进展的HER-2阳性转移性乳腺癌患者,继续使用曲妥珠单抗可显著提高客观缓解率,但对临床受益反应率以及无进展生存期/总生存期无明显改善;且继续使用曲妥珠单抗增加了腹泻的发生率,但对增加心脏毒性作用无统计学意义。
OBJECTIVE: To investigate the efficacy and safety of continuing trastuzumab treatment in women with HER-2 positive,trastuzumab-refractory metastatic breast cancer.METHODS: To search all of randomized controlled trials on continuing trastuzumab for HER-2 positive,trastuzumab-refractory Metastatic breast cancer in medline,embase,Cochrane Library,Clinical Trials,CHKD,Wanfang Database,VIP information and the data of American and Europe cancer conferences.A Meta-analysis was carried out by RevMan 4.2.RESULTS: The Meta-analysis included 3 trials from 1999-2010.A total of 625 patients were included in the analysis(304 in the study group and 321 in the control group).There was statistical differences between the study group(continuing trastuzumab)and the control group(stopping trastuzumab)in objective response rate(OR=1.62,95%CI:1.08-2.44,P=0.02),but no statistical diferences in clinical benefit rate(OR=1.57,95%CI: 0.78-3.14,P=0.20),or in progression free survival/overall survival(OR=1.02,95%CI: 0.67-1.56,P=0.92);There was statistical differences between the study group and the control group in diarrhea rate(OR=1.60,95%CI: 1.10-2.32,P=0.01),but no statistical defferences in grade 3-4 cardiac events rate(OR=2.39,95%CI: 0.61-9.41,P=0.21).CONCLUSION: Continuation of trastuzumab shows a significant improvement in objective response rate in women with HER-2 positive breast cancer who experienced progression during trastuzumab treatment,but no statistical diferences in clinical benefit rate or in progression free survival/overall survival;Continuation of trastuzumab may cause diarrhea,but was not associated with increased heart toxicity.
出处
《中华肿瘤防治杂志》
CAS
2011年第17期1321-1324,共4页
Chinese Journal of Cancer Prevention and Treatment
基金
国家自然科学基金(30973505
30945201)
广东省科技计划资助课题(2009B030801005)
广州市科技计划资助课题(2009Y-C011-1)
关键词
乳腺肿瘤
肿瘤转移
抗体
单克隆
META分析
breast neoplasms
neoplasms metastasis
antibodies
monoclonal
Meta-analysis