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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 curative effect and toxicity of trastuzumab in patients with HER-2-positive metastatic breast cancer after first-line treatment with trastuzumab. METHODS: A retrospective analysis of HER-2-positive metastatic breast cancer in Medline, Em-base, Cochrane Library, Clinical Trials Registry, Chinese Hospital Digital Library, Wanfang, VIP Database and the American and European Association of Clinical Oncology Patients, randomized controlled trials (RCTs) of trastuzumab following first-line use of trastuzumab-containing regimens and follow-up with Meta analysis software (RevMan 4.2). Results: From 1999 to 2010, a total of 3 clinical trials were enrolled, a total of 625 patients, of which 304 were in the test group and 321 in the control group. The objective response rates of HER-2-positive metastatic breast cancer receiving first-line treatment with trastuzumab-based therapy were statistically different from the trastuzumab-following trastuzumab following trastuzumab treatment, OR = 1.62 (95% CI: 1.08-2.44, P = 0.02). The clinical benefit response rate was 1.57 (95% CI 0.78-3.14), P = 0.20; progression free survival / overall survival OR = 1.02 95% CI was 0.61 ~ 9.41), P = 0.21; The incidence of diarrhea was OR = 1.60 (95% CI was 1.10 ~ 2.32), P = 0.01. CONCLUSIONS: Continued use of trastuzumab significantly improves objective response rates in patients with HER-2 positive metastatic disease who have received first-line therapy with trastuzumab, but are less likely to respond clinically to any benefit Survival time / overall survival no significant improvement; and the continued use of trastuzumab increased the incidence of diarrhea, but no effect on increasing the cardiotoxicity.