摘要
目的系统评价新辅助化疗对可手术乳腺癌保乳手术疗效和手术实施的影响。方法电子检索Cochrane图书馆(2007年第1期)、CENTRAL(1970～2007.3)、PubMed(1978～2007,3)、CBM(1978～2006)、CNKI(1994～2007)、CMCC(1994～2007.5)。网上检索查阅ASCO(1997～2007)、st.Gallen2005、NCCN 2007;手工检索四川大学医学图书馆内相关馆藏杂志,搜集新辅助化疗(NAC)+乳房切除术/保乳手术vs乳房切除术/保乳手术+术后化疗的随机对照试验(RCT)。研究对象限于T1-3N0-2M0期患者且手术前后共接受至少4个疗程(术前至少2个疗程)的化疗,按照Cochrane协作网的方法评价纳入研究质量和提取有效数据进行Meta分析。结果共纳入3个RCT包括2 931例患者,平均随访17～137个月。3个RCT质量均较高。Meta分析结果显示,NAC不影响可手术乳腺癌患者的9年总生存率[RR=0.99,95%C(I0.91,1.07)]和无瘤生存期[RR=1.04,95%C(I0.94,1.15)],不会显著增加可手术乳腺癌患者保乳手术后同侧乳腺肿瘤复发率[RR=1.34,95%CI(0.84,2.13)]。2个RCT结果显示,NAC可提高可手术乳腺癌的保乳手术率,但另一个小样本RCT不支持这一结论。1个RCT结果显示,NAC不会影响血清肿、出血、伤口感染等手术相关并发症的发生率。3个RCT均无单独关于保乳手术患者的生存率、无瘤生存期、术中组织切除量、重复切除率、手术时间、以及对局部美容效果影响的数据。结论NAC不影响可手术乳腺癌总9年生存率和无瘤生存期,不能提高保乳患者的同侧乳腺肿瘤复发率,但可能提高可手术乳腺癌的保乳手术率。对初始就能保乳的较小乳腺癌,NAC对其生存率、保乳率的影响还不明确。还需要开展大样本的RCT明确NAC对可手术乳腺癌保乳率、保乳术中重切率、组织切除量、手术时间、手术费用等的影响。
Objective To evaluate the effect of neoadjuvant chemotherapy （NAC） on breast conserving surgery and the outcomes of treatment for women with operable breast cancer. Methods We searched The Cochrane Library （Issue 1, 2007）, CENTRAL （!970 to 2007）, PUBMED （2978 to March 2007）, CBM （1978 to 2006）, CNKI （1994 to 2007）, CMCC （1994 to May 2007） and other relevant databases and journals. We identified randomized controlled trials （RCTs） comparing NAC plus breast conserving therapy （BCT） or mastectomy versus BCT or mastectomy plus postoperative chemotherapy in women with operable breast cancer, Two reviewers independently assessed trial quality and extracted data, Meta-analyses were performed for homogenous studies by using The Cochrane Collaboration＇ s RevMan 4.2,10, Results Three eligible studies involving 2 391 women were included. The median follow-up in the studies ranged from 17 to 237 months, The methodological quality of the three RCTs was high. Meta-analyses showed that NAC had no significant effect on overall survival （OS） （RR 0.99, 95%CI 0.92 to 1.07）, disease-free survival （RR 1.04, 95%CI 0,94 to 1.15） and ipsilateral breast cancer recurrence （RR 1.34, 95%CI 0.84 to 2,13）. Two RCTs revealed that NAC significantly increased the rate of BCT in operable breast cancer patients, but the other RCT reported similar rates of BCT in both groups. One RCT indicated that NAC did not increase the incidence of surgery-related local complications, Conclusions NAC is safe for the treatment of women with operable breast cancer, which may increase the rate of BCT and help to evaluate chemosensitivity. There is insufficient evidence to assess the eft＇ect of NAC on conserving surgery procedure and survival rate in operable BCT patients. More large-scale RCTs are needed to define further the role of NAC in the treatment of operable breast cancer patients.
出处
《中国循证医学杂志》
CSCD
2008年第7期551-557,共7页
Chinese Journal of Evidence-based Medicine
关键词
新辅助化疗
可手术乳腺癌
保乳手术
随机对照试验
系统评价
Neoadjuvant chemotherapy
Operable breast cancer
Breast conserving therapy
Randomized controlled trials
Systematic review
