放疗在乳腺癌术后应用的系统评价
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摘要
目的:
     通过系统评价的方法,研究乳腺癌根治术或改良根治术后腋窝淋巴结阴性或阳性转移患者辅助放疗与未行放疗在肿瘤复发率、患者生存率方面的差异,从而探讨放疗在乳腺癌根治术或改良根治术后腋窝淋巴结阴性、1-3个阳性转移和≥4个阳性转移患者应用的有效性。
     方法:
     制订纳入和排除标准;制订检索词检索外文数据库PubMed、 EMBASE、SCI、the Coehrane Library,中文数据库中国生物医学文献数据库、中国知网数据库、万方数据库及维普中文科技期刊数据库,手工检索及互联网查找;严格按照纳入标准:设计类型、研究对象特点、干预措施和结局指标,筛选关于乳腺癌根治术或改良根治术后放疗与未行放疗的随机对照试验的相关文献;对纳入文献进行数据收集;按照Cochrane协作网的偏倚风险评价工具进行质量评价;采用χ2检验研究各纳入研究结果间的异质性,采用RevMan5.1.0软件进行统计学分析(Meta-分析),采用相对危险度(relative risk, RR)为合并效应量的统计指标,通过敏感性分析评价Meta-分析结果的稳定性和可靠性。
     结果:
     1.检索结果:共6项试验研究,包括4765例患者符合纳入标准纳入本研究,其中腋窝淋巴结阴性患者1246例,1-3个阳性转移患者2315例,≥4个阳性转移患者1204例。
     2.质量评价:6个研究均为随机对照试验研究,2个研究采用中心随机,1个研究采用计算机产生随机序列;4个研究通过不透光的信封实施分配隐藏;6个研究未描述盲法;6个研究缺失数据均不影响结果数据的完整性;均未描述选择性报告研究结果;均不能排除其它偏倚来源。
     3.统计分析结果:
     (1)腋窝淋巴结阴性患者,放疗组与非放疗组相比:
     ①10年乳腺局部和区域淋巴结复发率差异有统计学意义[RR=0.33,95%CI(0.21,0.52),p<0.00001],即放疗可降低根治术或改良根治术后腋窝淋巴结阴性患者10年乳腺局部和区域淋巴结复发率;
     ②10年总生存率差异无统计学意义[RR=1.04,95%CI(0.90,1.13),p=0.37],即不足以证明放疗可提高根治术或改良根治术后腋窝淋巴结阴性患者10年总生存率。
     (2)腋窝淋巴结1-3个阳性患者,放疗组与非放疗组相比:
     ①10年乳腺局部和区域淋巴结复发率差异有统计学意义[RR=0.21,95%CI(0.16,0.28),p<0.00001],即放疗可降低根治术或改良根治术后腋窝淋巴结1-3个阳性患者10年乳腺局部和区域淋巴结复发率;
     ②10年总生存率差异有统计学意义[RR=1.18,95%CI(1.10,1.26),p<0.00001],即放疗可提高根治术或改良根治术后腋窝淋巴结1-3个阳性患者10年总生存率。
     (3)腋窝淋巴结≥4个阳性患者,放疗组与非放疗组相比:
     ①10年乳腺局部和区域淋巴结复发率差异有统计学意义[RR=0.29,95%CI(0.22,0.38),p<0.00001],即放疗可降低根治术或改良根治术后腋窝淋巴结≥4个阳性患者10年乳腺局部和区域淋巴结复发率;
     ②10年总生存率差异有统计学意义[RR=1.45,95%CI(1.20,1.76),p<0.00001],即放疗可提高根治术或改良根治术后腋窝淋巴结≥4个阳性患者10年总生存率。
     结论:
     一、根治术或改良根治术后腋窝淋巴结阴性患者,放疗可降低其10年局部和区域淋巴结复发率;但10年总生存率与非放疗组比较差异无统计学意义。
     二、根治术或改良根治术后腋窝淋巴结1-3个阳性转移性患者,放疗可降低其10年局部和区域淋巴结复发率和提高10年总生存率。
     三、根治术或改良根治术后腋窝淋巴结≥4个阳性转移性患者,放疗可降低其10年局部和区域淋巴结复发率和提高10年总生存率。
     目的:
     通过系统评价的方法,研究早期乳腺癌保乳术后大分割全乳放疗与常规分割全乳放疗在肿瘤复发率、患者生存率、放疗损伤及美容效果优良率方面的差异,从而探讨大分割全乳放疗在早期乳腺癌保乳术后应用的安全性和有效性。
     方法:
     制订纳入和排除标准;制订检索词检索外文数据库PubMeed、 EMBASE、SCI、the Coehrane Library,中文数据库中国生物医学文献数据库、中国知网数据库、万方数据库及维普中文科技期刊数据库,手工检索及互联网查找;严格按照纳入标准:设计类型、研究对象特点、干预措施和结局指标,筛选关于早期乳腺癌保乳术后大分割全乳放疗与常规分割全乳放疗的随机对照试验及病例对照试验的相关文献;对纳入文献进行数据收集;按照Cochrane协作网的偏倚风险评价工具进行质量评价;采用χ2检验研究各纳入研究结果间的异质性,采用RevMan5.1.0软件进行统计学分析(Meta-分析),采用相对危险度(relative risk, RR)为合并效应量的统计指标,通过敏感性分析评价Meta-分析结果的稳定性和可靠性。
     结果:
     1.检索结果:共4项试验研究,包括5884例患者符合纳入标准纳入本研究,其中大分割全乳放疗组2948例,常规分割全乳放疗组2936例。
     2.质量评价:4个研究均采用计算机产生随机序列;3个研究通过电话或传真实施分配隐藏;1个研究采用单盲,2个研究采用非盲;4个研究缺失数据均不影响结果数据的完整性;4个研究均未描述选择性报告研究结果;均不能排除其它偏倚来源。
     3.统计分析结果:大分割全乳放疗与常规分割全乳放疗比较,
     ①5年局部复发率[RR=0.83,95%CI(0.64,1.08),p=0.16]差异无统计学意义,10年局部复发率[RR=0.86,95%CI(0.65,1.13),p=0.27]差异无统计学意义;
     ②5年总生存率[RR=1.02,95%CI(1.00,1.03),p=0.09]差异无统计学意义;
     ③5年晚期放疗损伤:任何乳房外形改变发生率[RR=1.01,95%CI(0.85,1.19),p=0.95]差异无统计学意义,心肌缺血性改变[RR=0.67,95%CI(0.43,1.05),p=0.08]差异无统计学意义,放射性肺纤维化[RR=1.28,95%CI(0.73,2.26),p=0.39]差异无统计学意义,肋骨骨折的发生率[RR=1.03,95%CI(0.62,1.73),p=0.90]差异无统计学意义;
     ④5年整体美容效果优良率[RR=0.98,95%CI(0.92,1.05),RR=0.98,p=0.64]差异无统计学意义,10年整体美容效果优良率[95%CI(0.87,1.10),p=0.73]差异无统计学意义;
     结论:
     早期乳腺癌保乳术后大分割全乳放疗与常规分割全乳放疗在局部复发率、总生存率、远期放疗损伤及整体美容效果优良率方面差异无统计学意义。
     目的:
     通过系统评价的方法,研究早期乳腺癌保乳术后部分乳腺放疗与全乳放疗在肿瘤复发率、患者生存率及放疗损伤等方面的差异,从而探讨部分乳腺放疗在早期乳腺癌保乳术后应用的安全性和有效性。
     方法:
     制订纳入和排除标准;制订检索词检索外文数据库PubMed、 EMBASE、SCI、the Coehrane Library,中文数据库中国生物医学文献数据库、中国知网数据库、万方数据库及维普中文科技期刊数据库,手工检索及互联网查找;严格按照纳入标准:设计类型、研究对象特点、干预措施和结局指标,筛选关于早期乳腺癌保乳术后部分乳腺放疗与全乳放疗的随机对照试验及病例对照试验的相关文献;对纳入文献进行数据收集;按照Cochrane协作网的偏倚风险评价工具进行质量评价;采用χ2检验研究各纳入研究结果间的异质性,采用RevMan5.1.0软件进行统计学分析(Meta-分析),采用相对危险度(relative risk,RR)为合并效应量的统计指标,通过敏感性分析评价Meta-分析结果的稳定性和可靠性。
     结果:
     1.检索结果:共4项试验研究,共包括955例患者符合纳入标准纳入本研究,其中部分乳腺放疗组456例,全乳放疗组499例。
     2.质量评价:1个研究采用计算机产生随机序列;2个研究通过密闭信封实施分配隐藏;2个研究采用单盲;4个研究缺失数据均不影响结果数据的完整性;4个研究均未描述选择性报告研究结果;均不能排除其它偏倚来源。
     3.统计分析结果:保乳术后部分乳腺放疗与全乳放疗比较,
     ①5年局部复发率[RR=1.26,95%CI(0.47,3.37),p=0.65]差异无统计学意义,7年局部复发率[RR=0.71,95%CI(0.24,2.14),p=0.54]差异无统计学意义,8年局部复发率[RR=2.68,95%CI(0.87,8.22),p=0.08]差异无统计学意义,10年局部复发率[RR=1.25,95%CI(0.34,4.59),p=0.74]差异无统计学意义;
     ②5年对侧乳腺癌发生率[RR=2,.71,95%CI(0.73,9,98),p=0.13]差异无统计学意义,10年对侧乳腺癌发生率[RR=2.67,95%CI(0.72,9.91),p=0.14]差异无统计学意义;
     ③5年总生存率[RR=1.03,95%CI(0.97,1.10),p=0.35]差异无统计学意义,8年总生存率[RR=0.96,95%CI(0.79,1.15),p=0.65]差异无统计学意义;
     ④5年整体美容效果优良率差异有统计学意义[RR=1.23,95%CI(1.04,1.46),p=0.01],即5年整体美容效果优良率部分乳腺放疗较全乳放疗高;7年整体美容效果优良率差异有统计学意义[RR=1.27,95%CI(1.02,1.57),p=0.03],即7年整体美容效果优良率部分乳腺放疗较全乳放疗高。
     结论:
     一、早期乳腺癌保乳术后部分乳腺放疗与全乳放疗在局部复发率、对侧乳腺癌发生率及总生存率方面差异无统计学意义。
     二、早期乳腺癌保乳术后部分乳腺放疗与全乳放疗相比,提高了乳腺美容效果优良率。
Objective:
     We conducted a Systematic Review about the effect on the risk of local recurrence and overall survival of radiotherapy after mastectomy for breast cancer with negative,1-3and≥4positive axillary lymph nodes after mastectomy for breast cancer.
     Meterials and Methods:
     We used the searching algorithm to search the foreign language databases as PubMed, EMBASE, SCI and the Coehrane Library, and the Chinese databases as CBM, CNKI, Wanfang database, and VIP. The last search was updated on August2011. According with the type of study design, study characteristics, interventions and outcome measures, we considered all eligible RCTs (randomized controlled trials) by comparing radiotherapy after mastectomy with mastectomy only in breast-cancer patients. In addition, we tried to identify previous systematic review and Meta-analysis of randomized trials in this field. Manual searches were done by review articles and abstracts. We use RevMan5.1.0software for statistical analysis. The χ2test is used to compare heterogeneity. Sensitivity analysis is used to evaluate the stability and reliability of the results.
     Results:
     A search of six trials totally with4,765patients, including1246patients of negative axillary lymph nodes,2315patients of1-3positive axillary lymph nodes, and1204patients of^4positive axillary lymph nodes.
     For negative axillary lymph nodes:
     ①We found significant differences associated with10-year locoregional recurrence [RR=0.33,95%CI(0.21,0.52), p<0.00001] between patients with radiotherapy and patients without radiotherapy.
     ②We found no significant difference associated with10-year Overall survival [RR=1.04,95%CI(0.90,1.13),p=0.37] between patients with radiotherapy and patients without radiotherapy.
     For1-3positive axillary lymph nodes:
     ①We found significant differences associated with10-year locoregional recurrence [RR=0.21,95%CI(0.16,0.28), p<0.00001] between patients with radiotherapy and patients without radiotherapy.
     ②We found significant differences associated with10-year Overall survival [RR=0.36,95%CI(0.15,0.87),p=0.02] between patients with radiotherapy and patients without radiotherapy.
     For≥4positive axillary lymph nodes:
     ①We found significant differences associated with10-year locoregional recurrence [RR=0.29,95%CI(0.22,0.38),p<0.00001] between patients with radiotherapy and patients without radiotherapy.
     ②We found significant differences associated with10-year Overall survival [RR=1.18,95%CI(1.10,1.26), p<0.00001] between patients with radiotherapy and patients without radiotherapy.
     Conclusions:
     1. For negative axillary lymph nodes after mastectomy, study showed a significant reduction of10-year locoregional recurrences after post-mastectomy radiotherapy. No significant differences were found in 10-year overall survival.
     2. For1-3positive axillary lymph nodes after mastectomy, study showed a significant reduction of10-year loco-regional recurrences after post-mastectomy radiotherapy, and a steady improvement of10-year overall survival.
     3. For≥4positive axillary lymph nodes after mastectomy, study showed a significant reduction of10-year loco-regional recurrences after post-mastectomy radiotherapy, a steady improvement of10-year overall survival.
     Objective:
     We conducted a Systematic Review the effect on the risk of local recurrence, overall survival, cosmetic results and radiation damage of hypofractionated whole breast radiotherapy after breast-conserving surgery (BCS) for early breast cancer.
     Meterials and Methods:
     We used the searching algorithm to search the foreign language databases as PubMed, EMBASE, SCI and the Coehrane Library, and the chinese databases as CBM, CNKI,Wanfang database, and VIP. The last search was updated on August2011. In accordance with the type of study design, study characteristics, interventions and outcome measures, we considered eligible all randomized controlled trials or controlled clinical trials comparing hypofractionated whole-breast radiotherapy with conventional whole-breast radiotherapy after BCS in patients with early breast cancer.In addition, we tried to identify any previous systematic review and Meta-analysis of randomized trials in this.Manual searches were done by reviewing articles and abstracts. We use RevMan5.1.0software for statistical analysis. The%test is used to compare hetero-geneity. Sensitivity analysis is used to evaluate the stability and reliability of the results.
     Results:
     A search of four trials with pooled total of5,884patients.
     ①We found no significant difference associated with5-years and10-year ipsilateral breast cancer recurrence (p=0.16,p=0.27) between patients with hypofraction-ated and conventional whole-breast radiotherapy.
     ②We found no significant difference associated with5-year overall survival (p=0.09) between patients with hypofraction-ated and conventional whole-breast radiotherapy.
     ③We found no significant differenc associated with5-year long-term radiation damage:any change in breast appearance (p=0.95), ischaemic heart disease (p=0.08), symptomatic lung fibrosis (p=0.39), symptommatic rib fracture (p=0.90) between patients with hypofraction-ated and conventional whole-breast radiotherapy.
     ③We found no significant differences associated with5-year and10-year the cosmetic results of excellent/good (p=0.64, p=0.73) between patients with hypofractionated and conventional whole-breast radiotherapy.
     Conclusions:
     No significant differences were found in psilateral breast cancer recurrence, overall survival, long-term radiation damage:any change in breast appearance, ischaemic heart disease, symptomatic lung fibrosis, symptomatic rib fracture, and the cosmetic results of excellent/good between patients with hypofractionated and conventional whole-breast radiotherapy.
     Objective:
     We conducted a Systematic Review the effect on the risk of local recurrence, overall survival, cosmetic results and radiation damage of partial breast irradiation (PBI) after breast-conserving surgery (BCS) for early breast cancer.
     Meterials and Methods:
     We used the searching algorithm to search the foreign language databases as PubMed, EMBASE, SCI and the Coehrane Library, and the chinese databases as CBM, CNKI,Wanfang database, and VIP. The last search was updated on August2011. In accordance with the type of study design, study characteristics, interventions and outcome measures, we considered eligible all randomized controlled trials or controlled clinical trials comparing PBI with whole-breast irradiation (WBI) after breast-conserving surgery in patients with early breast cancer. In addition, we tried to identify any previous systematic review and Meta-analysis of randomized trials in this.Manual searches were done by reviewing articles and abstracts. We use RevMan5.1.0software for statistical analysis. The χ2test is used to compare heterogeneity. Sensitivity analysis is used to evaluate the stability and reliability of the results.
     Results:
     A search of four trials with pooled total of955patients.
     ①We found no significant differences associated with5-year,7-year,8-year and10-year ipsilateral breast cancer recurrence (p=0.65,p=0.54, p=0.0S,p=0.74) between patients with PBI and WBI.
     ②We found no significant differences associated with5-year and10-year contralateral breast cancer (p=0.13,p=0.14) between patients with PBI and WBI.
     ③We found no significant differences associated with5-year and8-year overall survival (p=0.35,p=0.65) between patients with PBI and WBI.
     ④However, We found significant differences associated with cosmetic results of5-year and7-year excellent/good [RR=1.23,95%CI(1.04,1.46), p=0.0l; RR=1.27,95%CI(1.02,1.57),1=0.03] between patients with with PBI and WBI.
     Conclusions:
     1. No significant differences were found in ipsilateral breast cancer recurrence, contralateral breast cancer, and overall survival between patients with PBI and WBI.
     2. PBI was statistically significantly associated with an increased the cosmetic results of excellent/good.
引文
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