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1、 彭海花 2012-12-14Backgroud Brachytherapy irradiates less breast tissue requires a much shorter course of treatment. emerged as an alternative to whole-breast irradiation(WBI)Backgroud Controversy WBI :1. decrease local recurrence 2. optimize the long-term likelihood of breast preservation Brachytherap
2、y :1. may insufficient for full tumor eradication 2. excess risks of postoperative and postradiation complications have not been well quantified.Backgroud Purpose compare breast brachytherapy vs WBI long-term breast preservation,complications,and survival.METHODS Patients retrospectively The nationa
3、l Medicare data . 92 735 women 67 years or older invasive breast cancer from 20032007 treated with lumpectomy followed by radiation therapyMETHODS Excluded: only 1 International Classification of Diseases,Ninth Revision(ICD-9)diagnosis code indicating breast cancer(n3990);a history of breast cancer(
4、n=10 363);noncontinuous Medicare Part A and B or health maintenance organization(HMO)coverage within 12 months before and afterdiagnosis(n=7123) ;actual treatment with radiation could not be confirmed using a stringent definition for receipt of radiation(n=1546),patients treated with both external b
5、eam radiation and brachytherapy(n=775),did not satisfy priori definition of WBI, which required treatment with at least 11 fractions of radiation(n=3027)METHODS Outcomes Subsequent mastectomy: failure of radiation to achieve optimize the long-term breast preservation Noninfectious postoperative comp
6、lications :postoperative shock,hemorrhage, seroma, hematoma persistent postoperative fistula,or nonhealing surgical wound Infectious postoperative complications: soft tissue infection that may have affected the breast(eg,mastitis and breast abscess)METHODS Post radiationassociated complications : ri
7、b fracture,fat necrosis,breast pain,and pneumonitisTime to postradiation complications :from the date of the first radiation. Overall survival was calculated from the date of diagnosis to the date of death Covariates and AnalysesAnalyses using SAS statistical software version 9.2(SAS Institute Inc)a
8、ssumed a 2-tailed =.05RESULTS median follow-up was 3.03 years(interquartile range,1.904.34) 13355(14.40%)were censored during the study interval due to loss of fee-for-service coverageRESULTS patients Characteristics Mean age 74.8(5.5)years82 418(92.11%)were white111 569(12.48%) had axillary nodal i
9、nvolvement6952(7.50%)received breast brachytherapy,5324(76.58)of thosetreated with single-entry catheter-based approachesRESULTS patients Characteristics 72251(77.91%)received axillary surgery13 504(14.56%)received chemotherapyRESULTS patients Characteristics RESULTSP.05).The interaction term for ra
10、diation therapy treatment by year of diagnosis was not significant(P=.44)indicatingthat outcomes of brachytherapy failed to improve over time.subsequent mastectomyRESULTSsubsequent mastectomyRESULTSsubsequent mastectomyRESULTS Infectious and non-infectious postoperative complications any complicatio
11、n within 1 year of lumpectomy: Brachytherapy: 1916 of 6952(27.56%;95%CI,26.51%28.63%) WBI: 14 518 of 85 783(16.92%;95%CI,16.67%17.18%) (P.001)RESULTSInfectious postoperative complicationsinfectious and non-infectious postoperative complications16.20%10.33%P.00116.25%9.00%P.001RESULTS Postradiation c
12、omplicationsany complication within 5 years of radiation:Brachytherapy: 24.96%(95%CI,23.29%26.72%)WBI : 18.80%(95%CI,18.44%19.17%) (P.001)RESULTSPostradiation complicationshigherhigherhigherRESULTS- complications in other wordsAt 5 years, an absolute 1.77%(95%CI,1.30%2.24%)excess mastectomy risk in
13、patients treated with brachytherapy compared with WBI meant that for every 56 women treated with breast brachytherapy,1 woman was harmed with unnecessary mastectomy(number needed to harmNNH,56;95%CI,4577).RESULTS- complications in other wordsAt 1 year, an absolute 10.64%(95%CI,9.57%11.72%)excess pos
14、toperative complication risk in women treated with brachytherapy :for every 9 women treated with brachytherapy,1 was harmed with an unnecessary postoperative complication(NNH,9;95%CI,810).RESULTS- complications in other wordsAt 5 years,an absolute 6.16%(95% CI;5.11%7.21%)excess radiation-associated
15、complication risk in patients treated with brachytherapy :for every 16 women treated with brachytherapy,1 was harmed with an unnecessary postradiation complication(NNH,16;95%CI,1420).RESULTS Overall survival5-y OS Brachytherapy 87.66%(95%CI,85.94%89.18%) WBI 87.04%(95%CI,86.69%87.39%) P=.02This diff
16、erence did not persist with multivariable adjustment(HR,0.94;95%CI,0.841.05;P=.26).COMMENT This study suggest Breast brachytherapy subsequent mastectomy risks of postoperative and postradiation complications women experiencing excess harm associated with brachytherapyCOMMENT The results underscore o
17、ver use brachytherapy As few data compare brachytherapy and WBI Randomized trials: Polgar C et.al Int J Radiat Oncol Biol Phys 2007 interstitial brachytherapy Vaidya JS et.al Lanct 2010 intraoperative brachytherapysimilar tumor control rates in comparison with WBI RTOG 0413/NSABP B-39 trial randomiz
18、es patients to WBI vs partial breast Irradiation ongoingCOMMENT This study provides critical interim companion data to awaited randomized results may help clinicians and patients quantify the risk-benefit ratio of Brachytherapy vs WBIWBI : 5-year local recurrence 0.6%to 0.9%in older patients brachyt
19、herapy outcomes might become increasingly favorable:in high-volume centers as physician experience matures or in the context of development of and adherence to patient selection criteria.Limitations focused on older patients with fee-for-service Medicare coverage Median ;follow-up was relatively sho
20、rt definitions of invasive cancer and radiation were claims based and may be subject to misclassification bias data set was unable to adjust for covariates such as cancer stage,histology,surgical margins,hormone receptor status,endocrine therapy,and radiation dose,with potential residual confounding of our modelLimitations detection bias may have affected complication outcomes subsequent mastectomy: local tumor recurrence or treatment-related complications data are limited in their ability to confirm actual cancer recurrenceSummary 研究背景:近距离放射疗法是一种用一个植入性放射源来进行放疗
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