乳腺癌前哨淋巴结与放疗精选PPT.ppt

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1、关于乳腺癌前哨淋巴结与放疗第1页，讲稿共49张，创作于星期一保乳手术保乳手术breast conservative treatment(BCT)safe-results of randomized trials in the 1980spatients with early breast cancer第2页，讲稿共49张，创作于星期一前哨淋巴结活检前哨淋巴结活检a high level accuracyfalse negative rate around 7%equivalent oncological outcomes in terms of distant disease-free and

2、 overall survivalsurprisingly low regional recurrence rate of less than 1%第3页，讲稿共49张，创作于星期一前哨淋巴结活检前哨淋巴结活检negative SN-completion ALND is not required第4页，讲稿共49张，创作于星期一前哨淋巴结活检前哨淋巴结活检axillary metastasis are limited the SN in 60-70%overall 90%for low volume involvement(micrometastasis/isolated tumour cel

3、ls detected by immunohistochemical staining only)第5页，讲稿共49张，创作于星期一前哨淋巴结活检前哨淋巴结活检patients with involved SN omit the completion ALNDno apparent detriment to oncological outcomes第6页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011American College of Surgeons Oncology Group(ACOSOG)-Z0011axillary dissection vs.no a

4、xillary dissection 第7页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011May 1999-Dec 2004 115 sites第8页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011Eligibility criteria older than 18 years,T1-2invasive breast cancer,no palpable axillary adenopathy,and 1 or 2 SN metastasis without extranodal extension 第9页，讲稿共49张，创作于星期一A

5、COSOG-Z0011ACOSOG-Z0011Exclusion criteria Clinically node positive disease more than 2 positive sentinel nodes,matted nodes,gross extranodal diseasePreoperative systemic treatmentsisolated tumour cells(ITC)in the SN 第10页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011Stratification age(younger or older than 5

6、0 years)ER statustumour size(2 cm)第11页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011BCS and SNBSN metastasis in 1 or 2 nodes randomly assigned ALND or no further axillary ALND a dissection of at least 10 lymph WBI Systemic adjuvant therapy第12页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011The main outcome measure ov

7、erall survivalSecondar youtcome measure disease free survival第13页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011noninferiority trial the SNB-only group having a 5-year OS not less than 75%of ALND groupTargeted enrolment was 1900 women with a final analysis after 500 deaths.第14页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSO

8、G-Z0011The trial was closed 891 patients due to lower than expected accrual and event rates第15页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011445 ALND446 SN biopsy alone35 patients(25 on the ALND arm and 10 on the SNB arm)excluded because withdrew consent第16页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011第17页，讲稿共49张，

9、创作于星期一ACOSOG-Z0011ACOSOG-Z0011第18页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011第19页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011第20页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011第21页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011第22页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011limited SN metastatic breast cancer Breast conservation and

10、systemic therapy,SNB alone compared with ALND did not result in inferior survival第23页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011Potential problems statistical design and interpretationenrolment of patientsimbalances between the treatment groups and missing data第24页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011Th

11、e planned target accrual 1900 patients-a prediction of an overall survival rate of 80%at 5 years for women with optimally treated node-positive breast cancerThe study had a slow accrual(115 sites over 4 years leading to 900 patients e some centres entered less than 3 patients which is not many per s

12、ite),was unable to complete enrolment,and therefore closed early with less than 50%of the targeted accrual and with lower-than-expected event rates第25页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011a significant amount of missing data 98 cases(11%)-the number of lymph node metastases was missing,217 cases(32

13、%)-tumour grade was missing20 cases(2%)-tumour size was missing 81 cases(9%)-receptor status was missingThe size of the SN metastasis was unknown in 125 cases(15%),33 cases(4%)had no lymph node metastases15 cases in the SN arm had more than 2 nodes involved第26页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z00112

14、7%patients in the ALND arm had further positive nodesThus 27%of the 388 patients in the SNB arm may have had undissected diseaseMacrometastases in the SN 62.5%of patients in the ALND group 55.2%of patients in the SNB group.第27页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011This statistically significant imba

15、lancebetween the groups raises the question the SNB group had less tumour burden in their nodes and,consequently,a more favourable prognosisthe axillary recurrence rate was double in the SNB group(0.9%vs.0.5%)第28页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011The most critical issue-eligibility criteria incl

16、uded patients over 18 years old with tumour 5cmwithmacrometastases in2 sentinel nodesthe patients recruited to the study were generally low risk cancersThe majority of patients had small(T1)ER positive invasive ductal carcinomasover 50 years oldraising the questionmany patients with cancers that wou

17、ld have met the eligibility criteria but were not represented in the cohort of patients in the trial.第29页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011Another concern the high proportion of patients lost to follow-up 21%ALND and 17%SN第30页，讲稿共49张，创作于星期一ACOSOG-Z0011ACOSOG-Z0011WBI with opposing standard tange

18、ntial fieldsthe fields were not uniform between the randomization armsthe radiation oncologists not blinded第31页，讲稿共49张，创作于星期一前哨淋巴结活检微转移前哨淋巴结活检微转移Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases(IBCSG 2301)a phase 3 randomised controlled trial第32页，讲稿共49

19、张，创作于星期一IBCSG 2301IBCSG 2301no axillary dissection non-inferior to axillary dissection one or more micrometastatic(2 mm)sentinel nodes tumour of maximum 5 cmone or more micrometastatic(2 mm)sentinel lymph nodes with no extracapsular extension第33页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301randomly assigned(in

20、 a 1:1 ratio)Randomisation was stratified by centre and menopausal statusTreatment assignment was not masked第34页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301primary endpoint disease-free survivalNon-inferiority as a hazard ratio(HR)of less than 1.25 for no axillary dissection versus axillary dissectionThe anal

21、ysis-intention to treat第35页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第36页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第37页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第38页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第39页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第40页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第41页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第42页，讲稿共49张

22、，创作于星期一IBCSG 2301IBCSG 2301第43页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第44页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301第45页，讲稿共49张，创作于星期一Analysis of subgroups defined by tumour size,OR,PR,Analysis of subgroups defined by tumour size,OR,PR,tumour grade,and type of surgery tumour grade,and type of surgery 第46页，讲稿共49张

23、，创作于星期一Multivariable proportional-hazards regression Multivariable proportional-hazards regression analysis of disease-free survivalanalysis of disease-free survival第47页，讲稿共49张，创作于星期一IBCSG 2301IBCSG 2301This trial and ACOSOG Z0011-change clinical practice,sparing many patients with early breast-cancer axillary dissectionthe sentinel node is minimally involved thus reducing surgical complications Axillary dissection with no adverse effect on survival第48页，讲稿共49张，创作于星期一2022/10/10感谢大家观看第49页，讲稿共49张，创作于星期一