10-yr follow-up results of NSABP B-32, a randomized phase Ⅲ clinical trial to compare sentinel node

来源 :2013年临床肿瘤学新进展学术研讨会 | 被引量 : 0次 | 上传用户:q2347386
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  Background: NSABP B-32,the largest surgical prospective randomized phase Ⅲ trial was designed to compare overall survival(OS),disease-free survival(DFS),and morbidity between SNR alone vs SNR + AD in SN negative(-)pts.We present 10 yr outcome data for primary endpoints as well as updated data on the effect of occult metastases,found later in the SN by central,detailed pathologic analysis.Methods: 5,611 women with operable,clinically N0,invasive breast cancer were randomized to SNR + AD(Group [Grp] 1)or to SNR alone with AD only if SNs were positive(Grp2).3,989(71.1%)of 5,611 pts were SN-.3,986(99.9%)of these SN-pts had follow-up information: Grp 1: 1,975,Grp 2:2,011.Median time on study was 9.4 yrs.Cox proportional hazard models adjusting for study stratification variables were used to compare OS and DFS between the two groups.Two-sided p values were used.HR values > 1 indicate a more favorable outcome in Grp 1 Results: At 10 yrs,there continues to be no significant difference in OS between the two groups(HR: 1.11,p = 0.27).10 yr Kaplan-Meier(K-M)estimates for OS are 87.8%for SNR alone and 88.9%for SNR + AD.There continues to be no significant difference in DFS between the two groups(HR: 1.01,p=0.92).10-yr K-M estimates for DFS were 76.9%for both groups.Occult nodal disease was originally detected in 3,884 pts(15.8%)with SN-on initial H and E analysis.Comparisons between the groups with and without occult disease yielded an adjusted HR for OS: 1.25(p = 0.08)with an absolute difference at 10 yrs of 2.8%and a HR for DFS: 1.24(p = 0.018)with an absolute difference of 4.1%.The cumulative incidences of local-regional events were low(10-yr values: SNR 4.0%,SNR+AD,4.3%)and not significant(HR: 0.95,p = 0.77).Conclusions: At 10 yrs there continues to be no significant differences in OS and DFS between SNR and SNR + AD in pts with negative SN.The relative increase in risk of DFS and OS for pts with occult SN metastases remains stable.
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