NSABP_PROTOCOL_B-32临床试验课件.pptx

NSABP PROTOCOL B-32A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Axillary Dissection in Clinically Node-Negative Breast Cancer Patients10 year UpdateTB Julian, SJ Anderson, DN Krag, SP Harlow, JP Costantino, T Ashikaga,D Weaver, EP Mamounas, N WolmarkAbstract # 1000Presented at the 2013 ASCO Annual Meeting. Data is the property of the author. StratificationAgeClinical Tumor SizeType of SurgeryClinically Negative Axillary NodesNSABPB-32RandomizationGROUP 2SN (2804)GROUP 1SN + AD (2807)Intraop cytology postop HE SN PosSN Neg(SN+AD) SN Pos+ ADSN Neg(SN only)829 ptsFUFU793 pts1,975 pts2,011 ptsKrag D et al: ASCO 2010 Abstr. LBA 505Lancet Oncology, 2010SN Detection MethodsTechnetium sulfurcolloid ( 24.1% cases)Blue dye(5.1% cases)Colloid and dye (65.1%)Palpation (~4% cases)NSABP B-32 Updated through December 31, 20123,989 – SN neg (71% of 5611) 3,986 (99.9%) – follow-up information 131.1 months – median time on study121.8 months – median follow-up time of patients who are still aliveEvenly BalancedEntry CharacteristicsAge: 75% 49Race: 90% CaucasianTumor size: 16% 2cmHormone status: 80% positiveSurgical treatment plan: 87% BCSAssociated TreatmentsSystemic Therapy: 85% 84%Radiation Therapy: 82% NSABP B-32 Sentinel Node Negative PatientsSurvivalTrt N DeathsSNR+AD 1975 228SNR 2011 252 HR=1.09 p=0.35Data as of Dec 31, 2012NSABP B-32 Sentinel Node Negative PatientsDisease-Free SurvivalTrt N EventsSNR+AD 1975 455SNR 2011 475 HR=1.02 p=0.72Data as of Dec 31, 2012NSABP B-32 Sentinel Node Negative PatientsDistant Disease-Free SurvivalTrt N EventsSNR+AD 1975 293SNR 2011 325 HR=1.09 p=0.29Data as of Dec 31, 2012B-32 SN Negative Patients: Hazard Ratios of OSBetween Groups According to Stratification Variables Planned MastectomyPlanned LumpectomyTumor size 2 cmTumor size ≤ 2 cmPatients 50 + at entryPatients 50 at entryHR= 1.08All patients with follow-upSNR betterSNR+AD better0.20.61.01.41.82.2Hazard RatioAs of Dec 31, 20