Presentation on theme: "Giuliano Pre-SSO mins ASCO Z mins"— Presentation transcript:
1 Giuliano Pre-SSO minsASCO Z minsACOSOG Z0011: A Randomized Trial of Axillary Node Dissection in Women with Clinical T1-2 N0 M0 Breast Cancer who have a Positive Sentinel NodeGiuliano AE, McCall L, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt K, Morrow M, Ballman KV1
2 Sentinel Lymph Node Dissection (SLND) for Breast Cancer SLND has replaced axillary lymph node dissection (ALND) for histopathologically node-negative womenNumerous studies have demonstrated its staging efficacy and safetyALND remains the gold standard for node-positive womenALND more morbidity than SLND
3 Contemporary Breast Cancer ASCO Z minsContemporary Breast CancerTumors are smaller than in pastFewer node-positive patientsSentinel node (SN) often only node involved (40-70%)BCT common – tangential field irradiation treats much of axillaAdjuvant systemic therapy usually given for node-positive women
4 Modern Randomized Trials of Axillary Treatment with BCT ALND vs. ObsAx RT vs. ObsALND vs. Ax RTAuthorMartelliVeronesiLouis-SylvestreN219435658Median F/U55.315AxillaryRecurrence0 vs 1.8%0.5% vs 1.5%1% vs 3%No significant differences in survivalMartelli G, Ann Surg 2005, 242:1;Louis-Sylvestre C, JCO 2004, 22:97;Veronesi U, Ann Oncol 2005, 16:383.
5 similar locoregional control and survival as Hypothesis:SLND alone achievessimilar locoregional controland survival asLevel I and II ALND for H&ESN node-positive women.
6 ACOSOG Z0011A randomized trial of axillary node dissection in women with clinical T1-2 N0 M0 breast cancer who have a positive SN165 Investigators / 177 Institutions50 investigators with 5 or more patientsTarget accrual 1900 patients (non-inferiority)Closed early
7 Inclusion/Exclusion Criteria EligibilityClinical T1 T2 N0 breast cancerH&E-detected metastases in SN (AJCC 5th edition)Lumpectomy with whole breast irradiationAdjuvant systemic therapy by choiceIneligibilityThird field (nodal irradiation) or APBIMetastases in SN detected by IHCMatted nodes3 or more involved SN
17 had additional positive 106 (27.4%) patientstreated with ALNDhad additional positivenodes removedbeyond SN.
18 Locoregional Recurrences ALND(420 pts)SLND(436 pts)RecurrenceLocal (Breast)15 (3.6%)8 (1.8%)Regional (Axilla,Supraclavicular)2 (0.5%)4 (0.9%)Total Locoregional17 (4.1%)12 (2.8%)P = 0.11Median follow-up = 6.3 yearsRegional recurrence seen in only 0.7% of the entire population
19 It is highly improbable that the 0. 9% regional or 2 It is highly improbable that the 0.9% regional or % locoregional recurrence with SLND would significantly impactsurvival.
29 Locoregional Recurrence-Free Survival SummaryLocoregional Recurrence-Free SurvivalLocoregional recurrence in only 2.8% of SLND and 4.1% of ALND patients.Only age (< 50) and higher Bloom-Richardson score were associated with locoregional recurrence by multivariable analysis.Neither number of positive SN, size of SN metastasis, nor number of lymph nodes removed was associated with locoregional recurrence.
30 Disease-Free and Overall Survival SummaryDisease-Free and Overall SurvivalNo significant difference in DFS between patients treated with SLND (83.9%) or ALND (82.2%)No significant difference in OS between patients treated with SLND (92.5%) or ALND (91.8%)Only older age, ER-, and lack of adjuvant systemic therapy - not operation - were associated with worse OS by multivariable analysis.
31 alone provided excellent locoregional control and ConclusionIn this prospectiverandomized study SLNDalone provided excellentlocoregional control andsurvival comparable tocompletion ALND.
32 breast cancer. The role of this operation should be This study does notsupport the routineuse of ALND in earlynodal metastaticbreast cancer. The role ofthis operation should bereconsidered.
33 Acknowledgments The authors thank our courageous patients as well as the ACOSOG staff andinvestigators for theircontributions to this study.