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SABCS 2012 Surgery Highlights

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1 SABCS 2012 Surgery Highlights
Frederick M. Dirbas, M.D. Associate Prof Surgery, Physician Leader Breast Clinical Cancer Program Stanford Cancer Institute

2 Fibro-epithelial tumors
Phyllodes tumors of the breast: what predicts recurrence? (P ) Retrospective analysis ( ), 87 patients, median age 47, mean size 46.6 mm Benign Borderline Malignant No. pts 60 (69%) 10 (11.5%) 17 (19.5%) Median age 45 55 BCS/Mast 66/2 (97%) 11/6 (65%) RT 2 IBTR 6 (8.6%) 5 (29.4%) Metastases 2 (followed IBTR) (18.2%) Time to mets - 2.5 yrs Relapse free 91.7% 90% 70.6% Classification scheme was that of Azzopardi and Salvadori 23 year period of study Authors indicate 1 cm margin is “standard” From time to abstract submitted to SABCS, IBTR in malignant group went from 4 to 5

3 Fibro-epithelial tumors
Phyllodes tumors of the breast: what predicts recurrence? (P ) Margins < 1 mm in 23, 1 to 20 mm in 31, and > 20 mm in only 1. They state margins unimportant, but only compared < 1 mm vs 1 to 20 mm. 32 pts margins not recorded. Authors overall did not break down margin width by phenotype, except for 3 pts with malig phyllodes who had margins < 1 mm. Of 3 patients with malig phyllodes with BCT < 1 mm margin. 1 recurred, 33%. Of 5 patients with malig phyllodes who had IBTR, 2 had distant recurrence. Conclusion: optimal margin for benign/borderline phyllodes is uncertain, is 1 mm as good as 1 cm? Conclusion: margins < 1 mm for malig phyllodes may not be optimal Conclusion: IBTR with malignant phyllodes is a bad prognostic marker for survival.

4 Atypical Epithelial Lesions and Excision
Is surgical excision warranted for atypical lesions found on core biopsy? Flat epithelial atypia – Loyola (P ) , 14 patients. 3 pts (21.4%) upgraded to DCIS or IBC on excision Flat epithelial atypia – 3 Dutch hospitals (P ) , 104 pts, treated ranged from observation to mastectomy Of those excised, 20.4% had DCIS or invasive breast cancer ADH on vacuum biopsy - Oscar Lambret Center, France (P ) , 320 pts with excision, 17.5% upstaged to DCIS or IBC Grade 1 DCIS (32.6%), Grade 2 DCIS (34.6%), IBC (4.7%) No prognostic marker identified for upstaging P : small study, recommend surgical biopsy P : Flat Epithelial Atypia (FEA) as a term was first coined by the WHO in 2003, to encompass lesions which were previously described in literature under a wide variety of names, including but not limited to: atypical columnar lesions, clinging type ductal carcinoma in situ of the monomorphic type and CAPSS (columar cell alterations with prominent apical snouts and secretions).

5 Atypical Epithelial Lesions and Excision
Can a nomogram predict the risk of histologic upgrades for full spectrum of atypical lesions, ADH, ALH, FEA, LCIS: when to excise? (P ) – Gustave Roussy . Retrospective analysis , 205 patient training set Sens 77.8%, Sp 66.1%, PPV 40%, NPV 91.1% P : small study, recommend surgical biopsy P : Flat Epithelial Atypia (FEA) as a term was first coined by the WHO in 2003, to encompass lesions which were previously described in literature under a wide variety of names, including but not limited to: atypical columnar lesions, clinging type ductal carcinoma in situ of the monomorphic type and CAPSS (columar cell alterations with prominent apical snouts and secretions).

6 Central review of pathology after lumpectomy and SNB for nonpalpable IBC
Use of expert breast pathologists to confirm diagnosis (P ) – UMC Utrecht 310 pts with IBC and SN bx. 24% discordance rate, 9% change in mgmt Applying current Dutch Guidelines, central review would have affected locoregional treatment in 2% (7/310), systemic treatment in 5% (16/310) and both in 1% (2/310) of the patients.(table 3) No definition given for “routine” No comparison among “central” review facilities

7 Breast MRI , 678 patients w staging MRI, ethnically mixed population (P ) - USC 141 pts (21%) had non-index lesions found 57 pts (8.4%) had 62 occult cancers detected (49 invasive, 9 in-situ) Non-index lesions, separate quadrant, breast or axillary nodes

8 Breast MRI pts with ductolobular IBC, prospectively offered breast MRI (P ) Increase in clinically relevant findings in 44% of patients More extens 25 pts (22%); addit ips foci 22 pts (19%), new contra dx 12 pts (10%) Any proportion lobular Only counted new lesions > 5 mm, additional ipsi or contralateral cancer Proportion of lobular carcinoma did not matter Does not define difference between more extensive vs increase in size Does not mention how many were to have mastectomy or bilateral mastectomy, so may overestimate clinical impact

9 Ductal carcinoma in situ
Utility margin index to predict residual DCIS (P ) - Yale 2009, 177 pts: closest margin distance (mm)/extent of DCIS (mm) 87 pts underwent re-excision: PR status most predictive of resid disease Median tumor size 16mm Media margin distance 1 mm Median margin index .125 22 (25.3%) high grade 53 (60.9%) int grade 12 (13.8%) low grade

10 Ductal carcinoma in situ
Prediction of recurrent DCIS and/or IBC after BCS for DCIS Use of molecular phenotypes (intrinsic subset) to predict to predict recurrence (PD ) – Univ of Manchester 1990 – 2010, 314 pts Manchester Lum A ER/PR pos, her2 neg Lum B ER/PR pos, her2 pos Her2 ER/PR neg, her2 pos Trip neg, ER/PR/her2 neg IHC, scored 0 to 3, >=2 was consid pos. Why did so few Lum A pts receive mastectomy? Low grade?

11 Perhaps molec phenotype can be used to predict pts who don’t need Tam, RT, etc
Limitations: no comment on RT, no RT Did not report Ki67 Note: Oncotype Dx (Solin)

12 Ductal carcinoma in situ
Use of Ki-67 in predicting LRR of DIN after RT (PD-04-07) – EIO : 1,171 consec pts, med f/u 86 months 872 pts BCT, 356 pts RT, 506 pts TAM Overall recurrence 10.7% RT protective if Ki67 > 14% RT effective overall in all groups except Lum A EIO Abstract did not report recurrence as IDC or DCIS

13 Ductal carcinoma in situ
Prediction of recurrent pure DCIS vs IBC +/- DCIS (PD-04-05) – MSKCC , 1873 pts 190 pts recurred (10%): 108 archival blocks available (57% of recur) 66 recurred DCIS (61%), 42 recurred IBC (39%) (mean 40 mos) Initial unsupervised hierarchical clustering of 32 genes showed 2 groups: RI + RD vs RI 14 genes w/ sig differential expression: 3 RI +/- RD vs 1 RD RD “only” recurrence had highest levels of AKT3, EGFR, CDKN2A, MKI67, typical of basal like tumors MSKCC BCS +/- RT Quantification of mRNA done by Nanostring nCounter system 32 breast cancer genes identified in Her2/PI3K/AKT signaling: did they pick the right genes?

14 Ductal carcinoma in situ
Prediction of recurrent pure DCIS vs IBC +/- DCIS (PD-04-05) – MSKCC Why does this differ from phenotype based on IHC, Univ of Manchester? IHC vs mRNA: profiling discrepancies exist in approx 5 to 10% Specific genes selected? Her2 did not differentiate as in Univ of Manchester study

15 Breast conservation surgery
Patient selection Current rates of breast conservation (SEER) (PD-04-04) Breast conservation in young women (PD-04-01) Breast conservation after neoadjuvant therapy (P ) Technique Intraoperative ultrasound (PD-04-01) Use of radioguided localization (ROLL) (P ) Radiofrequency ablation – long term results (P ) Repeat breast conservation (P )

16 Breast conservation surgery
What influences rates of BCS? (SEER) (PD-04-04) , 437 breast centers: 77, 248 pts Stage 0-II, 64.2% BCS No change during study period towards increase/decrease BCS. Limitations: Random audits, self reporting Bias towards BCS in facilities pursuing national accreditation No data regarding MRI use

17 Breast conservation surgery
Breast conservation in young women (PD-04-03) – Univ New South Wales, Au 1995 – 2008: 246 pts ≤ 40, 2004 pts > 40. Median f/u 70 months. Conclusion: women ≤ 40 have a 52% relative risk of IBTR

18 Breast conservation surgery
Breast conservation in young women (PD-04-03) – Univ New South Wales, Au 1995 – 2008: 246 pts ≤ 40, 2004 pts > 40 Conclusion: women ≤ 40 have a 52% relative risk of IBTR Does IBTR rate impact survival? Not provided.

19 Breast conservation surgery
Breast conservation after neoadjuvant therapy in clinical stage III pts (P ) - Seoul , 166 pts BCT or M after NCT and 193 pts surgery 1st After NCT, 94 pts (56.6%) had M: if T ≤ 4 cm 72 pts (43.4%) had BCT. f/u 62 mos. Seoul National University Hospital

20 Breast conservation surgery
Intraoperative ultrasound improves surgical accuracy (PD-04-01) - Netherlands , 6 medical centers, T1-T2 palpable breast tumors randomly assigned to standard excision (PGS, 69 pts) vs intraop US guided excision (USG, 65 pts) 12/69 pts (17%) PGS + margins, 2/62 pts (3%) USG + margins Netherlands, 6 medical centers, randomized but not blinded. No MRI reported. No def of margin adequacy provided Google Images

21 Breast conservation surgery
Cost effectiveness of ROLL vs wire guided localization (P ) – Utrecht Histologically non-palpable cancer Randomized to ROLL (162 pts) vs WGL (152 pts) Data on QOL, cost No difference in OR time ROLL associated with 7% increase in reoperation (27% vs 20%) ROLL associated with 13% increase in complications (30% vs 17%) QOL same Total costs same UMC Utrecht Google Images

22 Breast conservation surgery
Radiofrequency ablation – long term results (P ) – Kanazawa Hosital, Japan RFA is a promising technique for non-surgical local therapy. 95 deg C , 19 pts. T < 2 cm. 17/19 “luminal A” Ablated tumor sampled between 24 and 202 days Complete response confirmed in 8/19 pts. No clinical recurrences 60 mos f/u

23 Breast conservation surgery
Repeat breast conservation (P ) GEC-ESTRO Is BCT safe for IBTR? , 8 European Institutions. 217 pts repeat BCS + MIB. Mean T = 11mm Median f/u 3.9 years after 2nd BCS. 5 and 10 year actuarial LR rates 5.6% and 7.2%, resp, OSS 88.7% and 76.4% 141 pts/193 complications, most frequent was fibrosis. Cosmesis ex/g 85%

24 Mastectomy Nipple-Areolar sparing
Nipple-areolar complex ischemia ASBS registry (P ) 33/265 mastectomies had some degree of ischemia. 11% epidermolysis; 1% debridement; .3% surgical excision. No correlation w/ technique NAS increasing per SEER (P ) , NSM. Most T < 2 cm and node -. Increase in frequency Intraoperative biopsy: to freeze or not to freeze (P ) NSM, 179 had subareolar FS. 11 pos bx, 7 FN intraop. Of resected NAC, 33% had residual DCIS or IBC Conclusion: FS of limited utility. NAC can be resected at time of delayed recon Total skin sparing in BRCA patients (P ) , 293 M in 154 pts. 70 pts BRCA +. 4.8% occult DCIS or IBC 2/70 pts had late recurrence: 3yrs (non-NSM); 10 yrs (NSM) Conclusion: NSM safe in BRCA carriers.

25 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-1 (ACOSOG) S2-2 (SENTINA trial) Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

26 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-1 (ACOSOG) Primary endpoint: FN rate < 10% if preop node +, pt received NCT, and at least 2 SN removed after NAC Axillary FNA or core biopsy proving disease: surgery ≤ 12 weeks p NCT Standard H&E stains: node + defined as tumor > .2 mm on H&E Predicated on NSABP B-27 with 10.7% FN rate after NCT Meta-analysis of 21 studies with FN rate of 12% 756 pts enrolled; 701 had axillary surgery; 687 attempted SNB and ALND; 637 had SLND identified and ALND completed 50 patients SLN not detected Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03

27 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-1 (ACOSOG) Type of biopsy: FNA (39%) , core biopsy (61%) T1 (14%); T2 (55%); T3 (25%) Hormone +/Her2 neg (45%); Her2 pos (30%); Trip neg (24%) Anthracycline +/- taxane (80%), taxane based (17%) SN identification rate cN1 (92.9%), cN2 (89.5%) SN H&E results 40% node negative 60% residual nodal disease SN positive 326 patients (86%) SN negative and ALN positive 56 patients (14%) For patients with cN1 disease and 2 SN:FN rate = 12.6% Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03

28 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-1 (ACOSOG) Technique: FN rate blue dye 22.5%; radiocolloid 20%; both 10.8% (p=.046) 2 SN (21.1%) ; 3 SN (9%); 4 SN 6.7%); 5 SN (11%) (p=.004) 1 SN had FN rate of 31.5% Role of clip placement 172 of 525 pts (32.8%) had clip placed in LN at time of dx If clip placed and found in SN, FN rate 7.4% Further evaluation QOL, lymphedema, improve patient selection based on response to NCT Alliance A11202: if SN +, randomization to breast, chest wall, and regional nodal RT +/- cALND Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03

29 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-1 (ACOSOG) S2-2 (SENTINA trial) Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

30 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-2 (SENTINA trial): Sentinel Lymph Node Biopsy Before or After Neoadjuvant Chemotherapy (German Multi-Institutional Trial) 4 arm, prospective, multi-center study: colloid mandatory, no IHC Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

31 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-2 (SENTINA trial): Sentinel Lymph Node Biopsy Before or After Neoadjuvant Chemotherapy (German Multi-Institutional Trial Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

32 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-2 (SENTINA trial): Sentinel Lymph Node Biopsy Before or After Neoadjuvant Chemotherapy (German Multi-Institutional Trial Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

33 Sentinel Node biopsy Sentinel node biopsy after neoadjuvant chemotherapy S2-2 (SENTINA trial): Sentinel Lymph Node Biopsy Before or After Neoadjuvant Chemotherapy (German Multi-Institutional Trial Technique Local anesthesia (P ) Preservation of intercostobrachial nerve (P4-4-07) Reverse axillary mapping (P-01-05) Clinically node-negative breast cancer patients undergoing breast conservation therapy: followup vs SNB OT (Netherlands) [Milan SOUND trial] Z11 protocol after mastectomy (Netherlands) OT2-1-03 OT (GANEA 2) (French version of SENTINA)

34 APBI Single fraction IORT
S4-2 TARGIT for early stage breast cancer (S4-2) Verona experience (P )

35 APBI Single fraction IORT
S4-2 TARGIT for early stage breast cancer (S4-2) TARGIT vs WB-XRT TARGIT “ideal” pt age ≥ 45; T preferably ≤ 3.5 cm; MRI not required TARGIT 20 Gy at surface, 5 Gy at 10 mm If “high risk” add WB-XRT to single-fraction IORT (~ 15%) : 3451 pts randomized, 1222 patients median f/u 5 years 34 pts IBTR TARGIT IBTR rate 2% > WB-XRT – unselected TARGIT IBTR rate .18% > WB-XRT – selected for PgR + pts

36 APBI Single fraction IORT
S4-2 TARGIT for early stage breast cancer (S4-2)

37 APBI Single fraction IORT
S4-2 TARGIT for early stage breast cancer (S4-2)

38 APBI Single fraction IORT
S4-2 TARGIT for early stage breast cancer (S4-2)

39 APBI Single fraction IORT
Verona experience, phase II single fraction IORT with IOERT (P ) , 226 pts, “low risk”, early stage IBC Age > 50; T < 3 cm, G1-3, unifocal IDC. No DCIS, EIC, or ILC 21 Gy to tumor bed with 2 cm margins laterally Mean f/u 51 months, 4 IBTR IORT Following Lumpectomy for Breast Cancer Sem Br Dis Dirbas FM, Horst KC 2007

40 Summary – SABCS Surgical Presentations
Excision still recommended for atypical breast lesions Central pathology review may alter patient management in 10% of patients MRI will continue to identify satellite tumor foci in newly dx IBC with uncertain clinical benefit Research efforts will continue to identify biological markers to inform need for re-excision and adjuvant local therapies for DCIS and invasive breast cancer Excision to tumor-free margins remains standard of care for breast conservation Rates of breast conservation vs mastectomy may be more stable than some have reported Use of nipple-areolar sparing mastectomy is increasing for those who choose mastectomy Sentinel node biopsy after neoadjuvant chemotherapy requires resection of nodes with proven disease: dual tracer and/or localization of clipped nodes. Repeat SN bx alone to be avoided in setting of proven nodal disease Single fraction IORT may be equivalent to WB-XRT in select patient subsets, with higher recurrence rates in unselected patients: longer f/u required to determine if these results are sustainable Breast Reconstruction Barriers to reconstruction Barriers (PD08-03) Surgical mgmt in underinsured county population (PD08-05) Preparation Decision support tool (P4-7-04) Outcomes Standardized reporting (PR-7-03) 5 year outcomes after nipple/areolar sparing (P4-7-05) Tissue expanders w/ and w/o RT (P4-7-08) Efficacy and safety of lipomodeling (P4-7-09)


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