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Sentinel lymph node controversies: is this the end for ALND?

Fellows Institute Cincinnati 2011. Sentinel lymph node controversies: is this the end for ALND?. Hiram S. Cody III MD Attending Surgeon The Breast Service, Department of Surgery Memorial Sloan-Kettering Cancer Center Professor of Clinical Surgery Weill Cornell Medical College.

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Sentinel lymph node controversies: is this the end for ALND?

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  1. Fellows Institute Cincinnati 2011 Sentinel lymph node controversies:is this the end for ALND? Hiram S. Cody III MD Attending Surgeon The Breast Service, Department of Surgery Memorial Sloan-Kettering Cancer Center Professor of Clinical Surgery Weill Cornell Medical College No disclosures

  2. SLN biopsy works

  3. SLN 201069 validation studies in 8059 patients Kim T et.al. Cancer 2006;106:4-16

  4. SLN 2010Results of 5 randomized trials 61-73% had SLN-only disease

  5. NSABP B-32 Clinically Negative Axillary Nodes (n=5,611) Randomization GROUP 2 SLNB GROUP 1 SLNB  ALND Path. Neg. SLN Path. Pos. SLN Will false-negative SLN procedures affect survival? ALND No ALND Krag, DN et.al. Lancet Oncology 2010;11:927-33

  6. NSABP B-32OS: SLN negative (8 yr results) 100 * 300 deaths triggered the definitive analysis *309 reported as of 12/31/2009 80 60 84.6% received systemic therapy % Surviving 40 TrtNDeaths SNR+AD 1975 140 SNR 2011 169 HR=1.20 p=0.117 20 0 Data as of December 31, 2009 0 2 4 6 8 Years After Entry Krag, DN et.al. Lancet Oncology 2010;11:927-33

  7. NASBP B-32DFS: SLN negative (8 yr results) 100 80 60 84.6% received systemic therapy % Disease-Free 40 TrtNDeaths SNR+AD 1975 315 SNR 2011 336 HR=1.05 p=0.542 20 0 Data as of December 31, 2009 0 2 4 6 8 Years After Entry Krag, DN et.al. Lancet Oncology 2010;11:927-33z

  8. Milan/EIO trial: 10 yr results 561 patients 1998-1999 95 mo f/u Veronesi U et.al. Ann Surg 2010;251:595-600

  9. SLN 2010False-negative = axillary LR *all with >3 yrs followup Van der Ploeg IMC et.al. EJSO 2008:34:1277-84

  10. We’ve asked and answered the easiest questions

  11. SLN 2010Where have we come and what’s next? • definition • case selection • technique • nuclear medicine • surgery • pathology • results • morbidity • local control • survival • non-axillary SLN? • SLN and neoadjuvant? • SLN micromets? • SLN+ : ALND?

  12. SLN 2010What is the SLN? 1) a blue node 2) a hot node 3) a palpable node

  13. SLN 2010Case selection • SLN biopsy is indicated in almost every patient with a cN0 invasive breast cancer • for DCIS? • YES, selectively • for inflammatory/locally advanced CA? • NO, outside of clinical trials

  14. SLN 2010Louisville (99 surgeons) McMasters et.al.,JCO 2000;18:2560-2566

  15. SLN 2010Finding the positive SLN (n=255) Cody HS et.al. Ann Surg Oncol 2001;8:13-19

  16. SLN 2010Declining marginal benefit of dye (finding the positive SLN) Derossis et.al.JACS 2001;193:473-8

  17. SLN 2010Learning curve: ALMANAC Most failed and false-neg results occurred in the first procedure! Clarke DH. Ann Surg Oncol 2004;11:211S-15S

  18. SLN 2010Morbidity: early reports

  19. SLN 2010Z0010 morbidity • prospective observational study of SLN biopsy • >5500 patients accrued 1999-2003 • at 6 months • 8.6% axillary paresthesias (>90% mild) • 3.8% decreased upper extremity ROM • 6.9% lymphedema (>2 cm over non-operated side) • lymphedema was predicted by • increased BMI (p=0.0005) • increased age (p=0.04) Wilke LG et.al. Ann Surg Oncol (suppl) 2005;12:S27

  20. SLN 2010MSKCC morbidity McLaughlin SA et.al. JCO 2008:26:5213-26

  21. SLN 2010MKCC sensory morbidity p < 0.001 Temple LK, Ann Surg Oncol 2002;9:654-62

  22. There are still some areas of debate

  23. SLN 2010Non-axillary SLN: what to do?

  24. SLN 2010Internal mammary experience

  25. SLN 2010Reoperative SLN biopsy Port ER et.al. Ann Surg Onc 2007;8:2209-14

  26. SLN 2010SLN is better after neoadjuvant(my bias) • fewer operations • false-negative rate is probably not increased • avoidance of ALND for patients with pathologic CR • ACOSOG 1071 (PI J Boughey)

  27. Sentinel nodeSLN before vs after chemo: cN0 Hunt KK et.al. Ann Surg 2009 epub.

  28. SLN 2010Intraoperative assessment Brogi E et.al. Ann Surg Oncol 2005;12:173-80

  29. SLN 2010EIO study (RT-PCR) • 293 SLN in 293 pts • frozen section of entire SLN • 50m intervals • H&E (IHC selectively) • 118 sections (40-258)/SLN • intervening tissue • half for RT-PCR • half discarded Viale G et.al. Ann Surg 2008;247:136-42

  30. SLN 2010 Frozen vs RT-PCR Brogi E et.al. Ann Surg Oncol 2005;12:173-80 Viale G et.al. Ann Surg 2008;247:136-42

  31. SLN 2010MSKCC pathology protocol H&E and IHC 50 H&E and IHC 1 H&E and 1 IHC (cytokeratin AE1:AE3) stained section from each of two levels 50m apart Tan LK et.al. J Clin Oncol 2008; 26: 1803-9

  32. MSKCC micromet study DFS by method of staining p<0.001 H&E-/IHC- IHC+ H&E+ Tan LK et.al. JCO 2008; 26: 1803-9

  33. MSKCC micromet studyDFS by size of metastasis pN0 (negative) pN0i+ (<0.2 mm) pN1mi (0.3-2.0 mm) p<0.001 Tan LK et.al. JCO 2008;26:1803

  34. Netherlands micromet studyDFS by size of metastasis N0 vs N0i+ or N1mi N0 vs N0i+, N0 vs N1mi p<0.001 p<0.002 p<0.001 de Boer M et.al. NEJM 2009;361:653-63

  35. www.mskcc.org/nomograms Van Zee KJ. Ann Surg Oncol 2003;10:1140-51

  36. Predicting non-SLN metastases SLN+ (mets <2 mm) SLN+ (all pts) A comparison of 9 models by AUC curves Coutant C et.al. JCO 2009;27:2800-08

  37. SLN 2010 Selective ALND for SLN+ Park J et.al. Ann Surg 2007;245:462-8

  38. SLN 2010Selective ALND for IHC+ SLN Pugliese MS. Ann Surg Oncol 2010;17:1063-68

  39. SLN 2010Fewer ALND for SLN+(FS negative or not done) p<0.001 Park J et.al. Ann Surg 2007;245:462-8

  40. SLN 2010Patterns of ALND (NCDB) 23% no ALND 55% no ALND Bilomoria KY et.al. JCO 2009;27:2946-53

  41. SLN 2010Trends in ALND for SLN+ (NCDB) SLN+ and no ALND % Bilomoria KY et.al. JCO 2009;27:2946-53

  42. SLN 2010Outcome +/- ALND (NCDB) Bilomoria KY et.al. JCO 2009;27:2946-53

  43. 2010annus mirabilis!1) micromets on IHC?2) micromets on H&E?3) ALND for SLN+?

  44. ACOSOG Z0010-Z0011 suspended 12/04 at n=889 due to slow accrual and too few events www.acosog.org

  45. Z0010 trialSurvival by staining method Cote R et.al. ASCO 2010

  46. NSABP B-32 Clinically Negative Axillary Nodes (n=5,611) Randomization GROUP 2 SLNB * GROUP 1 SLNB*  ALND Path. Neg. SLN Path. Pos. SLN A combined 1390 pts had H&E+ SLNs with f/u in 1389 pts ALND No ALND Julian TB et.al. SABCS 2010

  47. NSABP Protocol B-32 1390 pts with H&E+ SLN Julian TB et.al. SABCS 2010

  48. NSABP B-32DFS by SLN status on H&E PatientsHR* (95% CI)P-value* Neg SN Pos SN (Micromets) 0.998 (0.765-1.302) 0.99 Pos SN (Macromets) 1.783 (1.480-2.150) <0.001 Julian TB et.al. SABCS 2010 * HR (95% CI) & p-value comparison with Neg SN

  49. NSABP B-32OS by SLN status on H&E PatientsHR* (95% CI)P-value* Neg SN Pos SN (Micromets) 0.788 (0.518-1.199) 0.27 Pos SN (Macromets) 2.387 (1.891-3.013) <0.001 Julian TB et.al. SABCS 2010 * HR (95% CI) & p-value comparison with Neg SN

  50. NSABP B-32IHC study • 5611 accrued • 3989 (71%) pN0 by H&E • 2 mm slices • routine IHC prohibited • 3887 (97%) path • 3884 (99.9%) follow up • 95 mo median f/u • IHC sections at UVM • 0.5 and 1.0 mm deeper • 15.9% IHC+ • 11.1% ITC (N0i+) • 4.4% micromets (N1mi) • 0.4% macromets (N1) Weaver DL et.al. NEJM 2011; epub 1/19/11

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