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Monica Morrow MD Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan-Kettering

18 th Annual Perspectives in Breast Cancer New York, NY. Memorial Sloan-Kettering Cancer Center 1275 York Avenue, New York, NY 10065. 18 August 2012. Treatment Decision Making for DCIS. Monica Morrow MD Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology

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Monica Morrow MD Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan-Kettering

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  1. 18th Annual Perspectives in Breast Cancer New York, NY Memorial Sloan-Kettering Cancer Center 1275 York Avenue, New York, NY 10065 18 August 2012 Treatment Decision Making for DCIS Monica Morrow MD Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan-Kettering Cancer Center

  2. Controversies in DCIS Management • Is nipple sparing mastectomy appropriate? • Is RT necessary for all DCIS? • When is SN biopsy indicated? • What about endocrine rx?

  3. Mastectomy in DCIS • Indicated when DCIS is too extensive to be encompassed with a cosmetic resection. • Outcome • Metaanalysis 21 studies, 1574 patients • Local recurrence 1.4% (0.7-2.1%) • Skin sparing mastectomy n = 223 • Local recurrence 3.1% Boyages J, Cancer 1999;85:616 Carlson G, JACS 2007;204:1074

  4. What About Nipple Sparing Mastectomy? • Concerns • NSM leaves behind ductal tissue + breast tissue in order to preserve blood supply. • Occult nipple involvement present in 6-31% of cancers. • Most studies of NSM are in invasive cancer.

  5. 10/26/2011

  6. Clinical Outcomes NSMEuropean Institute of Oncology 3/02-12/07 • Median f/u: 50 months • All patients received 16 Gy to NAC • CAUTION: At 20 mo f/u, no NAC recurrences, 1.4% LR Petit JY, Ann Oncol 2012;23:2053-8 Petit JY, Br Ca Res Treat 2009;117:333

  7. NSM in DCIS • Increased risk of LR due to retained breast tissue and poor exposure. • Contraindicated in patients with extensive DCIS necessitating mastectomy, localized DCIS in subareolar space.

  8. What do I really think about NSM? • It’s a great operation for a woman • who doesn’t actually need a mastectomy.

  9. Is RT Necessary for All DCIS?

  10. Randomized Trials of Excision ± RT in DCIS

  11. Metaanalysis Trials of Excision ± RT in DCIS n = 3729 10 yr IBTR EBCTCG JNCI Monograph 2010;41:162

  12. Metaanalysis Trials of Excision ± RT in DCIS 10 yr Survival Outcomes EBCTCG JNCI Monograph 2010;41:162

  13. Conclusions of Randomized Trials • RT reduces the risk of LR by 50%. • Patient subsets NOT benefitting from RT have not been identified.

  14. Academic U.S. Physicians Recommending RT For DCIS Ceilley E, Cancer 2004;101:1958

  15. Concerns Regarding Randomized Trials Detailed tissue processing/method of pathology evaluation not specified. Post-excision mammography not mandated. Impact of margin width on RT benefit not assessed.

  16. Does wide excision + detailed pathology exam result in local control equivalent to excision + RT?

  17. Local Recurrence: Margins ≥ 10 mm Silverstein M, NEJM 1999;340:1455

  18. E5194: Excision Alone ± Tamoxifen for DCIS Eligibility DCIS ≥ 3mm in size Minimum margin width ≥ 3mm Specimen completely embedded, sequentially sectioned Post-excision mammogram free of calcification Hughes L, J Clin Oncol 2009;27:5319

  19. Patient Characteristics: E5194 Hughes L, J Clin Oncol 2009;27:5319

  20. Intergroup Trial of Excision Alone Mean f/u 6.3 years Hughes L, J Clin Oncol 2009;27:5319

  21. Local Failure According to Pathology After Lumpectomy and Radiation Solin L, J Clin Oncol 1996;14:754

  22. Effect of Margin Width – No RT Hughes L, J Clin Oncol 2009;27:5319

  23. RTOG 9084: RT vs Observation for “Good Risk” DCIS Mammographic or incidental DCIS Low or intermediate grade Size (mammographic) ≤ 2.5 cm Margins ≥ 3 mm Eligibility McCormick B, ASCO 2012

  24. RTOG 9084 Schema Stratify Age < 50 ≥ 50 Margins Negative re-excision 3-9 mm ≥ 10 mm Size ≤ 1 cm > 1 cm-2.5 cm Grade Low Intermediate Tamoxifen No Yes RANDOMIZE Observation RT No Boost

  25. Patient Characteristics: RTOG 9084 McCormick B, ASCO 2012

  26. Local Failure Ipsilateral Breast 5-Years Rates: 3.2% 0.4%

  27. Local Recurrence After Excision +/- RT in Good Prognosis DCIS 5 yr LR Hughes L, J Clin Oncol 2009;27:5319 McCormick B, ASCO 2012

  28. Conclusions E5194 + RTOG 9084 Rates of LR after excision alone differed significantly among 2 populations with “favorable” DCIS selected with standard histopathologic criteria. Benefit for RT is present even in this good-risk subset.

  29. A QUANTITATIVE MULTIGENE RT-PCR ASSAY FOR PREDICTING RECURRENCE RISK AFTER SURGICAL EXCISION ALONE WITHOUT IRRADIATION FOR DUCTAL CARCINOMA IN SITU (DCIS): A PROSPECTIVE VALIDATION STUDY OF THE DCIS SCORE FROM ECOG E5194 Solin LJ, Gray R, Baehner FL, Butler S, Badve S, Yoshizawa C, Shak S, Hughes L, Sledge G, Davidson N, Perez EA, Ingle J, Sparano J, Wood W Eastern Cooperative Oncology Group (ECOG)North Central Cancer Treatment Group (NCCTG)Genomic Health, Inc (GHI)2011 San Antonio Breast Cancer Symposium

  30. DCIS Recurrence Score: Unanswered Questions • Do patients in the low-risk group benefit from RT? Is it predictive as well as prognostic? • Does it apply to the wider population of women with DCIS? • Validation needed

  31. Sentinel Node Biopsy in DCIS • DCIS lacks the ability to metastasize. • Rationale for axillary surgery is risk of unsampled invasive cancer. • ~15% risk of invasion after core bx diagnosis of DCIS.

  32. Risk of Axillary Recurrence in DCIS NSABP B17: 7 of 623 pts with axillary recurrence 1 s/p axillary dissection 3 with invasive IBTR 3 of 620 with DCIS at 15 yrs NSABP B24: 6 of 1799 pts at 11.6 yrs 1 with undiagnosed microinvasion Julian, Ann Surg Oncol 2006

  33. Risk of Axillary Recurrence in DCIS Julian, Ann Surg Oncol 2006

  34. When Should Axillary Nodes Be Examined in DCIS? • • Microinvasive carcinoma • Metastases in 3% - 20% of cases. • • DCIS treated by mastectomy. • Opportunity lost if invasion found. • • Done as a second procedure if invasion found after lumpectomy. • Prior biopsy does not interfere with mapping.

  35. Benefit of Tamoxifen in ER+ DCIS NSABP B24 n = 732 Allred DC, J Clin Oncol 2012;30:1268-73

  36. Other Therapies in DCIS • • Exemestane • MAP 3 — 112 of 4560 had DCIS • HR 0.47 (95% CI, 0.27-0.79) • No subset analysis • Data on other AIs coming from NSABP B35, IBIS II • Raloxifene • Equivalent to tamoxifen in STAR overall, better side- effect profile • DCIS analysis RR 1.46 (95% CI, 0.90-2.41) Goss PE, NEJM 2011;364:2381-91 Vogel VJ, JNCI Monogr 2010:181-6

  37. Conclusions: Endocrine Rx • Endocrine therapy is an option for women desiring to minimize future breast cancer events. • Most favorable risk-benefit ratio is in premenopausal women with 2 breasts.

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