Skip to main content

Performance and Practice Guideline for the Use of Neoadjuvant Systemic Therapy in the Management of Breast Cancer

Abstract

Purpose

The American Society of Breast Surgeons (ASBrS) sought to provide an evidence-based guideline on the use of neoadjuvant systemic therapy (NST) in the management of clinical stage II and III invasive breast cancer.

Methods

A comprehensive nonsystematic review was performed of selected peer-reviewed literature published since 2000. The Education Committee of the ASBrS convened to develop guideline recommendations.

Results

A performance and practice guideline was prepared to outline the baseline assessment and perioperative management of patients with clinical stage II–III breast cancer under consideration for NST.

Recommendations

Preoperative or NST is emerging as an important initial strategy for the management of invasive breast cancer. From the surgeon’s perspective, the primary goal of NST is to increase the resectability of locally advanced breast cancer, increase the feasibility of breast-conserving surgery and sentinel node biopsy, and decrease surgical morbidity. To ensure optimal patient selection and efficient patient care, the guideline recommends: (1) baseline breast and axillary imaging; (2) minimally invasive biopsies of breast and axillary lesions; (3) determination of tumor biomarkers; (4) systemic staging; (5) care coordination, including referrals to medical oncology, radiation oncology, plastic surgery, social work, and genetic counseling, if indicated; (6) initiation of NST; (7) post-NST breast and axillary imaging; and (8) decision for surgery based on extent of disease at presentation, patient choice, clinical response to NST, and genetic testing results, if performed.

This is a preview of subscription content, access via your institution.

Fig. 1

References

  1. 1.

    Wolmark N, Wang J, Mamounas E, et al. Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18. J Natl Cancer Inst Monogr. 2001;(30):96–102.

    Article  PubMed  Google Scholar 

  2. 2.

    Van der Hage JA, van de Velde CJ, Julien JP, et al. Preoperative chemotherapy in primary operable breast cancer: results from the European Organization for Research and Treatment of Cancer Trial 10902. J Clin Oncol. 2001;19:4224–37.

    PubMed  Google Scholar 

  3. 3.

    Gianni L, Baselga J, Eirmann W, et al. European Cooperative Trial in Operable Breast Cancer (ECTO): improved freedom from progression (FFP) from adding paclitaxel (T) to doxorubicin (A) followed by cyclophosphamide methotrexate and fluorouracil (CMF) (abstract 513). J Clin Oncol. 2005;23:7s.

    Article  Google Scholar 

  4. 4.

    Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003;21:4165–74.

    CAS  Article  PubMed  Google Scholar 

  5. 5.

    Gianni L, Baselga J, Eiermann W, et al. First report of the European Cooperative Trial in Operable Breast Cancer (ECTO): effect of primary systemic therapy (abstract 132). Proc Am Soc Clin Oncol. 2002;21:34a.

    Google Scholar 

  6. 6.

    Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: revised RECIST guidelines (version 1.1). Eur J Cancer. 2009;45:228–47.

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164–72.

    Article  PubMed  Google Scholar 

  8. 8.

    Jochelson MS, Lampen-Sachar K, Gibbons G, et al. Do MRI and mammography reliable identify candidates for breast conservation after neoadjuvant chemotherapy. Ann Surg Oncol. 2015;22:1490–5.

    Article  PubMed  Google Scholar 

  9. 9.

    Choy N, Lipson J, Porter C, et al. Initial results with preoperative tattooing of biopsied axillary lymph nodes and correlation to sentinel lymph nodes in breast cancer patients. Ann Surg Oncol. 2015;22:377–82.

    Article  PubMed  Google Scholar 

  10. 10.

    National Comprehensive Cancer Network. Clinical practice guidelines in oncology: breast Cancer, v2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed 24 May 2015.

  11. 11.

    Mieog JSD, van der Hage JA, van de Velde CJH. Neoadjuvant chemotherapy for operative breast cancer. Br J Surg. 2007;94:1189–200.

    CAS  Article  PubMed  Google Scholar 

  12. 12.

    Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278–84.

    CAS  Article  PubMed  Google Scholar 

  13. 13.

    Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzamab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (Neosphere): a randomized multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25–32.

    CAS  Article  PubMed  Google Scholar 

  14. 14.

    Saleh RR, Bouganim N, Hilton J, Arnaout A, Clemons M. Neoadjuvant endocrine treatment for breast cancer: from bedside to bench and back again? Curr Oncol. 2014;21:e122–e128.

    PubMed Central  CAS  Article  PubMed  Google Scholar 

  15. 15.

    Haddad TC, Goetz MP. Landscape of neoadjuvant therapy for breast cancer. Ann Surg Oncol. 2015;22:1408–15.

    PubMed Central  Article  PubMed  Google Scholar 

  16. 16.

    Caudle AS, Gonzales-Angulo AM, Hunt KK, et al. Impact of progression during neoadjuvant chemotherapy on surgical management of breast cancer. Ann Surg Oncol. 2011;18(4):932-8.

    PubMed Central  Article  PubMed  Google Scholar 

  17. 17.

    Bosch AM, Kessels AG, Beets GL, et al. Preoperative estimation of the pathological breast tumour size by physical examination, mammography and ultrasound: a prospective study on 105 invasive tumours. Eur J Radiol. 2003;48:285–92.

    Article  PubMed  Google Scholar 

  18. 18.

    Weiss A, Lee KC, Romero Y, et al. Calcifications on mammography do not correlate with tumor size after neoadjuvant chemotherapy. Ann Surg Oncol. 2014;21:3310–6.

    Article  PubMed  Google Scholar 

  19. 19.

    Moran M, Schnitt SJ, Giulianno AE, et al. Society of Surgical Oncology–American Society of Radiation Oncology consensus guidelines on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys. 2014;88:553–64.

    Article  PubMed  Google Scholar 

  20. 20.

    Wang F, Peled AW, Garwood E, et al. Total skin-sparing mastectomy and immediate breast reconstruction: an evolution of technique and assessment of outcomes. Ann Surg Oncol. 2014;21:3223–30.

    Article  PubMed  Google Scholar 

  21. 21.

    Radovanovic Z, Radovanovic D, Golubovic A, et al. Early complications after nipple-sparing mastectomy and immediate breast reconstruction with silicone prosthesis: results of 214 procedures. Scand J Surg. 2010;99:115–8.

    CAS  PubMed  Google Scholar 

  22. 22.

    Kelly AM, Dwamena B, Cronin P, Carlos RC. Breast cancer sentinel node identification and classification after neoadjuvant chemotherapy—a systemic review and meta-analysis. Acad Radiol. 2009;16:551–63.

    Article  PubMed  Google Scholar 

  23. 23.

    Xing Y, Foy M, Cox DD, et al. Meta-analysis of sentinel lymph node biopsy after preoperative chemotherapy in patients with breast cancer. Br J Surg. 2006;93:539–46.

    CAS  Article  PubMed  Google Scholar 

  24. 24.

    Mamounas EP, Brown A, Anderson S, et al. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005;23:2694–702.

    Article  PubMed  Google Scholar 

  25. 25.

    Kuehn T, Bauerfeind I, Fehm T, et al. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013;14:609–18.

    Article  PubMed  Google Scholar 

  26. 26.

    Boughey JC, Suman VJ, Mittendorf EA, et al. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013;310:1455–61.

    PubMed Central  CAS  Article  PubMed  Google Scholar 

  27. 27.

    NSABP B-51/RTOG 1304. ClinicalTrials.gov. Identifier: NCT01872975.

  28. 28.

    Alliance A112020. ClinicalTrials.gov. Identifier: NCT01901094.

  29. 29.

    Vidal-Sicart S, Giammarile F, Mariani G, et al. Pre- and intra-operative imaging techniques for sentinel node localization in breast cancer. Imag Med. 2013;5:275–91.

    CAS  Article  Google Scholar 

  30. 30.

    Ascherman JA, Hanasono MW, Newman MI, et al. Implant reconstruction in breast cancer patients with radiation therapy. Plast Reconstr Surg. 2006;117:359–65.

    CAS  Article  PubMed  Google Scholar 

  31. 31.

    Benediktsson K, Perbeck L. Capsular contracture around saline-filled and textured subcutaneously placed implants in irradiated and non-irradiated breast cancer patients: five years of monitoring of a prospective trial. J Plast Reconstr Aesthet Surg. 2006;59:27–34.

    CAS  Article  PubMed  Google Scholar 

  32. 32.

    Behranwala KA, Dua RS, Ross GM, et al. The influence of radiotherapy on capsule formation and aesthetic outcome after immediate breast reconstruction using biodimensional anatomical expander implants. J Plast Reconstr Aesthet Surg. 2006;59:1043–51.

    CAS  Article  PubMed  Google Scholar 

  33. 33.

    Barry M, Kelly MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011;27:15–22.

    Article  Google Scholar 

  34. 34.

    Lam TC, Hsieh F, Boyages J. The effects of postmastectomy adjuvant radiotherapy on immediate two-stage prosthetic breast reconstruction: a systematic review. Plast Reconstr Surg. 2013;132:511–8.

    CAS  Article  PubMed  Google Scholar 

  35. 35.

    Kronowitz SJ, Robb GL. Radiation therapy and breast reconstruction: a critical review of the literature. Plast Reconstr Surg. 2009;124:395–408.

    CAS  Article  PubMed  Google Scholar 

  36. 36.

    Garvey PB, Clemens MW, Hoy AE, et al. Muscle-sparing TRAM flap does not protect breast reconstruction from postmastectomy radiation damage compared with the DIEP flap. Plast Reconstr Surg. 2014;133:223–33.

    PubMed Central  CAS  Article  PubMed  Google Scholar 

  37. 37.

    Chang DW, Wang B, Robb GL, et al. Effect of obesity on flap and donor site complications in free transverse rectus abdominis myocutaneous flap breast reconstruction. Plast Reconstr Surg. 2000;105:1640–8.

    CAS  Article  PubMed  Google Scholar 

  38. 38.

    Chang DW, Reece GP, Wang B. Effect of smoking on complications in patients undergoing free TRAM flap breast reconstruction. Plast Reconstr Surg. 2000;105:2374–80.

    CAS  Article  PubMed  Google Scholar 

  39. 39.

    Garg AK, Buchholz TA. Influence of neoadjuvant chemotherapy on radiotherapy for breast cancer. Ann Surg Oncol. 2015;22:1434–40.

    Article  PubMed  Google Scholar 

  40. 40.

    Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15 year survival: an overview of the randomized trials. Lancet. 2005;336(9503):2087–106.

    Google Scholar 

  41. 41.

    Mamounas EP, Anderson SJ, Dignam JJ, et al. Predictors of locoregional recurrence after neoadjuvant chemotherapy: results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18 and B-27. J Clin Oncol. 2012;30:3960–6.

    PubMed Central  Article  PubMed  Google Scholar 

  42. 42.

    Buchholz TA, Katz A, Strom EA, et al. Pathologic tumor size and lymph node status predict for different rates of locoregional recurrence after mastectomy for breast cancer patients treated with neoadjuvant versus adjuvant chemotherapy. Int J Radiat Oncol Biol Phys. 2002;53:880–8.

    Article  PubMed  Google Scholar 

  43. 43.

    Katz A, Strom EA, Buchholz TA, et al. Locoregional recurrence patterns after mastectomy and doxorubicin-based chemotherapy: implications for postoperative irradiation. J Clin Oncol. 2000;18:2817–27.

    CAS  PubMed  Google Scholar 

Download references

Disclosure

The authors declare no conflict of interest.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Dennis Holmes MD.

Additional information

This journal article summarizes key factors that must be addressed in the care of the NST candidate. The full-length version of the guideline may be accessed at www.breastsurgeons.org.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Holmes, D., Colfry, A., Czerniecki, B. et al. Performance and Practice Guideline for the Use of Neoadjuvant Systemic Therapy in the Management of Breast Cancer. Ann Surg Oncol 22, 3184–3190 (2015). https://doi.org/10.1245/s10434-015-4753-3

Download citation

Keywords

  • Sentinel Node
  • Sentinel Node Biopsy
  • Axillary Lymph Node Dissection
  • National Comprehensive Cancer Network
  • Breast Reconstruction