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Annals of Surgical Oncology

, Volume 26, Issue 10, pp 3071–3079 | Cite as

Patient Selection for Clinical Trials Eliminating Surgery for HER2-Positive Breast Cancer Treated with Neoadjuvant Systemic Therapy

  • Susie Sun
  • Raquel F. D. van la Parra
  • Gaiane M. Rauch
  • Christina Checka
  • Audree B. Tadros
  • Anthony LucciJr.
  • Mediget Teshome
  • Dalliah Black
  • Rosa F. Hwang
  • Benjamin D. Smith
  • Savitri Krishnamurthy
  • Vicente Valero
  • Wei T. Yang
  • Henry M. KuererEmail author
George N. Peters Award and Scientific Impact Award

Abstract

Background

Patients with epidermal growth factor receptor 2-positive (HER2+) breast cancer and pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) may be candidates for nonoperative clinical trials if residual invasive and in situ disease are eradicated.

Methods

This study analyzed 280 patients with clinical T1-2N0-1 HER2+ breast cancer who underwent NST followed by surgical resection to determine key characteristics of patients with pCR in the breast and lymph nodes compared with those with residual disease.

Results

Of the 280 patients, 102 (36.4%) had pCR in the breast and lymph nodes after NST, and 50 patients (17.9%) had residual ductal carcinoma in situ (DCIS) in the breast only. For 129 patients (46.1%), DCIS was present on the pretreatment biopsy, and NST failed to eradicate the DCIS component in 64.3%. Patients with residual disease were more likely to have hormone receptor-positive (HR+) tumors than those with negative tumors (73.4% vs. 50.8%; p < 0.0001). Radiologic response (odds ratio [OR], 5.62; p = 0.002) and HR+ status (OR, 2.56; p < 0.0001) were predictive of residual disease. Combined imaging methods after NST had a sensitivity of 97.1% and a negative predictive value of 70.6% for detection of residual disease. Patients with invasive disease and DCIS shown on the pretreatment core biopsy were less likely than those without DCIS to achieve pCR in the breast (31% vs. 43%; p  = 0.038).

Conclusion

The study results delineate and identify unique characteristics associated with HER2+ breast cancers that are important in selecting patients for inclusion in clinical trials assessing nonoperative management after NST, and the low negative predictive value of imaging mandates image-guided biopsy for selection.

Notes

Acknowledgment

This work was supported by the PH and Fay Etta Robinson Distinguished Professorship in Cancer Research (HMK) and a cancer center support grant from the National Institutes of Health (NIH) (CA16672).

Disclosure

There are no conflicts of interest.

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Copyright information

© Society of Surgical Oncology 2019

Authors and Affiliations

  • Susie Sun
    • 1
  • Raquel F. D. van la Parra
    • 1
  • Gaiane M. Rauch
    • 2
  • Christina Checka
    • 1
  • Audree B. Tadros
    • 1
  • Anthony LucciJr.
    • 1
  • Mediget Teshome
    • 1
  • Dalliah Black
    • 1
  • Rosa F. Hwang
    • 1
  • Benjamin D. Smith
    • 3
  • Savitri Krishnamurthy
    • 4
  • Vicente Valero
    • 5
  • Wei T. Yang
    • 2
  • Henry M. Kuerer
    • 1
    Email author
  1. 1.Department of Breast Surgical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Department of Diagnostic RadiologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  3. 3.Department of Radiation OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  4. 4.Department of Breast Medical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  5. 5.Department of PathologyThe University of Texas MD Anderson Cancer CenterHoustonUSA

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