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

  • George N. Peters Award and Scientific Impact Award
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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.

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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).

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Authors and Affiliations

  1. Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Susie Sun MD, MS, Raquel F. D. van la Parra MD, PhD, Christina Checka MD, Audree B. Tadros MD, Anthony Lucci Jr. MD, Mediget Teshome MD, Dalliah Black MD, Rosa F. Hwang MD & Henry M. Kuerer MD, PhD, FACS

  2. Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Gaiane M. Rauch MD, PhD & Wei T. Yang MBBS, FRCR

  3. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Benjamin D. Smith MD

  4. Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Savitri Krishnamurthy MD

  5. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Vicente Valero MD

Authors
  1. Susie Sun MD, MS
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  2. Raquel F. D. van la Parra MD, PhD
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  3. Gaiane M. Rauch MD, PhD
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  4. Christina Checka MD
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  5. Audree B. Tadros MD
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  6. Anthony Lucci Jr. MD
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  7. Mediget Teshome MD
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  8. Dalliah Black MD
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  9. Rosa F. Hwang MD
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  10. Benjamin D. Smith MD
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  11. Savitri Krishnamurthy MD
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  12. Vicente Valero MD
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  13. Wei T. Yang MBBS, FRCR
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  14. Henry M. Kuerer MD, PhD, FACS
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Corresponding author

Correspondence to Henry M. Kuerer MD, PhD, FACS.

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Sun, S., van la Parra, R.F.D., Rauch, G.M. et al. Patient Selection for Clinical Trials Eliminating Surgery for HER2-Positive Breast Cancer Treated with Neoadjuvant Systemic Therapy. Ann Surg Oncol 26, 3071–3079 (2019). https://doi.org/10.1245/s10434-019-07533-2

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  • DOI: https://doi.org/10.1245/s10434-019-07533-2

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