Median initial tumor size was 3 centimeters and 40 percent of patients had nodal metastasis at the time of diagnosis. After NST, the median residual tumor size was 1.1 cm, with 94.1 percent of patients having no palpable abnormality.
Researchers found that following NST, VACB combined with FNA had 98 percent accuracy, 5 percent FNR, and 95 percent predictive value for determination of residual disease. Grade 1 biopsy associated adverse events, including bleeding, hematoma and bruising, occurred in six patients (20.4 percent).
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“With this knowledge, there’s an obligation to test whether no surgery, or ‘ultimate breast conserving therapy,’ is safe,” said Kuerer.
The accuracy of the preliminary findings led MD Anderson’s Institutional Review Board to approve and open a new Phase II clinical trial at MD Anderson and then across the MD Anderson Cancer Network®. The study is enrolling women with Stage I and II HER2-positive and triple negative breast cancer. Participants who achieve image-guided, biopsy-proved pCR after NST will undergo whole-breast radiation, without surgery. The trial is the first to use image-guided biopsies in this setting and not include surgery.
“There is an urgency to test whether surgery is needed. In conversations with my patients, many express concerns about overtreatment. They want the most personalized care with as minimal treatment as possible, and I am honored to be involved with this essential study,” says Kuerer. “If these findings prove to be true, it would be groundbreaking for patients – both physically and psychologically.”
In addition to Kuerer, other authors on the all-MD Anderson study include: Wei T. Yang, M.D., Gaiane M. Rauch, M.D., Ph.D., Beatriz E. Adrada, M.D., Lumarie Santiago, M.D., Rosalind Candelaria, M.D., Elsa Arribas, M.D., and Tanya Moseley, M.D., all of Diagnostic Radiology; Savitri Krishnamurthy, M.D., Michael Gilcrease, M.D., Ph.D., both of Pathology; Kelly K. Hunt, M.D., Abigail S. Caudle, M.D., Sarah M. DeSnyder, M.D., Anthony Lucci, Jr., M.D., Rosa Hwang, M.D., Mediget Teshome, M.D., and Makesha V. Miggins, M.D., all of Breast Cancer Surgery; Brian P. Hobbs, Ph.D., Biostatistics; Mariana Chavez Mac Gregor, M.D., Breast Medical Oncology and Health Services Research; Benjamin D. Smith, M.D., Ph.D., Radiation Oncology, and Vincente Valero, M.D., Breast Medical Oncology.
The study was financially supported by the PH and Fay Etta Robinson Distinguished Professorship in Cancer Research, a Cancer Center Support Grant from the National Institutes of Health (NIH), CA16672, a NIH P30 grant, CA016672, and funding from the MD Anderson Clinical Research Funding Award Program.
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