Image-guided biopsy identifies patients who achieve pathologic complete response after neoadjuvant therapy

December 09, 2016

n a pilot study conducted at The University of Texas MD Anderson Cancer Center, image-guided biopsies identified select breast cancer patients who achieved pathologic complete response (pCR) after chemotherapy and/or targeted therapy, neoadjuvant systemic therapy (NST). Should the findings be replicated in future studies, this research would be the first indication that as the field moves toward more selective, personalized treatment, surgery may altogether be eliminated for a large group of patients.

Henry M. Kuerer, M.D., Ph.D., professor, Breast Surgical Oncology, MD Anderson, and the study's principal investigator presented the Late-Breaking Abstract in a poster session at the 2016 San Antonio Breast Cancer Symposium.

Worldwide, triple negative and HER2 positive breast cancers account for about 370,000 women diagnosed annually, says Kuerer. With recent advances in neoadjuvant systemic therapy for both subsets of cancer, the pCR rates found at the time of surgery in these patients can be as high as 60 percent. This high rate of pCR naturally raises the question of whether surgery is required for all patients, particularly those who will receive adjuvant radiation.

"We believe surgery may potentially be redundant - at least for these two subtypes of breast cancer - because of such a high chance for no evidence of disease at the time of pathological review," says Kuerer. "If there's no cancer left after the patient has received chemotherapy and the patient is going to receive local radiation therapy, is surgery actually needed?"

The challenge has been that standard breast imaging methods cannot accurately predict residual disease after NST.

"However, by doing the same image-guided, percutaneous needle biopsies after NST that we do at time of diagnosis, our preliminary research reveals we may be able to accurately predict which women will have cancer or not," says Kuerer.

The prospective single-center study enrolled 34 women with early-stage (stage I, II, III) triple negative (23 patients) or HER-2 positive (11 patients) breast cancer. As per standard practice, all patients received NST. Prior to standard-of-care surgery, all participants consented to undergo image-guided fine needle aspiration (FNA) biopsy and an ultrasound and/or mammography guided vacuum-assisted core biopsy (VACB). The study measured for accuracy, false negative rate, and negative predictive value were calculated for FNA alone, VACB alone and FNA and VACB in combination. Breast pCR was defined as no residual disease at the time of surgery.

Median initial tumor size was 3 centimeters and 47.1 percent of patients had nodal metastasis at the time of diagnosis. After NST, the median residual tumor size was 0.9 cm, with 94.1 percent of patients having no palpable abnormality.

Researchers found that following NST, VACB combined with FNA had 100 percent accuracy, 0 percent FNR, and 100 percent predictive value for determination of residual disease. Grade 1 biopsy associated adverse events, including bleeding, hematoma and bruising, occurred in six patients (17.6 percent).

"With this knowledge, there's an obligation to test whether no surgery, or 'ultimate breast conserving therapy,' is safe," says Kuerer.

The accuracy of the preliminary findings led MD Anderson's Institutional Review Board to approve a Phase II clinical trial, which soon is to open at MD Anderson and then across the MD Anderson Cancer Network. The study will enroll 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 will be the first using 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," says Kuerer. "If these findings prove to be true, it would be groundbreaking for patients - both physically and psychologically."
-end-
In addition to Kuerer, other authors on the all-MD Anderson study include: Wei T. Yang, M.D., chair, 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., chair, 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 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.

University of Texas M. D. Anderson Cancer Center

Related Breast Cancer Articles from Brightsurf:

Oncotarget: IGF2 expression in breast cancer tumors and in breast cancer cells
The Oncotarget authors propose that methylation of DVDMR represents a novel epigenetic biomarker that determines the levels of IGF2 protein expression in breast cancer.

Breast cancer: AI predicts which pre-malignant breast lesions will progress to advanced cancer
New research at Case Western Reserve University in Cleveland, Ohio, could help better determine which patients diagnosed with the pre-malignant breast cancer commonly as stage 0 are likely to progress to invasive breast cancer and therefore might benefit from additional therapy over and above surgery alone.

Partial breast irradiation effective treatment option for low-risk breast cancer
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast irradiation for many women with low-risk, early stage breast cancer, according to new clinical data from a national clinical trial involving researchers from The Ohio State University Comprehensive Cancer Center - Arthur G.

Breast screening linked to 60 per cent lower risk of breast cancer death in first 10 years
Women who take part in breast screening have a significantly greater benefit from treatments than those who are not screened, according to a study of more than 50,000 women.

More clues revealed in link between normal breast changes and invasive breast cancer
A research team, led by investigators from Georgetown Lombardi Comprehensive Cancer Center, details how a natural and dramatic process -- changes in mammary glands to accommodate breastfeeding -- uses a molecular process believed to contribute to survival of pre-malignant breast cells.

Breast tissue tumor suppressor PTEN: A potential Achilles heel for breast cancer cells
A highly collaborative team of researchers at the Medical University of South Carolina and Ohio State University report in Nature Communications that they have identified a novel pathway for connective tissue PTEN in breast cancer cell response to radiotherapy.

Computers equal radiologists in assessing breast density and associated breast cancer risk
Automated breast-density evaluation was just as accurate in predicting women's risk of breast cancer, found and not found by mammography, as subjective evaluation done by radiologists, in a study led by researchers at UC San Francisco and Mayo Clinic.

Blood test can effectively rule out breast cancer, regardless of breast density
A new study published in PLOS ONE demonstrates that Videssa® Breast, a multi-protein biomarker blood test for breast cancer, is unaffected by breast density and can reliably rule out breast cancer in women with both dense and non-dense breast tissue.

Study shows influence of surgeons on likelihood of removal of healthy breast after breast cancer dia
Attending surgeons can have a strong influence on whether a patient undergoes contralateral prophylactic mastectomy after a diagnosis of breast cancer, according to a study published by JAMA Surgery.

Young breast cancer patients undergoing breast conserving surgery see improved prognosis
A new analysis indicates that breast cancer prognoses have improved over time in young women treated with breast conserving surgery.

Read More: Breast Cancer News and Breast Cancer Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.