MD Anderson News Release 05/30/2017 -- In a clinical feasibility trial 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 neoadjuvant systemic therapy (NST) consisting of chemotherapy and/or targeted therapy. Should the findings be replicated in future studies, this research would be the first indication that surgery altogether may be eliminated for a large group of patients.

The results of this trial are now updated with new data and published in Annals of Surgery. The study was first presented by principal investigator Henry M. Kuerer, M.D., Ph.D., professor, Breast Surgical Oncology, 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 triple negative and HER2 positive breast cancer – because of such a high chance for no evidence of disease at the time of pathological review,” said 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 research reveals we may be able to accurately predict which women will have cancer or not,” said Kuerer. “This study also demonstrated that imaging alone has decreased accuracy, specificity and predictive value compared with image guided biopsy in detecting residual disease.”

The prospective single-center study met its primary endpoint and enrolled 40 women with early-stage (stage I, II, III) triple negative (26 patients) or HER-2 positive (14 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 and false negative rate, and negative predictive value was 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.

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