MedicalResearch.com Interview with:
Audree Tadros, MD, MPH
Chief Administrative Fellow, Breast Surgical Oncology Training Program
Department of Breast Surgical Oncology
MD Anderson Cancer Center and
Henry M. Kuerer, MD, PhD, FACS
Executive Director, Breast Programs
MD Anderson Cancer Network
PH and Fay Etta Robinson Distinguished Professor in Cancer Research
Dept of Breast Surgical Oncology
Director, Breast Surgical Oncology Training Program
MedicalResearch.com: What is the background for this study?
Response: Neoadjuvant chemotherapy (NCT) has the ability to confer a pCR (pathologic complete response-when no residual cancer is found) in both the breast and axillary lymph nodes. We know that this is most likely to occur in women with HER2 positive and triple negative disease. The high rate of pCR among these patients raises the question of whether surgery is still required, particularly among those who will receive adjuvant radiation therapy.
Until recently, we lacked the ability to pre-operatively predict patients who achieved a breast pCR. Recently, we completed a clinical feasibility trial examining the ability of image-guided biopsy to predict a pCR after neoadjuvant chemotherapy. Our biopsy technique was able to accurately predict a pCR in 98% of patients with only a 5% false negative rate. Based upon these findings, we believe we can accurately determine which patients achieve a breast pCR. This led us to develop a clinical trial to see if breast surgery is redundant in patients who achieve a pCR. An important question that remained was if we are going to omit breast surgery in these exceptional responders, can we also omit axillary surgery?
MedicalResearch.com:? What are the main findings? What should readers take away from your report?
Response: The purpose of the current study was to analyze our prospectively collected data from 527 patients with T1-2N0-1, HER2 positive or triple negative breast cancer, in order to determine whether patients who will be enrolled in our new clinical trial, “Eliminating Breast Cancer Surgery in Exceptional Responder with Neoadjuvant Therapy”, will require axillary surgery. We found that among patient with initial, ultrasound-proven node negative disease(cT1-2N0), there is a 0% chance of finding residual disease on final pathology after surgery when there is a pCR in the breast. In comparison, patients who presented with an initial N1 documented breast cancer and had a pCR in the breast, the breast pathologic response was also highly concordant with approximately 90% converting to node-negative disease.
Based upon these findings women with initial, clinical and ultrasound node negative disease, enrolled in our trial, will avoid axillary surgery and breast surgery if they achieve a complete pathologic response in the breast after neoadjuvant chemotherapy and move on to standard radiotherapy. For women with initial N1 disease, they will undergo a targeted axillary dissection (removal of the clipped node in addition to a sentinel lymph node biopsy). If all nodes are negative, they will require no further axillary surgery.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: This single-institution study testing whether the ‘ultimate breast conserving therapy’ is safe is being replicated by many other single-centers and multicenter cooperative groups around the world. The key to success in these trials is a collaborative, multidisciplinary approach. Meticulous breast imaging and standardized pathology processing are critical to ensure that residual imaging abnormalities are sampled well in order to get accurate results.
MD Anderson’s Institutional Review Board (IRB) has approved a Phase II clinical trial, now open at MD Anderson and soon 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 NCT will undergo whole-breast radiation, without breast surgery. In patient with initial, ultrasound proven node negative disease, axillary surgery will also be avoided. Patients with initial, biopsy proven N1 disease, will undergo targeted axillary dissection.
The question that this study raises is whether we are over treating women who achieve a pathologic complete response. If surgery can safely be avoided in these patients, a more personalized, minimally invasive approach can be offered allowing patients greater choice in their treatment options.
MedicalResearch.com: Where can we learn more about the no-surgery trial for exceptional responders at MD Anderson?
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Tadros AB, Yang WT, Krishnamurthy S, Rauch GM, Smith BD, Valero V, Black DM, Lucci A, Caudle AS, DeSnyder SM, Teshome M, Barcenas CH, Miggins M, Adrada BE, Moseley T, Hwang RF, Hunt KK, Kuerer HM. Identification of Patients With Documented Pathologic Complete Response in the Breast After Neoadjuvant Chemotherapy for Omission of Axillary Surgery. JAMA Surg. Published online April 19, 2017. doi:10.1001/jamasurg.2017.0562
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