Pathologic complete response to neoadjuvant therapy in certain breast cancer patients predicts low risk for local metastases

MD Anderson study identifies patients who may avoid nodal surgery after chemotherapy

MD Anderson News Release April 19, 2017

Select breast cancer patients who achieved pathologic complete response (pCR) after chemotherapy may be able to avoid follow-up breast and lymph node, or axillary, surgery, according to new findings from researchers atThe University of Texas MD Anderson Cancer Center。The study, published today inJAMA Surgery,识别异常反应者谁在为当地转移风险最低，从而是微创治疗选择的候选人。

Worldwide, triple negative (TN) and HER-2 positive breast cancers account for about 370,000 women diagnosed annually, explainsHenry Kuerer, M.D., Ph.D., professor of Breast Surgical Oncology and the study’s principal investigator. In as many as 60 percent of these patients, neoadjuvant chemotherapy (NCT), given as the primary treatment, can result in pCR, or absence of residual disease, in both the breast and axillary lymph nodes.

“如此高的PCR率自然引发了丰胸手术是否需要对所有患者，尤其是那些谁将会接受辅助辐射的问题，” Kuerer说。“在这些特殊反应的一个重要辅助的问题是，我们是否也可以省略腋窝手术切除淋巴结。”

In order to determine those patients for whom surgery may be avoided, it is necessary to accurately identify those with a pCR following NCT. However, standard breast imaging techniques were not capable of accurately predicting residual disease.

最近Kuerer完成了临床试验的可行性研究图像引导活检的实用程序来预测乳腺癌的pCR。初步resultsof that study, originally presented at the 2016 San Antonio Breast Cancer Symposium, revealed the technique to have 100 percent accuracy and 100 percent predictive value for determining residual disease following NCT.

“By doing the same image-guided, percutaneous needle biopsies after NCT that we do at time of diagnosis, our preliminary research revealed we can accurately predict which women will have a complete response,” said Kuerer. “With that knowledge, there’s an obligation to test whether no surgery, or ‘ultimate breast conserving therapy,’ is safe.”

The current study sought to determine if patients achieving a pCR following NCT also may avoid axillary surgery for nodal metastases in addition to breast surgery. The prospective single-institution cohort study enrolled 527 women with T1-T2/N0-N1 stage triple negative (264) or HER-2 positive (263) breast cancer treated at MD Anderson between January 2010 and December 2014.

所有的参与者收到了NCT标准紧随其后breast and nodal surgery. Clinical staging was determined prior to NCT by core biopsy or fine-needle aspiration, followed by clinical examination, mammography and ultrasound of the breast and axilla. Breast pCR was defined as no residual disease at the time of surgery. Axillary pCR was defined as no evidence of metastatic carcinoma.

Overall, 36.6 percent of patients achieved a breast pCR, with a slightly higher rate among TN (37.5 percent) than HER-2 positive (35.7 percent) patients. Of patients presenting with N1 disease, 77 (32.5 percent) achieved a breast pCR compared to 116 of those with N0 stage disease (40 percent).

All 116 N0 stage patients with a breast pCR also achieved axillary pCR. Similarly, 89.6 percent of patients with N1 disease and a breast pCR were also free of nodal metastases. Overall, there were no significant differences between patients with TN and HER-2 positive breast cancers.

“In our study, patients achieving a breast pCR were more than seven times less likely to have residual nodal disease, with even more pronounced differences among patients presenting with N0 stage disease,” said Audree Tadros, M.D., fellow in Breast Surgical Oncology and the study’s lead author. “Based upon these findings, we anticipate women with initial node-negative disease may avoid breast and axillary surgery if they achieve a pCR after NCT and move on to standard radiotherapy.”

To investigate the efficacy and safety of this approach, MD Anderson’s Institutional Review Board has approved aPhase II clinical trial, which is now open at MD Anderson and will soon open within theMD安德森癌症网络^®。该研究招收女性I期和II HER2阳性和TN乳腺癌。谁实现图像引导研究参与者，NCT后活检证实的pCR将接受全乳照射，无需手术。在那些最初，超声证实淋巴结阴性，腋窝手术也将被避免。该试验将在此设置中率先采用影像引导活检和不包括手术。

“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,” said Kuerer. “If some women are able to avoid unnecessary surgery, it would be groundbreaking for patients – both physically and psychologically.”

Additional authors on the all-MD Anderson study include: Dalliah M. Black, M.D., Anthony Lucci Jr., M.D., Abigail S. Caudle, M.D., Sara M. DeSnyder, M.D., Mediget Teshomem, M.D., Makesha Miggins, M.D., Rosa F. Hwang, M.D., and Kelly K. Hunt, M.D., all of Breast Surgical Oncology; Wei T. Yang, M.D, Gaiane M. Rauch, M.D., Ph.D., Beatriz E. Adrada, M.D., and Tanya Moseley, M.D., all of Diagnostic Radiology; Savitri Krishnamurthy, M.D., Pathology; Benjamin D. Smith, M.D., Radiation Oncology; and Vicente Valero, M.D., and Carlos H. Barcenas, M.D., Breast Medical Oncology.

The study was financially supported by the PH and Fay Etta Robinson Distinguished Professorship in Cancer Research and a Cancer Center Support Grant from the National Institutes of Health (CA16672).