Accuracy of Magnetic Resonance Imaging-Guided Biopsy to Verify Breast Cancer Pathologic Complete Response After Neoadjuvant Chemotherapy: A Nonrandomized Controlled Trial.

Importance: After neoadjuvant chemotherapy (NAC), pathologic complete response (pCR) is an optimal outcome and a surrogate end point for improved disease-free and overall survival. To date, surgical resection remains the only reliable method for diagnosing pCR. Objective: To evaluate the accuracy of magnetic resonance imaging (MRI)-guided biopsy for diagnosing a pCR after NAC compared with reference-standard surgical resection. Design, Setting, and Participants: Single-arm, phase 1, nonrandomized controlled trial in a single tertiary care cancer center from September 26, 2017, to July 29, 2019. The median follow-up was 1.26 years (interquartile range, 0.85-1.59 years). Data analysis was performed in November 2019. Eligible patients had (1) stage IA to IIIC biopsy-proven operable invasive breast cancer; (2) standard-of-care NAC; (3) MRI before and after NAC, with imaging complete response defined as no residual enhancement on post-NAC MRI; and (4) definitive surgery. Patients were excluded if they were younger than 18 years, had a medical reason precluding study participation, or had a prior history of breast cancer. Interventions: Post-NAC MRI-guided biopsy without the use of intravenous contrast of the tumor bed before definitive surgery. Main Outcomes and Measures: The primary end point was the negative predictive value of MRI-guided biopsy, with true-negative defined as negative results of the biopsy (ie, no residual cancer) corresponding to a surgical pCR. Accuracy, sensitivity, positive predictive value, and specificity were also calculated. Two clinical definitions of pCR were independently evaluated: definition 1 was no residual invasive cancer; definition 2, no residual invasive or in situ cancer. Results: Twenty of 23 patients (87%) had evaluable data (median [interquartile range] age, 51.5 [39.0-57.5] years; 20 women [100%]; 13 White patients [65%]). Of the 20 patients, pre-NAC median tumor size on MRI was 3.0 cm (interquartile range, 2.0-5.0 cm). Nineteen of 20 patients (95%) had invasive ductal carcinoma; 15 of 20 (75%) had stage II cancer; 11 of 20 (55%) had ERBB2 (formerly HER2 or HER2/neu)-positive cancer; and 6 of 20 (30%) had triple-negative cancer. Surgical pathology demonstrated a pCR in 13 of 20 (65%) patients and no pCR in 7 of 20 patients (35%) when pCR definition 1 was used. Results of MRI-guided biopsy had a negative predictive value of 92.8% (95% CI, 66.2%-99.8%), with accuracy of 95% (95% CI, 75.1%-99.9%), sensitivity of 85.8% (95% CI, 42.0%-99.6%), positive predictive value of 100%, and specificity of 100% for pCR definition 1. Only 1 patient had a false-negative MRI-guided biopsy result (surgical pathology showed <0.02 cm of residual invasive cancer). Conclusions and Relevance: This study's results suggest that the accuracy of MRI-guided biopsy to diagnose a post-NAC pCR approaches that of reference-standard surgical resection. MRI-guided biopsy may be a viable alternative to surgical resection for this population after NAC, which supports the need for further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT03289195.

Results from the American Society of Breast Surgeons Oncoplastic Surgery Committee 2017 Survey: Current Practice and Future Directions.

INTRODUCTION: Oncoplastic surgery is emerging as a validated, safe, patient-centric approach to breast cancer surgery in the United States. The American Society of Breast Surgeons Oncoplastic Surgery Committee (ASBrS-OSC) conducted a survey to assess the scope of practice and level of interest in oncoplastic surgery among its members. Furthermore, the group sought to identify barriers to incorporating oncoplastic skills in a surgeon's practice. METHODS: A 10-question survey was administered in March 2017 to the entire ASBrS membership using an online format. Three solicitations were sent. Unique identifiers allowed a single response. RESULTS: Of the 2655 surveys sent out, 708 members responded. Nearly all (99%) respondents had at least some interest in oncoplastic surgery. The current rates of performing nipple-sparing mastectomy, adjacent tissue transfer, and breast reduction with lumpectomy were 80, 60, and 51%, respectively. A minority of respondents reported independently performing breast reductions/mammaplasties (19%) or contralateral symmetrization (10%). Barriers to learning oncoplastic surgery included surgeon's time and access to oncoplastic educational material/courses. Most respondents felt that training courses and videos may allow them to better incorporate oncoplastic techniques in their practices. CONCLUSIONS: The interest in oncoplastic surgery among U.S. surgeons is significant, yet there are barriers to incorporate these surgical techniques into a breast surgeon's practice. As professional organizations provide access to effective training and enduring educational resources, breast surgeons will be enabled to develop their oncoplastic skill set and safely offer these techniques to their patients.

Oncologic Outcomes After Treatment for MRI Occult Breast Cancer (pT0N+).

BACKGROUND: Studies assessing outcomes in occult breast cancer have often included women treated before the routine use of magnetic resonance imaging (MRI). This study examined outcomes for patients presenting with axillary adenopathy and no primary breast tumor detectable by MRI or other imaging methods. METHODS: All patients with axillary nodal metastases consistent with breast carcinoma and no breast primary tumor detectable by physical exam, mammography, or MRI treated between 1 January 1996 and 30 June 2011 were identified from an institutional database. Data were collected on local, regional, and distant recurrences. RESULTS: For the study, 38 patients were identified. Modified radical mastectomy (MRM) was performed for 13 of the patients, whereas 25 of the patients underwent axillary dissection (ALND) and whole-breast radiotherapy (WBRT). Most of the women had pathologic N1 disease [median number of positive nodes, 2 (MRM cohort) and 3 (ALND + WBRT cohort); p = 0.38]. All the patients received chemotherapy, and 30 (79%) of the 38 patients received an anthracycline and taxane. Regional nodal radiation was used for 60% of those with ALND + WBRT and for all 46% of the MRM patients who received chest wall radiotherapy. During a median follow-up period of 7 years, there were no nodal recurrences. Two patients treated with ALND + WBRT had in-breast recurrences, whereas none in the MRM group experienced a local recurrence. The proportion that experienced distant disease was similar between the MRM cohort (1 of 13) and the ALND + WBRT cohort (2 of 25). CONCLUSION: Breast cancer presenting as axillary adenopathy with no detectable primary tumor is rare. Breast conservation with WBRT is a viable option for patients with a diagnosis of occult breast cancer and a negative preoperative MRI.

Training a new generation of breast surgeons: are we succeeding?

BACKGROUND: Society of Surgical Oncology (SSO)-approved fellowships in Breast Oncology began training fellows in 2004. Here we ascertain methods of evaluating and improving the fellowship experience through fellowship alumni experience. METHODS: We conducted an electronic survey of fellowship graduates to learn perceived successes and weaknesses of their fellowship training, as well as their current practice experiences. Our electronic survey focused on their preparedness for practice, their job opportunities, and their use of image-guided biopsies in practice. RESULTS: Between 2005 and 2009, 142 fellows graduated and received our survey; 85 (60%) responded. Although 98% of graduates though that they were well prepared by their fellowship for performing breast cancer surgery, fewer thought that they were well prepared to perform oncoplastic techniques (53%), ultrasound (39%), and ultrasound-guided biopsies (28%). Nevertheless, many acquired additional training, and 63% were performing ultrasound-guided biopsies in practice. The majority (76%) were performing breast surgery exclusively, with 14% identifying themselves as director of a breast center and only 29% describing themselves as being in private practice-the rest being employed at a hospital or university. Only 8% of respondents were disappointed with the job market, and 67% stated they had received at least three job offers; 82% were satisfied in their current job. CONCLUSIONS: SSO breast oncology fellowships appear to be training confident, well-prepared graduates with good job outlooks, and many are achieving leadership positions. Deficiencies in sonography training, some advanced surgical techniques, and administrative experiences should be addressed by program directors as graduates do perceive the need for such training.

Morbidity and mortality following breast cancer surgery in women: national benchmarks for standards of care.

BACKGROUND: Most reports on postoperative (OP) morbidity and mortality following breast cancer surgery (BCS) are limited by relatively small sample size resulting in a lack of national benchmarks for quality of care. This paper reports the 30-day morbidity and mortality following BCS in women using a large prospective multi-institutional database. METHODS: The National Surgical Quality Improvement Program Patient Safety in Surgery, prospectively collected inpatient and outpatient 30 day postoperative morbidity and mortality data on patients undergoing surgery at 14 university and 4 community centers. Using the procedure CPT code, the database was queried for all women undergoing mastectomy (MT) or lumpectomy with an axillary procedure (L-ANP). Morbidity and mortality were categorized as mortality, wound, cardiac, renal, pulmonary, and central nervous system. Logistic regression models for the prediction of wound complications were developed. Preoperative variables having bivariate relationships with postoperative wound complications with P < or = 0.20 were submitted for consideration. RESULTS: We identified 1660 and 1447 women who underwent MT and l-ANP, respectively. The mean age was 55.9 years. The majority of procedures were under general anesthesia. The 30-day postoperative mortality for MT and l-ALNP were 0.24% and 0%, respectively. The most frequent morbid complication was wound infection, more commonly occurring in the mastectomy (4.34%) group versus the lumpectomy group (1.97%). Cardiac and pulmonary complications occurred infrequently in the mastectomy group (cardiac: MT, 0.12%; and pulmonary: MT, 0.66%). There were no cardiac or pulmonary complications in the lumpectomy group. CNS morbidities were rare in both surgical groups (MT, 0.12%; and l-ALNP, 0.07%). Development of a UTI was more common in women who underwent a mastectomy (0.66%) when compared with women that had a lumpectomy (0.14%). The only significant predictors of a wound complication were morbid obesity (BMI >30), having had a MT, low preoperative albumin and hematocrit greater than 45%. CONCLUSION: Morbidity and mortality rates following BCS in women are low, limiting their value in assessing quality of care. Mastectomy carries higher complication rate than l-ANP with wound infection being the most common.

Allergic reactions to isosulfan blue in sentinel lymph node mapping.

BACKGROUND: Sentinel lymph node (SLN) biopsy is often used in the assessment of lymph node status in melanoma and early stage breast cancer. With the rapidly increasing use of the technique, we can now better characterize and assess the rate of adverse reactions to the dye. METHODS: A retrospective review of all patients undergoing SLN mapping at the Columbia-Presbyterian Breast Center were identified from June 2000 to July 2002. All patients who experienced allergic reactions were documented and records examined. RESULTS: In total, three out of 351 patients had allergic complications from the procedure. All three patients developed "blue hives" after injection with isosulfan blue. The incidence at our Breast Center was 0.9%. All were treated with intravenous corticosteroids and diphenhydramine and recovered within twenty-four hours. CONCLUSIONS: The increasing utilization of the sentinel lymph node technique will make these complications more common. A high index of suspicion and appropriate clinical management are recommended to minimize the potential morbidity of these reactions.

Men with breast cancer have better disease-specific survival than women.

HYPOTHESIS: Male breast cancer patients have better disease-specific survival than carefully matched female breast cancer patients. DESIGN: Retrospective study. SETTING: University hospital. PATIENTS AND METHODS: Each man in the breast cancer database at Columbia-Presbyterian Medical Center (New York, NY) between the years 1980 and 1998 was matched with a woman. Matching was done based on age and date of diagnosis, stage, and primary histologic findings. MAIN OUTCOME MEASURES: The overall survivals and disease-specific survivals of the male breast cancer group and female breast cancer group were compared. RESULTS: Fifty-three male patients were matched with an equal number of female breast cancer patients. The Kaplan-Meier curves demonstrated that there was no significant difference in overall survival. The 5- and 10-year survivals for women were 0.77 and 0.51, and for men 0.77 and 0.56. When the Kaplan-Meier curves for breast cancer-specific survival were compared, however, there was a significant difference in the 5- and 10-year survivals (P = .05, log-rank test). For women, the 5- and 10-year disease-specific survival was 0.81 and 0.7, respectively, while for men it was 0.9 and 0.9, respectively. In a Cox regression analysis for time to death from breast cancer, stage was the only predictor of death that approached significance (P = .06). CONCLUSIONS: While the overall survivals were equivalent, male breast cancer patients had significantly better disease-specific survivals compared with their female counterparts. Male patients were 4 times more likely to die of other causes than their breast cancer.

The development of interval breast malignancies in patients with BRCA mutations.

BACKGROUND: At present, there is no consensus regarding how frequently BRCA mutation carriers should be screened for malignancies using breast imaging techniques. An interval malignancy is defined as a malignancy that becomes evident during the period between annual screening mammography scans; the finding of such a malignancy indicates that the malignancy either went undetected by the last breast imaging scan or developed during the interval since that last scan. METHODS: The authors retrospectively reviewed the medical charts of all BRCA mutation carriers who were followed by the genetic counselor at the Columbia-Presbyterian Comprehensive Breast Center (New York, NY) between September 1995 and September 2002. RESULTS: Thirteen BRCA mutation carriers elected to undergo close surveillance and thus were followed at our institution. Three of these 13 patients (23%) did not develop breast carcinoma, 4 (31%) developed breast carcinoma that was detected at the time of annual screening, and 6 (46%) developed palpable interval malignancies in less than 12 months. Among the six patients who developed interval malignancies, the mean time between the last screening mammogram and disease presentation was 5.1 months (range, 2-9 months); the average tumor size in this patient subgroup was 1.7 cm (range, 0.8-3 cm). Two of these six patients had ductal carcinoma in situ, whereas the remaining four had invasive breast carcinoma; three patients had positive lymph nodes at presentation. All six patients who developed interval disease exhibited dense breast tissue on the previous mammogram. Focused breast ultrasonography was able to identify the tumor mass in 3 of 4 patients (75%). CONCLUSIONS: Nearly half of all BRCA-positive women who chose to undergo close surveillance in the current study developed malignant disease less than a year after exhibiting normal findings on screening mammography. Half of these interval malignancies were positive for lymph node involvement. These results suggest that strong consideration should be given to screening BRCA-positive women at more frequent intervals and to using additional imaging techniques, such as breast ultrasonography and/or breast magnetic resonance imaging, as a part of this screening.

Pure mucinous carcinoma of the breast.

BACKGROUND: The lack of a standard definition of "pure" mucinous carcinoma of the breast has made it difficult to compare data from different studies. This study used the most stringent criteria to define parameters for truly pure lesions. METHODS: Sixty-five patients were identified. The database was used to evaluate patients' demographics, tumor characteristics, and outcomes. Survival curves and predictors of survival were analyzed. RESULTS: The mean age of presentation was 67 years. The majority (96%) of patients presented with early-stage disease. The 5- and 10-year overall survival rates were 93.6% and 72.8%, respectively. The number of involved axillary lymph nodes was the only significant predictor of death (P = 0.02). CONCLUSIONS: Pure mucinous carcinoma of the breast has a favorable prognosis. Tumor size does not appear to impact survival, perhaps because the volume of mucin overestimates tumor burden. The number of involved axillary lymph nodes was the only significant predictor of death from disease.

Interpectoral nodes as the initial site of recurrence in breast cancer.

HYPOTHESIS: Interpectoral nodes can be the initial site of recurrent breast cancer. DESIGN: Retrospective review. SETTING: Comprehensive breast center, located in a university-based tertiary care center. PATIENTS: All patients undergoing operations for breast cancer at our breast center from 1995 to 2002 were reviewed. MAIN OUTCOME MEASURES: Patients with interpectoral node recurrence as the initial site of recurrent breast cancer were identified. RESULTS: During the 8-year period, 4097 patients underwent surgical management for breast cancer. During this time, 4 patients (0.1%) had recurrence at the interpectoral nodes. Three of the 4 patients were node-negative at the original operation. All lesions were mammographically occult. Preoperative needle biopsy was effective in the confirmation of malignancy. All 4 underwent excision without complications. CONCLUSIONS: Recurrence at the interpectoral nodes can be the initial site of surgical failure. These nodes may represent the site of primary drainage in a percentage of patients. The sentinel node identification technique, therefore, should diminish the number of patients affected by recurrence at this site. In patients with a palpable mass in the infraclavicular location, however, a high index of suspicion should be maintained. Workup should include additional breast imaging and needle biopsy prior to operation.