Outcomes of Abbreviated MRI (Ab-MRI) for Women of any Breast Cancer Risk and Breast Density in a Community Academic Setting.

BACKGROUND: Abbreviated magnetic resonance imaging (Ab-MRI) has been evaluated for elevated breast cancer risk or dense breasts but has not been evaluated across all risk profiles. METHODS: Patients selected underwent Ab-MRI from February 2020 to September 2021. Women were older than aged 30 years, up to date with screening mammography, and paid $299 cash. RESULTS: A total of 93 patients were identified with a mean age of 52 years; 92.5% were Caucasian, 0% black, and 97.9% were from high socioeconomic status. Mean Gail score was 14.2, and 83.3% had a lifetime risk of breast cancer <20%. Reasons for Ab-MRI: dense breasts (36.6%); family history (24.7%); palpable mass (12.9%). Providers ordering: OBGYN (49.5%); breast surgeon (39.1%); primary care (6.6%). Thirteen biopsies (14%) detected one breast cancer. 31.1% had a change in follow-up screening: 58.6% 6-month MRI, 20.7% 6-month mammogram, and 10.3% 6-month ultrasound. Negative predictive value was 100% (95% confidence interval [CI]: 95-100%, p < 0.0001). Sensitivity was 100% (95% CI: 2.5-100%, p < 0.0001), and specificity was 87% (95% CI: 78.3-93.1%, p < 0.0001) compared with 77.6% and 98.8% for mammography. Only one cancer was detected: cost of $27,807 plus cost of 13 MRI or ultrasound (US)-guided biopsies and additional follow-up imaging. Historically 20% of abnormalities detected on full MRI are malignant; however, 7.7% of ab-MRI abnormalities were malignant CONCLUSIONS: One third of women were recommended a change in follow-up, which predominantly included a 6-month MRI. Ab-MRI may introduce average risk women to unnecessary follow-up and increased biopsies with a lower cancer detection rate. Ab-MRI should be evaluated closely before implementation.

COVID-19 Pandemic: Changes in Care for a Community Academic Breast Center and Patient Perception of Those Changes.

BACKGROUND: Philadelphia and its suburbs were an epicenter for the initial COVID-19 outbreak. Accordingly, alterations were made in breast cancer care at a community hospital. METHODS: The authors developed a prospective database of all the patients with invasive or in situ breast cancer between March 1 and June 15 at their breast center. Any change in a breast cancer plan due to the pandemic was documented, and the patients were grouped into two cohorts according to whether a change was made (CTX) or no change was made (NC) in their care. The patients were asked a series of questions about their care, including those in the Generalized Anxiety Disorder two-item questionnaire (GAD-2), via telephone. RESULTS: The study enrolled 73 patients: 41 NC patients (56%) and 32 CTX patients (44%). The two cohorts did not differ in terms of age, race, or stage. Changes included delay in therapy (15.1%) and use of neoadjuvant endocrine therapy (NET, 28.8%). The median time to surgery was 24 days (interequartile range [IQR], 16-45 days) for the NC patients and 82 day s (IQR, 52-98 days) for the CTX patients (p ≤ 0.001). The median duration of NET was 78 days. The GAD-2 showed anxiety positivity to be 29.6% for the CTX patients and 32.4% for the NC patients (p = 1.00). More than half (55.6%) of the CTX patients believed COVID-19 affected their treatment outlook compared with 25.7% of the NC patients (p = 0.021). CONCLUSIONS: A prospective database captured changes in breast cancer care at a community academic breast center during the initial phase of the COVID-19 pandemic. 44% of patients experienced a change in breast cancer care due to COVID-19. The same level of anxiety and depression was seen in both change in therapy (CTX) and no change (NC). 55.6% of CTX cohort believed COVID-19 affected their treatment outlook.

Metabolic Syndrome: does this influence breast cancer outcomes in the triple-negative population?

INTRODUCTION: Metabolic syndrome (MS) is defined by having at least 3 of 4 components: obesity, dyslipidemia, hypertension (HTN), and diabetes. Prior studies analyzed the individual components of MS for all breast cancers which are predominantly hormone positive. Our study is the first to evaluate MS in triple-negative breast cancer (TNBC). METHODS: A retrospective review of TNBC from 2007 to 2013 identified 177 patients with complete information for statistical analysis. Cox proportional hazards models were used to test the association between MS, disease-free survival (DFS), and overall survival (OS). RESULTS: 48 (27%) patients had MS. After controlling for age, race, pathologic stage, surgery type, and additional comorbidities outside of MS, MS was significantly associated with poorer DFS (adjusted HR: 2.24, p = 0.030), but not associated with OS (adjusted HR: 1.92, p = 0.103). HTN was significantly associated with poorer DFS (adjusted HR: 3.63, p = 0.006) and OS (adjusted HR: 3.45, p = 0.035) in the univariable and multivariable analyses. Diabetes was not associated with worse OS or DFS. The 5-year age-adjusted OS rates for 60-year-old patients with and without diabetes were 85.8% and 87.3%, respectively. The age-adjusted 5-year OS rate for 60-year old patients was higher in patients with a body mass index (BMI) > 30 (90.2%) versus BMIs of 25-29.9 (88.2%) or < 25 (83.5%). CONCLUSION: In the TNBC population, MS was significantly associated with poorer DFS, but not associated with OS. HTN was the only component of MS that was significantly associated with both DFS and OS. Obesity has a potential small protective benefit in the TNBC population.

Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ.

OBJECTIVE: The aim of this study was to determine the impact of the results of the 12-gene DCIS Score assay on (i) radiotherapy recommendations for patients with pure ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS), and (ii) patient decisional conflict and state anxiety. METHODS: Thirteen sites across the US enrolled patients (March 2014-August 2015) with pure DCIS undergoing BCS. Prospectively collected data included clinicopathologic factors, physician estimates of local recurrence risk, DCIS Score results, and pre-/post-assay radiotherapy recommendations for each patient made by a surgeon and a radiation oncologist. Patients completed pre-/post-assay decisional conflict scale and state-trait anxiety inventory instruments. RESULTS: The analysis cohort included 127 patients: median age 60 years, 80 % postmenopausal, median size 8 mm (39 % ≤5 mm), 70 % grade 1/2, 88 % estrogen receptor-positive, 75 % progesterone receptor-positive, 54 % with comedo necrosis, and 18 % multifocal. Sixty-six percent of patients had low DCIS Score results, 20 % had intermediate DCIS Score results, and 14 % had high DCIS Score results; the median result was 21 (range 0-84). Pre-assay, surgeons and radiation oncologists recommended radiotherapy for 70.9 and 72.4 % of patients, respectively. Post-assay, 26.4 % of overall recommendations changed, including 30.7 and 22.0 % of recommendations by surgeons and radiation oncologists, respectively. Among patients with confirmed completed questionnaires (n = 32), decision conflict (p = 0.004) and state anxiety (p = 0.042) decreased significantly from pre- to post-assay. CONCLUSIONS: Individualized risk estimates from the DCIS Score assay provide valuable information to physicians and patients. Post-assay, in response to DCIS Score results, surgeons changed treatment recommendations more often than radiation oncologists. Further investigation is needed to better understand how such treatment changes may affect clinical outcomes.

A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization.

Radioactive seed localization (RSL) has emerged as an alternative to wire localization (WL) in patients with nonpalpable breast cancer. Few studies have prospectively evaluated patient satisfaction and outcomes with RSL. We report the results of a randomized trial comparing RSL to WL in our community hospital. We prospectively enrolled 135 patients with nonpalpable breast cancer between 2011 and 2014. Patients were randomized to RSL or WL. Patients rated the pain and the convenience of the localization on a 5-point Likert scale. Characteristics and outcomes were compared between groups. Of 135 patients enrolled, 10 were excluded (benign pathology, palpable cancer, mastectomy, and previous ipsilateral cancer) resulting in 125 patients. Seventy patients (56%) were randomized to RSL and 55 (44%) to WL. Fewer patients in the RSL group reported moderate to severe pain during the localization procedure compared to the WL group (12% versus 26%, respectively, p = 0.058). The overall convenience of the procedure was rated as very good to excellent in 85% of RSL patients compared to 44% of WL patients (p < 0.0001). There was no difference between the volume of the main specimen (p = 0.67), volume of the first surgery (p = 0.67), or rate of positive margins (p = 0.53) between groups. RSL resulted in less severe pain and higher convenience compared to WL, with comparable excision volume and positive margin rates. High patient satisfaction with RSL provides another incentive for surgeons to strongly consider RSL as an alternative to WL.

Fine-needle aspiration cytology in the evaluation of patients with radiographically occult, palpable breast abnormalities.

BACKGROUND: Patients who present with occult, palpable breast abnormalities on radiographs represent a diagnostic challenge. We hypothesized that fine-needle aspiration cytology (FNAC) would be an accurate method for diagnosing and excluding malignancy in these patients. METHODS: The records of all patients undergoing FNAC at our institution between 2010 and 2012 were queried; 173 patients with 175 palpable breast masses without an imaging correlate were included. RESULTS: Of 175 FNAC performed, 2 (1%) were malignant, 16 (9%) were suspicious, and 157 (90%) were benign (n = 75) or nondiagnostic (n = 82). All 16 suspicious FNAC underwent an additional biopsy, of which 4 were malignant. FNAC led to the identification of 6 (3.4%) occult malignancies. At a median follow-up of 16.3 months, 1 patient within the benign cohort was found to have an incidental 2.5 mm cancer identified on reduction mammaplasty, which was unrelated to the index mass. The negative predictive value of FNAC in benign patients was 100%. CONCLUSION: FNAC detected malignancy in a small but significant percentage of patients with a palpable mass and negative breast imaging while excluding carcinoma in the remaining patients. FNAC may be included in the evaluation of patients with occult, palpable breast masses demonstrated on radiography.

A Prospective Validation Study of Bioimpedance with Volume Displacement in Early-Stage Breast Cancer Patients at Risk for Lymphedema.

BACKGROUND: Although volume displacement (VD) is considered the gold standard for diagnosing breast cancer-related lymphedema, it is inconvenient. We compared bioimpedance (L-Dex) and VD measurements in a prospective cohort of breast cancer patients at risk for lymphedema. METHODS: Between 2010 and 2014, a total of 223 breast cancer patients were enrolled. Following exclusions (n = 37), 186 received baseline VD and L-Dex; follow-up measurements were performed at 3-6 months intervals for 3 years. At each visit, patients fitted into one of three categories: normal (normal VD and L-Dex); abnormal L-Dex (L-Dex > 10 or increase in 10 from baseline and normal VD); or lymphedema (relative arm volume difference of >10 % by VD ± abnormal L-Dex). Change in L-Dex was plotted against change in VD; correlation was assessed using the Pearson correlation. RESULTS: At a median follow-up of 18.2 months, 152 patients were normal, 25 had an abnormal L-Dex, and 9 developed lymphedema without a prior L-Dex abnormality. Of the 25 abnormal L-Dex patients, 4 progressed to lymphedema, for a total of 13 patients with lymphedema. Evaluating all time points, 186 patients had 829 follow-up measurements. Sensitivity and specificity of L-Dex compared with VD were 75 and 93 %, respectively. There was no correlation between change in VD and change in L-Dex at 3 months (r = 0.31) or 6 months (r = 0.21). CONCLUSIONS: VD and bioimpedance demonstrated poor correlation with inconsistent overlap of measurements considered abnormal. Of patients with an abnormal L-Dex, few progressed to lymphedema; most patients with lymphedema did not have a prior L-Dex abnormality. Further studies are needed to understand the clinical significance of bioimpedance.

A retrospective study of the impact of 21-gene recurrence score assay on treatment choice in node positive micrometastatic breast cancer.

To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(-)/ER+ pN1mi breast cancer with low (<18) Recurrence Scores results are given adjuvant chemotherapy in a lower proportion than those with high scores (≥31). This was a multicenter chart review of ≥18 year old women with pN1mi breast cancer, HER2(-)/ER+ tumors, ductal/lobular/mixed histology, with the assay ordered on or after 1 January 2007. One hundred and eighty one patients had a mean age of 60.7 years; 82.9% had ECOG performance status 0; 33.7% had hypertension, 22.7% had osteoporosis, 18.8% had osteoarthritis, and 8.8% had type-2 diabetes. Mean Recurrence Score was 17.8 (range: 0-50). 48.6% had a mastectomy; 55.8% had a lumpectomy. 19.8% of low-risk group patients were recommended chemotherapy vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p < 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p < 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(-)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(-)/ER+ pN1mi breast cancer patients.

A comparison of complication rates in early-stage breast cancer patients treated with brachytherapy versus whole-breast irradiation.

BACKGROUND: The adoption of breast brachytherapy into clinical practice for early-stage breast cancer has increased over the last several years. Studies evaluating complication rates following treatment with brachytherapy have shown conflicting results. We compared local toxicity in patients treated with brachytherapy with those treated with whole-breast irradiation (WBI). METHODS: We identified 417 early-stage breast cancer patients treated with breast-conserving surgery and radiation between 2004 and 2010, and compared 271 women treated with intracavitary brachytherapy with 146 women treated with WBI. Long-term complications were assessed using Kaplan-Meier curves with the log-rank test. RESULTS: Median follow-up was 4.6 years, and the 5-year incidence of infectious skin complications (9.7 vs. 11.0 %, p = 0.84), abscess (1.1 vs. 0 %, p = 0.15), telangiectasia (8.0 vs. 5.3 %, p = 0.35), and breast pain (14.2 vs. 9.4 %, p = 0.2) was similar between the brachytherapy and WBI cohorts. The brachytherapy cohort had a higher 5-year rate of seroma (46.5 vs. 18.5 %, p < 0.001), and fat necrosis (39.5 vs. 24.4 %, p < 0.001). Brachytherapy patients trended towards more frequent biopsies as a result of fat necrosis to rule out a recurrence (11.2 vs. 6.7 %, p = 0.13). CONCLUSIONS: Patients treated with intracavitary brachytherapy had more local toxicity, particularly seroma and fat necrosis. Patients should be counseled on the possible increased rate of long-term complications associated with brachytherapy treatment.

Infrared imaging does not predict the presence of malignancy in patients with suspicious radiologic breast abnormalities.

The NoTouch BreastScan (NTBS) is a non-invasive infrared imaging device which measures thermal gradients in breasts using dual infrared cameras and computer analysis. We evaluated NTBS as a predictor of breast cancer in patients undergoing minimally invasive biopsy. In this IRB-approved prospective trial, 121 female patients underwent NTBS prior to scheduled tissue biopsy. Twenty-two patients were excluded due to uninterpretable scans (n = 18), diagnosis of a nonprimary breast malignancy (n = 1), or no biopsy performed (n = 3) for a total of 99 patients. Five patients had bilateral breast biopsies and one patient had two ipsilateral biopsies, resulting in 105 biopsies. Patients were prospectively scanned using a high specificity mode, termed NTBS1. All 99 patients were retrospectively re-evaluated in a high sensitivity mode, NTBS2. Of 105 biopsies performed in 99 women, 33 (31.4%) were malignant and 72 (68.6%) were benign. NTBS1 demonstrated a sensitivity of 45.5% and a specificity of 88.9%. Of 94 normal contralateral breasts, 9.6% had a positive NTBS1. In the retrospective evaluation, NTBS2 demonstrated a sensitivity of 78.8% and a specificity of 48.6%. Half (50%) of the normal contralateral breasts had a positive NTBS2. NTBS does not accurately predict malignancy in women with suspicious imaging abnormalities. The higher sensitivity mode results in an unacceptable number of false positives, precluding its use. Infrared imaging did not improve the sensitivity or specificity of mammography in this clinical setting.

Effect of preoperative MRI on mastectomy and contralateral prophylactic mastectomy rates at a community hospital by a single surgeon.

Magnetic resonance imaging (MRI) use in the preoperative evaluation of newly diagnosed breast cancer (BC) patients is rising. We evaluated MRI as a function of surgical year with respect to mastectomy and contralateral prophylactic mastectomy (CPM) rates by a single surgeon. From January 2000 to December 2010, 1,279 patients with 1,296 breast cancers were identified. Our breast MRI was installed in April 2006. Mastectomy and CPM rates were evaluated by surgical year and stratified as "pre-MRI" or "MRI" depending on whether surgery occurred before or after April 2006. There was a significant increase in the percentage of patients undergoing MRI in the "pre-MRI" versus "MRI" era (17.2% versus 78.7%, p < 0.001). In contrast, mastectomy rates decreased with 29.9% undergoing mastectomy before 2006 versus 24.5% after 2006 (p = 0.038). Except for 2007, where CPM rates dropped to 7.1%, CPM rates increased from 16.7% in 2000 to 51.9% in 2010 (p = 0.033). The use of MRI, additional MRI findings and additional MRI biopsies were not associated with the decision for CPM. Age <50 was the only factor associated with CPM (RR = 2.12, p = 0.001). In our community hospital, mastectomy rates have decreased despite the increased use of preoperative MRI. MRI alone may not explain the increasing rates of mastectomy reported in other series. CPM rates have dramatically increased over time, seemingly independent of MRI use. Prospective studies are needed to assess the role of surgeon bias, along with other factors, in surgical decision making.

The value of 6-month interval imaging after benign radiologic-pathologic concordant minimally invasive breast biopsy.

BACKGROUND: Current National Comprehensive Cancer Network guidelines recommend repeat imaging 6-12 months after a benign radiologic-pathologic concordant image-guided breast biopsy. We hypothesized that interval imaging <12 months after benign concordant biopsy has a low cancer yield and increases health care costs. METHODS: An institutional review board-approved retrospective chart review identified 689 patients who underwent image-guided breast biopsy at Bryn Mawr Hospital between January and December 2010. Charts were evaluated for documentation of radiologic-pathologic concordance. RESULTS: Of 689 patients, 188 (27 %) had malignant pathology, 3 (0.4 %) had nonbreast pathology, and 498 (72.3 %) had benign pathology. Of 498 patients with benign findings, 44 (8.8 %) underwent surgical excision as a result of discordance, atypia, papillary lesion, or other benign finding. Of the remaining 454 patients who did not undergo excision, 337 (74.2 %) had documented radiologic-pathologic concordance. Interval imaging <12 months after benign biopsy was obtained in 182 (54.0 %) concordant patients. Five (2.7 %) patients had suspicious [American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS) 4] findings on follow-up imaging. Only one breast cancer was identified, representing 0.5 % (95 % confidence interval 0-3.4) of all benign concordant patients undergoing interval imaging. The cost of detecting a missed cancer with interval imaging after benign concordant biopsy was $41,813.77 in this cohort. CONCLUSIONS: Interval imaging performed <12 months after benign concordant breast biopsy demonstrated a low yield for the detection of breast cancer and resulted in increased health care costs. Our data support the policy for discontinuation of routine interval imaging after benign concordant biopsy.

Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials.

BACKGROUND: Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. METHODS: A total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept. RESULTS: A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [(99m)Tc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [(99m)Tc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [(99m)Tc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [(99m)Tc]tilmanocept. CONCLUSION: [(99m)Tc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [(99m)Tc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.

Are the American Society for Radiation Oncology guidelines accurate predictors of recurrence in early stage breast cancer patients treated with balloon-based brachytherapy?

The American Society for Radiation Oncology (ASTRO) consensus statement (CS) provides guidelines for patient selection for accelerated partial breast irradiation (APBI) following breast conserving surgery. The purpose of this study was to evaluate recurrence rates based on ASTRO CS groupings. A single institution review of 238 early stage breast cancer patients treated with balloon-based APBI via balloon based brachytherapy demonstrated a 4-year actuarial ipsilateral breast tumor recurrence (IBTR) rate of 5.1%. There were no significant differences in the 4-year actuarial IBTR rates between the "suitable," "cautionary," and "unsuitable" ASTRO categories (0%, 7.2%, and 4.3%, resp., P = 0.28). ER negative tumors had higher rates of IBTR than ER positive tumors. The ASTRO groupings are poor predictors of patient outcomes. Further studies evaluating individual clinicopathologic features are needed to determine the safety of APBI in higher risk patients.

A single-institution review of accelerated partial breast irradiation in patients considered "cautionary" by the American Society for Radiation Oncology.

BACKGROUND: The American Society for Radiation Oncology (ASTRO) issued a consensus statement in 2009 regarding patient selection for accelerated partial breast irradiation (APBI) following breast-conserving surgery (BCS) for breast cancer (BC). We reviewed our single-institution experience with APBI in patients considered "cautionary" by ASTRO to determine patterns of recurrence. METHODS: An institutional review board-approved, retrospective chart review was conducted from January 2004 to November 2009. We identified 106 "cautionary" patients with 109 BC. All patients were treated with BCS followed by APBI via balloon catheter brachytherapy. "Cautionary" criteria include patients aged 50-59 years, tumor size 2.1-3.0 cm, close margins (<2 mm), focal lymphovascular invasion, estrogen receptor (ER)-negative tumors, invasive lobular carcinoma, or ductal carcinoma in situ (DCIS) ≤ 3 cm. Rates of recurrence at any site were evaluated. RESULTS: Median follow-up was 3 years. There were 3 IBTR (2.8%) at a median of 3.2 years. The 3-year actuarial IBTR rate was 1.8%. Patients with ER-negative invasive cancers had a higher IBTR rate compared with ER-positive patients (11.8% vs. 2.2%), although this did not reach statistical significance (P = 0.18). There were no IBTR in 46 patients with DCIS. On univariate analysis, there was no association between "cautionary" criteria and risk of local, regional, or distant recurrence. CONCLUSIONS: Patients considered "cautionary" for APBI based on ASTRO guidelines had low rates of IBTR. ER-negative patients trended toward a higher IBTR rate with APBI compared with ER-positive patients. Longer follow-up is needed to establish the safety of APBI in "cautionary" patients.

Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.

BACKGROUND: Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects. METHODS: NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤ 49 years, ≥ 50 years), clinical tumour size (≤ 2·0 cm, 2·1-4·0 cm, ≥ 4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1-126·7). This study is registered with ClinicalTrials.gov, number NCT00003830. FINDINGS: 5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96-1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4-93·3) in group 1 and 90·3% (88·8-91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90-1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5-84·4) in group 1 and 81·5% (79·6-83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye. INTERPRETATION: Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes. FUNDING: US Public Health Service, National Cancer Institute, and Department of Health and Human Services.

Is there a role for MRI in the preoperative assessment of patients with DCIS?

BACKGROUND: Breast magnetic resonance imaging (MRI) is used to identify residual and additional disease in patients with invasive carcinoma. The use of MRI in assessing extent of disease for ductal carcinoma in situ (DCIS) is less well defined. This study assessed the value of MRI in the preoperative evaluation of DCIS. MATERIALS AND METHODS: We identified 98 patients with DCIS in 2007. Of these, 63 underwent stereotactic biopsy, followed by MRI. There were 35 who underwent stereotactic biopsy alone. Concordance between MRI and histopathology was defined as the presence or absence of residual disease. RESULTS: There was no significant difference in mastectomy rates between the MRI and non-MRI group (20.3% vs 25.7%, P = .62). In patients undergoing breast-conserving surgery (BCS), there were fewer positive margins in the MRI versus the non-MRI group (21.2% vs 30.8%, P = .41). Of the 64 cases that underwent preoperative MRI, 43 (67.2%) were concordant. Also, 15 of 43 cases (34.8%) had MRI results that accurately predicted pathologic size. In 28 of 43 patients (65.2%), MRI overestimated disease in 20, by a mean of 1.97 cm. In patients with MRI tumor size >2 cm, MRI overestimated disease by a mean of 3.17 cm. Of the 64 cases, 21 (32.8%) were discordant. Also, 10 of 21 (47.6%) had a positive MRI and no residual disease on histopathology, and 11 of 21 (52.3%) had negative MRI and residual disease on pathology. CONCLUSIONS: MRI does not accurately predict extent of disease in patients with extensive DCIS. In patients with MRI tumor size < or = 2 cm, MRI may assist in surgical planning. MRI results in patients with DCIS should be interpreted with caution; decision for mastectomy should not be made on MRI findings alone.