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.

Nonpuerperal mastitis and subareolar abscess of the breast.

OBJECTIVE: The purpose of this article is to show radiologists how to readily recognize nonpuerperal subareolar abscess and its complications in order to help reduce the time to definitive therapy and improve patient care. To achieve this purpose, the various theories of pathogenesis and the associated histopathologic features are reviewed; the typical clinical characteristics are detailed in contrast to those seen in lactational abscess and inflammatory breast cancer; the common imaging findings are described with emphasis on the sonographic features; correlative pathologic findings are presented to reinforce the imaging findings as they pertain to disease origins; and the various treatment options are reviewed. CONCLUSION: Nonpuerperal subareolar mastitis and abscess is a benign breast entity often associated with prolonged morbidity. Through better understanding of the underlying disease process the imaging, physical, and clinical findings of this rare process can be more readily recognized and treatment options expedited, improving patient care.

Shared decision making in breast cancer: national practice patterns of surgeons.

BACKGROUND: The purpose of this study was to assess national practices of surgeons who treat breast cancer in order to identify opportunities to improve patient education. METHODS: In June 2012, the membership of the American Society of Breast Surgeons (ASBrS) (n = 2,818) was surveyed via email questionnaire to evaluate their current practice of shared decision making and informed consent for breast cancer patients. RESULTS: A total of 737 members (26 %) responded, including 384 breast surgeons and 306 general surgeons, 13 midlevel providers, and 25 other specialists. It was found that 90 % of surgeons spent more than 30 min meeting with a new cancer patient, and of these, 30 % spent more than an hour. Surgeons who spent more than 1 h face-to-face with a new cancer patient reported higher levels of overall patient knowledge compared with those who spent less (mean = 3.80 vs. 3.64 of 5; p = 0.001). Also, 89 % of respondents reported using educational tools, of whom more than 90 % used written tools. In addition, 65 % of members stated an interest in a free online educational tool if available and indicated a preference for a flexible tool that could be used by the patient alone or with a nurse. CONCLUSIONS: While practice patterns may vary, our results reveal that one-third of surgeons spend at least 1 h in consultation with a new breast cancer patient. More time spent translated to a higher perceived patient understanding of their disease and treatment options. Although the majority of surgeons currently use written materials, there was clear support for a free online educational tool.

Use of breast simulators compared with standardized patients in teaching the clinical breast examination to medical students.

OBJECTIVE: Simulators have replaced some standardized patients in medical student teaching, and their use seems to decrease anxiety related to the clinical breast examination (CBE). We compared learning the CBE on a breast palpation simulator with learning on a standardized patient with respect to skill acquisition and comfort level. METHODS: At Penn State College of Medicine, the class of 2008 (historical control group, n = 113) learned the CBE on a standardized patient, whereas the class of 2009 (experimental group, n = 131) learned on the breast palpation simulator. We used measures of the process (conducting the CBE) and measures of the outcome (examination scores and detection of abnormal findings). During their third-year surgical clerkship, students in both groups completed a questionnaire reporting the number of CBEs performed and confidence in performing the CBE. The students then performed an observed examination on the simulator, and the number of positive findings detected was recorded. The mean number of positive findings was compared between groups, and an economic analysis was conducted. RESULTS: The experimental group had a significantly higher mean examination score than the historical control. In subgroups, this difference was significant for those who reported performing 0-5 clinical examinations but for not those who had performed >6 examinations. On individual items, the experimental group scored significantly higher in examining for neck nodes, nipple retraction, skin changes, and axillary evaluation. The 2 groups did not differ significantly in the mean number of positive findings detected or in ratings of comfort level. CONCLUSIONS: Medical students who learned the CBE on breast palpation simulators performed as well or better than those who learned on standardized patients; however, a subgroup analysis revealed that the benefit was limited to students with less clinical experience.

Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors.

BACKGROUND: This study compared the surgical results of 2 localization methods-cryo-assisted localization (CAL) and needle-wire localization (NWL)-in patients undergoing breast lumpectomy for breast cancer. METHODS: A total of 310 patients were treated in an institutional review board-approved study with 18 surgeons at 17 sites. Patients were randomized 2:1 to undergo either intraoperative CAL or NWL. A cryoprobe was inserted under ultrasound guidance in the operating room and an ice ball created an 8- to 10-mm margin around the lesion. The palpable ice ball then was dissected. NWL was placed according to institutional practice and resection was performed in a standard fashion. Surgical margins, complications, re-excisions, tissue volume, procedure times, ease of localization, specimen quality, and patient satisfaction were evaluated. Positive margins were defined as any type of disease present 1 mm or less from any specimen edge. RESULTS: Positive margin status did not differ between the 2 groups (28% vs. 31%). The volume of tissue removed was significantly less in the CAL group (49 vs. 66 mL, P = .002). Re-excisions were similar in both groups. CAL was superior in ease of lumpectomy, quality of specimen, acute surgical cosmesis, short-term cosmesis, patient satisfaction, and overall procedure time for the patient. CAL had a lower invasive positive margin rate (11% vs. 20%, P = .039) but a higher observed ductal carcinoma in situ-positive margin rate (30% vs. 18%, approaching statistical significance, P = .052). CONCLUSIONS: CAL is a preferred alternative to standard wire localization because it provides a palpable template, removes less tissue and improves cosmesis, decreases overall procedure time, and is more convenient for the patient and surgeon.

Limitations of splenic angioembolization in treating blunt splenic injury.

BACKGROUND: When angiography is performed in all hemodynamically normal patients with splenic injury, only 30% require embolization. This study examines the use of selective splenic angioembolization (SAE) as part of a management algorithm for adult splenic injury. METHODS: Criteria for selective SAE were added to our adult splenic injury protocol in July 1999. SAE was performed in hemodynamically stable patients if computed tomographic (CT) scan revealed injury to the hilum or vascular blush and when nonoperative patients had a gradual decrease in hematocrit. Patients were grouped by management strategy: nonoperative; operative; or SAE. Demographics, injury severity, and outcomes of the different groups were compared. Medical records, CT scans, and registry data were reviewed for all SAE cases, deaths, and treatment failures. Data are means +/- SE. p < 0.05 versus nonoperative management by analysis of variance. RESULTS: From July 1999 to August 2003, 194 adults were treated for splenic injury. Nine patients underwent SAE, six for CT findings (1 vascular blush) and three for decreasing hematocrit. Three patients failed SAE (33%), one for bleeding and two for delayed splenic infarction. Eleven patients failed nonoperative therapy (8%); splenorrhaphy was performed in three and splenectomy in eight. Operative patients were more seriously injured and had higher Injury Severity Scores and mortality; splenectomy (39 of 48) was more commonly performed than splenorrhaphy (9 of 48) in this group. CONCLUSION: Use of a splenic injury algorithm is associated with a high success rate for nonoperative management of splenic trauma. Using selective criteria, only 5% of patients were treated with SAE. SAE salvaged six patients with high-grade splenic injury or decreasing hematocrit but had a 33% failure rate. Failure of nonoperative management was most commonly caused by errors in judgment, primarily recognition of "high-risk" injury patterns on CT scan or attempting nonoperative management in anticoagulated or coagulopathic patients.

Office-based cryoablation of breast fibroadenomas with long-term follow-up.

Approximately 10% of women will experience a breast fibroadenoma in their lifetime. Cryoablation is a new treatment that combines the better attributes of the current standards: surveillance and surgery. It is a minimally invasive office-based procedure that is administered without the use of general anesthesia, involving minimal patient discomfort and little to no scarring. This work aimed to establish the long-term (2-3 years) efficacy, safety, and satisfaction of the procedure, as well as the impact of cryoablation on mammogram and ultrasound images. Thirty-seven treated fibroadenomas were available for assessment with an average follow-up period of 2.6 years. Of the original 84% that were palpable prior to treatment, only 16% remained palpable to the patient as of this writing. Of those fibroadenomas that were initially < or = 2.0 cm in size, only 6% remained palpable. A median volume reduction of 99% was observed with ultrasound. Ninety-seven percent of patients and 100% of physicians were satisfied with the long-term treatment results. Mammograms and ultrasounds showed cryoablation produced no artifact that would adversely affect interpretation. Cryoablation for breast fibroadenomas has previously been reported as safe and effective both acutely and at the 1-year follow-up mark, and thus has been implemented as a treatment option. At long-term follow-up, cryoablation as a primary therapy for breast fibroadenomas demonstrates progressive resolution of the treated area, durable safety, and excellent patient and physician satisfaction. The treatment is performed in an office setting rather than an operating room, resulting in a cost-effective and patient-friendly procedure. Cryoablation should be considered a preferred option for those patients desiring definitive therapy for their fibroadenomas without surgical intervention.

Comparison of cryopreservation and standard needle biopsy for gene expression profiling of human breast cancer specimens.

Given the growing importance of molecular profiling of breast cancer, we initiated a small study to test whether human breast biopsies obtained via cryopreservation large core needle biopsy (C-LCNB) provided similar gene expression profiles compared with 'optimally handled' standard large core needle biopsy (S-LCNB) specimens. Five matched pairs of C-LCNB versus S-LCNB were obtained at the same visit, and subjected to gene array expression analysis using the Affymetrix system with U133A chips. No significant changes in gene expression were identified comparing the C-LCNB versus the matched S-LCNB from individual patients. This was corroborated by a paired t-test analysis, which supported the hypothesis that the S/C biopsies measured equivalent samples. A small number of genes (17) showed decreased expression when second biopsies were compared with first biopsies, suggesting a slight patient response to the first biopsy. A scatter plot analysis comparing first biopsy versus second biopsy values disclosed a slope of 0.859, further indicating that the first biopsy affects the second biopsy measurement. It therefore appears that conventional biopsies, when handled appropriately, provide RNA which is equivalent to RNA from biopsies which are frozen immediately, but that multiple biopsy protocols may introduce additional complexities.

Cryoablation treatment of benign breast lesions with 12-month follow-up.

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.

Validation of 2 approaches to predicting resting metabolic rate in critically ill patients.

BACKGROUND: Indirect calorimetry is the criterion method for determining resting metabolic rate for nutrition support in critically ill patients. However, calculation equations are more commonly used. In the current study we tested the validity of 2 such calculation systems. METHODS: Indirect calorimetry was performed with an open-circuit device in mechanically ventilated surgical, trauma, and medical patients at rest. Feedings were not stopped for the measurements. Two predictive equations by Ireton-Jones and 3 versions of a multivariate equation developed at our institution (referred to as Penn State equations) were then used to estimate resting metabolic rate. These estimates were compared on a percentage basis with the measured value of resting metabolic rate. Estimated resting metabolic rate within 10% of measured was considered accurate, whereas estimations >15% different from measured were considered large errors. RESULTS: Forty-seven subjects were measured. A larger percentage of subjects were estimated accurately by the Penn State equations (72% in the best equation) than by the Ireton-Jones equations (60% in the best equation; not significant). The incidence of errors >15% of measured was significantly lower in the Penn State equation (11% of subjects) compared with the Ireton-Jones equation (32% of subjects) (p < .05). CONCLUSIONS: The Penn State equation for resting metabolic rate in mechanically ventilated intensive care patients receiving nutrition support appears to be a valid clinical tool for determining energy goals in the absence of or as a supplement to indirect calorimetry. The Ireton-Jones equation performed less well, especially in that a higher number of large errors occurred.

Office-based cryoablation of breast fibroadenomas: 12-month followup.

BACKGROUND: Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. STUDY DESIGN: A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. RESULTS: Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. CONCLUSIONS: Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.

Validation of several established equations for resting metabolic rate in obese and nonobese people.

OBJECTIVE: To evaluate several equations for predicting resting metabolic rate against measured values in obese and nonobese people. DESIGN: Resting metabolic rate was measured with indirect calorimetry. Four calculation standards using various combinations of weight, height, and age were used to predict resting metabolic rate: a) Harris-Benedict equation, b) Harris-Benedict equation using adjusted body weight in obese individuals, c) Owen, and d) Mifflin. Main outcome was percentage of subjects whose calculated metabolic rate was outside a +/-10% limit from measured values. Subjects/Setting 130 nonhospitalized adult volunteers grouped by degree of obesity (range of body mass index, 18.8 to 96.8). Statistical Analysis Performed Analysis of proportions was used to determine differences in the percentage of subjects estimated accurately by each equation; alpha was set at 0.05. RESULTS: Calculated resting metabolic rate was more than 10% different from measured in 22% of subjects using the Mifflin equation, 33% using the Harris-Benedict equation (P=.05 vs Mifflin), and 35% using the Owen equation (P<.05 vs Mifflin). The error rate using Harris-Benedict with adjusted weight in obesity was 74% (vs 36% in obese subjects using actual weight in the standard Harris-Benedict equation). APPLICATIONS/CONCLUSION: Of the calculation standards tested, the Mifflin standard provided an accurate estimate of actual resting metabolic rate in the largest percentage of nonobese and obese individuals and therefore deserves consideration as the standard for calculating resting metabolic rate in obese and nonobese adults. Use of adjusted body weight in the Harris-Benedict equation led to less overestimation by that equation in obese people at the expense of increased incidence of underestimation.

Office-based ultrasound-guided cryoablation of breast fibroadenomas.

BACKGROUND: Fibroadenomas commonly found by palpation and routine mammography account for approximately 20% of open surgical breast biopsies. Alternatives to open surgery include tumor removal using an automated coring device and tumor ablation using heating or cooling elements. We report our initial experience with cryoablation of biopsy-proven benign fibroadenomas. METHODS: A table-top cryoablation system employing a 2.4-mm cryoprobe was used to treat biopsy-proven benign fibroadenomas up to 4 cm in maximum diameter in a prospective nonrandomized fashion. The cryoprobe was placed under ultrasound guidance. Using a treatment algorithm based on fibroadenoma size, all tumors were subjected to two freeze cycles with an interposing thaw. Skin appearance and temperature, probe temperature, iceball size, and patient comfort were closely monitored during the procedure. Follow-up examinations including ultrasonography and photographs were scheduled for up to 12 months postablation. RESULTS: Fifty patients with 57 core biopsy-proven benign fibroadenomas were treated. Seven early cases were treated in an ambulatory surgery center setting. The remaining procedures were completely office-based using only local anesthetic. Tumor diameter varied from 7 mm to 42 mm (mean 21 mm). The iceball engulfed the target lesion in each case. Transient postoperative side effects were local swelling and ecchymosis. Postoperative discomfort rarely required medication beyond acetaminophen or ibuprofen. Lesions showed progressive shrinkage and disappearance over 3 to 12 months. No skin injury was noted and appearance remained excellent. Patient satisfaction was excellent. CONCLUSIONS: With office-based use of ultrasound-guided cryoablation for fibroadenomas there was little or no pain, target lesions were reduced in size or eliminated, scarring was minimal, cosmesis outstanding, and patient satisfaction was excellent. Cryoablation offers a useful office-based alternative to surgical excision of benign fibroadenomas.

Three Mile Island : The silent disaster

From Wednesday, March 28, 1979,to Wednesday, April 4, 1979, Dauphin County, Pennsylvania, was in a state of near-panic in response to the Three Mile Island nuclear accident. The Dauphin County Office of Emergency Preparedness quickly attempted to develop a plan to evacuate not only the population of an area 20 miles in radius from the plant but the short-term and long-term care medical facilities as well. For medical evacuation, a system of classification of patients was defined and matched to needed transportation. Furthermore, a critical coordinating link was established with the Hospital Association of Pennsylvania to identify and categorize relocation beds in receiving hospitals far from the incident site in the event of evacuation. Just as this incident was unusual, so too were the planning activities unique since they were never before conceived or accomplished (AU)