bluuebunny/crossref_metadata_2025_split huggingface dataset:
Intraoperative margin assessment with the MarginProbe at different mammographic breast densities.
Authors: Police Alice , Lin Erin , Lane Karen 
Published: February 2017

47 Background: Mammographic breast density (BD) is known to affect breast imaging. MarginProbe is an RF Spectroscopy intraoperative margin assessment tool. We looked at the effect of mammographic breast density (BD) on the performance of the device. Mammographic density was assigned by Breast Imaging-Reporting and Data System (BI-RADS) classification prior to breast conserving surgery with the MarginProbe. Methods: For the current study we analyzed MarginProbe device arm data from the MarginProbe Pivotal Trial for which BD data was available. Clear margins of the main specimen, which is where the MarginProbe was applied, were defined as no tumor on ink. Clinical benefit was defined as clearing positive main specimen margins or cancer in the shaving. Analysis was performed based on logistic and linear regression, with univariate analysis. Results: The dataset for the analysis included 196 patients for which preoperative BD data was available. With higher BD, there was an increase in the rate of main lumpectomy specimen with positive margins (OR 1.65 per change in density category, p=0.025). The rate of shavings with clinical benefit showed an upward trend, with increasing BD. The number of shavings per patient increased with BD, however the overall volume of shavings did not increase. There was an increase in the per patient relative clinical benefit as BD increased (OR 1.6 per change in density category, p=0.024). Conclusions: With higher breast density patients and surgeons face an increase in risk for main specimen positive margins. With the increased BD and main specimen positivity more shavings were removed, but shavings volume did not increase as average shaving volume decreased with higher BD. Higher level of patient clinical benefit was observed with higher BD.
Assessing the value of hepatic arterial phase CT imaging in patients with breast cancer.
Authors: Motiuk David , Ng Danny 
Published: February 2017

5 Background: Hypervascular liver metastases, classically seen in melanoma and other cancers, may be best seen on a hepatic arterial phase (HAP) CT and possibly missed on the standard portal venous phase (PVP). Breast cancer sometimes produces hypervascular liver metastases, but the incidence of this is not well established. Hence, some centers perform biphasic liver CT (HAP + PVP) as standard protocol in breast cancer patients, while others do not. Our center does not include HAP in this patient population; although, it is sometimes protocolled with HAP as per radiologist preference. We sought to determine if the detection for presence or absence of liver metastases is significantly affected by the addition of HAP in breast cancer. Methods: This retrospective study was conducted using a custom search on our Picture Archiving and Communication System for all female patients who received a biphasic liver CT (HAP + PVP) from Mar 2013 - Mar 2015. Inclusion criteria included known breast cancer, liver metastases described on CT report, and follow-up imaging to confirm the finding. A total of 25 CT studies met inclusion criteria. Results: 14/25 (56%) studies demonstrated typical non-hypervascular hepatic metastases. 11/25 (44%) demonstrated hypervascular hepatic lesions. Of these latter, 4/25 (16%) represented hypervascular metastases, while 7/25 (28%) pertained to indeterminate arterial-enhancing lesions called suspicious by the reporting radiologist. Further imaging including MRI, ultrasound, and follow-up CT were recommended in these indeterminate suspicious lesions, all of which confirmed benign entities. Of the 18 studies with true hepatic metastases, the presence of metastatic disease was detectable on the PVP in 18/18 (100%, P< .0001) regardless of the metastases’ hypervascular status. Conclusions: We found hypervascular metastases to be present in 22% (4/18; CI95 [3-41%]) of breast cancer patients with true liver metastases. However, the detection for the presence of hepatic metastases was not improved with the addition of HAP. The HAP instead led to detection of more indeterminate but ultimately benign entities of no clinical significance, thus resulting in unnecessary imaging and arguably greater patient anxiety.
Breast density and the risk for positive lumpectomy margins.
Authors: Schnabel Freya Ruth , Allweis Tanir 
Published: February 2017

50 Background: Current methods for intraoperative assessment of lumpectomy margins are limited, and a meaningful proportion of patients require re-excision to achieve acceptable margins. There is little available information regarding the relationship of mammographic breast density (BD) and positive margin rate. Methods: The MarginProbe device uses radiofrequency spectroscopy to evaluate the margins of lumpectomy specimens. The current study utilized data from the MarginProbe Pivotal Trial (Dune Medical Devices, Israel, NCT00749931). This randomized clinical trial compared adjunctive intraoperative use of the MarginProbe device with surgeons’ standard approach to lumpectomy surgery. For the current analysis, data was compiled from the period prior to patient randomization and device use. Variables of interest included BD, patient and tumor characteristics, and the margin status of the main lumpectomy specimen (prior to device use in the device arm). For the purpose of this analysis, a positive margin was considered tumor on ink. Statistical analysis was performed with univariate and multivariate analysis, and linear/logistic regression. Results: A total of 664 patients were enrolled in the trial. 450 patients had preoperative breast density information available, and formed the basis for this analysis. As expected, higher BD was associated with younger age, lower BMI and smaller breast and specimen volume. Increased BD was also associated with increased use of preoperative MRI imaging (odds ratio 2.2, p<0.0001). Higher BD was also associated with a significant increase in main lumpectomy specimen positive margin rate (Table). The odds ratio was 1.46 per change in density category (p=0.011). BD remained significantly associated with positive margins after controlling for age, BMI and breast volume. Conclusions: Higher BD is an independent risk factor for positive margins in main lumpectomy specimens, suggesting that adjunctive methods for intraoperative margin assessment may be particularly helpful in these patients. [Table: see text]
Avoiding skin creams right before radiation: Myth or sound advice?
Authors: Baumann Brian C. , Verginadis Ioannis I , Zeng Chuan , Vachani Carolyn , Solberg Timothy , Koumenis Costas , Metz James M. 
Published: February 2017

51 Background: Radiation dermatitis in breast cancer patients is common and often treated with topical creams. Patients are traditionally advised to avoid lotions for several hours before radiotherapy (RT) based on concern that creams might increase skin dose. With modern RT’s improved skin sparing, this recommendation may be irrelevant. We hypothesize that applying either metallic or non-metallic creams before treatment would have minimal effect on skin dose. Methods: We conducted an online, 24-question OncoLink survey of patients and providers to determine current skin cream practices. To evaluate the dosimetric effect of creams, we delivered 200 MU at 100 cm SSD and measured the dose at the surface and 2 cm depth in a tissue equivalent phantom, with or w/o 2 common skin creams, Aquaphor and silver sulfadiazine. We assessed the effect of various photon and electron energies, cream thicknesses and beam incidence on dose. The effect of creams on skin dose was also evaluated in C57BL/6 mice using γ-H2AX IHC staining. Results: 27 of 33 surveyed breast cancer patients (82%) and 43 of 45 providers (96%) either received or gave the advice to avoid applying creams prior to RT treatments. Measurements showed no difference in dose at the surface or 2 cm depth with or w/o a 1-2 mm application of either cream when using enface 6 or 15 MV photons. The same application of cream had no effect on surface dose as a function of beam incident angle from 15-60°, except for a 7% increase at 60° with the silver cream. Surface dose for 6 & 15 MV beams were significantly increased with a thicker (≥3 mm) layer of cream. For 6 MV, the surface dose was 105 cGy (Aquaphor), 102 cGy (silver cream) and 88 cGy (controls). For 15 MV, the doses were 70, 60 and 52 cGy. With 6 and 9 MeV electrons, there was only a 2-5% increase in surface dose with use of creams. There were no dose differences at 2 cm depth. Irradiated skin in mice showed no difference in γ-H2AX positive foci with or w/o creams. Conclusions: This is the first dosimetric assessment of the effect of skin creams for RT dermatitis. Our findings suggest that thin or moderately applied creams, even if applied just prior to RT, have minimal impact on skin dose, regardless of beam energy or beam incidence. Applying very thick amounts of cream just prior to RT increased surface dose and should be avoided.
Clinical use of a three-dimensional tissue marker to target postlumpectomy radiation.
Authors: Kaufman Cary Steven , Hall William H. , Wolgamot Greg M , Hill Laurie , Caro Rebecca , Nix Sid , Evans Erik , Zacharias Karen , Mahon Carol , Ness Karen , Schnell Nancy , Schnell Nancy 
Published: February 2017

53 Background: A three dimensional bioabsorbable coiled tissue marker has been developed to facilitate targeting for radiation therapy post lumpectomy. Proposed advantages are a) clarified targeting of closest margins to the excised tumor, b) providing a three dimensional structure that allows fibrosis to add volume to contribute to cosmesis, c) aiding in re-excision localization. Our experience has demonstrated the array of clinical findings after placement, the imaging findings over time, and pathologic findings for early and late removal. Methods: Consecutive lumpectomy patients who were candidates for targeted radiation therapy were implanted with the 3-D bioabsorbable marker from May 2014 to June 2015. After informed consent, each of 36 patients were followed to gather clinical, imaging and pathologic findings. Standard breast cancer management decisions were made (NCCN). Patients requiring re-excision were examined for pathologic findings related to the device. Routine imaging with mammography and ultrasound were obtained at 6 and 12 months post lumpectomy. Results: The use of the spiral tissue marker with the fixed array of six titanium clips provided a predictable target for radiation treatments. As the tissue marker was sewn to the closest tumor bed, inadvertent dissection planes caused by oncoplastic techniques could be avoided. Clinically the lumpectomy site was firm/dense in 94% of patients at 3 months (n = 36), but in only 60% at one year (n = 21). Two patients who underwent re-excision for positive margins were guided by the 3-dimensional device. Two patients had removal at one month and at 12 months for reasons unrelated to the tissue marker. Histologic examination demonstrated typical foreign body reaction and organization (fig 1b). Mammography at one year demonstrated marker clips coalescing as the bioabsorbable device dissolves with maintenance of the volume of the cavity in 50% of patients(fig 1c). Cosmetic outcome has been good to excellent measured at 6 and 12 months. Conclusions: Clinical, radiologic and pathologic findings during use of a novel bioabsorbable 3-dimensional tissue marker were presented. A national registry to further define these attributes will soon be started.
The association of clinical-pathologic factors and Oncotype Dx recurrence score (RS) in the outcome of early stage breast cancer.
Authors: Chadha Manjeet , Stewart Robert , Wallach Jonathan 
Published: February 2017

55 Background: Oncotype Dx recurrence score (RS) is routinely used to guide systemic therapy based on the estimated risk for distant relapse. Patients with early stage disease are also at risk for locoregional recurrence, and in some instances local relapse is the only site of failure. The objective of this study is to evaluate patient outcomes in association with known clinical-pathologic risk factors and RS. Observations in context of known clinical-pathologic features and RS may have important clinical implications relative to adjuvant locoregional therapy. Methods: This is an IRB approved retrospective study that includes patients with unilateral breast cancer and in whom the RS was reported. A total of 716 patients met this defined criteria. Seventy two percent underwent breast conserving therapy (BCS) and 28% underwent mastectomy; 68% had stage I and the remaining had > Stage II disease.The clinical-pathologic variables including age, stage, BRCA mutation, extent of surgery, and RS were studied in evaluating patient outcomes. Results: The median age was 56 years (27 to 84 years). The overall distribution of RS reported as low (18), intermediate (19-30), and high ( > 31) was 59%, 31%, and 10%, respectively. This distribution ratio was no different among patients treated with BCS and mastectomy. However, among BRCA mutation carriers there was a higher incidence of the high RS.Overall, the median follow up was over 3 years, and 25% of the patients have been followed over 5 years. The 3-year and 5-year any relapse-free survival was 93% and 89%, respectively. Age was significantly associated with observed inferior any relapse-free survival; 85% and 91% in women < 40 years vs > 40 years, respectively (p = 0.018). On univariate analysis, RS had no significant association with local regional relapse free survival. Further, associations between the clinical-pathologic features and RS using multivariate analysis will be presented. Conclusions: Observations with early follow up do not suggest a select role of RS in guiding risk tailored local regional therapy. Longer follow will further our understanding of patients at risk for local regional relapse.
Rates of unacceptable variation (UV) of normal tissue constraints in patients undergoing chest wall/breast and regional nodal irradiation (RNI) in a routine clinical practice.
Authors: Bazan Jose , DiCostanzo Dominic , Majithia Lonika , Quick Allison Marie , Gupta Nilendu , White Julia R. 
Published: February 2017

67 Background: TheNSABP B51/RTOG 1304 clinical trial defines dose-volume constraints for targets/normal tissue receiving RNI. We sought to evaluate UV rate in normal tissue based on the NSABP B51/RTOG 1304 protocol in patients receiving chestwall/breast (CW/B) and RNI in daily practice. Methods: Treatment records of CW/B+RNI patients from 2/2012-5/2015 were studied for: CW or B radiotherapy (RT), RT type (intensity modulated [IMRT] or 3D conformal [3DCRT]), internal mammary node (IMN) inclusion, primary site boost, and nodal boost. No case is enrolled on B51/1304. Dose volume histogram (DVH) was analyzed for the rate of ≥ 1 UV for the following normal tissue constraints: Heart mean dose ≤ 5 Gy; ipsilateral lung (IL): V20 ≤ 35%, V10 ≤ 60%, V5 ≤ 70%; contralateral lung (CL) V5 ≤ 15%; contralateral breast (CB) V4.1 ≤ 5%. Logistic regression is used to test the association between UV and key variables. Results: 203 consecutive cases received CW/B+RNI (105 left, 98 right). RT was to CW in 170 (84%), B in 33 (16%), primary site boost 133 (66%), and IMN 170 (84%). 38 (19%) received IMRT and 14 (6.9%) had a nodal boost. 46 patients (22.6%) had ≥ 1 UV. 19 patients (9.4%) had ≥ 2 UV, all in IMRT patients. 2 patients (1.0%) had a heart UV at 5.2 Gy and 5.6 Gy. The most common UV was CB (n = 32, 15.7%) and IL V5 (n = 22, 10.8%). Higher UV rates are associated with use of IMRT (vs. 3DCRT): 86.8% vs. 7.9%, OR = 77.2 (95% CI 25.7-231.4, p < 0.0001); IMN irradiation: OR = 11.5 (95% CI 1.5-86.8, p = 0.02); and use of nodal boost: OR = 7.4 (95% CI 2.3-23.4, p = 0.001). The most common UVs in IMRT cases are CB (n = 27, 71%), IL V5 (n = 19, 50%), CL V5 (n = 14, 37%) and for 3DCRT are IL V20 (n = 5, 3%), CB (n = 5, 3%) and IL V5 (n = 3, 1.8%). On multivariate analysis, use of IMRT (OR = 64.7, 95% CI 20.8-201.5, p < 0.001) and use of nodal boost (OR = 5.5, 95% CI 1.1-27.1, p = 0.04) but not IMN irradiation (OR = 2.7, 95% CI 0.3-22.0, p = 0.35) were independently associated with higher UV rate. Conclusions: The rate of UV per B51/1304 criteria with 3DCRT in routine clinical practice is low (7.9%). Women treated with IMRT had a significantly higher overall UV rate and clinicians should be aware of this as they initiate treatment planning for RNI.
Phase III study of APF530 versus ondansetron with a neurokinin 1 antagonist + corticosteroid in preventing highly emetogenic chemotherapy-induced nausea and vomiting: MAGIC trial.
Authors: Schnadig Ian D. , Agajanian Richy , Dakhil Shaker R. , Gabrail Nashat Y. , Smith Robert E. , Taylor Charles W. , Wilks Sharon , Cooper William , Mosier Michael , Payne Yvette , Klepper Michael , Vacirca Jeffrey L. 
Published: February 2017

68 Background: Managing chemotherapy-induced nausea and vomiting (CINV) associated with delayed ( > 24-120 h) highly emetogenic chemotherapy (HEC) is an unmet need. APF530, extended-release granisetron, provides sustained release over ≥ 5 days to prevent acute (0-24 h) and delayed CINV. This trial compared the efficacy and safety of APF530 in preventing CINV after HEC in a 3-drug regimen vs a standard 3-drug regimen with ondansetron (Ond). Methods: In this double-blind, multicenter study (NCT02106494), patients (pts) receiving single-day HEC (2011 ASCO guidelines) were randomized 1:1 to APF530 500 mg SC (10 mg granisetron) or Ond 0.15 mg/kg IV and stratified by cisplatin ( ≥ 50 mg/m2, yes/no). Pts were scheduled to receive concomitant dexamethasone (Dex) 12 mg IV + fosaprepitant (Fos) 150 mg IV on day 1 + PO Dex on days 2-4. The primary end point was delayed-phase complete response (CR) (no emesis, no rescue medication). Secondary end points included CR in acute and overall phases and complete control (CC; CR and no more than mild nausea) in acute, delayed, and overall phases. Treatment (tx) comparisons used chi-square test controlling for cisplatin. Adverse events (AEs) and injection-site reactions (ISRs) were assessed. Results: Modified intent-to-treat analysis included 902 pts (APF530, n = 450; Ond, n = 452) with baseline demographics balanced between tx groups. A significantly higher % of APF530 (65%) vs Ond (57%) pts had delayed-phase CR (P= .014). A significantly higher % of APF530 (61%) vs Ond (53%) pts had delayed-phase CC (P= .022, Table). CR and CC rates in acute and overall phases were numerically higher with APF530 vs Ond, but not statistically significant. APF530 was well tolerated. Most common AEs were ISRs, mostly mild or moderate. Conclusions: APF530 with Fos+Dex led to statistically higher CR and CC rates in delayed-phase CINV with HEC vs a standard 3-drug regimen of Ond with Fos+Dex. Clinical trial information: NCT02106494. [Table: see text]
Clinical utility of the radiation dose management system for full field digital mammography (FFDM): In Asian women with dense breast tissue.
Authors: Kang Bong Joo , Baek Ji Eun , Lee Hyun Sil , Kim Sung Hun 
Published: February 2017

70 Background: In the perspectives on radiation dose, there are consensus of importance on radiation dose management for patient safety and trends to reduce radiation dose for patient safety. Radiation dose management system like Radimetrics helps radiologists optimize protocols and reduce radiation dose. There is no previous data applying the radiation dose management system in mammography.We investigated the clinical usefulness of the radiation dose management system in full field digital mammography (FFDM) using commercial Radiation dose management system. Methods: We did radiation dose tracking, monitoring, and statistics through the existed radiation dose management system (Radimetrics). The utilization data, parameter, and dose report were sent to the conventional picture archiving and communication system (PACS) and the Radimetrics enterprise flat form. And we could review the data including age, kVp, mAs, breast thickness, and compression force under the web base. We analyzed the breast composition depending on the BI-RADS assessment categories. We evaluated the correlation of the age, kVp, mAs, breast thickness, compression force, and breast composition with organ dose of breast. Additionally, in patients with above diagnostic reference level ( ≥ 75%) of radiation dose, the causes were analyzed. Results: From February to May 2015, 3076 sets of FFDM were performed and sent to PACS and the radiation dose management system (Radimetrics). In total 3076 sets, 2520 were routine bilateral FFDM with 4 views. The mean glandular dose was 6.59± 2.87 mGy (2.63-18.46). In the correlation analysis, the age had moderate negative linear relationship with organ dose. The mAs and breast composition had moderate positive linear relationship with organ dose. The kVp, breast thickness, and compression force had weak positive linear relationship with organ dose. Patients with above diagnostic reference level ( ≥ 75%) of radiation dose showed dense breast composition and thicker breast. Conclusions: The radiation dose management system is useful in FFDM. Especially in Asian women with thick and dense breasts, radiation dose should be carefully managed.
Unnecessary axillary lymph node dissection in the era of sentinel lymph node biopsy.
Authors: Yen Tina W.F. , Laud Purushottam W. , Pezzin Liliana E , McGinley Emily , Wozniak Erica , Sparapani Rodney A. , Nattinger Ann B 
Published: February 2017

71 Background: No population-based effectiveness studies have been performed to determine to what extent breast cancer patients are benefiting from sentinel lymph node biopsy (SLNB). This study investigates the extent of unnecessary axillary lymph node dissection (ALND) by surgeon volume and specialty, and estimates the resultant rates of excess lymphedema (LE). Methods: Women with Stage I-III pathologically node-negative (pN0) breast cancer diagnosed in 2008-2009 were identified from the SEER-Medicare linked database. Patients who received neoadjuvant chemotherapy were excluded. Type of axillary surgery was defined by claims. Unnecessary ALND was defined as a patient who underwent either an initial ALND or SLNB followed by ALND. Surgeon volume tertiles were created with roughly a third of cases in each volume group (low, medium, high). Surgical specialty (surgical oncologist, general, other) was determined by the specialty code listed on the claim. A logistic regression model, adjusting for patient and tumor characteristics, was performed to predict the likelihood of receiving an unnecessary ALND. Estimates of LE rates were determined based on the number of nodes removed. Results: 7,946 pN0 patients underwent surgery by 2,101 surgeons. Half underwent SLNB only; 50% had unnecessary ALND (39% converted from SLNB to ALND, 11% ALND only). There was an interaction between surgeon volume and specialty (p < 0.01); surgical oncologists, compared to non-surgical oncologists, were less likely to perform unnecessary ALND in all three volume groups. This effect was largest in the medium volume group (OR 0.37; 95% CI: 0.26-0.51). The LE probability was 14% with an excess LE rate of 4.5%. Unnecessary ALNDs accounted for 84% of the estimated excess LE patients and represented 27% of all potentially avoidable LE cases. Conclusions: Half of pN0 patients underwent unnecessary ALNDs, which accounts for 27% of all potentially avoidable LE cases. The likelihood of undergoing an unnecessary ALND was lower in all three surgeon volume groups if patients were operated on by surgical oncologists. Policies to assess surgeon proficiency in SLNB and/or regionalization of care should be considered to decrease rates of unnecessary ALND and ultimately LE.