bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical and cost outcomes associated with multiple open procedures following percutaneous breast biopsy in Medicare patients.
Authors: Nichols Christine Ida , Kimball Chloe C , Vose Joshua 
Published: September 2018

e12083 Background: Percutaneous core-needle biopsy (PCNB) is the standard of care to diagnose suspicious lesions of the breast. Dependent upon histology, many women require additional open procedures for definitive diagnosis and excision. However, there remains little nationally-representative research on the proportion of women undergoing multiple open biopsy or lumpectomy procedures and the associated incremental burden to the health system. Methods: This study used Medicare 100% Standard Analytic Files (2010–2014) to identify patients undergoing PCNB in an outpatient setting. Patients included females aged ≥65; continuous Medicare enrollment; no history of cancer, chemotherapy, radiation or breast cancer surgery in the prior year. Open procedures were defined as an open biopsy or lumpectomy. Study follow-up was defined as 90 days from initial PCNB or until the day prior to chemotherapy, radiation, or mastectomy—to limit analysis to diagnosis-related payments. Payments were defined as Medicare payments. Results: 110,944 patients were identified; the mean age was 73.5; 74.1% underwent only PCNB, 23.8% had one open procedure and 2.1% had multiple open procedures. Among the PCNB-only cohort, 2.7% had multiple PCNBs; among those with subsequent open procedures, 4.1-4.4% had multiple PCNBs (P < .001). Incidence of all-cause complications was significantly lower among those with no open procedure (8%) versus those with one (11%) or more (20%, P < .001). Mean incremental breast-related payments were $3003 greater among those with one open procedure versus none ($4526 v $1523, P < .001), and $1978 greater among those with multiple open procedures ($6504 v $4526, P < .001). Prior receipt of multiple PCNBs and diagnosis of breast cancer were significantly positively correlated in logistic regression with having multiple open procedures, while age ≥ 80 was a negative predictor. Conclusions: There continues to be a percentage of women that require multiple open procedures following initial biopsy. These results suggest that incomplete excision at the first open procedure remains a meaningful concern, and merits further investigation into methods to ensure excisional completeness.
Targeted intraoperative radiotherapy tumor bed boost during breast conserving surgery after neoadjuvant chemotherapy in hormone receptor positive HER2 negative breast cancer.
Authors: Kolberg Hans-Christian , Loevey Gyoergy , Akpolat-Basci Leyla , Stephanou Miltiades , Fasching Peter A. , Untch Michael , Bulsara Max , Vaidya Jayant S. , Liedtke Cornelia 
Published: September 2018

e12090 Background: Targeted intraoperative radiotherapy (TARGIT – IORT) as a tumor bed boost during breast conserving surgery is an established option for women with early breast cancer. In a previous study our group could show a beneficial effect of TARGIT-IORT on overall survival after neoadjuvant chemotherapy compared to an external boost in an unselected cohort. In this study we present an analysis of the hormone receptor positive HER2 negative subgroup. Methods: In this non-randomized cohort study involving 46 hormone receptor positive HER2 negative patients after NACT we compared outcomes of 21 patients who received a tumour bed boost with IORT (TARGIT-IORT) during lumpectomy versus 25 patients treated in the previous 13 months with external (EBRT) boost. All patients received whole breast radiotherapy. Disease free survival (DFS) and overall survival (OS) were compared. Results: There were no statistical differences between the two groups regarding tumor size, grading, nodal status and pCR rates. Median follow up was 49 months. Whereas DFS was not significantly different between the groups the 5-year Kaplan-Meier estimate of OS was significantly better by 21% with IORT: TARGIT-IORT 0 events 100%, EBRT 5 events 79%, log rank p = 0.028. Conclusions: Although our results have to be interpreted with caution due to a possible selection bias and the small numbers, we could show that the improved OS as previously demonstrated in our dataset for TARGIT-IORT during lumpectomy after neoadjuvant chemotherapy as a tumor bed boost compared to an external beam radiotherapy boost is driven by the hormone receptor positive HER2 negative subgroup. These data give further support to the inclusion of such patients in the TARGIT-B (Boost) randomised trial that is testing whether IORT boost is superior to EBRT boost and to the analysis of subgroups based on tumor biology in this trial.
The radiation doses to the heart and the left anterior descending coronary artery for various modes of radiation treatment of the breast cancer patients.
Authors: Maslyukova Elizaveta , Korytova Luiza , Bondarenko Anna , Zhabina Razifa , Korytov Oleg , Odintsova Svetlana 
Published: September 2018

e12092 Background: The comparison of the radiation load to the organs at risk for three modes of radiation treatment of the breast cancer patients. Methods: The research includes the dosimetric radiation treatment plans for the 20 breast cancer patients with the left-side localization. They all underwent a computed tomography (CT) scan in standard supine position in free-breathing (FB), supine position with Active Breathing Control (ABC) device in deep inspiratory breath hold, and prone position in free-breathing (PP). Three-dimensional treatment plans were made for all 3 CTs. The dose valuations for 3D-planning were carried out for three CT- series. For each mode of radiation, the doze-volume parameters of organs at risk were estimated. Results: For all cases the contoured heart volume varied from 477 см3 - 1056 см3, with medium volume 769 см3. The best marks such as V25heart, medium doses to the heart and LAD, were achieved with on ABC methods (V25heart 4,26%, Dmean heart 3,13Gy, DmeanLAD 13,8Gy) in comparison FB (V25heart 9,49%, Dmean heart 4,97Gy, DmeanLAD 19,55Gy) and PP (V25heart 12,8%, Dmean heart 9,06Gy, DmeanLAD 24,18 Gy) (V25heart P = 0.00153, Dmean heart: P =0,000; Dmean LAD: P = 0.00088), when both the breast and the axillary nodes were included in the volume. The advantage of the dosimetric indexes for FB and ABC did not change while axillary and supraclavicular nodes were added to the radiation volume ABC (V25heart 3,49%, Dmean heart 3,08Gy, DmeanLAD 13,88Gy) in comparison with FB methods (V25heart 7,91%, Dmean heart 4,99Gy, DmeanLAD 19,89Gy) (V25heart P = 0.00205, Dmean heart: P =0,004; Dmean LAD: P = 0.03). Conclusions: Radiation treatment in the position on the back with controlled delay of breath on inspiration height contributed to the statistically significant reduction of the heart volume exposed to more than 25 Gy (V25heart), mean dose to the heart and mean dose to LAD.
Treatment and risk of mortality for 58,953 cases of stage 1, ER+/PR+/HER2- breast cancer in four mutually exclusive race/ethnicities.
Authors: Caggiano Vincent , Parise Carol 
Published: September 2018

e12101 Background: The estrogen receptor positive (ER+), progesterone receptor positive (PR+), human epidermal growth factor 2 negative (HER2-) subtype is the most common. Cases of stage 1, ER+/PR+/HER2- are most often treated with hormone therapy alone, although this is not universal. The purpose of this study was to determine if there were differences in mortality for patients with stage 1, ER+/PR+/HER2- breast cancer given no treatment, chemotherapy alone, or both chemotherapy and hormone therapy when compared with hormone therapy alone for four mutually exclusive race/ethnicities. Methods: We identified 58,953cases of Stage 1, ER+/PR+/HER2- first primary female invasive breast cancer from the California Cancer Registry 2000-2014. Cases were stratified into white (n = 41,716), black (n = 2,310), Hispanic (n = 8,186) and Asian/Pacific Islander (API) (n = 6,741). Treatment was categorized as none, hormone therapy alone, chemotherapy alone, or both chemotherapy and hormone therapy. Kaplan Meier survival analysis and Cox Regression were used to assess the risk of mortality associated with treatment using hormone therapy alone as the reference category. Treatment was considered a risk for mortality and hazard ratios (HR) and 95% confidence intervals reported if the Wald χ2 was statistically significant (p < 0.05). Models were adjusted for age, grade, socioeconomic status, and tumor size. Separate analyses were conducted for each race/ethnicity. Results: White women, having no treatment (HR = 1.33; 1.14-1.54), or chemotherapy alone (HR = 1.49; 1.10-2.00) was associated with an increased risk of mortality. For API women, having the combination of chemotherapy and hormone therapy was associated with increased risk of mortality (HR = 2.47; 1.34-4.56). For black and Hispanic women, there was no difference in risk of morality for any combination of treatment when compared with hormone therapy. Conclusions: The effectiveness of treatment modalities for the Stage 1, ER+/ER+/HER2- subtype varies considerably by race/ethnicity.
Long-term risk of second malignancies in women with ductal carcinoma in situ or early-stage invasive breast cancer after breast conservation treatment.
Authors: Kushner Carolyn J. , Hwang Wei-Ting , Solin Lawrence J. , Vapiwala Neha 
Published: September 2018

e12103 Background: Women with ductal carcinoma in situ (DCIS) or early stage breast cancer have a good prognosis after breast conservation treatment (BCT), and are at risk for second malignant neoplasms (SMNs). The long-term risk of SMNs is not well established and carries important public health implications. Methods: A total of 755 women with DCIS or stage I-II invasive breast cancer underwent breast-conserving surgery followed by definitive breast irradiation between 1995 and 2001. Systemic therapy (chemotherapy and/or hormonal therapy) was given to 73% of the patients. We have previously described patient demographics and 15-year oncologic outcomes in detail (Vapiwala, Cancer, 2017). The patient records were reviewed for development of SMNs. SMNs of any anatomic site (other than contralateral breast cancer and basal/squamous cell carcinoma of the skin) were included for analysis. The Kaplan-Meier method was used to determine the rate of SMNs over time. Median follow-up was 13.8 years. Results: The 5-, 10-, and 15-year rates of developing any SMN were 3.6% (95% CI 2.4-5.3%), 7.8% (95% CI 6.0-10.2%), and 12.7% (95% CI 10.2-15.8%). The most common SMNs were uterine (n=12), leukemia/lymphoma (n=11), melanoma (n=10), ovarian (n=9), and lung (n=7). Conclusions: Development of SMNs is a substantial risk for a protracted period of time following BCT. Clinical patterns of specific SMN histologies, locations and time course of development suggest potential opportunities for screening and treatment to guide patient survivorship clinics and protocols.
Surgical management associates independently with improved survival among de novo stage IV breast cancer patients without liver or brain metastasis.
Authors: Geng Cuizhi , Zhang Wenjin , Li Zhensheng 
Published: September 2018

e12106 Background: To examine the independent effect of surgical management of the primary tumor and axillary lymph node on survival in patients with de novo Stage IV breast cancer (BC) Methods: 113 patients with de novo stage BC between 2010 to 2013 were followed up to Oct. 1, 2016. Multivariable Cox proportional hazard models were constructed to assess the effect of mastectomy (MAS) and axillary lymph node dissection (ALND) on overall survival (OS) after univariate analyses and K-M curves. Non-treatment covariates included age, BMI, menopause, Stage T, Stage N, ER, PR, HER2, Ki67>14% status, and metastasis sites (lung, liver, bone, brain and others). Chemotherapy, hormonal, target treatement and radiotherapy before the disease progression were others. Results: Mean age 52 (24 - 84) years old, metastasis site by bone 53% (60), lung 32% (36), liver 32% (36), brain 2% (2), and other 23% (23). Median survival 21.4 months. All 42% (48) surgical patients had simultaneous MAS and ALND. Younger (mean 49 vs. 54) and fewer post-menopause (42% vs. 62%) were significantly noticed in surgical patients with median survival 37.8 vs. 14.2 months of others. Multivariable analysis showed OS favorable HRs 0.53 (95% CI 0.24 - 1.17, p=0.12) of surgery and HR 0.48 (0.22 - 1.04, p=0.06) of hormonal drug, and significant HR 0.10, (0.02 - 0.52, p<0.01) of target therapy, insignificant effects of chemotherapy HR 0.60(0.26 - 1.42, p=0.25) and radiotherapy HR 0.70 (0.33 - 1.50, p =0.36). Unfavorable metastasis sites were identified as brain and liver at multivariable model for subgroup analysis. K-M curves estimated median survival 29.3 vs. 14.4 months (favorable vs. unfavorable patients). Both univariate and multivariate analyses showed the significant effect of surgery in favorable subgroup (N=76) with HR 0.30 (0.16 - 0.56, p <0.01) and 0.33 (0.11 - 0.98, p=0.05) on OS, respectively. In unfavorable subgroup (N=37), the results were insignificant effect of surgery on OS with HR 0.75 (0.37 - 1.55, p=0.54) and 1.60 (0.33 - 7.81, p=0.56). Conclusions: Surgical management associated independently with improved survival among de novo stage IV BC patients without liver or brain metastasis.
Sentinel lymph node biopsy using indocyanine green fluorescence navigation method after neoadjuvant chemotherapy for patients with clinically node-positive breast cancer.
Authors: Yamagami Kazuhiko , Matsumoto Hajime , Hashimoto Takashi , Yanai Seiji , Yuen Sachiko , Kuramitu Hitomi , Ichinose You , Deai Teruyuki , Toi Masakazu 
Published: September 2018

e12108 Background: Sentinel lymph node biopsy (SNB) for initially clinically node-positive (cN1) after neoadjuvant chemotherapy (NAC) is controversial. Even if approximately 40% of node positive disease converts to node negative after NAC, SNB using blue dye (BD) and/or radioisotope (RI) agent showed the high false-negative rate (FNR) (SENTINA, ACOSOG Z1071). These trials showed the accuracy of SNB was closely related to the number of sentinel lymph nodes (SNs) removed. We presented the efficacy of indocyanine green (ICG) fluorescence navigation method for SNB in clinically node-negative (cN0) patients (ASCO2008). The ICG method can provide higher numbers of SNs and it helps to identify lymph nodes with the remained metastases. Methods: Of 1900 patients (Jan. 2010 - Dec. 2016), 242 women with cN0 or cN1 received NAC: Group 0 (cN0 before NAC, n=150), Group 1 (cN1 converted ycN0 after NAC, n=71) , Group 2 (cN1 remained ycN1 after NAC, n=21). Node status was evaluated by ultrasound. All patients underwent SNB using both ICG- and BD-method together. Fluorescence images were obtained by a CCD camera with a cut filter as a detector, light emitting diodes at 760nm as the light source. ALND was performed in Group1 and Group 2. Results: Pathological complete nodal response rate (pcNRR) was 48.4%. Table shows the number of SNs removed by ICG or BD. SNs detection rates (ICG, BD): Group 0 (98.7%, 84.7%), Group 1 (98.6%, 83.1%), Group 2 (85.7%, 47.6%). Resulting of a FNR (ICG, BD): Group 1 (5.7%, 15.3%), Group 2 (22.2%, 60.0%). Conclusions: The pcNRR and a FNR of BD in Group 1 were similar to those of SENTINA or ACOSOGZ 1071 trials. In patients who converted from cN1 to ycN0, the fluorescent ICG method showed a high detection rate of SNs and a low FNR. [Table: see text]
Characterization of the tumor immune microenvironment (TIM) with multiplex immunohistochemistry (mIHC) in patients with breast cancer following treatment with MK-2206.
Authors: Marks Douglas Kanter , Gartrell Robyn Denise , El Asmar Margueritta , Hart Thomas , Lu Yan , Esancy Camden , Hibshoosh Hanina , Connolly Eileen , Kalinsky Kevin , Saenger Yvonne M. 
Published: September 2018

e12109 Background: The PAM (PI3K/Akt/mTOR) signaling pathway has been implicated in the oncogenesis of multiple solid malignancies, including breast cancer (BC). Our aim is to characterize the TIM in a series of patients with operable stage I-III BC treated with MK-2206, an allosteric Akt inhibitor within a presurgical trial. In NCT01319539 , patients received 2 doses of MK-2206 with first dose at day -9 and second at day -2 from surgery. Methods: mIHC was performed using immune biomarkers (DAPI, CD3, CD8, CD4, FOXP3, CD68, Pancytokeratin) on full section (4uM) tissue slides from core biopsy specimens and postsurgical specimens of 10 patients - 5 treated with MK-2206, 5 paired controls. Images were taken using Vectra, a novel pathology workstation and analyzed using inForm software to perform cell classification and phenotyping. T- tests were used to compare biomarker changes before and after MK-2206. Results: Our preliminary analysis demonstrates that patients treated with MK-2206 exhibited an increase in median cytotoxic T-cells (CD3CD8+) density, as compared to the control population , which was statistically significant (87% vs.0.2%, p < 0.05). We did not identify a change in macrophage (CD68) or T helper/T reg (CD4/CD4FOXP3+) density following MK-2206 treatment in this small cohort. We are currently expanding our myeloid panel as well as performing additional tissue analysis to validate our findings. As data is exploratory no correction was made for multiple comparisons. Conclusions: Tumor infiltrating lymphocytes (TILs) are both prognostic of overall survival as well as predictive of response to neoadjuvant chemotherapy in BC. At present, there are currently both FDA approved therapies, as well as agents in clinical development that exert antineoplastic activity through the PAM pathway. Investigations that endeavour to understand the impact of these therapies on the tumor immune microenvironment may lead to both an increased understanding of the bioactivity of these agents and potentially identify aspects of the immune response which can be exploited in future therapeutics.
Concurrent use of capecitabine with radiation therapy and survival in breast cancer (BC) after neoadjuvant chemotherapy.
Authors: Liu Ying , Catanese Benjamin Peter , Chin Christine , Lee Shing , Zhan Serena , Kalinsky Kevin , Connolly Eileen 
Published: September 2018

e12117 Background: Capecitabine has been studied as a radiosensitizer in rectal cancer, but its role in BC is unclear. Our study seeks to examine the association of concurrent capecitabine/radiation therapy (RT) on survival in women with BC and residual disease after neoadjuvant chemotherapy (NAC). Methods: In a retrospective study of women with stage I-III BC who received Adriamycin/Taxane-based NAC from 2010-2016, we identified 21 women administered concurrent capecitabine/RT. To assess differences in survival, we selected a clinical control cohort (n = 64) based on criteria used to select patients for capecitabine/RT including pathological stage II/III disease and non-HER2+ tumor subtype. We also created a matched cohort (2:1), matching on tumor subtype, pathological stage, and age ( < 50 or 50+ years). Differences in progression-free survival (PFS), using STEEP criteria, and overall survival (OS), using all-cause mortality, between those who received capecitabine/RT and controls were assessed. Results: Of the 21 women who received capecitabine/RT, the majority were 50+ years (n = 12), pathological stage III (n = 15), and hormone receptor positive/HER2 negative BC (n = 20). Compared with clinical controls, women who received capecitabine/RT had larger disease (p = 0.041) and a higher pathological stage (p = 0.067), but there were no other differences. In those receiving capecitabine/RT, there were 9 recurrences (3 local, 6 distant) compared with 14 recurrences (4 local, 10 distant) in the clinical controls and 10 recurrences (all distant) in the matched controls. In multivariate models, capecitabine/RT was associated with worse PFS (HR 3.04 95% CI 1.24-7.43 p = 0.015) and OS (HR 4.29 95% CI 1.45- 12.6 p = 0.008), after adjusting for clinical size and pathologic stage. In the 2:1 matched cohort, capecitabine/RT was also associated with worse PFS (HR 2.96 95% CI 1.20-7.29 p = 0.018) and OS (HR 5.61 95% CI 1.76-17.9 p = 0.004). Conclusions: Capecitabine/RT after NAC is associated with worse PFS and OS using two control populations, suggesting capecitabine/RT should be discouraged in BC.
Survival advantage associated with neoadjuvant chemotherapy compared to neoadjuvant hormonal therapy in postmenopausal women with hormone receptor positive breast cancer: A National Cancer Data Base study.
Authors: Basnet Alina , Wang Dongliang , Sivapiragasam Abirami 
Published: September 2018

e12119 Background: Neoadjuvant endocrine therapy (NET) and neoadjuvant chemotherapy (NCT) are both considered effective strategies in postmenopausal, hormone receptor positive breast cancer patients. Small prospective studies show comparable response rates and breast conservation rates. Using National Cancer Data Base (NCDB) we report overall survival (OS) differences between these two strategies with subgroup analysis by Estrogen Receptor (ER), Progesterone Receptor (PgR) status. Methods: We extracted data on hormone receptor positive breast cancer patients without metastasis in women aged ≥ 50 from the NCDB registry (2004-2014). We excluded patients who did not receive adjuvant endocrine therapy after NCT and patients who received adjuvant chemotherapy after NET as this could affect OS. We calculated OS using Kaplan Meier analysis with hazard ratio (HR) from cox regression model. Subgroup analysis was performed by ER, PgR status. Results: Out of 2,246,279 patients, 30,348 patients met our inclusion criteria. 7836 received NET and 22512 received NCT. OS rate was 70.8% vs 81.7% at 5 yrs and 42.5% vs 62.1% at 9 yrs for NET and NCT respectively with adjusted hazard ratio (HR) of 1.818; 95% CI (1.657-1.996). OS outcome for ER+/PgR+ group was 72.3% vs 83.5% at 5 yrs and 43.5% vs 64% at 9 yrs for NET and NCT respectively with adjusted HR of 1.807; 95% CI (1.624-2.010). OS for ER+/pgR- group was 62.9% vs 76.8% at 5 yrs and 33.1% vs 54.2% at 9 yrs for NET and NCT respectively with adjusted HR of 1.890; 95% CI (1.549-2.306). Our analysis also revealed that 5591 T1 patients received neoadjuvant therapy among which 2541 received NET and 3050 received NCT. Conclusions: We find a significant survival advantage in patients treated with NCT as opposed to NET. All subgroups showed imporved OS with NCT compared with NET. Limitations that should be considered in this registry based study are: not accounting for Her-2 status, differences in surgical technique, duration and choices of adjuvant chemotherapy and radiotherapy options.