bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment patterns and outcomes with HER2-directed therapy for the treatment of HER2-positive metastatic breast cancer.
Authors: Luthra Rakesh , Fisher Maxine , Brammer Melissa , Lalla Deepa 
Published: March 2020

e11063 Background: The goal of this study was to compare treatment patterns and outcomes in patients receiving a HER2 directed therapy for the treatment of HER2+ metastatic breast cancer (mBC). Methods: Female mBC patients (with ≥2 claims with ICD9 diagnosis codes for mBC), age ≥18 years receiving treatment with trastuzumab (T) or lapatinib (L) between 1/1/06 and 8/31/11 were identified in the HealthCore Integrated Research Database (HIRDSM). The earliest mBC claim was defined as index date. Patients with <12 months preindex and ≥6 months postindex continuous eligibility were excluded. Two cohorts were identified: T group received T only; TL group received both L and T (sequentially or together). Treatment duration, metastasis site (mets) at mBC diagnosis, no. of chemotherapy agents, no. of hospitalizations, and total cost of care were assessed in the two groups. Results: Of 1449 patients who received a HER2 directed agent, 1165 were in the T group (mean age 56 yrs) and 284 in the TL group (mean age 54 yrs). T group mets included bone (n=553, 48%), liver (n=336, 29%) and brain (n=283, 24%) mets; TL group had bone mets (n=225, 79%), brain mets (n=167, 59%) and liver mets (n=153, 54%). Mean no. of chemotherapy agents received was lower in T group 3.3 (SD 1.7) compared to TL group 5.8 (SD 2.1) (p=0.0002). The time from 1st mBC diagnosis to treatment with T or L was 117 (SD 217) days in T group and 107 (SD 208) days in TL group. For TL group, time between index date and treatment was 114 (SD 214) days for T and 690 (SD 400) days for L. The mean treatment duration was shorter in T group 417 (SD 366) days compared to TL group 724 (SD 433) days (p<0.0001). TL patients received 579 (SD 402) days of T and 205 (SD 234) days with L. Number of hospitalizations and total cost of care (mean monthly) were 0.1 (SD 0.2) and $12561 (SD $10,975), respectively for T group and 0.1 (SD 0.1) and $13,532 (SD $7,220), respectively for TL group. Conclusions: Mean treatment duration and mean number of chemotherapy agents suggest that the TL group may have received more lines of treatment than the T group. There was no difference in mean monthly costs between the two groups. Medical chart data will be used to confirm treatment patterns and evaluate treatment outcomes in both groups.
Retrospective study of predictors and consequences of nonadherence with lapatinib (LAP) in women with metastatic breast cancer (MBC) who were previously treated with trastuzumab.
Authors: Kartashov Alex , Delea Thomas E. , Sharma Puza P. 
Published: March 2020

e11067 Background: LAP, an oral small molecule dual tyrosine kinase inhibitor has been shown to improve time to progression in combination with capecitabine vs. capecitabine alone in women with HER2+ MBC previously treated with trastuzumab, an anthracycline, and taxanes. Data on adherence, persistence, predictors and consequences of non-adherence with LAP in typical clinical practice are scarce. Methods: This was retrospective observational study of predictors and consequences of non-adherence with LAP in women with MBC who were previously treated with trastuzumab using Thomson MedStat MarketScan® Commercial and Medicare claims databases covering 80 million lives. Measures of LAP adherence were calculated from information on pharmacy claims and included medication possession ratio (MPR) and time to first treatment interruption (gap during treatment of 30 days without supply). Predictors of non-adherence to LAP and the association between non-adherence and healthcare utilization and costs were examined using multiple regression analyses. Results: A total of 666 patients met all inclusion criteria. Median follow-up was 12 mos. Mean(SD) MPR was 87% (19%); 22% of patients had MPR<80%. Twenty seven percent of patients had >=1 treatment interruptions during follow-up. Concomitant therapy with a taxane was a predictor of non-adherence (Odds ratio MPR<80%=10.3, 95%CI 3.3 to 31.9, p<0.001). In generalized linear regression models, non-adherence with LAP (1-MPR[range: 0 to 1]) was associated with more physicians' office / hospital outpatient visits (Rate ratio = 1.26, 95%CI: 1.03-1.54, p=0.028). There was a statistically non-significant trend towards an association between adherence and total costs excluding the costs of LAP (Cost ratio = 1.23, 95%CI: 0.93-1.63, p=0.146). Conclusions: Most patients receiving LAP are adherent to therapy, although there is a small group with high non-adherence that may negatively impact healthcare resource utilization. Further research is needed to identify additional predictors of LAP non-adherence so that clinicians may develop strategies to enhance adherence and improve patient outcomes.
The impact of site of care (office clinic versus hospital outpatient) on treatment patterns in HER2-positive breast cancer.
Authors: Parthan Anju , Lalla Deepa , Small Art , Brammer Melissa 
Published: March 2020

e11077 Background: This study examines treatment (tx) patterns in patients (pts) with breast cancer (BC) receiving trastuzumab (T) in a physician clinic (MD) & outpatient hospital (HOSP) setting. Methods: Pts ≥18 yrs with BC (≥2 claims with ICD-9-CM 174.xx, ≥30 days apart) and ≥2 T claims from 1/1/2006 to 12/31/2010 were identified from a large US commercial insurance claims database. Pts continuously enrolled for ≥ 6mths before & after index date (date of 1st T claim) were included. Pts receiving T at both sites of care, receiving T before the index date &/or pts with > 1 primary cancer were excluded. Metastatic (mBC) vs. early stage (ESBC) tx was identified by presence of ≥2 claims of metastases after index date. Pts were followed from index date to 30 days after the last infusion prior to a gap of ≥ 90 days, death, disenrollment, or end of study period. Pts were stratified by site of care- MD or HOSP. Descriptive & multivariate analyses were conducted to examine differences in tx patterns (duration and doses/mo) & number of missed doses during the tx period. Results: 2,823 BC pts receiving T were identified; 480 (17%) were treated for mBC. Most patients received T in the MD setting (94% ESBC pts and 87% of MBC pts). Compared to the MD setting, pts treated in the HOSP were more likely to be older (ESBC: 61 vs 53 yrs; MBC: 64 vs 54 yrs; each p <0.001) & have Medicare benefits (ESBC: 54% vs 7%; MBC: 63% vs 9%; each p <0.001). There was no difference in mean baseline Charlson comorbidity index in any group. Mean T duration in HOSP was significantly shorter vs MD among ESBC pts (303 & 333 days, p<0.05) but not MBC pts (313 for HOSP vs 355 days for MD, p>0.05). Compared to the MD setting, HOSP treated patients had more treatment gaps of 30-59 days (ESBC: 58% vs 25%; MBC 56% vs 27%; each p<0.001) and fewer infusions/month (ESBC: mean 1.45 vs 1.99; MBC 1.54 vs 2.07; each p<0.001). In multivariate analyses, infusion counts remained lower among HOSP treated patients (ESBC: IRR 0.74, CI 0.67-0.79; MBC: IRR 0.76, CI 0.66-0.87). Conclusions: MBC and ESBC pts treated in the MD setting were younger and received more infusions with fewer treatment gaps than HOSP pts. Further research assessing the impact of these differences in tx patterns on clinical outcomes is needed.
Cross-sectional observational study to describe the clinicopathological and biological characteristics and the management of patients with HER2+ metastatic breast cancer who experienced complete or partial remission or disease stabilization during at least 3 years: LongHer study.
Authors: Zamora Pilar , Fresno-Vara Juan Angel , Gámez-Pozo Angelo , Perez-Carrion Ramon , Manso Luis , Crespo Massieu Carmen , Mendiola Cesar , Alvarez Isabel , Margeli Vila Mireia , Bayo Calero Juan Lucas , Gonzalez Xavier , Santaballa Ana , Ciruelos Gil Eva Maria , Afonso Gomez Ruth , Lao Romera Juan , Catalan Gustavo , Alvarez Gallego Jose Valero , Miramon Lopez Jose , Salvador Bofill Francisco Javier , Ruiz Borrego Manuel 
Published: March 2020

e11081 Background: Trastuzumab has shown an improvement in survival outcomes among patients with HER2+ metastatic breast cancer (MBC). Identification of factors and tumor molecular profiles that may predict long-term remission has become a key-issue. Methods: Multicenter, observational, cross-sectional study. Data were collected from women with HER2+ MBC treated with a trastuzumab-based regimen that experienced CR, PR or SD during at least 3 years. FFPE samples(at least 70% tumor cells)for Microarray Analysis were obtained. L2 Boosting for classification with classical Akaike Information criterion based on the binomial log-likelihood for stopping the boosting iterations algorithm was applied to RNA expression data, to identify variables related to clinical information. Predictive models of long term response were built using a Binary Logistic Regression with the Fisher's scoring. Results: 103 patients.Median age: 58(51-68) years. Metastatic disease diagnosed after a median of 24.7(1.8-51.9) months since primary diagnosis. Predominant type: ductal carcinoma(91.9%) and 59% histological grade III. Hormonal status: Progesterone receptor positive 39.2% and estrogen receptor positive 41.2%. Most common metastatic sites: multiple locations(31.4%), lung(23.5%), bone(14.7%) and liver(13.7%). Overexpression of HER2 assessed by IHC in 98.1% of patients, 91.1% were HER2+(3+) and 18.4% had FISH+ HER2 status. Tumor was positive for p53 (>30%) and Ki67(>20%) in 47.3% and 73.6%. Surgery: 87.4% of patients, 77.5% radical mastectomy. Surgery of metastases was performed on 16.8%. Trastuzumab used in combination in 88.3% with a median number of cycles of 35.5(7.0-46). 68.9% of patients achieved a CR, 20.4% PR and 10.7% had SD, during an overall median time of 55 (43-79) months. 4 patients discontinued trastuzumab due to toxicity. Conclusions: Trastuzumab may provide a substantial long-term survival benefit with a manageable safety profile in these patients. Molecular analysis will be presented in the forthcoming Congress.
The impact on case findings by transferring clinical breast examination skills to female community health volunteers in limited resources country like Nepal.
Authors: Hyoju Sanjiv Kumar 
Published: March 2020

e11094 Background: In limited resources countries, patients with breast cancer present to the hospital in the late stage because of lack of awareness, screening program. Clinical Breast Examination (CBE) may be the only means of detecting the breast cancer early in countries with limited resources since mammography is less likely to be cost effective approach and CBE by surgeons are also not possible because of limited health care facility. Hence CBE by FCHVs seems to be more feasible. This study was conducted to observe the skill transfer to FCHVs for detection of clinical abnormalities in breast by determining kappa agreement, sensitivity, specificity, positive predictive value and negative predictive value of CBE by FCHVs considering CBE by the Surgeon as gold standard. Methods: It is a cross-sectional study conducted in Eastern Nepal for period of one year from June 2008 to May 2009. Total 1238 women were examined by both a FCHV and the Surgeon. The results were analyzed to find out interobserver kappa agreement, sensitivity, specificity, positive predictive value and negative predictive value for detection of clinical abnormalities in breast following CBE by FCHVs considering CBE by the Surgeon as gold standard. Results: Total 1238 women received CBE by both a FCHV and the Surgeon. The interobserver kappa agreement for the detection of clinical abnormalities in breast was 67% indicating a good agreement exists between the FCHVs and the Surgeon’s CBE Sensitivity, specificity, positive predictive value and negative predictive values of “FCHVs’ CBE” to detect clinical abnormalities in breast in comparison to “the Surgeon’s CBE” as gold standard were 70%, 95%, 74% and 94% respectively. Conclusions: In view of good CBE skills transfer to FCHVs for detection of clinical abnormalities in breast, the effective training of FCHVs may diagnose and refer the women with clinical breast abnormalities to the hospital for further investigation and treatment.
Smoking and increased breast cancer risk in younger women in Appalachian Kentucky.
Authors: Reddy Indraneel , Shankar Anjali , Mallikarjun Priya , Jabbour Nicola , Dignan Mark 
Published: March 2020

e11097 Background: Smoking rates in Kentucky are among the highest in the US. Data from the Centers for Disease Control and Prevention for 2011 showed that in Kentucky 25.2% of the adult population are current smokers compared to 18.4% nationwide. In addition, smoking rates in the Appalachian region are substantially higher than the state rate. Breast cancer rates are also elevated in Appalachian Kentucky, with data from the Kentucky State Cancer Registry for 2004-2008 showing an incidence rate of 67.3 per 100,000 in Appalachia compared to 65.6 per 100,000 for the state. Our objective was to evaluate the association of smoking and breast cancer among women in Appalachian Kentucky. Methods: We reviewed all the breast cancer data from a large community hospital serving the Appalachian areas of Kentucky. Data were collected from the hospital tumor registry for the period 1996-2005 and included demographic characteristics and smoking status, in addition to information about the breast cancer. No personal identifiers were collected. Breast cancers were coded as invasive or non-invasive and smoking status was coded as current smoker, non-smoker or unknown. Results: Data from records of 392 patients were included in the analyses. Over 90% of the breast cancers in the 392 were invasive. Age at diagnosis ranged from 24 to 92 and the mean was 59.9 years (standard deviation= 13.5. 21.2% of the records indicated a family history of breast cancer. Of the 392 patients, 162 (41.3%) were smokers. Analysis of the data by age at diagnosis showed that of the 120 women diagnosed with breast cancer at age less than 65, 46.5% were smokers, compared to 31.3% of those age 65 or older (p=.005, Fisher’s Exact Test). Conclusions: The risk of breast cancer in women under age 65 appears to be associated with smoking in this population. Additional research is needed to more fully explore this association.
Nonpegylated liposomal doxorubicin (nPLD) in neoadjuvant treatment of local advanced breast cancer (LABC) patients (pts).
Authors: Rossi Luigi , Tomao Federica , Papa Anselmo , Zoratto Federica , Ricci Fabio , Spinelli Gian Paolo , Lo Russo Giuseppe , Basso Enrico , Caprio Giuliana , Barberi Simona , Verrico Monica , Giordani Erika , Zaccarelli Eleonora , Rinaldi Giulia , Stati Valeria , Pasciuti Giulia , Strudel Martina , Tomao Silverio 
Published: March 2020

e11514 Background: Anthracycline is very effective in treatment of breast cancer, however it can cause cardiac toxicity events. nPLD has greater safety profile and comparable efficacy than conventional anthracyclines. We evaluated safety and efficacy, in neoadjuvant setting, of nPLD in pts with LABC. Methods: 11 pts (median age 57 years). Their clinical stage was: stages IIA and IIB 1 pt respectively, IIIB 7 pts, IIIC 2 pts. 8 pts presented at diagnosis with cT4 disease. All pts were treated with nPLD (50 mg/mq, d1q21) plus Docetaxel (75 mg/mq, d1q21) and Cyclophosphamide (500 mg/mq, d1q21); only 1 pt received Cyclophosphamide, nPLD and Trastuzumab. At beginning of therapy, overall population had left ventricular ejection fraction (LVEF) ≥55%. Results: After a median of 4 chemotherapy cycles, we observed following clinical response: stable disease 2 pts (18%); partial response 7 pts (64%); complete response 2 pts (18%). 9 pts were evaluable for radiological response: objective response rate and clinical benefit were 78 % and 100% respectively. 8 pts underwent surgery, in 3 pts was performed breast-conserving surgery. At the definitive histological examination pathologic stage was: IA 4 pts (50%), IIIA 1 pts (12,5%), IIIB 2 pts (25%) and IIIC 1 pts (12,5%). 2 pts experienced cardiac toxicity: 1 pt had an atrial fibrillation G2 while 1 pt had an symptomatic decline of LVEF G3 after first cycle, causing interruption of treatment. Other pts not showed clinically significant reduction of LVEF (>5%). Conclusions: Despite small number of pts, our experience suggests a safety profile and efficacy of nPLD in neoadjuvant settings for LABC; breast conservation was possible in 3 pts, in other pts (73%) this was not possible mainly for the advanced stage (T4).
Relationship between positive sentinel node (SN) and micrometastases (mMTS) or isolated tumor cells (ITC) with breast tumor pathological features.
Authors: Calvo Isabel , Suárez Ana , Perez Francisco Jose , Fernandez Abad Maria , Cardenas Jose M , García Lina , Alonso Paloma , Miro Cristina , Quevedo Paloma , Parras Manuela , Marquez Cristina , Herrero Mercedes , Buelga Paula , Rodriguez Isabel , Skaarup Jesika , Chereguini Maria F , Marcos Manuel , Contreras Ana Cecilia , Hidalgo Manuel , García-Estevez Laura 
Published: March 2020

e11517 Background: Aim:To study the relation of positive(pos) SN and mMTS or ITC in negative(neg) SN at surgery with tumor pathological(pathol) features (grade;carcinoma type;Ki67;Her2;hormonal status;tumor size). Methods: Cohort of 271 patients with clinically and ultrasonographically node-neg pT1-2 breast cancer and high grade or extended intraductal who received breast cancer surgery with SN biopsy alone in the last 2 years was studied. No previous chemotherapy was administered. Hormone(ER/RP) and Ki67 status were analyzed by inmunohistochemistry(IHC) while HER2 by FISH. Presence of mMTS and ITC were studied by IHC(AE1-AE3). Statistical analysis was conducted to ascertain significant relation among pos-SN or detection of mMTS/ITC in neg-SN and each of the tumor pathol features (test U-Mann-Whitney). Results: Data from 263 patients were analyzed (28 pos-SN;235 neg-SN;8 technique failures). Carcinoma type: Ductal (158;60%);lobular (46;17.5%);in-situ(53;20.2%);others(6;2.3%). Infiltrative cancer:(56% grade 2;20% grade 3;10% Her2+;9% triple-neg;81% pos-RE/RP). In-situ:(28% grade 2;64% grade 3;39% Her2+;55% pos-RE/RP). Mean pathological size 16.2mm(1-118) for infiltrative tumor and 20.1mm(1-90) for in-situ. Mean of SN found at surgery 1.98(1-5). In neg-SN, 35 cases with mMTS(14;6.2%) or ITC(21;9.2%) were found. No statistically significant relation was established between the finding of mMTS or ITC and any of the pathol features at in-situ or infiltrative tumors. In pos-SN a statistically significant relation between pos-SN and pathol size was found (p=0.003; mean pathol size 20.16mm and 15.69mm for pos and neg-SN). Conclusions: A significant relation was established with pathol size and pos-SN. In patients with neg-SN no significant relationship was found between detection of mMTS or ITC and the pathol features of the tumor.
Breast MRI in elderly patients with breast cancer: Does breast density matter?
Authors: Casher Jennifer , Stempel Michelle , Eaton Anne , Morris Elizabeth Ann , Gemignani Mary 
Published: March 2020

e11531 Background: MRI of the breast (BR) is useful in patients (pts) with dense BR in extent of disease evaluation (EOD) and high risk screening. The purpose of this study was to investigate whether MRI breast cancer (BC) detection was associated with BR density in elderly pts. Methods: Retrospective review included pts age >69 diagnosed with BC at our institution between 2/2001 and 12/2005 and their concurrent BR MRIs as well as clinical and pathologic factors. BR density was defined as mild (M) if BR were fatty/mildly dense, and dense (D) if BR were moderately/extremely dense. MRI data was coded for the number of additional sites beyond the known cancer site. Results: MRI occurred in 113 BR in 59 pts; 5 pts had unilateral MRI. 3 pts had bilateral BC. The mean age was 74 (range 69-84). Median tumor size was 1.2 cm (range 0.06-2.6, n=54). 27 pts (46%) had M density and 32 (54%) had D density. In 51/62 (82%) the index lesion was mammographically detected, and in 11 (17%) it was mammographically occult. The majority of BR MRIs 36/62 (58%) identified no additional sites. Biopsy was performed for 18/29 (62%) of the additional sites and 6 cancers were found (PPV of 33%). MRI detected an additional site of BC in 6/62 (9.7%) diseased BR and a new BC in 4/51 (7.8%) screened BR. Pts with D density had more additional MRI sites 18/33 (54.6%) as compared with M density 8/29 (27.6%) p = 0.04. However, D density was not associated with increase in BC detection; 4/33 (12%) D vs 2/29 (7%) M density, p =0.67. BR conserving surgery was performed in 46 pts and mastectomy in 16. We did not find a correlation between additional sites on MRI and final mastectomy, p=0.56. Conclusions: In our study the majority of pts had mammographically evident BC at the time of diagnosis and unifocal BC on MRI. We found that although 54% of our pts had dense BR, the additional detection of BC in the BR by MRI was the same as in pts with mild density. However, we found that increased density was associated with an increased detection of additional lesions on MRI. [Table: see text]
Breast-conserving surgery after neoadjuvant chemotherapy for stage III breast cancer patients.
Authors: Shin Hee-Chul , Han Wonshik , Moon Hyeong-Gon , Moon Woo Kyung , Im Seock-Ah , Kim Tae-You , Park In-Ae , Noh Dong-Young 
Published: March 2020

e11532 Background: Neoadjuvant chemotherapy (NCT) is a reasonable option for operable breast cancer in terms of downsizing large tumor and increasing the rate of breast-conserving surgery (BCS). However, BCS in patients with large breast tumors down-staged by NCT remains still controversial because of the possibility of residual tumor and resistance to NCT. Aims of this study were to evaluate the long-term survival results of patients who received NCT and BCS compared to patients who received BCS first and to compare recurrence and survival rates between patients who received preplanned BCS and those who received down-staged BCS among patients who underwent NCT. Methods: Between 2000 and 2007, 70 patients with clinical stage III breast cancer who received BCS after NCT (NCT group) and 72 patients with clinical stage III breast cancer who underwent BCS first (Surgery group) were retrospectively reviewed. Among 70 patients received NCT, 45 patients (64.3%) received preplanned BCS (preplanned BCS group) and 25 patients (35.7%) received down-staged BCS (down-staged BCS group). The long-term results including ipsilateral breast tumor recurrence (IBTR), locoregional recurrence (LRR), disease recurrence and survival rates were compared with groups. Results: There was no significant difference in IBTR-free survival, LRR-free survival rates, disease-free survival and overall survival rates between the NCT and the Surgery group (p=0.971, p=0.294, p=0.863 and p=0.933, respectively). Among patients who received NCT, IBTR-free survival, LRR-free survival, disease-free survival and overall survival rates was not also different between the preplanned BCS group and the down-staged BCS group (p=0.278, p=0.501, p=0.776 and p=0.412, respectively). Conclusions: Our study demonstrated that patients who received BCS after NCT showed similar long-term resutls compared to patients who received BCS first in clinical stage III breast cancer patients. Also, down-staged BCS shows is oncologically as safe as preplanned BCS in clinical stage III breast cancer patients in terms of recurrence and survival.