bluuebunny/crossref_metadata_2025_split huggingface dataset:
Combined use of indocyanine green fluorescence and methylene blue dye versus methylene blue dye alone for sentinel lymph node biopsy in breast cancer patients.
Authors: Wang Shu , Guo Jiajia , Yang Deqi , Cao Yingming , Tong Fuzhong , Zhou Bo , Liu Peng , Liu Hongjun , Cheng Lin , Liu Miao , Yang Houpu , Xie Fei , Wang Siyuan 
Published: March 2020

e12006 Background: Methylene blue (MB) dye is widely used in China for sentinel lymph node biopsy (SLNB). Recently indocyanine green (ICG) was reported to be an innovative fluorescent tracer that could be visualized by near-infrared camera. In this study we compared the efficacy of combined use of ICG fluorescence and methylene blue eye versus methylene blue alone for SLNB in breast cancer patients. Methods: Two hundred and sixteen consecutive early breast cancer patients in our hospital underwent SLNB from December 2010 to May 2012, 107 patients received combined use of ICG and MB as the lymphatic mapping tracer and 109 patients received MB alone. In combination group, sentinel lymph nodes were identified by ICG fluorescence using a near-infrared camera and/or blue dye, while in blue dye alone group sentinel lymph nodes were identified as blue nodes along the blue lymphatic vessel. Intra-operative frozen section analysis was performed, followed by conventional histopathologic examination. Results: In combination group, subcutaneous lymphatic channels were successfully visualized in all the patients, 325 sentinel lymph nodes were identified in 105 patients. While in blue dye alone group, 242 SLNs were found in 100 patients. The detection rate was 98.1% vs. 91.7 %(p=0.033), the average number of SLNs was 3.1 versus 2.4(p<0.001). 29 metastatic SLNs were found in 19 patients by combination method vs. 21 metastatic SLNs in 17 patients by MB alone. No axillary recurrence was observed in either group during 16 months of median follow-up. Conclusions: The combined use of ICG fluorescence and MB enables visualized and more sensitive SLN detection than MB alone.
EUFORIA study (Eribulin Use for the Treatment of Advanced Breast Cancer: Observational, Retrospective Analysis): Initial experience with eribulin in daily clinical practice in Spain.
Authors: Ruiz-Borrego Manuel , Garcia Saenz José Ángel , Hornedo Javier , Manso Luis , Calvo Isabel , Lao Juan , González-Martín Antonio , Feijoo Margarita , Florián Gericó Jesús , Morales Serafin , Illarramendi Jose J. , Jimenez Valero Pedro , Sánchez-Jiménez Javier , Rodriguez Cesar Augusto , Sánchez-Rovira Pedro , Ayala Francisco , Alvarez Isabel , Virizuela Juan Antonio , Lopez Rafael , Rodríguez-Villanueva Julio 
Published: March 2020

e12015 Background: Spanish MoH authorized eribulin in 04/2011 for use in patients as per license. Pending reimbursement, public hospitals used it through a national compassionate use program. After 1 year, we analyzed the pre-specified patient selection criteria and eribulin efficacy and safety results in a representative sample to confirm whether real world use matched the data from the pivotal phase III study. Methods: An observational, retrospective analysis was proposed to the top 20 hospitals by eribulin use, with at least 3 candidate patients who had/could have received ≥3 cycles of treatment by 03/2012. Patient and disease characteristics, as well as efficacy and safety parameters were obtained. Patient´s data were collected until September 2012. Living patients able to respond at the time of the study signed an informed consent. Study was approved by ethics committees. Results: Out of 112 screened ABC patients in 19 participating hospitals, 104 were enrolled. Median age was 56.6 years and 66% were post-menopausal. Visceral disease occurred in 2/3 of patients. ECOG status was ≤1 in 75,4% of patients. Estrogen receptor expression was found in 64.4% of tumors; 15.4% overexpressed HER2. 49% of patients received 1-5 treatment lines for ABC before eribulin. Mean eribulin treatment duration was 3 months (4,7 cycles). Disease control rate was 48.8% (1.1% CR, 22.1% PR, 25.6% SD). By 09/2012, 64,4% patients were still alive and median PFS was 97 days (95% IC: 81-129). 78.8% of patients reported ≥1 adverse events, being asthenia, neutropenia, anemia, alopecia, nauseas, and mucositis the most frequent ones (≥10%). Grade ≥3 adverse events occurred in ≤5% of patients. Conclusions: The favorable efficacy and safety profile of eribulin observed in this observational study is consistent with the pivotal phase III study (EMBRACE) and confirms its position for the treatment of ABC. Pre reimbursement usage has been restricted to later lines but use per the licensed indication in 3L is expected to yield additional clinical benefit. A confirmatory observational study (EUFORIA-2) is planned.
Activity of eribulin on skin metastases in breast cancer patients.
Authors: La Verde Nicla Maria , Moretti Anna , Gamucci Teresa , Borgonovo Karen , Botta Mario , Salesi Nello , Zuradelli Monica , Pavese Ida , Barbieri Elena , Cretella Elisabetta , Saladino Tiziana , Varese Paola , Addamo Gianfranco , Ciccarese Mariangela , Rispoli Anna Iolanda , Pellegrino Arianna , Mentuccia Lucia , Piva Sheila , Farina Gabriella , Di Maio Massimo 
Published: March 2020

e12021 Background: Skin metastases (SM) occur in 20% of metastatic breast cancer (mBC). Clinical trials rarely describe them, even if they affect quality of life and self-perception of the disease. Eribulin (E) is a new drug, approved in mBC, after at least 2 lines of chemotherapy. The aim of this survey is to evaluate the activity of E treatment on SM compared to other metastatic sites, and on cutaneous symptoms (pain, infiltration, bleeding, smell, ulceration). Methods: This multicenter survey was conducted from November 2012 to January 2013 in 14 Italian Cancer Centers. Oncologists completed a database with patient (pts), tumor and treatment characteristics. Descriptive summary statistics were applied. Progression-free survival (PFS) was calculated according to Kaplan-Meier method. Results: 109 pts with mBC on E treatment were considered. 23/109 (21%) pts with SM were identified and analyzed. E was started between January 2012 and October 2012. Median age 63 (31-81). Prior chemotherapy lines: 4 (1-10). Prior hormonal lines: 1 (0-4). Basal Karnofski performance status 90 (50-100). 21/23 pts had other metastases, the remaining 2 had exclusively skin disease. SM were predominantly in the thorax (91%) and presented infiltration in 78%, ulceration in 70%, pain in 43%, bleeding in 43% and smell in 17% of cases. According to RECIST criteria, after E 43% of patients obtained a partial response (PR), 35% stable disease (SD), 22% progressive disease (PD). We evaluated skin response independently and found that 26% obtained a complete response (CR); 22% PR, 39% SD, 13% PD. Skin responses were in complete accordance with overall response in 16/23 (70%) pts, in partial accordance in 4 pts (skin CR, with an overall PR) and were discordant in 3 pts (1 skin SD despite overall PR, and 2 cutaneous CR despite overall PD). We found an improvement in SM symptoms: pain control was gained in 50% (5/10) of pts, as well as improvement in smell (50%, 2/4) and bleeding (50%, 5/10). Infiltration disappeared in 3/18 pts (17%). With a median follow up of 6 months, 21 (91%) pts had PD, median PFS was 4.3 months (95%CI 2.9–6). Conclusions: During E an improvement in skin metastases symptoms was observed; in the majority of cases, the response rate of SM was coherent with systemic responses.
Classification of subtype using IHC patterns for treatment decision of DCIS.
Authors: Date Yuko , Takimoto Masafumi , Morohoshi Toshio , Nakamura Seigo 
Published: March 2020

e12035 Background: Ductal carcinoma in situ (DCIS) is a heterogenous group of breast lesion and demands a broad range of surgical management techniques. Previous studies reported the importance of receptor expression and referred to the risk of recurrence.We classified ductal carcinoma in situ (DCIS) into 4 subtypes using IHC staining (ER, PgR, HER2 and Ki-67) and investigated the frequency and their characteristics. Also we investigated whether this classification is related to the risk of recurrence. Methods: 117 women who underwent operation between 2010 and 2012 were included our study. We defined 4 subtypes as follows; luminal A (LA), ER and/or PgR (HR)(+) HER2(-) Ki-67(low), luminal B (LB), HR(+) HER2(-) Ki-67(high) or HR(+) HER2(+),HER2(H), HR(-) HER2(+), and basal-like(BL), HR(-) HER2(-).We also evaluated the risk of recurrence using Van Nuys Prognostic Index (VNPI), an algorithm based on DCIS size, nuclear grade (NG), necrosis, margin width and patient age. Results: The frequency of subtype was as follows; LA 77 cases (65.8%), LB 18 (15.3%), H 14 (12.0%) and BL 8 (6.8%). LA tended to smaller size (average: 3.2cm, range: 0.2-12), low NG (NG1 was 97.4%). In a contrary, H and BL were larger size (average: 3.7cm (H), 4.5cm (BL)) and high NG (these percentages of NG3 were 64.3% (H) and 50.0% (BL)). All of the BL had necrosis. About half of the LA was VNPI 6 and 7, but many of the other subtypes were more than VNPI 7 (p=0.02). Conclusions: Classification of subtypes using IHC patterns is simple, useful and, moreover, that are related to the risk of recurrence. Though it is important whether the woman is BRCA1/2 mutation carrier, we might be determined a treatment of DCIS by the subtype.
Prevalence of renal insufficiency (RI) in cancer (Ca) patients (pts) with bone metastases (BM).
Authors: Chen Kristina S , Hernandez Rohini Khorana , Quigley Jane M , Pirolli Melissa A. , Quach David , Liede Alexander , Arellano Jorge 
Published: March 2020

e12508 Background: Upon diagnosis of BM, cancer pts are at increased risk of serious debilitating bone complications. Of the U.S. approved bone-modifying agents (BMAs) [bisphosphonates (BPs), RANKL inhibitor] for the prevention of skeletal-related events (SREs) in these pts, BPs are nephrotoxic and may require dose adjustment or discontinuation. As low persistence to BMAs is associated with higher rates of SREs (Hatoum et al 2008), understanding the extent of RI in a real-world setting is warranted. K/DOQI guidelines recommend monitoring renal function using estimated glomerular filtration rate (eGFR) along with serum creatinine (SCr). Methods: Oncology Services Comprehensive Electronic Records (OSCER), a large electronic medical record database from U.S oncology clinics, was used. Cancer pts (age ≥ 18) with BM diagnosis in 2008 – 2012 were identified excluding acute renal failure, end-stage renal disease, and multiple myeloma. RI prevalence was examined using SCr and eGFR calculated with aMDRD and Cockroft-Gault formula. RI was defined as elevated SCr > 1.2 mg/dl or eGFR < 60 and < 90 ml/min/1.73m2. The analysis was also performed in the subgroup receiving BMAs. Results: The cohort included 15,623 pts (mean age 67.1±12.0, weight 76.5±18.5 kg; female; 56%). Using highest SCr during follow-up, 36% had elevated SCr, 87% eGFR < 90, and 47% eGFR < 60. Among pts with BM diagnosis in 2011 (n=3,839) and normal SCr (taken 1 month before or 3 months after diagnosis; n=3,192), almost 60% of the pts had mildly decreased renal function (eGFR < 90), and 8% had moderately decreased renal function (eGFR < 60) (table). Rates of RI based on eGFR estimated by both formulas were consistent. Conclusions: Nearly half of the cancer pts with BM had RI (eGFR < 60) during the course of their disease. As the risk of renal impairment is high in this population, assessment of renal function using eGFR and careful treatment consideration is imperative to achieve optimal therapeutic outcomes. [Table: see text]
Adverse changes in body composition of cancer surivors with BRCA mutations.
Authors: Caceres Aileen 
Published: March 2020

e12514 Background: Post-diagnosis weight gain is a risk factor for cancer recurrence and many individuals diagnosed with breast and ovarian cancer gain weight during and after treatment. In the present study, we have measured the anthropometrics of cancer survivors with BRCA mutations and have studied the association between anthropometrics and post-diagnosis weight gain. Methods: The study population included 37 breast and ovarian cancer survivors with BRCA mutations, 45 BRCA previvors, and 26 controls. Anthropometric measurements included body mass index (BMI; kg weight/ m2 height) and body composition (% fat and lean tissue, assessed by using 4-lead bioelectric impedance). Post-diagnosis weight gain was determined via questionnaire. Potential effectors of anthropometrics included: diet (3-day food records), physical activity (General Practice Physical Activity Questionnaire), physical health (co-morbidities, Rand-36 Physical Health Quality of Life (QoL)), and psychological status (Beck Anxiety Inventory, Rand-36 Emotional Health QoL). Results: We found no significant differences in BMI between the survivors, previvors or controls (26+2 (SEM), 25+1, 25+1, respectively). However, the % lean body mass of the cancer survivors was significantly lower and their % body fat significantly higher than the previvors or controls (p=0.0005). Measures of body composition (% fat and lean mass) were independent predictors of post-diagnosis weight gain (r=0.86, p<0.001). No significant association was found between body composition measures and psychological status, energy intake or food composition. However, the adverse body composition measures of the survivors were associated significantly with physical inactivity (p<0.01), number of co-morbidities (p<0.0001), and physical health QoL (p<0.01). Conclusions: BRCA cancer survivors have adverse changes in body composition that increase their risk for weight gain and disease relapse. Based upon these findings, it is important for the survivorship care plan to include: 1) education regarding post-diagnosis weight gain, 2) a physical activity regimen, 3) health management, and 4) interval assessment of anthropometrics, including body composition, during and after treatment.
Clinicopathologic characteristics of pure papillary breast carcinoma.
Authors: Turkoz Fatma P. , Solak Mustafa , Keskin Özge , Arik Zafer , Arslan Cagatay , Kertmen Neyran , Aksoy Sercan , Altundag Kadri 
Published: March 2020

e12521 Background: Pure papillary breast carcinoma (PPBC) is a very rare entity which usually occurs in older women with a favorable prognosis. The aim of this cohort study was to evaluate the demographic, clinicopathologic characteristics and survival rates of PPBC compared to invasive ductal carcinoma (IDC). Methods: A total of 2451 invasive breast cancer patients from a single center were analyzed retrospectively. Of these, 24 patients were PPBC (1%) and 1785 (73%) patients were pure IDC. Results: PPBC were significantly different from IDC with respect to the age at diagnosis, menopausal status, tumor size, grade and lymph node involvement (p<0.05) (Table 1). The median follow-up period was 26,5 months (4-400 months). Only one patient with PPBC had lung and bone metastasis, others were alive with no evidence of disease. PPBC was associated with a better 5-year overall survival (100 vs. 84%) and disease-free survival (75 vs. 54%) compared to IDC. Conclusions: Compared to IDC, PPBC is a small, low-grade tumor and less likely to involve the lymph nodes. Cases are usually older, postmenopausal women and have a better prognosis. [Table: see text]
Antibiotic exposure and risk of breast cancer: A causal association or a skyfall?
Authors: Koumarianou Anna , Manali Efrosyni D , Fragou Archontoula , Katsaounis Panagiotis , Bouga Georgia , Karageorgopoulou Sofia , Christodoulou Marianna , Pantazis Nikos , Athanasas George , Arkadopoulos Nikos , Tsionou Christina , Papiris Spyros , Xiros Nikolaos , Antoniadou Anastasia , Giamarellou Helen 
Published: March 2020

e12524 Background: Although it has long been hypothesized that the use of antibiotics may increase the risk of breast cancer, through effects on inflammation, immunity and gastrointestinal microflora that alter the metabolism of phytochemicals, clinical data on this association are sparse. Methods: Matched case-control study among 158 women with newly diagnosed primary invasive breast cancer from a single cancer unit and 158 age-matched controls (± 12 months) from healthy individuals accompanying patients to the outpatient clinics between January 1, 2006 and December 30, 2007. Clinical examination and a standard questionnaire for the collection of baseline characteristics and known aggravating factors, such as body mass index, smoking, age of menarche and menopause, parity, breastfeeding, history of respiratory, urinary or other infections and previous estrogen use, were carried out in all individuals. All antibiotic classes, such as β-lactams, amoxyl and clavulanic acid, cephalosporins, macrolides, quinolones, tetracyclines, trimethoprim, clindamycin and imidazoles, were recorded. Type of antibiotic and dose was ascertained from health insurance’s pharmacy records. Data were analyzed using multivariable conditional logistic regression models including adjustments for potential confounding factors. Results: The age matched groups of patients and controls were found to have statistically significant differences in the considered parameters such as delayed age of menopause, less parity and less smoking in the control group and more antibiotic intake in the patient population. The cumulative use for more than 21 days of any antibiotic classes were found to statistically significant correlate with increased risk of breast cancer [odds ratio(OR):3.5, 95%confidence interval(CI):1.7-7.3, p=0.001]. By subanalyses according to antibiotic class this increased risk was mainly associated with β-lactams (OR:11.4, 95%CI:3.8, 34.1, p<0.001) and less with macrolides (OR:2.8, 95%CI:1.1-7.5, p=0.039). Conclusions: Our study links β-lactam and macrolide consumption with increased breast cancer risk but further investigation of this association in large cohorts together with exploration of the underlying cause are needed.
Pancreas cancer: Influence of gender and other demographic and clinical parameters on survival.
Authors: Blank Patricia Renee , Szucs Thomas D. 
Published: March 2020

e12529 Background: Research suggests that lower excess mortality risk for females compared to men do exist for several cancer types. The primary aim of this study was to investigate whether gender affects pancreatic cancer prognosis. In addition, the relationship of sex and survival adjusted for clinical and demographic factors was assessed. Methods: The Surveillance, Epidemiology, and End Results (SEER) database (version 1973-2009) was used to identify patients with primary histological confirmed pancreas cancer (≥18 years, 80,689 males and 82,356 females). The analysis was stratified by five different stages (in situ, locally invasive, regional, distant, unstaged). The crude effect of gender was assessed in the total sample and in age-stratified Kaplan-Meier Curves (<55 years) in all five stages, respectively. Univariate and multivariate Cox proportional hazard models were run within the local stage. The predictors included in the models were demographic and clinical factors. P-values (2-sided) of 0.05 were assumed as statistical significant. Results: Between 1973 and 2009, 128,645 pancreas cancer-related deaths were reported. The median follow-up time of the censored patients was 13 months. The Kaplan-Meier curves showed a significant difference in survival among men and female in the locally invasive group (median survival in male and female: 7 months; 1-year survival: 35.5% and 35.1% among female and men, respectively; Log-Rank: p=0.0072). Of the remaining strata, all others had non-significant differences, except the unstaged group (Log-Rank: p= <.0001). The univariate Cox-regression indicated a 5.6% (95%CI: 1.4%, 9.9%, p=0.0081) higher rate of dying among men compared to female (local recurrence). Among the younger population (<55 years), the gender difference was significant across all disease stages, except the in situ group. Histology grade, age, race, and marital status was associated with survival from pancreatic cancer in the multivariate analysis. Conclusions: The present study indicates a gender difference in survival among pancreas cancer patients. The study findings are, however, preliminary and hypothesis generating and a matter for further investigation to give a distinct conclusion.
Interim decisions in oncology trials.
Authors: Yao Bin , Zhang Kathy , Jemiai Yannis , Chang David D. 
Published: March 2020

e12530 Background: Interim analyses are commonly performed in oncology clinical trials. For a phase III trial, interim monitoring rules are in general pre-specified for an independent data monitoring committee (DMC) to allow for the possibility of early stopping. Challenges and controversies exist when interim monitoring and subsequent decisions alter the course of the trial. Methods: Abstracts and primary publications of ASCO plenary session presentations for the last 10 years (2003-2012) were reviewed. Interim analyses related to the study design, conduct, endpoints, DMC decision, and reporting were reviewed. Mid-trial adaptations not limited to interim results were also summarized. Results: Fifty-two presentations were identified. Forty-one were randomized controlled trials; almost all were phase III trials. Interim monitoring and analyses were discussed in the primary manuscripts of 31 trials. The objectives of these interim analyses were safety monitoring, inference for superior efficacy, or futility. Fourteen trials crossed interim boundaries and were declared by the DMCs to have met the study objectives on efficacy endpoints such as progression-free survival and overall survival (OS). Mid-trial adaptations included dropping an arm or selecting a dose based on interim safety results. Other trial adaptations, motivated by issues such as slower accrual rate, change in treatment paradigm, or unexpected longer trial duration, included modifications of trial objectives, primary endpoints, sample sizes, and unplanned analyses. Conclusions: Interim monitoring is an important component of clinical trials but is not consistently reported. Decisions made after the primary endpoint has crossed the interim boundary have an impact on subsequent inferences of other endpoints (e.g. OS). Greater transparency and practical guidelines are needed to ensure continued trial integrity and valid inferences post interim.