bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prediction of the probability of breast cancer-related lymphedema after axillary lymph node dissection.
Authors: Soran Atilla , Ibrahim Ahmad , DeGore Lori , Johnson Ronald 
Published: February 2017

140 Background: Early detection and timely intervention demonstrate the greatest promise of reducing incidence of late-stage lymphedema (LE) in breast cancer patients undergoing axillary lymph node dissection (ALND). A nomogram was developed for predicting the risk of arm LE in this group. This study’s aim was to test the preoperative prediction model for the early diagnosis of clinical and subclinical LE in ALND including patients prospectively monitored by bioimpedance spectroscopy (BIS). Methods: Patients with pre-existing clinical LE were selected from our existing database. In addition, data on subclinical LE was prospectively collected through our LE monitoring program. This program tracks patients from a baseline, using an L-Dex U400 measurement preoperatively or postoperatively (if no clinical LE), and at 3-6 month intervals. The 5 year probability of LE after ALND was calculated using The Cleveland Clinic Risk Calculator. The discrimination of the nomogram was assessed by calculating the area under (AUC) the receiver operating characteristic curve (ROC); AUC values between 0.7–0.8 represent considerable discrimination. Results: A total of 334 patients who underwent ALND were included in this study; 116 patients with previously diagnosed clinical LE and 218 patients at-risk of LE (monitored with BIS since 2010). Since BIS monitoring began, a total of 58 patients were diagnosed with subclinical LE; a total of 174 patients with clinical or subclinical LE (LE group). The mean age was 60.6+11.4 years in LE group and 57.8+12.03 years in No-LE group (p=0.03). BMI was higher in LE group compared with no LE group (29.8 + 7.4 vs.28.3+6.3 kg/m2(p=0.05). The AUC value was calculated from the nomogram (AUC=0.609). Conclusions: The recently created preoperative prediction model for the diagnosis of LE in ALND is not accurate in predicting who will develop clinical or subclinical LE. Periodic monitoring of women at high risk for LE, with modern technology, helps early detection and timely intervention for LE, which can minimize or eliminate more advanced LE among women undergoing ALND.
Tracking viewership of survivorship topics from an online educational resource for breast cancer survivors: Findings from the Pink Ribbon Survivors Network Curriculum for Recovery Library.
Authors: Fisher Robert E. , Adams Kelly Ann 
Published: February 2017

141 Background: The Pink Ribbon Survivors Network created a virtual library, The Curriculum for Recovery Library, as part of its online resources for breast cancer survivors and the health care providers who care for them. The website's library became available on July 11, 2012. 199 articles are organized into 19 categories within the library. Within each category, article titles are directly linked to their online text. The library is hosted on the organization's website: www.PinkRibbonSurvivorsNetwork.org. Methods: Through the website's administrative site, we tracked and reviewed the number of visits to each of the 19 categories's content in The Curriculum for Recovery Library between July 11, 2012 and April 21, 2013. Results: The five following categories were most were accessed by our viewership, in descending order: " Fatigue," "Doubt and Hope," "Your Survivorship Document," "Diet/Exercise/Selfcare," and "Leaving a Legacy." The tally has been determined by review of the first 2,800 viewings of the website, during this 9 month period. Conclusions: When given free access to 19 categories relevant to survivorship, our data reveals that treatment related fatigue and doubt about a breast cancer survivor's future are the most sought after categories among our viewership population. This data will help to prioritize research and resources for breast cancer survivors in the future.
Correlation of molecular alterations with efficacy of everolimus in hormone-receptor–positive, HER2-negative advanced breast cancer: Results from BOLERO-2.
Authors: Rugo Hope S. , Hortobagyi Gabriel N. , Piccart-Gebhart Martine J. , Burris Howard A. , Campone Mario , Noguchi Shinzaburo , Perez Alejandra T. , Deleu Ines , Shtivelband Mikhail , Provencher Louise , Masuda Norikazu , Dakhil Shaker R. , Anderson Ian , Chen David , Damask Amy , Huang Alan , McDonald Robert , Taran Tanya , Sahmoud Tarek , Baselga Jose 
Published: February 2017

142 Background: Everolimus (EVE) plus exemestane (EXE) more than doubled progression-free survival (PFS) while maintaining quality of life vs EXE alone in postmenopausal women with hormone receptor–positive (HR+), HER2-negative (HER2–) advanced breast cancer (BOLERO-2 phase III; NCT00863655). PFS benefit was seen in all clinically defined subgroups. We evaluated genetic variations of a broad panel of cancer-related genes and explored their correlations with EVE benefit. Methods: Exon sequence and gene copy number variations were analyzed in 182 cancer-related genes by next-generation sequencing (NGS). Correlations with PFS were evaluated using univariate and multivariate Cox models. Results: NGS data (>250x coverage) were successfully generated from archival tumor specimens from 227 patients (NGS population, 157 in EVE + EXE arm and 70 in EXE arm) whose baseline characteristics and clinical outcome were comparable to the trial population (PFS HR = 0.40 and 0.45, respectively). The treatment benefit of EVE + EXE over EXE was maintained in the subgroups defined by each of the 9 genes with a mutation rate >10% (e.g., PIK3CA, FGFR1, CCND1) or when less frequently mutated genes (e.g., PTEN, AKT1) were included in their respective pathways. Patients with 0 or 1 genetic alteration in PI3K or FGFR pathways or CCND1 had a greater treatment effect from EVE (HR = 0.27, 95% CI 0.18-0.41, adjusted by covariates, in 76% of the NGS population), indicating the value of these pathways for predicting sensitivity to EVE in this setting. Conclusions: This is the first global registration trial in which efficacy-predictive biomarkers were explored by correlating broad genetic variations with clinical efficacy. The preliminary results suggest that a large subgroup of patients (76%), defined by minimal genetic variations in the PI3K or FGFR pathways or CCND1, derives the most benefit from EVE therapy (HR = 0.27 vs 0.40 for the full NGS population). These exploratory results and their implication in understanding the interplay of multiple pathways in tumor cells and testing new hypotheses for targeted combination therapies in HR+/HER2– BC will be further investigated. Clinical trial information: NCT00863655.
Prognostic factors and survival of patients with brain metastasis (BM) from breast cancer (BC) who underwent craniotomy.
Authors: Leone Jose Pablo , Cunningham Diana E. , Lee Adrian , Bhargava Rohit , Hamilton Ronald L. , Wiener Erik , Okada Hideho , Brufsky Adam 
Published: February 2017

143 Background: BC is the second most frequent cause of BM after lung cancer, with metastases occurring in 10% - 16% of all patients. BM in patients with BC is a catastrophic event that results in poor prognosis. Identification of prognostic factors associated with breast cancer brain metastases (BCBM) could help to identify patients at risk. The aim of this study was to assess clinical characteristics, prognostic factors and survival of patients with BCBM who had craniotomy and resection in a series of patients treated with modern multimodality therapy. Methods: We analyzed 42 patients with BCBM who underwent resection. Patients were diagnosed with BC between April 1994 and May 2010. Cox proportional hazards regression was selected to describe factors associated with time to BM, survival from the date of first recurrence, and overall survival (OS). Results: Median age was 51 years (range 24-74). Median follow-up was 4.2 years (range 0.6-18.5). The mean time to BM from primary diagnosis was 49 months (range 0-206.22). Patients had a median of 2 BM with a median size of 3.25 cm. The proportion of the biological subtypes of BC was ER+/HER2- 25%, ER+/HER2+ 15%, ER-/HER2+ 30% and ER-/HER2- 30%. Brain radiotherapy was given to 28 patients, of which 10 had stereotactic radiosurgery, 7 whole brain radiation, and 11 both. Median OS from the date of primary diagnosis was 5.74 years. Median survival after diagnosis of BM was 1.33 years. In multivariate Cox regression analyses, stage was the only factor associated with shorter time to the development of BM (P=0.059), whereas age was the only factor associated with survival from the date of recurrence (P=0.027) and with OS (P=0.037). Controlling for age and stage, neither the biological subtype of cancer, the radiation modality nor the site of first recurrence showed any impact on survival. Conclusions: Stage at primary diagnosis correlated with shorter time to the development of BM, while age at diagnosis was associated with shorter survival in BCBM. None of the other clinical factors had influence on survival.
Updated results of neoadjuvant chemotherapy with carboplatin AUC 6 and docetaxel 75 mg/m2 in triple-negative breast cancer (TNBC).
Authors: Kern Peter , Kolberg Hans C. , Kalisch Anne , Kimmig Rainer , Pott Dirk , Otterbach Friedrich , Kurbacher Christian M. 
Published: February 2017

149 Background: Triple-negative breast cancer (TNBC) is associated with a poor prognosis unless a pathological complete response (pCR) is achieved or almost achieved (near-pCR). Treatment of TNBC remains a challenge as some patients fail to respond to the use of standard anthracyclin-based chemotherapy regimens. Phenotypic and molecular similarities between TNBC and BRCA1-associated breast cancer suggest that TNBC may share the same sensitivity to platinum analogues as tumors associated with BRCA1. Methods: 30 patients with primary, unilateral, non-metastasized TNBC (majority of them cT1 or cT2, two cT4) had to be unsuitable for standard anthracycline-based chemotherapy. They received 6 cycles, respectively in two case sonly 5 cycles, of carboplatin AUC 6 and docetaxel 75 mg/m² q3w. Adverse effects were recorded according to CTCAE V4.07. Primary endpoint was pathological complete response (pCR) and near-pCR, secondary endpoint toxicity. Results: 70% (21/30) of patients had either a pathological complete response (55%; 15/27) or a near-complete response (20%; 6/30) - defined as pT1mic and ypT1a - both being associated with a good prognosis. Eight remaining patients had still good partial response, leaving only low residual cancer burden, which was specified as ypT1, in contrast only one ypT4 tumor. Treatment was well tolerated - grade IV toxicities were predominantly hematological side effects (especially concerning neutropenia) and in 2 cases grade IV edema and joint pain. Carboplatin dose reduction (to an AUC of 5) was required in 5 cases (because of limited renal function, hematological side effects or patient’s age). Conclusions: Our results demonstrate a high-anti-tumour activity of docetaxel 75mg/m² in combination with carboplatin AUC 6, promising high rates of tumour regression and pathological complete remission. The omission of exposure to anthracyclines in patients with considerable heart disease risks seems to be feasible with a good pCR-rate, the latter being a surrogate-marker for long-term survival. Survival data of this trial are currently being updated and will be presented on the Breast Cancer Symposium.
Population-attributable risks for modifiable lifestyle factors and breast cancer in New Zealand women.
Authors: Hayes James 
Published: February 2017

15 Background: Breast cancer is an important cause of illness and death in New Zealand women. It is the most commonly registered cancer in women, and the second most common cause of cancer death in women. In 2009, 2,759 women were diagnosed with breast cancer and 658 women died from breast cancer. The incidence of breast cancer is projected to stabilise in New Zealand, but the actual number of women diagnosed with breast cancer will increase because of the increasing proportion of older people and increasing size of the population. Methods: Estimates of the magnitude of modifiable lifestyle risk factors for breast cancer (relative risks and odds ratios obtained from published epidemiological studies) and the prevalence of exposure in New Zealand were used to calculate the population attributable risk percent (PAR%) for each risk factor. The PAR%s show the relative importance of these risk factors, and give an indication of the potential impact of reducing the prevalence of these lifestyle risk factors on the incidence of breast cancer in New Zealand. Results: Six modifiable lifestyle factors were identified for breast cancer. These were obesity, lack of physical activity, high alcohol intake, oral contraceptive use, hormone replacement therapy (HRT), and delayed first birth. The PAR%s for these risk factors ranged from 1% for delayed first birth to 10% for obesity (16% for Maori women and 17% for Pacific women). Conclusions: The most important primary preventive strategies to reduce the risk of breast cancer in New Zealand are promoting lifestyle changes to reduce obesity, promoting regular physical activity (which may in turn reduce the prevalence of obesity), reducing HRT use, and avoiding high alcohol intake. A strategy to promote regular physical activity and reduce obesity could also have other benefits, such as reduced risks of cardiovascular disease and diabetes.
Invasive micropapillary breast cancer: Single-institution experience in the modern era.
Authors: Voci Amy E. , Boafo Camilla , Eaton Anne , Stempel Michelle , Reis- Filho Jorge , King Tari A. 
Published: February 2017

150 Background: Invasive micropapillary breast cancer (IMPC) is a rare special histologic type of breast cancer with a propensity for nodal metastases. Molecularly, IMPCs have been classified as luminal B; however, clinical outcome data in the era of targeted therapy are limited. Here we report our institutional experience with IMPC. Methods: We retrospectively reviewed our prospective database from 1995-2009 to identify patients who had surgery for IMPC. Clinical characteristics and outcomes were abstracted from the medical record. Overall survival (OS) was estimated using Kaplan-Meier methods. Factors associated with OS and trends over time were assessed using the log-rank test and Cox regression. Results: We identified 258 patients with IMPC. Median patient age 56yrs (range 26-91), 157(61%) postmenopausal, 147(57%) presented with a palpable mass. The majority of IMPCs were grade 3 (83%), estrogen receptor (ER)-positive (86%) and HER2-neg (81%) with LVI (60%) and nodal metastasis (62%). 194 (75%) patients received chemotherapy (CTX), 204 (81%) hormonal therapy and 37/48 (77%) HER2-pos patients received trastuzumab. At a median follow-up of 55 months (range 1-173mos), 5yr OS is 89.5% with a trend towards improved survival in later yrs; 5 year OS 1995-2005 vs 2006-2009, 85% vs 91%, respectively (p=0.06) Clinical factors associated with OS are shown (Table). Among ER-pos/HER2-neg patients, progesterone receptor (PR) status was strongly associated with 5yr OS. Conclusions: In this large cohort of patients with IMPC treated at a single center, OS was associated with tumor size, PR status, use of CTX and trastuzumab but not with ER or hormonal therapy. These clinical data support the molecular classification of IMPC as luminal B cancers which have a more aggressive clinical behavior than other ER+ cancers. The trend towards improved survival in later years likely reflects the benefits of targeted therapy. [Table: see text]
Phase Ib study of eribulin (ERB) and cyclophosphamide (CTX) in metastatic breast cancer (MBC).
Authors: Truong Thach-Giao , Pelayo Michael , Grabowsky Jennifer A. , Melisko Michelle E. , Magbanua Mark Jesus Mendoza , Moasser Mark M. , Reinert Anne , Hwang Jimmy , Park John W. , Munster Pamela N. , Rugo Hope S. 
Published: February 2017

153 Background: ERB is a non-taxane microtubule inhibitor approved for the treatment (Tx) of taxane (TAX) and anthracycline-treated MBC based on improved OS compared to treatment of physician choice. In the adjuvant setting, docetaxel/CTX (TC) was superior to doxorubicin/CTX for DFS and OS. ERB is active in TAX-resistant disease with a low rate of peripheral neuropathy (PN); its primary dose-limiting toxicity (DLT) is bone marrow suppression. We hypothesized that the combination of ERB and CTX would be well tolerated and active in patients with TAX-resistant disease, with potential applicability to the adjuvant setting. Methods: We designed a 3+3 phase Ib study of ERB, administered in 2 escalating doses on day 1 and 8, with CTX 600 mg/m2day 1 every 21 days. Eligibility included PN ≤ grade 1. Correlative studies to identify predictors of response and toxicity included whole blood for SNPs, GWAS, circulating tumor cells (CTC), and archived tumor RNA/protein expression analysis. Toxicity assessment included QoL and evaluation of PN. Results: 6 patients (pts) with MBC, median age 50 (47-63), were enrolled. All pts had prior TAX exposure and 4 pts had baseline grade 1 PN. Tumor characteristics included hormone receptor + (5 pts), HER2+ (2 pts), and triple-negative (1 pt). Median number of prior Tx for MBC was 5 (1-8). No DLTs were observed; the RP2D is eribulin 1.4 mg/m2 on D1 and D8 with CTX D1 600mg/m2. Neutropenia was the only G3/G4 non-DLT observed at this dose, requiring GCSF support in cycle 1 in 2 of 3 pts. All grade toxicities included neutropenia (50%), thrombocytopenia, fatigue, nausea, PN, rash, mucositis, alopecia (33% each), and elevated liver enzymes (17%). Pts received a median of 5.5 cycles (range 3-13), with 3 pts still on Tx. Responses included 2PRs (33%) and 4 SD (67%). 2 pts stopped study Tx for QoL and continued ERB alone. Only 2 pts met threshold of >5CTC/7.5ml at baseline; these had a mean decrease of 90.5% at the start of cycle 2. Conclusions: ERB and CTX is a well-tolerated regimen with promising activity in MBC, with the primary toxicity being neutropenia requiring growth factor support. A phase II study in MBC is underway. Additional correlative studies are ongoing, including molecular analyses of CTC. Clinical trial information: NCT01554371.
Current patterns and costs associated with oral and injectable therapy for metastatic breast cancer in U.S. women: A SEER-Medicare analysis.
Authors: Rugo Hope S. , Clements Karen , McGarry Lisa , Faria Claudio , Teitelbaum April H. 
Published: February 2017

156 Background: A prior SEER-Medicare analysis (2001-2008 data) of injectable treatment (tx) after MBC diagnosis (dx) found fulvestrant was the most common 1st-line received (15% of patients) and vinorelbine the most common 2nd- and 3rd-line tx (17% and 13%, respectively). Lifetime cost of treating MBC averaged $110,000. The current study updates this analysis and focuses on a subgroup with prescription drug (Part D) Medicare coverage to evaluate tx patterns and costs including oral agents. Methods: Sample included women with breast cancer dx 2001-2007 with concurrent or subsequent MBC dx, Medicare enrollment from 12 mo prior to dx through 2009 or death, and indication of pharmacologic MBC tx. Subgroup with part D coverage and MBC diagnosis in 2007 was identified. Lines of tx were designated as: 1st-line if 1st agent (or combination if on same day) after dx of MBC; new agents administered > 42 days after the previous agent are a new line, as well as an agent administered > 60 days after last dose of the same agent. Costs were adjusted for length of follow-up. Results: Tx patterns in the overall sample were similar to prior results. Fulvestrant remained the most common 1st-line tx (19% of patients), and vinorelbine the most common 2nd- (18%) and 3rd-line tx (16%). Total costs ($127,000) were higher than in prior study. In the subgroup with Part D coverage (Table) use of oral agents was common for all tx lines. Mean lifetime treatment costs were lower than in overall sample ($102,000) and varied by treatment received. Conclusions: In this population, oral agents are common MBC tx. Inclusion of Part D claims provides a more complete picture of tx patterns in MBC. [Table: see text]
Effects of dose modification of eribulin mesylate in patients with locally recurrent or metastatic breast cancer.
Authors: Faria Claudio , Li Xuan , Powers Annette , Vahdat Linda T. 
Published: February 2017

157 Background: Eribulin mesylate is indicated for patients with metastatic breast cancer after treatment with ≥ 2 prior chemotherapeutic regimens. Recommended dosing is 1.4 mg/m2on specific cycle days with options for dose modification (dose reduction/delay) based on severity and duration of specific toxicities. The goal for therapy is to administer the full studied dose; however, for patients experiencing an adverse event (AE) the impact of dose modification has not yet been explored. The purpose of this study was to determine the effects of dose modification due to AEs on duration of therapy. Methods: Data from patients receiving eribulin in a phase III open label, randomized clinical trial evaluating eribulin vs. ‘Treatment of Physician’s Choice’ (E7389-G000-305) was utilized. Analyses were performed on the population with AEs. Patients were classified into a dose modification cohort for any dose reduction/delay related to an AE, or a dose non-modification cohort for patients who did not receive a dose modification but experienced an AE. Descriptive statistics were calculated and survival analyses were conducted. Results: Overall, 462 patients had an AE that was treatment-related: 204 patients (44.2%) had dose modification (delay only [61.8%], reduction only [17.6%], and both [20.6%]), and 258 (55.8%) did not have dose modification. Average age was 55 years, and most patients were Caucasian (92.4%). Patients with dose modification had a mean of 7.36 (±4.56) chemotherapy cycles and a median of 143 treatment days, while patients without modification had a mean of 5.71 (±3.68) cycles and a median of 105 treatment days (p < 0.001). The median PFS was also longer in the dose modification cohort (130 vs. 92 days based on independent review). However, there were no statistically significant correlation between PFS and dose modification after adjusting for the length of treatment exposure using time-dependent and landmark approaches. Conclusions: Delaying or reducing the dose of eribulin in patients who experience AEs may allow patients to remain on therapy longer. Further prospective studies are warranted to confirm the impact on overall efficacy and safety.