bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract S5-07: SWOG S0500 – A randomized phase III trial to test the strategy of changing therapy versus maintaining therapy for metastatic breast cancer patients who have elevated circulating tumor cell (CTC) levels at first follow-up assessment
Authors: Smerage JB , Barlow WE , Hayes DF , Winer EP , Leyland-Jones B , Srkalovic G , Tejwani S , Schott AF , O'Rourke MA , Lew DL , Gralow JR , Livingston RB , Hortobagyi GN 
Published: August 2014

Abstract
Introduction:
CTC are detectable in approximately 75% of patients with metastatic breast cancer (MBC), and are elevated (≥5CTC/7.5 ml whole blood (WB)) in about half. Elevated CTC at baseline are associated with a worse prognosis, and a decline in CTC levels suggests response to therapy. We initiated a prospective randomized clinical trial (SWOG S0500) to test whether a change in chemotherapy after failure to clear CTC after one cycle of first line chemotherapy would improve outcomes of patients starting first line cytotoxic chemotherapy for MBC.
Methods:
Patients initiating first-line chemotherapy for MBC were enrolled. All patients had measurable or evaluable disease that included bone metastases. Patients with elevated CTC at baseline and who continued to have elevated CTC after 21 days of therapy were randomly assigned to either continue initial therapy until progression or to change to a second line chemotherapy (physician choice) immediately at cycle 2. Patients with elevated CTC at baseline, which were not elevated at the 21-day follow-up were maintained on their initial therapy. Patients without elevated CTC at baseline were followed in an observation arm. The primary endpoint was overall survival, and progression-free survival was a secondary endpoint. It was expected that approximately 500-650 patients would have to be screened to enroll 120 patients in the randomized trial. Power was 81% with 2-sided α = 0.05 to detect a 70% increase in median overall survival for patients randomized to change therapy. Three interim analyses were planned during the course of the trial.
Results:
From 10/1/2006 until 3/15/2012, 624 patients were registered of whom 612 were eligible. A baseline CTC was obtained in 593 (97%) eligible patients of whom 317 (53%) had elevated CTC at baseline. Thirty-one patients (10%) with elevated baseline CTC did not complete the follow-up CTC due to death, progression, withdrawal, or assay failure. Of the 286 remaining patients, 123 patients (43%) continued to have elevated CTCs after the first cycle of chemotherapy and were randomly assigned to either maintain original chemotherapy (n = 64) or switched to new chemotherapy (n = 59).
Final outcome results will be analyzed in October 2013 and will be reported if released by the SWOG Data Safety Monitoring Board.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S5-07.
Abstract A54: The association of county level characteristics with the incidence of squamous cell carcinoma of the cervix in Hispanic women.
Authors: Ward Kristy K. , Roncancio Angelica M. , Plaxe Steven C. 
Published: August 2014

Abstract
Purpose: To evaluate the association of county level characteristics with the incidence of invasive squamous cell carcinoma of the cervix among Hispanic women.
Methods: The Surveillance, Epidemiology, and End Results (SEER) Program's 18 registries from 2000-2009 were queried and average annual age-adjusted incidence rates per 100,000 Hispanic women for invasive squamous cell carcinoma of the cervix (SCC) were calculated. Patients were stratified by residence in a county with high versus low percent language isolation, percent of Hispanics with less than a high school education and percent of Hispanic families below the poverty level.
Results: Between 2000-2009, 5,534 Hispanic women were diagnosed with SCC in SEER. Incidence rates were highest among those living in counties with high levels of LI (8.9 v 10.7), or low levels of education (8.9 v 10.8) or income (8.7 v 11.0). The incidence of SCC was significantly less in women living in counties with higher levels of education and income and lower levels of LI than among those living in counties with lower levels of education and income and higher levels of LI (8.6 v. 11.3). Counties that have higher levels of income and education are less likely to be LI whereas counties with lower levels of income and education are more likely to be LI.
Conclusions: Among Hispanic women, county level characteristics such as LI, education, and income have a complex interaction that appears to be associated with the incidence of SCC. Community level interventions need to be evaluated to decrease the high incidence of SCC in this population.
Citation Format: Kristy K. Ward, Angelica M. Roncancio, Steven C. Plaxe. The association of county level characteristics with the incidence of squamous cell carcinoma of the cervix in Hispanic women. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr A54.
Abstract B06: Rural women's decision making about cervical cancer prevention in South Carolina.
Authors: Bellinger Jessica D. , Millegan Whitney , Abdalla Azza , Creek Kim 
Published: August 2014

Abstract
Objective: Despite advances in screening and prevention, cervical cancer disparities have been detected in minority, rural, and underserved women. This study explored women's knowledge, attitudes, and behavior related to human papillomavirus (HPV) and cervical cancer prevention in South Carolina, which ranks fourteenth in the United States in cervical cancer incidence and mortality.
Methods: Three focus groups were conducted in two rural and urban counties as part of a community-based participatory (CBPR) project. Instrument development and participant recruitment were conducted in partnership with a community advisory board. Snowball sampling was employed to recruit twenty-eight adult women (18-70 years of age). An Institutional Review Board approved the study and informed consent was obtained.
Results: Cervical cancer prevention knowledge varied, with urban women reporting greater exposure to public health campaigns. Most participants had more positive views about screening than HPV vaccination, but were less knowledgeable about current screening guidelines. Lack of health insurance, transportation, and costs were main barriers to screening. Provider recommendations for HPV vaccination also emerged as a barrier. Lack of provider recommendations and ineffective patient-provider communication were viewed as greater barriers to HPV vaccination than cost due to expanded access vaccination programs.
Conclusions: Rural women view cervical cancer screening as an important health service; however, their health decisions are informed by cancer prevention knowledge, access to care, cost concerns. Providers are a trusted source of health information and present an opportunity to convey culturally-appropriate evidence-based messages about cervical cancer prevention and control.
Citation Format: Jessica D. Bellinger, Whitney Millegan, Azza Abdalla, Kim Creek. Rural women's decision making about cervical cancer prevention in South Carolina. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B06.
Abstract B08: Examining community-perceived cancer mortality from industrial toxins along the Houston Ship Channel through spatial-temporal analysis in a GIS environment.
Authors: Jordan Demetrice R. , King Denae Waller , Jones Lovell A. 
Published: August 2014

Abstract
Studies demonstrate that economically deprived minority communities are often disproportionately located in close proximity to industrial sources of pollution, and often these pollutants are known to cause cancer. Additionally, prolonged exposure to toxins such as, benzene and 1,3 butadiene, known human carcinogens and by-products of petroleum refining, can result in high premature cancer mortality. Recent studies have revealed an increased risk of cancer for port communities, similar to Galena Park, Texas located along the Houston Ship Channel; however, these studies did not investigate mortality concerns. This project seeks to investigate the community-identified concerns regarding cancer-related death clusters within the Galena Park community and other communities located along the Houston Ship Channel, between 1990 and 2010, through spatial analysis using Geographic Information Systems (GIS). Preliminary findings suggest that approximately 1 in 5 premature cancer related deaths within the study area were attributed to cancers with a known association to benzene and 1,3 butadiene exposure. Spatially the findings reveal that the historically high premature cancer mortalities occurred in the predominantly minority and economically disadvantaged areas in close proximity to the Houston Ship Channel with higher ambient air concentrations of these toxins than more affluent areas in the region.
Citation Format: Demetrice R. Jordan, Denae Waller King, Lovell A. Jones. Examining community-perceived cancer mortality from industrial toxins along the Houston Ship Channel through spatial-temporal analysis in a GIS environment. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B08.
Abstract SS01-04: Objective and perceived risk of cervical cancer risk among Appalachian women.
Authors: Paskett Electra D. , Bons Nicolas P. , Reiter Paul L. 
Published: August 2014

Abstract
Objectives: Appalachia is a geographic area with elevated cervical cancer incidence rates, yet little research has examined the accuracy of the cervical cancer risk perceptions of women living in this region. We examined the accuracy of Appalachian women's cervical cancer risk perceptions and identified factors correlated with accurate risk perceptions.
Methods: Completed in 2006, we surveyed women (n=411) from Appalachian Ohio for the Community Awareness Resources Education (CARE) study. We calculated women's actual cervical cancer risk using the CARE Risky Sexual Behavior Index (classified as high, medium, or low risk), and women indicated their perceived risk of cervical cancer (classified as higher than, about the same as, or lower than other women). We used multivariate logistic regression to identify factors correlated with women accurately classifying their risk.
Results: About 38% of women had high actual risk of cervical cancer, 31% had medium risk, and 31% had low risk. Most women (56%) perceived their risk of cervical cancer to be about the same as other women. About 38% of women accurately classified their cervical cancer risk. Women ages 31-50 (OR=1.77, 95% CI: 1.03-3.05; compared to women ages 51 and older) and those with a prior abnormal Pap test (OR=1.56, 95% CI: 1.01-2.39) were more likely to accurately perceive their cervical cancer risk.
Conclusions: Most Appalachian women do not accurately perceive their risk of developing cervical cancer. This may be particularly true for older women and those who have no history of abnormal Pap tests. Education efforts are needed to help Appalachian women better understand their risk for cervical cancer, which may in turn help improve cervical cancer screening rates among this population.
Citation Format: Electra D. Paskett, Nicolas P. Bons, Paul L. Reiter. Objective and perceived risk of cervical cancer risk among Appalachian women. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr SS01-04.
Inflammation and Oxidative Stress Markers and Esophageal Adenocarcinoma Incidence in a Barrett's Esophagus Cohort
Authors: Hardikar Sheetal , Onstad Lynn , Song Xiaoling , Wilson Angela M. , Montine Thomas J. , Kratz Mario , Anderson Garnet L. , Blount Patricia L. , Reid Brian J. , White Emily , Vaughan Thomas L. 
Published: August 2014

Abstract
Background: Persons with Barrett's esophagus experience increased risk of esophageal adenocarcinoma. Prediagnostic inflammation markers predict several cancers, but their role in predicting esophageal adenocarcinoma is unknown.
Methods: We investigated whether biomarkers of inflammation [C-reactive protein (CRP), interleukin-6 (IL6), soluble tumor necrosis factor (sTNF) receptors I and II], and of oxidative stress (F2-isoprostanes) predicted progression to esophageal adenocarcinoma in a prospective cohort of 397 patients with Barrett's esophagus, 45 of whom developed esophageal adenocarcinoma. Biomarkers were measured in stored plasma samples from two time points during follow-up, the mean of which served as the primary predictor. Adjusted hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox regression.
Results: CRP level above the median was associated with an 80% increased risk of esophageal adenocarcinoma. The HR and 95% CI adjusted for age, gender, and further adjusted for waist–hip ratio and smoking were 1.98 (1.05–3.73) and 1.77 (0.93–3.37), respectively, with Ptrend for continuous CRP = 0.04. Persons with IL6 levels above the median also had almost 2-fold increased risk [HR and 95% CI adjusted for age and gender, and further adjusted for waist–hip ratio and smoking were 1.95 (1.03–3.72) and 1.79 (0.93–3.43), respectively, but no evidence of a trend was observed]. Concentrations of TNF receptors and F2-isoprostanes were not associated with esophageal adenocarcinoma risk.
Conclusions: Further research is needed to evaluate the role of inflammation and associated markers in esophageal adenocarcinoma development in persons with Barrett's esophagus.
Impact: This prospective study suggests that inflammation markers, particularly CRP and IL6, may help identify persons at higher risk of progression to esophageal adenocarcinoma. Cancer Epidemiol Biomarkers Prev; 23(11); 2393–403. ©2014 AACR.
Plasma 25-Hydroxyvitamin D and Risk of Colorectal Cancer after Adjusting for Inflammatory Markers
Authors: Song Mingyang , Wu Kana , Chan Andrew T. , Fuchs Charles S. , Giovannucci Edward L. 
Published: August 2014

Abstract
Despite the substantial epidemiologic evidence on the inverse association between circulating 25-hydroxyvitamin D [25(OH)D] and colorectal cancer, it remains controversial whether this relationship is causal or due to confounding by inflammation. We reevaluated the association between plasma 25(OH)D and colorectal cancer risk by additionally accounting for inflammatory markers in a prospective case–control study nested within the Nurses' Health Study and Health Professionals Follow-up Study (615 cases and 1,209 matched controls). Conditional logistic regression was used to estimate relative risk (RR) and 95% confidence interval (CI) of colorectal cancer in relation to quartiles of plasma 25(OH)D. Results were compared before and after adjusting for inflammatory markers in the multivariable model. Plasma 25(OH)D was associated with reduced risk of colorectal cancer (multivariable RR comparing extreme quartiles = 0.71; 95% CI, 0.52–0.97; Ptrend = 0.01). Additional adjustment for C-reactive protein, IL6, soluble tumor necrosis factor receptor 2, or a composite inflammatory score did not change the results [multivariable (including inflammatory score) RR = 0.72; 95% CI, 0.53–0.98; Ptrend = 0.02). Our findings suggest that confounding by inflammation, as reflected by circulating inflammatory markers, does not appear to account for the inverse association between plasma 25(OH)D and colorectal cancer. Cancer Epidemiol Biomarkers Prev; 23(10); 2175–80. ©2014 AACR.
Molecular Pathways: Linking Tumor Microenvironment to Epithelial–Mesenchymal Transition in Metastasis
Authors: Jung Hae-Yun , Fattet Laurent , Yang Jing 
Published: August 2014

Abstract
During tumor development, tumor cells constantly communicate with the surrounding microenvironment through both biochemical and biophysical cues. In particular, the tumor microenvironment can instruct carcinoma cells to undergo a morphogenesis program termed epithelial-to-mesenchymal transition (EMT) to facilitate local invasion and metastatic dissemination. Growing evidence uncovered a plethora of microenvironmental factors in promoting EMT, including proinflammatory cytokines secreted by locally activated stromal cells, hypoxia conditions, extracellular matrix components, and mechanical properties. Here, we review various biochemical and biophysical factors in the tumor microenvironment that directly impinge upon the EMT program. Specifically, cytokines such as TGFβ, TNFα, and IL6 and hypoxia are capable of inducing EMT in various tumors. Several extracellular matrix (ECM) proteins, including collagen-I, fibronectin, and hyaluronan, and ECM remodeling via extracellular lysyl oxidase are also implicated in regulating EMT. In preclinical studies and ongoing clinical trials, targeting these tumor microenvironmental signals has shown promises in halting tumor progression in various human cancers. Clin Cancer Res; 21(5); 962–8. ©2014 AACR.
Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303
Authors: Egloff Ann Marie , Lee Ju-Whei , Langer Corey J. , Quon Harry , Vaezi Alec , Grandis Jennifer R. , Seethala Raja R. , Wang Lin , Shin Dong M. , Argiris Athanassios , Yang Donghua , Mehra Ranee , Ridge John Andrew , Patel Urjeet A. , Burtness Barbara A. , Forastiere Arlene A. 
Published: August 2014

Abstract
Purpose: Treatment with cisplatin or cetuximab combined with radiotherapy each yield superior survival in locally advanced squamous cell head and neck cancer (LA-SCCHN) compared with radiotherapy alone. Eastern Cooperative Oncology Group Trial E3303 evaluated the triple combination.
Experimental Design: Patients with stage IV unresectable LA-SCCHN received a loading dose of cetuximab (400 mg/m2) followed by 250 mg/m2/week and cisplatin 75 mg/m2 q 3 weeks ×3 cycles concurrent with standard fractionated radiotherapy. In the absence of disease progression or unacceptable toxicity, patients continued maintenance cetuximab for 6 to 12 months. Primary endpoint was 2-year progression-free survival (PFS). Patient tumor and blood correlates, including tumor human papillomavirus (HPV) status, were evaluated for association with survival.
Results: A total of 69 patients were enrolled; 60 proved eligible and received protocol treatment. Oropharyngeal primaries constituted the majority (66.7%), stage T4 48.3% and N2-3 91.7%. Median radiotherapy dose delivered was 70 Gy, 71.6% received all three cycles of cisplatin, and 74.6% received maintenance cetuximab. Median PFS was 19.4 months, 2-year PFS 47% [95% confidence interval (CI), 33%–61%]. Two-year overall survival (OS) was 66% (95% CI, 53%–77%); median OS was not reached. Response rate was 66.7%. Most common grade ≥3 toxicities included mucositis (55%), dysphagia (46%), and neutropenia (26%); one attributable grade 5 toxicity occurred. Only tumor HPV status was significantly associated with survival. HPV was evaluable in 29 tumors; 10 (all oropharyngeal) were HPV positive. HPV+ patients had significantly longer OS and PFS (P = 0.004 and P = 0.036, respectively).
Conclusions: Concurrent cetuximab, cisplatin, and radiotherapy were well tolerated and yielded promising 2-year PFS and OS in LA-SCCHN with improved survival for patients with HPV+ tumors. Clin Cancer Res; 20(19); 5041–51. ©2014 AACR.
Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee
Authors: Paller Channing J. , Bradbury Penelope A. , Ivy S. Percy , Seymour Lesley , LoRusso Patricia M. , Baker Laurence , Rubinstein Larry , Huang Erich , Collyar Deborah , Groshen Susan , Reeves Steven , Ellis Lee M. , Sargent Daniel J. , Rosner Gary L. , LeBlanc Michael L. , Ratain Mark J. 
Published: August 2014

Abstract
Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. The phase I trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase I clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamics (i.e., biomarker). Clin Cancer Res; 20(16); 4210–7. ©2014 AACR.
Pharmacogenomic Modeling of Circulating Tumor and Invasive Cells for Prediction of Chemotherapy Response and Resistance in Pancreatic Cancer
Authors: Yu Kenneth H. , Ricigliano Mark , Hidalgo Manuel , Abou-Alfa Ghassan K. , Lowery Maeve A. , Saltz Leonard B. , Crotty Joseph F. , Gary Kristen , Cooper Brandon , Lapidus Rena , Sadowska Mariola , O'Reilly Eileen M. 
Published: August 2014

Abstract
Purpose: Despite a challenging prognosis, modern cytotoxic therapy can induce tumor responses and extend life in pancreatic adenocarcinoma (PDAC). Pharmacogenomic (PGx) modeling of tumor tissue can predict the efficacy of chemotherapeutic agents in preclinical cancer models. We hypothesized that PGx profiling of circulating tumor and invasive cells (CTIC) isolated from peripheral blood could predict tumor response, progression, and resistance.
Experimental Design: A PGx model was created and validated in preclinical models. A prospective clinical trial was conducted. Fifty patients with advanced PDAC were enrolled. Before treatment, 10 mL of peripherally drawn blood was collected. CTICs isolated from this blood sample were expression profiled and the PGx model was used to predict effective and ineffective chemotherapeutic agents. The treating physicians were blinded to PGx prediction.
Results: We found that CTICs could be reliably isolated, total RNA extracted and profiled from 10 mL of peripheral blood from patients with unresectable PDAC before chemotherapy treatment and at disease progression. Using previously created PGx models to predict chemotherapy sensitivity, we found that clinical benefit was seen for study participants treated with chemotherapy regimens predicted to be effective versus chemotherapy regimens predicted to be ineffective with regard to progression-free (10.4 mo vs. 3.6 mo; P &lt; 0.0001; HR, 0.14) and overall survival (17.2 mo vs. 8.3 mo; P &lt; 0.0249; HR, 0.29).
Conclusions: These findings suggest that PGx profiling of CTICs can predict treatment response. Clin Cancer Res; 20(20); 5281–9. ©2014 AACR.