bluuebunny/crossref_metadata_2025_split huggingface dataset:
Biomarq: A novel approach to automated HER2-analysis of circulating tumor cells (CTCs).
Authors: Pestka Aurelia , Friedl Thomas W. P. , Majunke Leonie , Jaeger Bernadette , Andergassen Ulrich , Neugebauer Julia Katharina , Jueckstock Julia Kathrin , Keij Jan , Friese Klaus , Fehm Tanja N. , Mueller Volkmar , Janni Wolfgang , Rack Brigitte Kathrin 
Published: March 2020

638 Background: Targeted treatment approaches directed against CTCs might improve the outcome of metastatic breast cancer patients. Accurate and reproducible assessment of the CTC phenotype is a requirement to use CTCs as treatment targets. The aim of this study was to test the suitability of the automated BioMarQ System (Veridex, USA) – an enhancement of the FDA-approved CellSearch System (Veridex USA) for CTC detection– for assessing the Her2-status of CTCs based on fluorescence and cell-morphology data. Methods: Data on classification of the Her2-status into four groups (0, +, ++, +++) obtained by visual inspection of CTCs after immunocytochemical staining with the CellSearch System, and of BioMarQ-generated automatic measures on fluorescence and cell morphology via image clips generated from raw images were available for 329 CTCs from 17 metastatic breast cancer patients. A discriminant analysis was performed to test whether linear combinations of the fluorescence and/or cell morphology measures allow a separation of CTCs into four groups according to the visual classification of their Her2-status. Results: The highest concordance with the visual classification was obtained by a set of three discriminant functions based on the five variables mean-, maximum- and integrated fluorescence intensity, cell area (µm2), and coefficient of variation for the pixel fluorescence values within a cell. All five variables differed significantly among the 17 patients (Kruskal-Wallis-test, all p < 0.001). Based on the three discriminant functions, 74.5% of all cases were correctly assigned to the four visually obtained categories (6 out of 8 CTCs classified as +++; 57 out of 80 as ++; 17 out of 65 as +, 165 out of 176 classified as 0). Conclusions: Our preliminary analysis shows that discriminant functions derived from measures on fluorescence and cell morphology generated by BioMarQ correctly assigned the Her2-status of CTCs to the four visually obtained categories in 75% of all cases. Further analysis based on a larger number of Her2-positive CTCs, and cross validation by FISH-analysis will provide deeper insight into the suitability of BioMarQ for objectively assessing the Her2-status of CTCs.
Exposure–safety relationship of trastuzumab emtansine (T-DM1) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC).
Authors: Jin Jin , Wang Bei , Gao Yuying , Samant Meghna , Li Chunze , Song Chunyan , Swain Sandra M. , Untch Michael , Girish Sandhya 
Published: March 2020

646 Background: Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate composed of trastuzumab, the cytotoxic agent DM1, and a stable thioether linker. The effects of T-DM1 exposure on safety in patients with HER2-positive locally advanced or MBC are reported. Methods: The exposure–safety analysis included 618 patients with pharmacokinetic (PK) data who received single-agent T-DM1 3.6 mg/kg q3w from five phase 2 or 3 studies: TDM4258g, TDM4374g, TDM4450g/BO21976, TDM4688g, and EMILIA. Exposure parameters observed in cycle 1 were T-DM1 conjugate AUC, T-DM1 conjugate Cmax, and DM1 Cmax, (no PK accumulation). Safety endpoints were worst grade of thrombocytopenia (TCP) or hepatotoxicity (HPT) by protocol definitions. A multivariate logistic regression analysis was conducted to evaluate the association of exposure and clinically relevant covariates with the probability of experiencing TCP or HPT. Platelet counts (PLT), alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin (TBL) versus time profiles were also evaluated by exposure quartiles to further test exposure effect on lab values. A secondary analysis for patients in the EMILIA study alone (n=307) was also conducted. Results: Grade ≥3 TCP and grade≥ 3 HPT were observed in 72 patients and 45 patients in the exposure–safety data set, respectively. Data from the pooled studies showed no statistically significant association between exposure and the incidence of grade ≥3 TCP (T-DM1 AUC P=0.99, T-DM1 Cmax P=0.97, DM1 Cmax P=0.72), or grade ≥3 HPT (T-DM1 AUC P=0.25, T-DM1 Cmax P=0.93, DM1 Cmax P=0.95). Additionally, no obvious difference was observed for longitudinal PLT, ALT, AST, or TBL profiles across exposure quartiles, with no exposure–safety relationship for the probability that PLT, ALT, AST, or TBL exceeded grade 3 thresholds. Similar results were observed for the EMILIA analysis. Conclusions: For patients with HER2-positive locally advanced or MBC treated with T-DM1 3.6 mg/kg q3w, no exposure–safety relationship was observed for TCP, HPT, PLT, or liver function based on T-DM1 or DM1 exposure.
Augmenting state cancer registry data for quality-of-care assessment: A Georgia-based application to evaluate receipt of adjuvant therapies for breast cancer and colorectal cancer.
Authors: Lipscomb Joseph , Ward Kevin C. , Adams Kathleen , Joski Peter , Roblin Douglas , Gillespie Theresa Wicklin , Li Juan 
Published: March 2020

6523 Background: The value of linking population-based cancer registry data with insurance claims files to assess quality of care has been demonstrated in numerous studies, including those using NCI’s linked SEER-Medicare database, covering patients age 65+ in fee-for-service plans, and studies linking registry data with Medicaid, private insurance, or managed care data covering the under-65 population. We describe a prototype program linking registry data with multiple data sources to assess quality of care for at-risk populations in a defined geographical area. Methods: Data exchange agreements were executed among the investigative site (Emory University), Georgia state government, and the claims data sources/vendors. We linked Georgia Cancer Registry (GCR) records for 1999-2005 incident cases of breast and colorectal cancer with enrollment and medical services records from Medicare, Medicaid, Kaiser Permanente of Georgia, and the State Health Benefit Plan (SHBP) which covers all state workers and dependents. Following data quality checks, algorithms based on National Quality Forum (NQF) endorsed breast and colorectal cancer quality measures were applied to each linked data set to assess performance. Results: The linked data sets included 60% of all breast and colorectal cancer cases in the GCR over the study period. Quality measure performance rates varied notably across payers. For example, the percent of Stage III colon cancer patients meeting the NQF standard for adjuvant chemotherapy in the linked GCR-Medicaid, GCR-Kaiser, and GCR-SHBP data were, respectively, 75%, 92%, and 92% (p<0.05). The rates for breast cancer patients meeting standards for adjuvant chemotherapy were 86%, 84%, and 87% (p=NS), respectively. Patients in the linked GCR-Medicare data (all age 65+) generally had lower performance rates for each NQF measure. Conclusions: Linking state cancer registry data with multiple public and private sources of administrative data is technically feasible, and may represent a viable strategy for building a national cancer data system for quality improvement, as recommended in 1999 by the Institute of Medicine.
Breast cancer patient surveillance following curative-intent treatment: Variation among metropolitan statistical areas.
Authors: Avino Robert J. , Allam Emad S. , Chen Ling , Virgo Katherine S. , Margenthaler Julie A. , Johnson Frank E. 
Published: March 2020

6526 Background: There are about 3 million breast cancer survivors in the US, with about 230,000 new cases of breast cancer diagnosed annually. Most receive curative-intent treatment. Post-treatment surveillance is commonly done. We previously documented dramatic variation in surveillance intensity among ASCO experts. The only surveillance modalities endorsed by ASCO for asymptomatic patients are office visit and mammogram. We sought to determine the effect of the physician’s practice location on the intensity of surveillance by comparing Metropolitan Statistical Areas (MSAs). MSAs are large urbanized areas. Methods: The 3245 ASCO members who indicated that breast cancer was a major clinical focus of their practice were surveyed regarding their surveillance practices. They were asked to consider 4 idealized clinical vignettes and indicate their surveillance plan for each. A menu of 12 testing modalities was offered. Repeated-measures ANOVA was employed to compare practice patterns by MSA. Results: There were 1012 responses; 915 were evaluable. The modalities most frequently recommended were office visit, CBC, LFTs, and mammogram. We analyzed the 8 MSAs (New York, Chicago, Philadelphia, Los Angeles, Pittsburgh, Washington, Boston, and St. Louis) with enough responses for analysis. Every modality discouraged by ASCO was recommended by some respondents. Significant variation (p<0.05) in recommended frequency of use was present for all frequently recommended surveillance modalities. For example, in year 1, office visit was recommended 2.8 ± 0.9 (mean ±SD) times in Philadelphia and 4.0 ± 1.9 times in Los Angeles. Conclusions: Evidence-based clinical guidelines have proven effective in providing high quality care and decreasing variation in practice.ASCO members often recommend surveillance modalities that are not recommended by ASCO clinical guidelines, suggesting overuse. Statistically significant variation among the 8 MSAs in recommended use of most testing modalities was present. However, this variation was clinically quite small. Variation among MSAs cannot explain the known marked variation in clinical practice we have previously documented.
Impact of performance evaluation on the quality of care in non-small cell lung cancer.
Authors: Tanvetyanon Tawee , Lee Ji-Hyun , Fulp William J. , Jacobsen Paul B. ,   for the Florida Initiative for Quality Cancer Care
Published: March 2020

6531 Background: Improvement in the quality of care can translate into an improvement in the patient outcome. Evaluation of care quality among oncology practices has been associated with an improvement in the care of breast or colorectal cancer patients previously. Lung cancer is the leading cause of cancer death. Recently quality of care indicators specific for non-small cell lung cancer (NSCLC) have been developed. We investigated the impact of oncology practice evaluation on care quality in NSCLC. Methods: In 2008, members of the Florida Initiative for Quality Cancer Care submitted medical records of randomly sampled, new NSCLC patients who were seen in 2006 for review as baseline practice performance. Results were then circulated among members and voluntary improvement projects independently undertaken in each practice. In 2010, a repeat evaluation was conducted of new NSCLC patients first seen in 2009 to characterize change(s). Results: 10 practices (7 private and 3 university-based) contributed 1,091 patient records for analysis: 518 in 2006 and 573 in 2009. Baseline characteristics of patients were well balanced; however, the proportion of Medicaid or unfunded patients was higher in 2009 than in 2006 (14.8% vs. 7.7%, p=0.002). Of the 7 quality indicators measured, 4 showed a significant improvement when adjusted by practice site and patient characteristics (Table). Notable improvements included the use of brain staging before chemoradiation for stage III patients, performance status documentation and the use of cisplatin for adjuvant therapy. Conclusions: Performance evaluation is associated with an improvement in selected indicators of the quality of care in NSCLC. [Table: see text]
Cancer care coordination systematic review and meta-analysis: Twenty-two years of empirical studies.
Authors: Sheinfeld Gorin Sherri , Haggstrom David , Fairfield Kathleen , Han Paul , Krebs Paul , Clauser Steven B. ,   QCCC_CCI Working Group
Published: March 2020

6536 Background: To our knowledge, no systematic review of empirical papers describing cancer care coordination interventions has yet been conducted. The aim of this presentation is to describe the methods and findings from a systematic review and meta-analysis of all empirical papers describing cancer care coordination published between 1990-2012. Methods: Of 1241 abstracts collected from a search of PubMed and EMBASE, 108 studies were retrieved and reviewed; 49 were included in the systematic review. Each study had US or Canadian adult or child participants; each paper had comparison or control groups, measures, samples, and/or interventions. Two researchers independently applied a standardized search strategy, coding scheme, and on-line coding program to each study. Eight RCT’s met additional criteria for meta-analysis; a random effects estimation model was used for data analysis. Results: Among the 49 articles included in our systematic review, those that included implicit or explicit definitions of cancer care coordination described four components: (1) roles and models for communication and transfer of care between primary care physicians and oncologists during active treatment and survivorship; (2) care navigation through designated personnel or telecommunication processes among care team members; (3) treatment summaries and survivorship care plans; and (4) multidisciplinary communication accompanying patient and practice management within the framework of the Chronic Care Model (N=14). We found a medium-sized effect of cancer care coordination on care usage outcomes among the randomized clinical trials (e.g., reduced Emergency Department visits; g = 0.37 [95% CI = 0.29 - 0.44], I2= .000. Fail-safe N = 86). Conclusions: The findings from this current systematic review and meta-analysis will contribute to the evidence base on strategies that can improve the coordination of cancer care, particularly for patients with multiple chronic conditions, and thereby advance the goals of health care reform in the US.
What do patients with cancer think of the use of their tumor tissue for medical research?
Authors: Karapetis Christos Stelios , Kumar Rajiv , Timothy Quek , Sukumaran Shawgi , Kichenadasse Ganessan , Dua Divyanshu , Takhar Harminder Singh , Richards Alison , Mead Kelly , Ly Marleesa , Koczwara Bogda 
Published: March 2020

6541 Background: Research involving archival tumor tissue has become increasingly important in molecular oncology and has led to improved therapeutics. There are important ethical considerations for such research. We examined the attitudes of patients with cancer toward research that used their tumor tissue. Methods: From January to April 2012, consecutive patients with cancer attending the outpatient clinic of the Flinders Cancer Centre were asked to complete a 27-item investigator-developed questionnaire. The questionnaire included 4 sections: 1) demographics, 2) understanding of cancer research, 3) donation of tumor tissue and 4) ethical issues. Results: 118 patients completed the questionnaire, 53% male and mean age 61. 95% stated that they believed that research involving tumor tissue was beneficial to the public and to cancer patients in the future. 72% responded such research could have a direct benefit for them. 94% would allow their tissue to be used for future research. 86% stated that nothing would prevent them from allowing tissue research. Only14% believed that they needed to be informed about the research. Only 5% were of the opinion that the tissue still belonged to them after it had been removed from their body. 72% were not concerned where their tissue was sent for research, whilst 19% preferred that the research be conducted in Australia. When asked about the use of tissue for research after death, 10% stated that their prior approval was required, less than 1% wanted their family members to approve the research whilst 80% felt that ethics committee approval without individual consent was acceptable. Less than 1% stated that the tissue should be destroyed after death. 69% expressed a preference for the research findings to be available to everyone without commercialisation. Conclusions: The majority of patients permit the use of their tumor tissue for research with ethical approval but without the expectation of individual consent. After death, most patients did not want to have their tissue discarded and were accepting of research without the need for prior consent or family approval. We need to understand the preferences of the majority of patients in determining optimal policy for correlative tumor tissue research.
Saving lives and costs through screening (Sc) for colorectal cancer (CRC): Implications for limited-resource healthcare systems (LRHS).
Authors: Barzi Afsaneh , Directo Michael , Dasu Sriram , Lenz Heinz-Josef , Sadeghi Sarmad 
Published: March 2020

6545 Background: While USPSTF and ACP have determined that Sc for CRC is beneficial, the practice of Sc and its benefits are not established in LRHS caring for the uninsured. We tested the hypothesis that Sc could result in a reduction in the therapy (Tx) costs for CRC and offset Sc costs. Methods: Using a Markov model we performed individual level microsimulations (ILMS) of 100,000 subjects ≥ 50 years with average risk of CRC. Five Sc strategies (ST) were tested: Fecal occult blood (FOBT) and fecal immune chemical (FIT) annually and biannually (FOBT2, FIT2), and colonoscopy (CS) every 10 years. No Sc was used as referent ST (Ref). Compliance with Sc was assumed at 16% for FOBT and FIT and 56% for CS. Sc was offered to 100, 50 and 25% of the subjects in 3 separate ILMS. Life Years Gained (LYG) and Incremental Cost Effectiveness Ratios (ICER) were calculated. Costs and LYG discounted at 3%. Results: Mean follow up: 12.6 years. At all coverage levels all STs resulted in decreased CRC costs by 9-17% and deaths by 14-41%. CS decreases CRC incidence by 5-26%. At higher coverage rates, CS remains the best ST, but at 25% and lower coverage FOBT and FIT function better. Conclusions: These data support systematic use of Sc for CRC in LRHS. Until resources for CS are available, lives and costs could be saved by simple measures such as FOBT and FIT and enrolling as few as 4,552 subjects. [Table: see text]
Racial disparities in initiation of endocrine therapy for early-stage breast cancer.
Authors: Reeder-Hayes Katherine Elizabeth , Meyer Anne-Marie , Dusetzina Stacie , Liu Huan , Wheeler Stephanie B. 
Published: March 2020

6572 Background: Oral endocrine therapy (ET) is the cornerstone of adjuvant therapy for hormone receptor-positive (HR+) breast cancer, greatly reducing the risk of recurrence and death when taken for at least 5 years. Failure to initiate ET is a known problem that adversely affects recurrence and survival. The survival gap between black and white women with breast cancer is most pronounced in HR+ subtypes, and could be related to differences in ET use. The relationship between race and failure to initiate ET is not well defined. We investigated patterns of ET initiation by race in a diverse cohort of women covered by commercial health insurance. Methods: We identified 2753 women with incident HR+ breast cancer in the North Carolina Central Cancer Registry whose records linked to insurance claims using the statewide Integrated Cancer Information and Surveillance System (ICISS) database maintained by the University of North Carolina. The sample included privately insured women age <65 years who were diagnosed with stage I-III HR+ breast cancer between 2004 and 2009 and received primary therapy including breast surgery within 12 months of diagnosis. We used multivariate Poisson regression with robust variance to examine the effect of race on likelihood of initiating ET (tamoxifen, anastrozole, letrozole or exemestane). Results: 14% of eligible women did not initiate any form of ET within 12 months of diagnosis. Black women initiated ET at a significantly lower rate (IRR 0.83, 95% CI 0.73-0.93) after adjustment for age, disease characteristics, other treatments, and socioeconomic variables. Women receiving breast conserving surgery (BCS) without radiation (RT) were less likely to initiate compared to those receiving BCS + RT or mastectomy, and women whose treatment included chemotherapy were less likely to initiate ET. Conclusions: Black women in our sample were significantly less likely to initiate ET in a timely fashion than their white counterparts. This underutilization may contribute to the pronounced survival gap among black women with HR+ breast cancer, and represents an opportunity for intervention to reduce breast cancer disparities. Further investigation is needed to understand the reasons why black women do not initiate ET.
Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: Cognitive function (FACT-Cog) in breast cancer patients.
Authors: Chan Alexandre , Foo Yu Lee , Ham Guo Maung Shwe , Kee Yuan Chuan , Tan Yee Pin , Yong Wei Sean , Madhukumar Preetha , Ooi Wei Seong , Chay Wen Yee , Dent Rebecca Alexandra , Ang Soo Fan , Lo Soo Kien , Yap Yoon Sim , Ng Raymond C.H. , Cheung Yin Ting 
Published: March 2020

6589 Background: Establishing the Minimal Clinically Important Difference (MCID) is essential for interpreting the clinical relevance of patient reported outcomes. This is the first study to date to determine the MCID of FACT-Cog, a 37-item validated subjective neuropsychological instrument designed to evaluate cancer patients’ perceived cognitive deterioration on their quality of life. Methods: This prospective, observational study involved 220 breast cancer patients who have completed FACT-Cog and EORTC-QLQ-C30 at two time points: baseline and at least 3 months following chemotherapy. The MCID was computed using 3 approaches: 1) an anchor-based approach utilized the validated EORTC-QLQ-C30-Cognitive Functioning scale (CF) as the anchor for patients who showed a minimal deterioration on the CF (defined as a one-step deterioration on the CF scale); 2) a Receiver Operating Characteristic (ROC) curve was used to identify an optimal MCID cut-off point for deterioration; 3) a distribution-based approach utilized the 0.33 SD, 0.5 SD and one standard error of measurement (SEM) of the total FACT-Cog score (148 points) to estimate the MCID. Results: There was moderate correlation between the mean change scores of FACT-Cog and CF (rp= 0.43, p<0.001). The CF-anchored MCID was 9.6 points (95% CI 4.4 - 14.8). MCID derived from the ROC method was 7.5 points (AUC: 0.75; sensitivity: 75.6%; specificity: 68.8%). Using the distribution-based approach, MCID corresponding to effect sizes of 0.33SD to 0.5SD of the total FACT-Cog score ranged from 6.9 – 10.3 points and one-SEM criterion resulted in a MCID estimate of 10.6 points. Combining results from all approaches, the MCID identified for FACT-Cog ranged from 6.9 – 10.6 points (4.7% to 7.2% of total score). Conclusions: A 6.9 to 10.6 points reduction of the FACT-Cog score corresponds to the smallest clinically-relevant perceived cognitive deterioration. These estimates are important as they can facilitate the interpretation of patient-reported cognitive changes and sample size estimation in future studies.