bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized phase III double-blinded placebo-controlled trial of first-line chemotherapy and trastuzumab with or without bevacizumab for patients with HER2/neu-overexpressing metastatic breast cancer (HER2+ MBC): A trial of the Eastern Cooperative Oncology Group (E1105).
Authors: Arteaga Carlos L. , Mayer Ingrid A. , O'Neill Anne M. , Swaby Ramona F. , Alpaugh R. Katherine , Yang Ximing J , Wagner Lynne I. , Meropol Neal J. , Saphner Thomas James , Jahanzeb Mohammad , Perez Edith A. , Lin Nancy U. , Sledge George W. 
Published: March 2020

605 Background: Pre-clinical and nonrandomized clinical data support synergy of the combination of bevacizumab and trastuzumab. We conducted a randomized double-blinded phase III trial of chemotherapy/trastuzumab ± bevacizumab to evaluate efficacy (PFS after treatment initiation) of the addition of bevacizumab in first-line treatment of HER2+ MBC. Methods: Days 1, 8 and 15 paclitaxel ± carboplatin were administered with trastuzumab and either placebo or bevacizumab 10 mg/kg every 2 weeks for a total of 6 months. Antibody therapy was then continued without chemo every 3 weeks, until disease progression or unacceptable toxicity. Disease assessments were performed every 3 months. Results: Ninety-six of the planned 489 analyzable patients (pts) were accrued between 2007 and 2009, at which time the study terminated due to poor accrual. Seventy % of pts were post-menopausal, 60% had ER+/HER2+ BC. Median age was 55 years (28-80). Outcomes and toxicities are summarized on the tables below. Median follow-up was 30 months. Conclusions: The combination of chemotherapy, trastuzumab, and bevacizumab did not significantly increased toxicity, and was overall safe and well tolerated. No significant differences in clinical benefit were observed between both treatment arms. Data on CTCs and Quality of Life will be presented at the meeting. This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA32291, CA31946, CA49957, CA27525, CA14548, CA17145, CA32102, CA25224, CA49. [Table: see text] [Table: see text]
Improving the impact of clinical research: A systematic analysis of kidney cancer trials.
Authors: Hirsch Bradford Richard , Mitchell Aaron , Cheng Steven Kunyuan , Tasneem Asba , Schulman Kevin A. , Dilts David M. , Abernethy Amy Pickar 
Published: March 2020

6051 Background: Clinical trials are essential to advancing cancer care, but the means to evaluate and improve the portfolio have been lacking. This study analyzes the renal cell carcinoma (RCC) trial portfolio using the database for the Aggregate Analysis of ClinicalTrials.gov. As RCC is an area of promise, what insights can an evaluation of the portfolio provide? Methods: 40,970 clinical studies registered with ClinicalTrials.gov between October 2007 and September 2010 were aggregated by specialty using MeSH terms and submitted conditions. 8,942 oncology trials were identified and categorized by cancer type. 108 trials opening in October 2007 or later were identified as evaluating treatments for RCC. Descriptive statistics were used to characterize trial design, study agent(s), accrual and sponsorship. Results: 52 trials (48%) assessed agents already recommended as 1st or 2nd-line treatments in the National Comprehensive Cancer Network (NCCN) RCC Guidelines at the time of study initiation and 19 (18%) studied other FDA-approved treatments. 37 trials (34%) included a novel (non-FDA approved) agent or vaccine. Total anticipated or actual accrual was 12,753, with 50% accrued/accruing to trials of only NCCN agents, 34% to novel agents and 16% to other FDA-approved agents. Industry was identified as a sponsor or collaborator in 48% of trials assessing only NCCN agents, 73% of novel agent trials and 53% of other FDA-approved agent trials. As shown in the table, a minority of trials were randomized, blinded or late-phase (Phase III or IV), regardless of approval status of study agent. Conclusions: The majority of new studies and accrual in RCC assess questions of treatment sequence and setting for established therapies, many of which lack rigorous design. Across the portfolio, studies are predominantly industry sponsored. Optimizing clinical research includes increasing studies of novel therapeutics and improving the comparative effectiveness research portfolio by increasing utilization of pragmatic designs, registries and late-phase programs. [Table: see text]
A brief educational intervention to increase communication about complementary and alternative medicine (CAM) in community oncology settings.
Authors: Cohen Lorenzo , Urbauer Diana , Fisch Michael , Fellman Bryan , Hough Holly , Miller Jessica , Lanzotti Victor J. , Whisnant Mindy , Weiss Matthias , Fellenz Lori , Bury Martin J. , Kokx Patricia , Finn Kathleen T. , Daily Maureen , Parker Patricia A. 
Published: March 2020

6054 Background: The widespread use of CAM in academic oncology settings has been well documented. However, there is a lack of communication between patients and health care professionals on CAM that may have negative health consequences. No comprehensive study of CAM use in community oncology settings exists. We examined the benefits of a brief educational intervention on nurse discussions of CAM with patients. Methods: A multi-site, randomized trial of an educational intervention (brief video, resource list) designed to encourage oncology nurses to discuss CAM use with their patients was conducted within the MD Anderson CCOP network. Nurses (N=175) and patients (baseline N=699 and different set of patients after intervention N=650) completed questions about CAM use, communication, and knowledge. Results: Nurses were 97% female, 96% non-Hispanic white. Two months after the intervention, nurses in the intervention group reported that they were more likely to ask about CAM use than those in the control group (OR=4.2; p<.005) and asked more of their last 5 patients about CAM use (p=.003). No significant intervention effect was found for the proportion of patients in the clinic who indicated they were asked about CAM use after the intervention (OR=1.6, p>.10). Approximately 40% of patients reported using CAM following their cancer diagnosis yet the majority of nurses estimated less than 25% of their patients used CAM. Conclusions: CAM use in community-based oncology patients is high and there is an underestimation of use by the oncology nurses. This very brief intervention significantly improved how often nurses reported asking patients about their CAM use. However, the patients of the nurses did not reflect this change in communication. Additional types of interventions are needed to increase communication between patients and nurses.
Self-reported conflicts of interest (sfCOI) of authors and the interpretation of randomized phase III trials (RCT) and related editorials (REd) in cancer research.
Authors: Bariani Giovanni Mendonca , De Celis Ferrari Anezka Carvalho Rubin , Hoff Paulo Marcelo , Riechelmann Rachel 
Published: March 2020

6055 Background: Growing participation from industry in cancer research has resulted in increased reporting of COI. We aimed to test any association between author’s conclusion and sfCOI in cancer studies. Methods: All RCT and REd published in 6 major cancer journals in a 3.5 year period were selected. Two investigators blinded to COI disclosure independently analyzed each RCT and REd, classifying authors’ conclusions as highly positive, positive, neutral, negative, and highly negative with respect to author’s opinion on the experimental therapy. The agreement rate between investigators for conclusion classification was 90% (consensus was achieved for the remaining 10%). We also collected data on study results, COI and sponsorship. COI was defined as any self-reported financial tie between author and industry except for research funds. Predictors of positive/highly positive conclusions of RCT and of REd were tested separately in logistic regression multivariable models. Results: From Jan 2008 to Oct 2011, 1,485 articles were retrieved: 150 RCT and 140 REd were eligible. Among the RCT, 82 (55%) were positive, and 78 (52%) were entirely or partially funded by industry. Any sfCOI was present in 103 (69%) RCT and in 71 (47%) REd. Conclusions of REd and RCT were: 7.3% and 11.3% highly positive, 42.7% and 57.3% positive, 8.0% and 2.0% neutral, 29.3% and 18.7% negative, and 12.7% and 10.7% highly negative, respectively. Multivariable analysis showed that RCT positive result was the only significant predictor for positive conclusion by RCT authors (OR=109, 95% CI: 21-567; p<0.001). The only factor associated with positive conclusions of REd authors was a positive conclusion by RCT author (OR=42, 95% CI: 7-244; p<0.001). While 64 (43%) RCT reported negative results, 103 (68.7%) RCT authors interpreted studies positively. Logistic regression for discordance between RCT result and RCT conclusion did not find any association with COI. Conclusions: The interpretation of RCT results by authors was not influenced by sfCOI or trial sponsorship. Authors of REd were not influenced by study results or by their sfCOI when discussing cancer RCT.
The cost-effectiveness of improving cancer screening compliance.
Authors: Broder Michael S. , Yermilov Irina , Ko Clifford Y. , Maggard Gibbons Melinda , Chang Eunice , Bentley Tanya G. , Cherepanov Dasha , Hsiao Wendy C. , Keeler Emmett B. 
Published: March 2020

6057 Background: Expensive treatments and a growing number of cancer patients have resulted in increased spending on cancer care. Within a framework we developed for measuring the value of quality improvement (QI), we describe the cost-effectiveness of improving compliance with cancer screening measures compared to other quality measures. Methods: We used our framework to examine 18 Healthcare Effectiveness Data and Information Set (HEDIS) 2010 quality measures, synthesize related cost-effectiveness (CE) data and describe measure-specific QI-adjusted incremental cost-effectiveness ratios (ICERs). For each measure we: 1) quantified current compliance; 2) reviewed literature for ICERs; 3) estimated per-person steady state cost and quality-adjusted life years (QALYs); 4) estimated affected population size; 5) estimated the cost of QI; and 6) calculated QI-adjusted ICERs at full compliance, defined as 95%. We assumed per-person QI costs did not change with compliance and varied this in sensitivity analyses. We compared QI-adjusted ICERs for 3 cancer screening measures to the remaining measures. Results: Published ICERs for the cancer screening measures were $43,180/QALY (breast), $5,102/QALY (cervix) and $15,173/QALY (colon) and for other measures from $195/QALY (drug treatment) to $35,616/QALY (flu shots). Incorporating QI costs for cancer screening measures gave QI-adjusted ICERs of $64,549/QALY (breast), $15,463/QALY (cervix) and $22,991/QALY (colon), respectively. Incorporating QI costs for all 18 measures resulted in QI-adjusted ICERs from $195/QALY (drug treatment) to $9,075,868/QALY(antidepressant management), with a median of $15,463/QALY. Reaching 95% compliance with the 3 cancer measures would cost $5.1 billion and add 160,000 QALYs ($32,640/QALY) and with all 18 measures would cost $13.4 billion and add 5.8 million QALYs ($2,313/QALY). Conclusions: Improving compliance with cancer screening may be cost-effective at a threshold of $50k/QALY, although improving care on all HEDIS measures may be even more cost-effective. Accurate assessment of the cost of increasing cancer screening requires integration of both the cost-effectiveness of the screening tests and the cost of the QI programs needed to change practice.
Rural versus urban differences among patients (pts) with hormone-receptor positive (HR+) breast cancer (BC) and a 21-gene assay recurrence score (RS).
Authors: Andreason Molly , Zhang Chong , Onitilo Adedayo A. , Charlson John A. , Ledesma Wendy M. , Ridolfi Kimberly , Kim KyungMann , Wisinski Kari Braun , Champeny Torie L , Engel Jessica Marie , Millholland Robert , Dean James T , Tevaarwerk Amye 
Published: March 2020

6063 Background: Differences in BC outcomes have been noted between rural and urban women. The influence of tumor biology vs treatment factors as the driver of these differences remains unclear. The Oncotype Dx 21-gene assay RS predicts distant recurrence risk for HR+BC; a RS>18 indicates possible chemotherapy benefit. We assessed rural vs urban differences in RS and therapies received (endocrine therapy; chemotherapy for RS>18). Methods: Retrospective chart review was conducted on BC pts diagnosed 2005–2010 with a 21-gene assay RS. Stage, grade, medications and receptor status were abstracted; RS information was obtained from Genomic Health. Rural-Urban Commuting Area (RUCA) codes defined rural vs urban status. Comparisons between rural vs urban pts were made using two-sample tests, chi-square or Fisher’s exact test for discrete data such as RS (≤ 18 vs > 18), stage and ER status. T- or Wilcoxon rank sum test were used for continuous data (RS 0-100 and age.) All tests were at a two-sided significance level of 0.05. Results: Of 495pts with RS, 488 had RUCA codes (91% white, 61% postmenopausal). For rural vs urban pts, mean RS was 18 vs 19, p=0.15. The table shows univariate analysis for other predictors. For treatment, 321/354 (97%) rural vs 118/134 (94%) urban pts started endocrine therapy (p=0.2). For RS>18, 17/55 (31%) rural vs 83/165 (50%) urban pts received chemotherapy (p=0.02, Chi-square test). Conclusions: Rural pts did not have significantly different RS compared with urban pts, but received significantly less chemotherapy for RS>18. This suggests that for HR+ BC, rural vs urban discrepancies may be explained in part by treatment factors. We suggest prospective comparison or confirmation in another cohort. [Table: see text]
Utility of positron emission tomography (PET) scans on the management of cancers of unknown primary.
Authors: Chen Hao , Cheung Winson Y. 
Published: March 2020

6066 Background: PET scans can be potentially useful in the diagnostic and staging workup of certain cancers. Although frequently ordered, its precise role in the investigation and management of cancers of unknown primary (CUP) remains poorly defined. Our main study aims were to 1) compare the utility of PET vs. CT scans in determining the primary site, lymph node status, and metastases for patients with CUP, and 2) describe the overall survival of patients for whom the primary site was determined by PET vs. those who were not. Methods: Patients diagnosed with CUP in British Columbia, Canada from 2006 to 2009, evaluated at 1 of 5 regional cancer centers in the province, and underwent a PET scan were reviewed. We measured concordance rates between PET and CT scans and constructed regression models to characterize the effect of PET scans on treatment and survival. Results: A total of 175 patients were included: median age was 60 years and 76% were men. PET scans were most commonly performed for the following indications: locating primary (45%); staging (42%); and others (13%). Among those in whom CT did not detect the primary site, PET revealed the location of the primary in 9% of cases. CTs and PETs were concordant in demonstrating nodal status and metastases in 91% and 95% of patients, respectively. PET scans were able to show additional nodal involvement and uncover metastatic disease in 9% and 5%, respectively, when compared to CT scans. Identification of the site of primary cancer by PET did not substantially modify subsequent therapy (p=0.37) and it also failed to significantly improve the median overall survival (10.1 vs. 7.3 months, p=0.57) when compared to those in whom the location of the primary was unconfirmed. Conclusions: In this retrospective cohort of CUP patients, CT and PET scans appear to provide a similar level of diagnostic and staging information. For a small proportion of CUP patients, PETs were superior in clarifying the primary site, nodal status, and metastases, but these did not alter therapy or increase overall survival. Based on these findings and considering the cost implications of intensive imaging studies, the diagnostic value of PET scans over CT scans appears limited to a small subset of patients with CUP.
Out-of-pocket (OOP) health care expenditure burden for Medicare beneficiaries with cancer.
Authors: Zuckerman Ilene H. , Pandya Naimish B. , Stuart Bruce C. , Shaffer Thomas , Erten Mujde Z. , Ke Xuehua , Shoemaker J. Samantha , Tai Ming-Hui , Davidoff Amy J. 
Published: March 2020

6075 Background: Concern is increasing about the OOP burden faced by cancer patients (pts). Medicare beneficiaries have multiple comorbidities, have limited financial resources, and may face substantial cost sharing under traditional Medicare if they do not have generous supplemental coverage. We examined OOP spending and burden relative to income for Medicare beneficiaries with cancer, compared to a non-cancer comparison group. Methods: We used Medicare Current Beneficiary Survey data (1997-2007). Newly diagnosed cancer pts were selected using ICD-9CM codes on claims after a 12 mos washout period. OOP spending was assessed using self report for the index(diagnosis) and subsequent year. Pt characteristics were self reported. Generalized Linear Models estimated effects of pt characteristics on OOP spending; logistic regression identified pt characteristics associated with high burden, defined as OOP spending >20% of income. Results: The cohort included 1,869 beneficiaries with, and 10,057 beneficiaries without cancer. Relative to the non-cancer cohort, cancer pts were older, had greater comorbidities, and were more likely to lack supplemental coverage (22 vs 16%) (all at p<0.01).OOP spending was $4,727 or 11.4% of total spending for cancer pts. The unadjusted difference between cancer and non-cancer pts in OOP spending was $1,518 (p<.001); with adjustment for patient characteristics, cancer patients faced an incremental $956 (p<.01) in OOP spending. Median[mean] OOP/income was 10%[24%] for beneficiaries with, compared to 6%[14%] without cancer (p<.001). Over ¼ (28%) of beneficiaries with cancer spent 20% of their income OOP, compared to 16% of beneficiaries without cancer (p<.001). Supplemental insurance and higher income were protective against high OOP burden, whereas assets, comorbidity, and receipt of cancer-directed radiation and antineoplastic therapy were associated with higher OOP burden. Conclusions: Medicare beneficiaries with cancer face higher OOP burden than their counterparts without cancer; some of the higher burden was explained by higher comorbidity burden and lack of supplemental insurance. Financial pressures may discourage some elderly patients from pursuing treatment.
Surveillance after potentially curative breast cancer treatment: The impact of HMOs.
Authors: Avino Robert J. , Allam Emad S. , Margenthaler Julie A. , Chen Ling , Virgo Katherine S. , Johnson Frank E. 
Published: March 2020

6079 Background: Over 230,000 new cases of breast cancer are diagnosed in the US annually. Most patients receive curative-intent treatment. Post-treatment surveillance is commonly done. We have 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. It is commonly believed that health maintenance organizations (HMOs) restrict test utilization. We sought to determine the effect of HMO penetration rate on the known variation in surveillance strategies. Methods: The 3245 ASCO members who indicated that breast cancer was a major clinical focus of their practice were surveyed regarding their surveillance practices. Members were asked to consider 4 idealized clinical vignettes and indicate their surveillance plan for each. A menu of 12 testing modalities was offered. Practice patterns were stratified by HMO penetration rate (0-14%, 14-22%, 22-33%, 33-61%) in each physician’s practice location. Repeated-measures ANOVA was employed for analysis. Results: Of the ASCO members surveyed, 1012 responded; 915 were evaluable. The modalities most frequently recommended were office visit, CBC, liver function tests (LFTs), and diagnostic mammogram. There was significant variation (p<0.05) in the recommended frequency of utilization of diagnostic mammogram, but in no other modalities. For example, in year 1, diagnostic mammogram was recommended 1.9 ± 1.8 (mean ±SD) times for the 0-14% penetration rate cohort and 1.5 ± 1.1 times for the 14-22% cohort. Conclusions: We found little evidence that HMOs restrict test utilization. The HMO penetration rate in the clinician’s practice location cannot account for the overall variation we have documented previously.
Physician age and surveillance intensity following curative-intent treatment for breast cancer patients.
Authors: Abboud Steven F. , Allam Emad S. , Margenthaler Julie A. , Chen Ling , Virgo Katherine S. , Johnson Frank E. 
Published: March 2020

6081 Background: Breast carcinoma is a large health care concern for patients, physicians, and society. 2.5 million women have been treated for breast cancer and are candidates for surveillance in the US. We have documented dramatic variation in post-treatment surveillance strategies utilized by ASCO experts caring for such patients. Since it is often asserted that younger physicians order more tests than older physicians, we sought to measure the effect of clinician age on post-treatment surveillance intensity for breast cancer patients by analyzing a recent survey of ASCO members. Methods: We surveyed the 3245 ASCO members who indicated that breast cancer treatment was a major focus of their practice. 4 succinct clinical vignettes describing generally healthy women with breast cancer of varying prognoses and a menu of 12 surveillance modalities were offered. The menu was chosen after a literature search indicated that no other surveillance tests were commonly used. We analyzed data from one of the 4 idealized vignettes only (the patient with TNM IIA carcinoma) and stratified responses by clinician age. Practice patterns were compared by years after completion of training (0-10, 11-20, 21-30, 30-40, >40 years), a surrogate measure of physician age. Statistical analysis employed ANOVA. Results: There were 1012 responses; 915 were evaluable. Statistically significant differences were observed across age strata for CBC, liver function tests (LFTs), and serum CEA level only. For example, ASCO clinicians in practice for 0-10 years after completion of training recommended CBCs 1.3 + 1.4 (mean + SD) times in year 1. Those > 40 years after completion of training recommended CBCs 2.4 + 1.3 times in year 1 (p<0.001). Conclusions: Younger physicians recommend statistically significantly fewer CBCs, LFTs, and serum CEA levels during post-treatment surveillance than older physicians. However, the magnitude of the difference is clinically small for all 3 modalities and does not explain the known overall variation in surveillance practice among clinically active experts.