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392s Health Services Research 6040 General Poster Session (Board #1C), Mon, 1:15 PM-5:15 PM Utilization of accelerated partial breast irradiation for ductal carcinoma in situ, 2002-2007: Report from the National Cancer Data Base. Presenting Author: Tomasz Czechura, North Shore University HealthSystem, Evanston, IL Background: The use of accelerated partial breast irradiation using brachytherapy (APBI-b) for patients with invasive cancer is increasing but data for ductal carcinoma in situ (DCIS) cases are limited. The American Society of Radiation Oncology (ASTRO) guidelines suggest that APBI-b should be used only on a �cautionary� or �on trial� basis for women with DCIS. The purpose of this study was to examine utilization trends and correlates of APBI-b use for patients with DCIS. Methods: A total of 70,043 postlumpectomy patients from the National Cancer Database diagnosed with DCIS between 2002 and 2007 were studied. Chi-square tests and logistic regression models were used to determine trends and factors related to APBI-b use. Results: The use of APBI-b increased from 0.7% in 2002 to 10.0% in 2007 (p�0.001). Independent predictors APBI-b use were age, race, insurance status, comorbidity index, facility type, and facility location. Older patients were more likely to use APBI-b; relative to patients 30-39 years old, the OR for patients 80-89 years old was 5.9 (95% CI: 3.7-9.6). APBI-b use was higher in whites (4.9%), compared to blacks (4.4%), Hispanics (2.8%), and Asian pacific islanders (1.5%; p�0.001). Compared to noninsured, Medicare (OR�2.1, 95% CI: 1.3-3.3) and managed care patients (OR�2.0, 95% CI: 1.3-3.2) were more likely to undergo APBI-b. 2.3% of community cancer programs, 5.7% of comprehensive community programs and 4.1% of academic/research programs utilized APBI-b for treating DCIS (p�0.001). The use of APBI-b varied significantly by facility location; the West and South regions of the country were more likely to use APBI-b (OR�14, 95% CI: 10.1-19.6) than the Northeast region. 91% of the APBI-b patients fit the ASTRO �cautionary� guideline and 9% of patients fit the ASTRO �on trial� guidelines. In 2002, 4% of ABPI-b patients fit the �on trial� guidelines which increased to 8.6% in 2007 (p�0.001). Conclusions: The use of APBI-b for DCIS increased from 2002-2007. APBI-b use varies by socioeconomic and facility factors with age being the most significant factor. Future studies are needed to determine the indications for APBI-b in patients with DCIS. 6042 General Poster Session (Board #1E), Mon, 1:15 PM-5:15 PM Prospective evaluation of perceived barriers to medication adherence by patients on oral antineoplastics. Presenting Author: Benyam Muluneh, University of North Carolina Hospitals and Clinics Department of Pharmacy, Chapel Hill, NC Background: Appropriate use of oral antineoplastics (OA), especially those with a food-effect, is a challenge for patients and clinicians. Patient adherence is essential to optimize outcomes, minimize toxicity, minimize bias in clinical trials, and reduce health care costs. As the use of OA grows, due to the narrow therapeutic margin, it is critical to understand the barriers to patient adherence. The purpose of this study was to analyze cancer patients’ use of OAs and identify opportunities to improve patient adherence. Methods: We developed and tested a 30-question survey to address frequency and reasons for reducing/skipping doses; sources of information for OA use; perceived importance of food-drug effects, and ease of understanding directions on vial label. Surveys, consisting of Likert scale and multiple choice questions, were distributed to adult cancer patients on OAs at the UNC Cancer Hospital clinics. Results: Seventy-seven patients taking OAs with CML, RCC, breast cancer, and GI tumors completed the survey with a response rate of 97%. This was a welleducated population with 71% having completed some college; 54% female and 58% older than 50 years. Forty-three percent of patients taking drugs with a significant food-drug effect (sorafenib, pazopanib, lapatinib, imatinib, nilotinib, and capecitabine) did not think about the last time they ate before taking their OA and 23% did not know that their OA had a food-drug effect. In addition, 21% of patients indicated they intentionally skipped/cut back on their OAs and 38% of those did not inform their physician. Although 97% reported no difficulty reading instructions on drug vial, nearly 20% had some difficulty understanding the directions. Conclusions: There are three main barriers associated with appropriate use of OAs: confusion or misunderstanding about the timing of drug with food; reducing/stopping drug without informing MD; and difficulty understanding directions on the drug vial label. A multipronged integrated approach involving the pharmacist, physician and nurse is needed to optimize communication of directions for optimal OA use. 6041 General Poster Session (Board #1D), Mon, 1:15 PM-5:15 PM Conflict of interest disclosure in off-label oncology clinical trials. Presenting Author: Blair Billings Irwin, Duke University Medical Center, Durham, NC Background: Off-label prescribing of anti-cancer targeted therapies is increasingly prevalent. Post-regulatory evidence and reporting requirements for reimbursement for off-label oncologic indications are less stringent than the threshold for United States Food and Drug Administration registration. What are the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements in published reports of studies of cancer targeted therapies conducted in the postregulatory setting? Methods: As a part of a federally-funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to authoritative compendia in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and the presence of COI and funding disclosure statements. Results: Sixty-nine studies were included in the systematic review. Prevalence of COI and funding disclosures was low, at 33% and 58%, respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high impact factor journals (p�0.001), large study sample size (p�0.001), enrollment exclusively in the US (p�0.04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (p�0.03). Studies with multiple sites were more likely to include a funding disclosure statement (p�0.01). Conclusions: There is need for more consistent disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anti-cancer targeted therapies. 6043 General Poster Session (Board #1F), Mon, 1:15 PM-5:15 PM Bias in reporting of endpoints of efficacy and toxicity in randomized clinical trials (RCTs) for women with breast cancer (BC). Presenting Author: Francisco Emilio Vera Badillo, Princess Margaret Hospital, Toronto, ON, Canada Background: Phase III RCTs are designed to assess clinically important differences in endpoints that reflect benefit to patients. Accurate and unbiased reporting is essential to guide rational therapy. Here we evaluate the quality of reporting of the primary endpoint (PE) and of toxicity in RCTs for BC. Methods: PUBMED was searched from 1995-2011 to identify RCTs for BC. Scales for assessing bias in reporting of the PE and of toxicity were developed. For the PE, scales assessed whether the concluding statement of the abstract (CSAbs) was (a) based on the PE, (b) described appropriately a statistically positive or negative result for the PE, or (c) was based on secondary endpoints. Bias and completeness of reporting of toxicity was assessed using a hierarchy scale of whether reporting occurred in the CSAbs, elsewhere in the abstract, in the discussion of the article or only in the results. Association of bias with Journal Impact Factor (JIF); changes in the PE compared to protocol information in clinicaltrials.gov and funding source was also evaluated. Results: 164 trials were evaluated; 33% showed bias in reporting of the PE. The PE was more likely to be reported in the CSAbs if statistically significant [OR 5.2, 95% CI 1.9-14.3, p�0.001]. A statistically negative PE was not reported in the CSAbs in 27% of trials. Of the 30 trials where protocol information was available in clinicaltrials.gov, there were non-significant associations for the PE to show a positive result if had been changed, and for greater bias in reporting the PE if it was unchanged. 67% of studies showed bias in reporting of toxicity. Only 14% mentioned toxicity in CSAbs. When the PE was positive, bias in reporting of toxicity was more common [OR 2.0, 95% CI 1.0-3.9, p�0.04]. There was no apparent association between bias in reporting of either the PE or toxicity and JIF or funding source, but a non-significant association between change in the PE and industry funding. Conclusions: Bias in reporting of the PE is common especially for studies with a negative PE. Reporting of toxicity is poor especially for studies with a positive PE. Changing of the PE appears to be a strategy to increase the likelihood of observing a statistically significant result. Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.
6044 General Poster Session (Board #1G), Mon, 1:15 PM-5:15 PM Unintended consequences of health information technology: Evidence from Veterans Affairs Colorectal Cancer Oncology Watch Intervention. Presenting Author: John Bian, South Carolina College of Pharmacy, Columbia, SC Background: Although health information technology (HIT) has been hypothesized to help achieve greater adherence to recommended clinical guidelines and increase use of preventive care, well-conducted empirical studies evaluating this hypothesis are lacking. This study evaluated the ongoing Colorectal Cancer (CRC) Oncology Watch intervention, a clinical reminder system, implemented in 8 Veterans Affairs (VA) hospitals in 2008 for improving CRC (1) screening adherence among average- or higher-risk veterans, and (2) surveillance. Methods: VA administrative data were used to construct 4 cross-sectional groups of average-risk age 50-64 veterans, one for each of 2006, 2007, 2009, and 2010. We applied a linear probability model with hospital fixed-effects for estimation, using a natural experiment in which the 8 hospitals served as the intervention and other 121 hospitals as a control and with 2006-2007 designated as the pre-intervention period and 2009-2010 as the post-intervention period. Results: The sample included 4,352,082 veteran-years in 4 years. The proportions adherent to screening were 37.6%, 31.6%, 34.4%, and 33.2% in the intervention in 2006, 2007, 2009, and 2010, respectively, and the corresponding proportions in the control were 31.0%, 30.3%, 32.3%, and 30.9%. Regression analysis showed that among those eligible for screening, the intervention was associated with a 2.2-percentage-point decrease in likelihood of adherence (P-value�0.0001). Additional analyses showed that the intervention was associated with a 5.6-percentagepoint decrease in likelihood of screening by colonoscopy among the adherent, but with increased total colonoscopies (any indication) of 3.6 per 100 veterans age 50-64. Conclusions: The intervention may have slightly reduced CRC screening rates for the studied population. This consequence may have been caused by an unintentional shift of limited VA colonoscopy capacity from average-risk screening to higher-risk screening and to CRC surveillance, or by physicians’ fatigue due to the large number of clinical reminders implemented in the VA. 6046 General Poster Session (Board #2B), Mon, 1:15 PM-5:15 PM Association of increases in quality of care with the NCI Community Cancer Center Program (NCCCP) pilot. Presenting Author: Michael T. Halpern, RTI International, Washington, DC Background: The NCCCP pilot is an initiative designed to enhance research and improve cancer care at community hospitals. As part of a multi-method evaluation of this pilot, we assessed changes in quality of care among the 16 pilot NCCCP hospitals over time (before vs. after program initiation) and in comparison to a group of 25 similar hospitals that did not participate in the NCCCP. Methods: We compared changes in 5 NQF-approved quality of care measures (3 for breast cancer, 2 for colon cancer) from 2006/07 (before NCCCP initiation) vs. 2008/09/10 (post-initiation) for NCCCP and comparison group hospitals. Data were collected from all study hospitals using the Commission on Cancer’s Rapid Quality Reporting System, which allowed near real-time tracking of quality of care process measures. Results: Analyses included 18,608 breast cancer and 7,031 colon cancer patients. Patient-level concordance rates for all 5 quality of care measures increased significantly among both NCCCP and comparison group hospitals. The change (from baseline to post-NCCCP) in quality of care among NCCCP hospitals was significantly greater than the change among comparison group hospitals for two measures: radiation therapy following breast conserving surgery (RT-BCS) and hormonal therapy for women with hormone receptor positive breast cancer (HT). For the RT-BCS measure, NCCCP patients from underserved populations also experienced significantly greater changes in concordance than did corresponding populations from comparison group hospitals. In multivariate regression analyses controlling for patient characteristics, the change for the HT measure among NCCCP hospitals was significantly greater than that among comparison group hospitals. Conclusions: While both NCCCP and comparison group hospitals showed improved quality of care, participation in the NCCCP was associated with significantly greater improvements for a subset of measures. Including a separate comparison hospital group was critical for assessing changes associated with NCCCP participation while controlling for broader U.S. trends in improved quality of care. Future work will examine how hospital networks may have facilitated improvements in quality of care. Health Services Research 393s 6045 General Poster Session (Board #2A), Mon, 1:15 PM-5:15 PM Osteoporosis screening among prostate cancer survivors treated with androgen deprivation therapy. Presenting Author: Alicia Katherine Morgans, Massachusetts General Hospital Cancer Center, Boston, MA Background: Androgen deprivation therapy (ADT), the standard systemic treatment for prostate cancer, has adverse effects including bone loss and fractures. Current national guidelines suggest that men receiving ADT undergo dual energy x-ray absorptiometry (DXA) before and during ADT to better characterize fracture risk. We assessed receipt of DXA testing in a population-based cohort of men treated continuously with ADT for at least 1 year and identified factors associated with testing. Methods: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified men aged �65 with local or regional prostate cancer diagnosed during 2001-2007 and followed through 2009 who received at least 1 year of continuous ADT. We identified receipt of DXA testing in the 18-month period beginning 6 months before the first dose of ADT. We used logistic regression to identify factors associated with DXA testing, including patient and tumor characteristics and the physicians with whom they had outpatient visits. Results: Among 28,960 men treated with ADT for �1 year, 6.5% had at least one DXA scan from 6 months before the first dose of ADT through 1 year after. DXA testing increased over time, with men initiating ADT in 2007-2009 more likely to be tested than those treated in 2001-2002 (10.0% vs. 3.4%, OR 2.29, 95% CI 1.83-2.85). Men aged �85 were less likely than men aged 66-69 to undergo testing (OR 0.76, 95% CI 0.65-0.89). Black men were less likely than white men to undergo testing (OR 0.92, 95% CI 0.61-0.86), as were men living in areas with lower educational attainment (P�.001). Compared with men seeing a urologist but no medical oncologist or primary care provider (PCP), men seeing a medical oncologist and a urologist (OR 2.11, 95% CI 1.39-3.21) and those seeing a medical oncologist, urologist and PCP (OR 2.59, 95% CI 2.01-3.34) had higher odds of testing. Conclusions: Few men receiving ADT for prostate cancer undergo DXA testing, with particularly low rates of testing among older men, black men, and those living in areas with low educational attainment. Visits with a medical oncologist were associated with increased odds of testing. Interventions are needed to increase bone density testing among men receiving long-term ADT. 6047 General Poster Session (Board #2C), Mon, 1:15 PM-5:15 PM Geographic and network analysis of oncology trials: Portfolio assessment of ClinicalTrials.gov. Presenting Author: Steven Kunyuan Cheng, Oregon Health & Science University, Portland, OR Background: Increasing complexity and specificity of cancer trials (CT) necessitates collaboration across the CT network to optimize research efforts. The relationship among CT sites and networks provide unique insights into improving coordination and accrual. Methods: 5971 interventional CTs registered between 2007 and 2010 were aggregated by trial and location. CTs in the Aggregate Analysis dataset from ClinicalTrials.gov (AACT) were identified using MeSH terms. The distribution of mid-phase (MP)(phase I/II,II) and late-phase (LP)(PII/III,PIII) CTs for the ten most represented cancer types by number of sites was assessed using network graph theory and geographic analysis comparing distribution of trials across metropolitan statistical areas. Results: 66,566 CT sites were identified across the sample, 59.6% were in the United States (MP: 50.2%; LP: 42.9%). Geographical availability of CTs and local cancer incidence rates were highly correlated (0.797, p� 0.001) but varied depending upon disease type. Network density (the degree of dyadic interconnections between sites studying similar cancer types) showed overall that MP trials were less dense with sparser interconnections among sites than LP trials. Network density of LP trials was higher for cancer types that had poorer correlation between geographic distribution of incidence and enrolling sites (-0.777, p�0.008). MP trials did not show a similar trend. Conclusions: The relationship between the distribution of CT and site location can be envisaged through geographic and network analysis of CT registry data. LP high-density networks should strive to diversify trial locations to better meet regional incidence rates. Incidence and trials MP (mid-phase) LP (late-phase) Pearson Corr. (all p
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Volume 30, Issue 15S, Part I of II
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Editor: Michael A. Carducci, MD Man
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Volume 30, Issue 15S Supplement to
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Letter from the Editor The 2012 ASC
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JOURNAL of CLINICAL ONCOLOGY ......
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ASCO Conflict of Interest Policy an
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2012 ASCO Annual Meeting Proceeding
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500 Oral Abstract Session, Sun, 8:0
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Author Index Note: Numerals refer t
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Alexanian, Raymond 8093 Alexeev, Bo
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Arkenau, Hendrik-Tobias 2540, 3000,
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Ballen, Karen K. 6606, 6617, 6618,
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Ben-Aharon, Irit 548, 2556, e13080
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Blancas, Isabel e11535, e11545, e21
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Brandes, Johann Christoph 7048, 106
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Cakir, Betul 9567 Calabek, Bernadet
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Ceraulo, Domenica 4017 Cerbone, Lin
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Chinen, Ludmilla T.D. e16046 Chinen
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Come, Steven E. 9071, 9100 Comis, S
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Dahlheimer, Tambra 2546 Dahmane, El
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DeLacure, Mark D. e16052 Delage, Ju
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Domingo, Gelenis 6568, 6575, 6588 D
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El Sherbeiny, Esam e15129 El-Deiry,
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Fayad, Luis 6501, 8067 Fayette, Jer
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Foroni, Chiara e11546 Foroni, Letiz
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Gang, Wu 7091, e14511 Gangaram, Anj
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Gimenez Capitan, Ana 4068, 10596, e
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Granowetter, Linda 9537 Grant, Barb
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Hainsworth, John D. 618, 1018, 1086
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Heerschap, Arend e13111 Heersink, M
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Hong, Seung-Mo 3568 Hong, Sook Hee
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Im, Young-Hyuck 598^, 644, TPS649,
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Ji, Yongling e17527 Jia, Jingquan e
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Kaparelou, Maria 583 Kapaun, Christ
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Kim, Chan Kyu e14688 Kim, Chang Won
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Komatsu, Yoshihiro e14689 Komatsu,
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Laack, Nadia N. 2032, e14507 Laadem
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Lee, Ji-Hyun TPS3114, 6100 Lee, Jih
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Lim, Kian-Huat e14584 Lim, Kiat Hon
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Loupakis, Fotios 3518, 3540, 3546,
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Man, Shan e11061, e15177^ Manaloor,
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Mathieu-Nicot, Florence e19623 Math
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Mergenthaler, Hans-Guenther e15026
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Ng, Daniel e15050 Ng, Dawn Marie e1
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Palassini, Elena 10026, 10053, 1006
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Peisker, Uwe 10600 Peker, Deniz e18
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Piwnica-Worms, Helen 3047 Pizzo, Fa
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Rabinowits, Guilherme 5501, 5582, 9
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Reyes-Rivera, Irmarie CRA3503 Reyna
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Rose, Steven C. 3590 Rosell, Rafael
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Sakata, Shinya e18059 Sakata, Yuh 3
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Schenkein, David P. 6606 Schepp, Wo
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Sha, Dan 3564 Sha, Huifang e13528 S
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Silva, Jose D. 5567 Silva, Milton J
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Sousa, Carlos Eduardo Pires 643 Sou
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Su, Xinying 4124 Su, Yu-Chieh e1600
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Tan, Chee Seng 1064, e19523 Tan, Ch
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Tillmanns, Todd D. 5014, e15514 Til
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Uchiyama, Tomotaka e21108 Udovitsa,
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Wang, Yuan e15124 Wang, Yunfei 547
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Wischnewsky, Manfred 1078 Wischnik,
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Yasuda, Hiromi e14029 Yasuda, Hiroy
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Zhang, Xinmin e16022 Zhang, Xu Dong
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