National Cancer Institute Center Research Articles

Quality of information addressing treatment options for women with breast cancer on NCI cancer center websites.

135 Background: The internet is increasingly utilized by cancer patients for information that may influence treatment decisions. National Cancer Institute (NCI)-designated cancer center websites and nationally recognized cancer research agencies are trusted sources of information, however little data exists regarding the quality of information on these sites. We evaluated the quality and accessibility of breast cancer treatment information on cancer center websites addressing therapeutic options. Methods: Websites of all NCI cancer centers, the NCI, and Susan G. Komen were reviewed. Quality was measured using 33 questions from three validated Breast Cancer Decision Quality Instruments (DQI). Two blinded reviewers determined if websites provided information to answer each question. Number of clicks to reach the breast-specific webpage, evaluation time, and Spanish and mobile accessibility were recorded. Kappa coefficient was used to measure inter-observer variability. Correlation between evaluation time and questions answered was measured using Pearson coefficient. Results: Of the 63 cancer center websites evaluated, 94% had breast cancer webpages reached in a median of 2 clicks. Average evaluation time was 11 minutes. 24% were Spanish accessible. 59% were mobile friendly. No site provided information that addressed all questions. The most informative cancer center site addressed 76% of questions. On average, 21% of questions were addressed per site. 16% of sites did not have sufficient information to answer any question. In comparison, the NCI and Komen sites covered higher proportions of questions than cancer center sites (85 and 88%). Inter-observer variability was fair to moderate (avg. Kappa 0.37). Evaluation time strongly correlated with number of questions answered (r = 0.75). Conclusions: NCI cancer center websites provided informative feedback for breast cancer patients across an average 21% of key knowledge points in a validated DQI. This information is less accessible to Spanish speaking patients and patients using mobile devices. Website improvements represent an opportunity to enhance knowledge that may improve shared decision making for women with breast cancer.

Enhancing a Culture of Inquiry: The Role of a Clinical Nurse Specialist in Supporting the Adoption of Evidence.

This article describes a Magnet®-designated, national cancer institute comprehensive cancer center's quest to restructure the organization's evidence-based practice (EBP)/performance improvement (PI) framework leveraging the role of the clinical nurse specialist (CNS) as a coach to support staff nurses in EBP/PI initiatives. The support of the CNS is essential in developing effective projects, minimizing barriers, and maintaining a level of engagement in the EBP process from problem identification through dissemination and sustainment of practice changes.

Impact of proximity to NCI- and NCCN-designated cancer centers on outcomes for patients with prostate cancer undergoing radical prostatectomy.

14 Background: National Cancer Institute (NCI) and National Comprehensive Cancer Network (NCCN)-designated cancer centers (CCs) offer patients state-of-the-art treatment. We sought to identify whether proximity to NCI/NCCN CCs was associated with survival outcomes for prostate cancer patients who undergo radical prostatectomy (RP). Methods: A total of 12,478 total patients diagnosed with clinical stage T1 or T2 prostate cancer between 2004–2011 using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data were included. Multivariable regression analyses were used to quantify overall survival and use of secondary therapies for RP patients according to proximity to NCI/NCCN CCs. Cox proportional hazards models were used to quantify the association between survival outcomes and access to NCI/NCCN CCs. Results: Patients with proximity to ≥ 2 NCI centers and those diagnosed in 2011 enjoyed a statistically significant overall survival advantage when compared to no access to an NCI center (Hazard Ratio (HR) 0.72; 95% confidence interval (CI) 0.57–0.92, p < 0.01). Proximity to an NCCN CC, when compared with men who did not have access, was associated with improved overall survival (HR 0.76; 95% CI 0.61–0.95, p = 0.015). There was no significant difference in use of secondary therapies according to NCI or NCCN access. Conclusions: Patients who undergo RP with access to an NCI/NCCN CCs experienced improved overall survival with no significant difference in utilization of secondary therapies. Given the need for improved health quality measures in cancer care, these findings may support health policy implementation and regionalization of care to these centers.

The role of magnetic resonance image guided prostate biopsy in stratifying men for risk of extracapsular extension at radical prostatectomy. Raskolnikov D, George AK, Rais-Bahrami S, Turkbey B, Siddiqui MM, Shakir NA, Okoro C, Rothwax JT, Walton-Diaz A, Sankineni S, Su D, Stamatakis L, Merino MJ, Choyke PL, Wood BJ, Pinto PA. Urologic Oncology Branch, National Cancer Institute, National Institutes

PurposeMagnetic resonance imaging detects extracapsular extension by prostate cancer with excellent specificity but low sensitivity. This limits surgical planning, which could be modified to account for focal extracapsular extension with image directed guidance for wider excision. In this study, we evaluate the performance of multiparametric magnetic resonance imaging in extracapsular extension detection and determine which preoperative variables predict extracapsular extension on final pathology when multiparametric magnetic resonance imaging predicts organ confined disease. Materials and methodsFrom May 2007 to March 2014, 169 patients underwent pre-biopsy multiparametric magnetic resonance imaging, magnetic resonance imaging/transrectal ultrasound fusion guided biopsy, extended sextant 12-core biopsy, and radical prostatectomy at our institution. A subset of 116 men had multiparametric magnetic resonance imaging negative for extracapsular extension and were included in the final analysis. ResultsThe 116 men with multiparametric magnetic resonance imaging negative for extracapsular extension had a median age of 61 years (IQR: 57–66) and a median prostate specific antigen of 5.51 ng/ml (IQR: 3.91–9.07). The prevalence of extracapsular extension was 23.1% in the overall population. Sensitivity, specificity, and positive and negative predictive values of multiparametric magnetic resonance imaging for extracapsular extension were 48.7%, 73.9%, and 35.9% and 82.8%, respectively. On multivariate regression analysis, only patient age (P = 0.002) and magnetic resonance imaging/transrectal ultrasound fusion guided biopsy Gleason score (P = 0.032) were independent predictors of extracapsular extension on final radical prostatectomy pathology. ConclusionsBecause of the low sensitivity of multiparametric magnetic resonance imaging for extracapsular extension, further tools are necessary to stratify men at risk for occult extracapsular extension that would otherwise only become apparent on final pathology. Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy Gleason score can help identify which men with prostate cancer have extracapsular extension that may not be detectable by imaging.

Abstract A70: Geographic management of cancer health disparities programs (gmap) region 5: Strategies to promote and support the next generation of cancer researchers

Abstract Background: The National Cancer Institute's Center to Reduce Cancer Health Disparities (CRCHD) is invested in supporting and strengthening workforce diversity by increasing the number and quality of competitive grant applications and awards from underrepresented trainees, scholars and early stage investigators via the Continuing Umbrella Research Experience (CURE) program. More specifically, CRCHD is interested in receiving a greater number of competitive mentored career development award applications from under-represented applicants. Chief among these are the K-series awards. In response to this call to action, GMaP Region 5 has developed and implemented a number of strategies aimed at increasing the quantity of high-quality competitive career development award submissions from under-represented early stage investigators within the region. Methods: To be successful, Region 5 has put into place a number of strategies and resources to identify potential K-series applicants and to provide on-going support and mentorship to encourage competitive submissions of K-series applications by new under-represented applicants. Recognizing that different strategies work for different individuals, the totality of strategies is designed to address a variety of needs, including mentoring, feedback, communication with one's peers, and networking. To facilitate this, Region 5 has developed the following: a mentorship program that pairs applicants with a senior investigator from within the region who will provide feedback on grant proposals, a travel scholarship program that facilitates opportunities for regional and national networking and grant writing workshop participation, a one day career development workshop for potential applicants, a weekly listserv email that includes job/funding/training opportunities and relevant resources for early stage investigators, among other activities. Results: Based on an evaluation, a key finding is that scholars and early stage investigators located in Region 5 were not only aware of the various strategies, they also found them to be valuable resources that they either utilize or intend to utilize. A number of early stage investigators, for example, have availed themselves of mentoring from senior investigators. Other early stage investigators have received feedback from senior academicians. The last one-day training workshop, as another example, included 14 trainees from diverse venues in the region, which extends from Alaska to Guam. Evaluations from the workshop will be discussed. Conclusion: Building on our hypothesis that diverse applicants respond differently to specific strategies, GMaP Region 5 is implementing a number of diverse strategies to reach under-represented applicants. The results indicate that different applicants respond to different strategies. By offering diversity in our approach to engage potential K-series award applicants, Region 5 will contribute to the pool of successful under-represented minority early stage investigators who conduct scientifically sound cancer health disparities research. Citation Format: Heidi Tham, Megan Brown, Beti Thompson. Geographic management of cancer health disparities programs (gmap) region 5: Strategies to promote and support the next generation of cancer researchers. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A70.

Abstract B27: A synergistic regional network's infrastructure to reduce cancer related health disparities

Abstract Cancer Health Disparities is defined by the National Cancer Institute (NCI) as “adverse differences in cancer incidence, prevalence, morbidity, mortality, survivorship, and burden of cancer or related health conditions that exist among specific population groups in the United States.” NCI recognizes the substantial progress in cancer treatment, screening, diagnosis, and prevention over the past several decades. However, addressing cancer-related health disparities in certain populations is an area in which progress has not kept pace. Therefore, NCI's Center to Reduce Center Health Disparities (CRCHD) created region-based “hubs” under the Geographic Management of Cancer Health Disparities Program (GMaP) to advance the science of cancer health disparities in the regions, contribute to the next generation of cancer health disparities researchers, and achieve measureable reductions in cancer health disparities in the United States. GMaP Region 1 North (R1N) hub is based at the University of Kentucky Markey Cancer Center, with Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, University of South Carolina Cancer Prevention and Control Program, and the University of Virginia Cancer Center as lead institutions. The overall goal of GMaP R1N is to enhance the capacity of regional cancer centers, associated academic partners, community partners, and early-stage investigators to contribute to the reduction of cancer health disparities in the region covering Kentucky, West Virginia, Virginia, Delaware, Maryland, New Hampshire, Vermont, Maine, and Washington DC. GMaP R1N is utilizing an infrastructure of investigators and partners throughout the region that serve on the Advisory Committee, Education and Outreach Subcommittee, Diversity Training Subcommittee, and/or Evaluation Subcommittee to: create opportunities for scientific exchange, cooperation, and collaboration among cancer and cancer-related health disparities researchers throughout the region; attract underrepresented students, trainees/scholars, and investigators to the biomedical cancer research enterprise; enhance access of underrepresented students, trainees, and scholars to career development and mentoring opportunities; and increase cancer information dissemination and sharing of best practices among researchers and trainees/ scholars. Using this infrastructure, R1N anticipates enhanced collaboration between regional cancer centers and other academic partners, including regional minority serving institutions; increases in the number of competitive collaborative grant applications to NCI from regional cancer and academic centers; increases in the number of successful K- and R- award applications to NCI by underrepresented students, trainees/scholars, and investigators in the region; increased mentoring relationships developed, both within and across regional cancer and academic centers; and increased dissemination of research and career development opportunities across regional institutions. Citation Format: Neha Jaggi, Julia Faith Houston, James R. Hebert, Mark Dignan, Nathan L. Vanderford, Mark Cromo, Mark Evers, Janice Bowie, Adrian Dobs, Olive Mbah, Ashleigh DeFries Gallagher, Roger Anderson. A synergistic regional network's infrastructure to reduce cancer related health disparities. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr B27.

Adolescent and Young Adult Oncology Patients with Acute Lymphoblastic Leukemia: Shifting Location of Care over Time

BackgroundOver the past decade, research has demonstrated superior outcomes for adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) when they are treated on pediatric versus adult ALL protocols, which occurs more frequently at academic centers. We hypothesized that this knowledge resulted in a greater proportion of younger adults with ALL receiving treatment at National Cancer Institute (NCI)/Children's Oncology Group (COG) designated centers over the past decade, and that an increased proportion of younger AYAs (ages 18-21) received care at pediatric (COG) versus adult centers.MethodsWe used the Office of Statewide Health Planning and Development patient discharge database to conduct a retrospective analysis of AYA patients with ALL, ages 18 to 25 and diagnosed and treated in California from 2004 to 2013. The primary outcome was receiving care at a NCI/COG designated center up to 5 years after diagnosis. Multivariable logistic regression was used to determine socio-demographic factors associated with AYAs ever receiving care from an NCI/COG designated center. Descriptive analyses were used to evaluate changes in the percentage of admissions from NCI and COG designated centers over time using a chi-square test to make comparison of proportions over time.ResultsThere were 703 patients, ages 18-25 years (52.5%, 18-21; 47.5%, 22-25 years) who were newly diagnosed with ALL and hospitalized in California between 2004 and 2013. Sixty-five percent were male and 51% had private insurance. Of these patients, 37% always received care at an NCI/COG center, while 28% sometimes and 35% never received care at these centers. Younger AYAs (18-21 years) had a higher odds of ever being discharged from a NCI/COG center (OR 1.52, CI 1.10-2.10), while AYAs living farther from a NCI/COG center were less likely to receive care at these centers (OR 0.45, CI 0.27-0.76 for 10-20 vs 0-5 miles). Over the past decade, there was an increase in the percentage of admissions to NCI/COG centers among 18-21 year-olds (53% in 2004 to 72% in 2013; p<0.001), whereas there was no significant increase for 22-25 year-olds (44% in 2004 to 49% in 2013; p=0.435) (Figure). When admissions to an NCI and COG center were considered separately, differences were observed by age group. There was a lower percentage of admissions to NCI centers over time in 18-21 year-olds (34% in 2004 to 27% in 2013; p=0.183), but a significant increase in admissions to NCI centers in 22-25 year-olds (27% in 2004 to 40% in 2013; p=0.035). Alternatively, there was a significant increase in the percentage of admissions to COG centers in the 18-21 year-olds (48% to 67%; p<0.001), with a somewhat smaller increase in admissions to COG centers in 22-25 year-olds (25% to 32%; p=0.278) from 2004 to 2013.ConclusionsOver the past decade, approximately 37% of younger (18-25 years) AYAs with ALL always received care at NCI/COG designated centers, with younger age and shorter geographical distance to a NCI/COG designated center being the main predictors for receiving care at these centers. Over the study period, the percentage of admissions increased at NCI centers for 22-25 year-olds and COG centers for 18-21 year-olds. These findings support our hypothesis that there has been a shift in treatment of younger AYAs (18-21 years) to COG designated centers over the past decade. Further research is warranted to determine the roles that referral patterns, insurance networks, patient preference and other barriers play in receiving care at NCI and/or COG institutions and the effect of care at these centers on survival in population-based data. [Display omitted] DisclosuresWun:Janssen Scientific Affairs, LLC: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Daiichi: Research Funding.

Complications of intrathecal pump therapy in malignancy-related pain.

102 Background: Intrathecal pumps (ITP) are used to manage severe malignancy related pain by delivering analgesics directly into the cerebrospinal fluid, in theory allowing for a reduced opioid dose and fewer complications. Although there is literature to support efficacy in patients with cancer, including improved survival, this mode of drug delivery also carries a risk of serious complications. Reports of complications in non-malignant pain suggest the risks and mortality related to ITP may be under-appreciated and that injury and liability occur with both ITP placement and ITP maintenance. Additional burdens to consider in patients with cancer include accurate prognostication to identify appropriate candidates, and the logistics of providing ITP maintenance. Methods: A retrospective chart review of 26 consecutive patients that underwent implantation of a programmable ITP at a National Cancer Institute center between 2008 and 2014 for malignancy related pain. Results: 53% (n = 14) of patients experienced major and minor ITP complications. Major complications occurred in 35% (9) including leg weakness post operatively requiring wheelchair use for months; granuloma formation causing leg weakness and requiring repeat operation; pump infection leading to sepsis and death; intra-abdominal abscess; significant bleeding requiring discontinuation of therapeutic anticoagulation for PE; and neurological complications including delirium and protracted seizures requiring ICU admission. Minor complications occurred in 31% (8) and included wound infections, urinary retention requiring catheterization, foot drop, and spinal headaches related to CSF leaks. 42% (11) died &lt; 90 days after ITP implantation; 19% (5) died &lt; 30 days after ITP implantation. 7 patients (27%) were either lost to follow up, relocated, transitioned to hospice, or had difficulty finding providers to refill the pump. Conclusions: More than a third of patients with cancer receiving an ITP at our institution experienced major complications including death, sepsis, and neurological problems.

Commentary on Betts et al. (2016): Polysubstance use and opioid substitution therapy among people who inject drugs.

Keywords: Causal inference; clinical trials; heroin; opioid substitution therapy; people who inject drugs (PWID); polysubstance use; prescription drug abuse; propensity score matching; Respondent Driven Sampling (RDS)

A Global Cancer Project Map Integrating Global Cancer Statistics to Guide International Efforts

Abstract 39 Background: In response to the growing burden of cancer, Global Oncology, Inc., and the National Cancer Institute Center for Global Health launched a free, online, interactive map, the Global Cancer Project Map (GCPM) [ http://gcpm.globalonc.org ], to allow policy makers, researchers, and civil society around the world to search this central repository of international cancer control and research projects. The GCPM serves to catalyze collaboration in cancer research and clinical care, as well as inform research and care gaps. Methods: In addition to search options by project attributes, the GCPM provides map overlays of epidemiological measures using IARC’s GLOBOCAN cancer-specific estimates of incidence, prevalence, and mortality, cancer disability--adjusted life years, and UN Human Development Index country values. Currently, the map displays projects with international collaborators collated from the NCI, NCI-Designated Cancer Centers, UICC and ASCO. Results: The GCPM search options offer countless angles of looking at projects worldwide. Of the 1,479 currently-mapped projects, 44.8% have investigators or collaborators in less-developed countries (LDCs) (as defined by the UN). Of the 1218 with a project type classification, 104 relate to capacity building and/or training, with 69 of these projects (66.3%) occurring in LDCs. Utilizing the cancer type search options, the GCPM currently displays 54 cervical cancer projects with LDC collaborators, where the cervical cancer mortality age--standardized risk is more than 2.5 times higher for LDCs than more-developed countries. Conclusions: The GCPM is a real-time needs assessment tool to allow the cancer community to visualize international efforts in cancer control and link need to action. To better address the growing burden of cancer, the partnership is actively seeking collaboration and additional project submissions. Utilized with cancer statistic overlays, the GCPM can help develop regional priorities in cancer research and control. Funding: This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Ali Chisti No relationship to disclose Nour Sharara No relationship to disclose Manaswi Gupta No relationship to disclose Jane Craycroft No relationship to disclose Ilyana Rosenberg Employment: Connance, Inc., Hayes Management Consulting Camille Morgan No relationship to disclose Kalina Duncan No relationship to disclose Rachel Abudu No relationship to disclose Billy Andre No relationship to disclose Shannon Silkenson No relationship to disclose Jennifer Silva No relationship to disclose Ami Bhatt No relationship to disclose Ted Trimble No relationship to disclose Franklin Huang Stock or Other Ownership: GlaxoSmithKline, Abbvie

Abstract A16: Impact of targeted communications within a National Cancer Institute Center to Reduce Cancer Health Disparities Geographical Management of Cancer Health Disparities Program Regional Network

Abstract Purpose: The purpose of the Geographical Management of Cancer Health Disparities Program (GMaP) regional networks is to establish a multi-institutional framework to support and expand research and training of cancer health disparities researchers and trainees to reduce cancer-related health disparities. This study examined the efficacy of communication strategies within GMaP Regions 1 and 2 (R1R2) to improve uptake of communication and dissemination of jobs, training, fellowship, and collaboration opportunities over a two year period. Background: An unequal burden of cancer among population groups exists in the United States. The National Cancer Institute (NCI) defines cancer health disparities as “adverse differences in cancer incidence, prevalence, morbidity, mortality, survivorship, and burden of cancer or related health conditions that exist among specific population groups in the United States.” Collaborative efforts across institutions within geographic regions have been limited despite previous efforts. Therefore, NCI's Center to Reduce Cancer Health Disparities (CRCHD) created GMaP, which consists of five hubs throughout the U.S. to increase collaborative efforts to reduce cancer health disparities intra- and inter-regionally. GMaP R1R2 includes 11 Eastern states and the District of Columbia. Members of GMaP R1R2 identified the need for an improved infrastructure to streamline program communications and facilitate collaborative efforts across a large membership group within R1R2. Methods: A communications strategy was developed to improve efficiency and measure uptake. GMaP R1R2 launched an online platform including a Google® website that integrated social media, Google® applications, infographics and additional media channels for broader dissemination efforts. Google+ Circle®, Twitter®, and Facebook® accounts were created for R1R2. MailChimp® was selected for newsletter distribution replacing ineffective email communications to investigators of all career levels. Results: Built-in analytics for each platform reflected uptake, which informed Program and Regional coordinator efforts. The GMaP R1R2 Google+ Circle® recruited 129 members and its Google® website averaged 1807 page views. MailChimp® includes an average of 920 subscribers. These members are grouped into 3 different listservs including GMaP R1/R2 Overall Group Email, Trainee's E-Blast, and Minority Serving Institutions (MSI) E-Blast. GMaP R1/R2 Group has an average open rate of 24.16%. The Trainee's E-blast group has an average open rate of 36.49%. The majority of these recipients viewed job and training opportunities, CRCHD Funding for Research and Training, and Funding Opportunities posted on the GMaP R1R2 website. The MSI list was created to recruit CURE trainees from minority serving institutes and had an average open rate of 20.87%. The MSI E-Blast revealed that information about CURE, Job/Training opportunities, CRCHD Funding for Research and Training, and Funding opportunities links were the most viewed (“clicks”) of the MailChimp® newsletter. Conclusion: Improved communication and dissemination efforts were realized through the use of electronic media tools to address cancer-related health disparities by GMaP R1R2. Regional Coordinators cite that analytics reports provide valuable information for future communications and online development efforts. Additional research is needed to poll GMaP R1R2 listserv members to learn about the usefulness of this communications platform, the preferred method of social media communication among GMaP R1R2 network members and how to increase their contribution to the current platform for broader dissemination. Citation Format: Julia F. Houston, Neha Jaggi, James R. Hebert, Ashleigh D. Gallagher, Mark Cromo, Athena Kheibari. Impact of targeted communications within a National Cancer Institute Center to Reduce Cancer Health Disparities Geographical Management of Cancer Health Disparities Program Regional Network. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A16.

Cancer surveillance and research on environmental contributions to cancer.

Cancer surveillance is a fundamental component of national or sub-national cancer control planning and research. Cancer incidence and mortality data allow countries to monitor change in cancer incidence, mortality, and survival over time, by geographic region, and by demographic characteristics. Such data provide important clues to form hypotheses for cancer etiologic research, including research to examine environmental contributions to cancer. Strengthening cancer surveillance systems is urgently needed to conduct high quality research in environmental pollution and cancer in many countries. The United States National Cancer Institute Center for Global Health organized the first symposium on Environmental Contributions to Cancer during the 16th International Conference of Pacific Basin Consortium (PBC) for Environment and Health. PBC provided an important forum for dialog to establish partnerships and collaborations among researchers of environmental pollution and cancer.

Implementation of the 21-gene recurrence score test in the United States in 2011.

We examined hospital use of the 21-gene breast cancer test in the United States. We report state-level differences in utilization and propose a model for predicting implementation of guideline-recommended genomic testing. Genomic Health provided test orders for calendar year 2011.We summarized utilization at the hospital and state levels. Using logistic regression, we analyzed the association between the likelihood to order the test and the hospital's institutional and regional characteristics. In 2011, 45% of 4,712 acute-care hospitals ordered the test, which suggests that 25% of newly diagnosed invasive female breast cancer cases were tested. Significant predictors of testing included participation in National Cancer Institute (NCI) clinical research cooperative groups (odds ratio (OR) 3.73; 95% confidence interval, 2.96-4.70), advanced imaging (OR, 2.19; CI, 1.78-2.68), high-complexity laboratory (OR, 2.15; CI, 1.24-3.70), affiliation with a medical school (OR, 1.57; CI, 1.31-1.88), and reconstructive surgery (OR, 1.23; CI, 1.01-1.50). Significant regional predictors included metropolitan county (OR, 3.77; CI, 2.83-5.03), above-mean income (OR, 1.37; CI, 1.11-1.69), and education (OR, 1.26; CI, 1.03-1.54). Negative predictors included designation as a critical-access hospital (OR, 0.10; CI, 0.07-0.14) and distance from an NCI cancer center (OR, 0.998; CI, 0.997-0.999), with a 15% decrease in likelihood for every 100 miles. Despite considerable market penetration of the test, there are significant regional and site-of-care differences in implementation, particularly in rural states.Genet Med 18 10, 982-990.

Helping hands: Organizations, institutions work to assist and mentor early career investigators.

Helping hands: Organizations, institutions work to assist and mentor early career investigators.

Ethics of Clinical Trials in Low-Resource Settings: Lessons From Recent Trials in Cancer Medicine.

National Cancer Institute, Bethesda, MD, and Memorial Sloan Kettering Cancer Center, New York, NY Corresponding author: Sham Mailankody, MBBS, Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, NY 10065; e-mail: mailanks@mskcc. org. Randomized clinical trials in cancer medicine are increasingly conducted in lowand middle-income countries (LMICs). The proper way to conduct such studies is complex and the subject of much debate. Two key questions outline the debate. First, what is the appropriate control arm for such studies? For example, when can trials use placebo or some control less than global best practice? Second, what obligations do trial sponsors have toward host nations and communities?

Impact of access to NCI- and NCCN-designated cancer centers on outcomes for multiple myeloma patients: A SEER registry analysis.

National Cancer Institute (NCI)/National Comprehensive Cancer Network (NCCN)-designated cancer centers (CCs) offer patients state-of-the-art treatment, but their impact on multiple myeloma (MM) patient outcomes has not been evaluated. Adult MM patients diagnosed between 1973 and 2011 were identified from the Surveillance, Epidemiology, and End Results database and were stratified by the county of residence at the time of diagnosis and the year of CC designation. The influence of NCI/NCCN CC access, race, and the year of diagnosis on overall survival (OS) was evaluated with a Cox regression model. A statistically significant OS improvement was noted in patients diagnosed after 1995 with access to 2 or more NCI CCs overall (P = .002 for 1996-2002; P < .001 for 2003-2011) and by race for whites (hazard ratio [HR] for 1996-2002, 0.85; 95% confidence interval [CI], 0.78-0.91; HR for 2003-2011, 0.85; 95% CI, 0.79-0.91) but not for nonwhites. For NCCN access, improvement was seen in 1996-2002 (P = .003), in 2003-2011 (P < .001), and by race for whites (HR, 0.917; 95% CI, 0.88-0.95) and nonwhites (0.94; 95% CI, 0.89-0.99), but within nonwhites, this was true only for African Americans (AAs; HR, 0.88; 95% CI, 0.81-0.97) and not for Asians, Hispanics, or Native Americans. Improvement in OS was seen in MM patients diagnosed after 1995 with access to 1 NCCN CC or 2 or more NCI CCs. NCI access benefited only whites, whereas NCCN access benefited only white and AA patients. No OS benefit was seen for any subgroup with access to only 1 NCI center. Eliminating racial disparities in health care access and utilization is needed to improve outcomes.

Cancer Center Website Rankings in the USA: Expanding Benchmarks and Standards for Effective Public Outreach and Education.

The 68 National Cancer Institute (NCI)-designated comprehensive and cancer centers have been tasked with leading the campaign in the fight against cancer, as well as providing education and outreach to the public. Therefore, it is important for these organizations to have an effective online presence to disseminate information and engage patients. The purpose of this study was to assess both the functionality and usability of cancer centers' websites. The 68 center web domains were evaluated using two separate but complementary approaches. First, a webcrawler was used to score each website on five dimensions: accessibility, content, marketing, technology, and usability. Rankings on each dimension and an average ranking were calculated for all 68 centers. Second, a three-reader system was used to determine a list of all functionalities present on the websites. Both webcrawler scores and functionality prevalence were compared across center type. No differences were observed in webcrawler scores between comprehensive and cancer centers. Mean scores on all dimensions ranged between 5.47 and 7.09. For the functionality assessment, 64 unique functions were determined and categorized into 12 domains, with the average center possessing less than 50% of the functions. This census assessment of NCI centers' websites suggests the need for improvement to capitalize on new dissemination platforms available online. Progress in development of this technology can help achieve the goals of public education and outreach to a broad audience. This paper presents performance guidelines evaluated against best-demonstrated practice to facilitate social media use improvement.

Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer.

Tissue from research biopsies provides access to insights into tumor biology. We aimed to determine medical oncologists' (MOs') attitudes toward research biopsies in patients with metastatic breast cancer (MBC). A total of 309 breast MOs from National Cancer Institute (NCI)-designated cancer centers were invited to complete a self-administered survey about their attitudes toward approaching patients for research purpose-only biopsies (RPOBs), performed as a standalone procedure, or additional biopsies, performed with a clinically indicated biopsy. The MOs were asked to predict what proportion of their MBC patients would consider undergoing research biopsies. Of the 309 MOs, 221 (72%) responded. Of these 221 MOs, 30 were ineligible, leaving 191 eligible responders. Nearly all the MOs reported they were comfortable approaching patients regarding research biopsies of blood or skin. One fifth of MOs were uncomfortable approaching patients for RPOBs of the breast. One half of MOs were uncomfortable approaching patients for RPOBs of the liver. A significant variation was found in the perceptions by MOs of their patients' willingness to undergo research biopsies. The factors associated with increased comfort in approaching patients for research biopsies included fewer years in practice, caring for patients who had undergone recent research biopsies, and the predicted willingness of patients to consent to biopsies. The risk of a biopsy and biopsy-related pain were the most common reasons for reluctance to refer patients for research biopsies. Significant variation exists, even at NCI centers, in the comfort level of MOs in approaching MBC patients for research biopsies. MOs' attitudes toward research biopsies might be a modifiable factor in increasing tissue collection for research. Tissue-based research is critical in advancing our understanding of cancer biology, and obtaining tissue from a research biopsy provides an essential resource. This study demonstrates the variability of oncologists' attitudes toward research biopsies and elicits factors associated with increased comfort levels with approaching patients for research biopsies. Biopsy risk and biopsy-related pain were commonly cited reasons not to refer patients for research biopsies. If the risk of a research biopsy is deemed sufficiently low enough to be acceptable, oncologists' attitudes might be a potential target for education and change, which may assist in increasing the availability of tissue for cancer research.

Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study

Worldwide, although predominantly in low-income countries in the Middle East and Africa, up to 13% of hepatitis C virus (HCV) infections are caused by HCV genotype 4. For patients with HCV genotype 1, the combination of ledipasvir and sofosbuvir has been shown to cure high proportions of patients with excellent tolerability, but this regimen has not been assessed for the treatment of HCV genotype 4. We assessed the efficacy, safety, and tolerability of 12 weeks of combination therapy with ledipasvir and sofosbuvir for patients with chronic HCV genotype 4 infections. In this single-centre, open-label cohort, phase 2a trial, patients with HCV genotype 4 who were treatment naive or interferon treatment experienced (HIV-negative) were sequentially enrolled at the Clinical Center of the National Institutes of Health, Bethesda, MD, USA. We gave patients 12 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) as a single combination tablet once per day. The primary efficacy endpoint was sustained viral response at 12 weeks (SVR12), as measured by the proportion of patients with HCV RNA concentrations less than the lower limit of quantification (COBAS TaqMan HCV test, version 1.0, 43 IU/mL). The primary safety endpoint was the frequency and severity of adverse events. We did our analyses on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT01805882. Between Sept 16, 2013, and Nov 2, 2014, we recruited 21 patients. 20 (95%) of 21 patients completed 12 weeks of treatment and achieved SVR12 (95% CI 76-100), including seven patients with cirrhosis. One patient was non-adherent to study drugs and withdrew from the study, but was included in the intention-to-treat analysis. No patients discontinued treatment because of adverse events and no grade 3 or 4 adverse events occurred that were related to study medications. The most common adverse events were diarrhoea (two patients), fatigue (three patients), nausea (two patients), and upper respiratory infections (two patients). Ledipasvir and sofosbuvir treatment for 12 weeks was well tolerated by patients with HCV genotype 4 and resulted in 100% SVR for all patients who received all 12 weeks of study drugs, irrespective of previous treatment status and underlying liver fibrosis. This is the first report of a single-pill, all-oral, interferon-free, ribavirin-free treatment for patients with HCV genotype 4. NIAID, National Cancer Institute and Clinical Center Intramural Program. The study was also supported in part by a Cooperative Research and Development Agreement between NIH and Gilead Sciences.

Semi-quantitative exposure assessment of occupational exposure to wood dust and nasopharyngeal cancer risk.

Occupational exposure to wood dust is one cause of nasopharyngeal cancer (NPC); however, assessing this exposure remains problematic. Therefore, the objective of this study was to develop a semi-quantitative exposure assessment method and then utilize it to evaluate the association between occupational exposure to wood dust and the development of NPC. In addition, variations in risk by histology were examined. A case-control study was conducted with 327 newly diagnosed cases of NPC at the National Cancer Institute and regional cancer centers in Thailand with 1:1 controls matched for age, gender and geographical residence. Occupational information was obtained through personal interviews. The potential probability, frequency and intensity of exposure to wood dust were assessed on a job-by-job basis by experienced experts. Analysis was performed by conditional logistic regression and presented in odds ratio (ORs) estimates and 95% confidence intervals (CI). Overall, a non significant relationship between occupational wood dust exposure and NPC risk for all subjects was observed (ORs=1.61, 95%CI 0.99-2.59); however, the risk became significant when analyses focused on types 2 and 3 of NPC (ORs=1.62, 95%CI 1.03-2.74). The significant association was stronger for those exposed to wood dust for >10 year (ORs=2.26, 95%CI 1.10-4.63), for those with first-time exposure at age>25 year (ORs=2.07, 95%CI 1.08-3.94), and for those who had a high cumulative exposure (ORs=2.17, 95%CI 1.03-4.58) when compared with those considered unexposed. In conclusion, wood dust is likely to be associated with an increased risk of type 2 or 3 NPC in the Thai population. The results of this study show that semi-quantitative exposure assessment is suitable for occupational exposure assessment in a case control study and complements the information from self-reporting.