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Background/Aims Estimates of the nation’s costs of cancer care are largely based on the SEER-Medicare datalink supplemented by modeling to estimate costs for non-aged patients. The SEER-Medicare data, however, are missing data on HMO (Medicare Advantage) enrollees with cancer. To address this shortfall, this study estimated the incremental medical care resources used to diagnose and treat cancer within integrated delivery systems stratified by phases of cancer care and patient age—before and after age 65.

Background/Aims A prostate specific antigen (PSA) level =4 ng/mL has historically been used as a screening threshold to recommend biopsy; however, guidelines have been changing to recommend lower cutoffs (2.5 ng/mL) and incorporate velocity in decisions to refer men to biopsy. Little is known about how physicians and patients respond to elevated PSA tests. Our objective was to examine trends in biopsy practices over the past decade to identify whether there has been a shift towards lowering PSA thresholds for biopsy referral.

Background Adverse events and medical errors are challenging aspects of clinical care delivery, and also present challenges as topics for research. Nonetheless, understanding how and why such errors occur is critical to rendering improvements. Using examples from a multi-site study of problems in cancer care, we identify potential pitfalls and strategies to consider when researching sensitive or thorny topics in our delivery systems.

Background Prostate cancer screening is controversial; treatment of early stage cancer has uncertain benefits, and complications are likely. Physician-patient discussions about PSA testing may be brief or absent. We investigated men’s familiarity and experiences with PSA testing, and perceived benefits and barriers.

Background Patients with inherited mutations in one or both of the BRCA1/ BRCA2 genes are at substantially higher risk for developing breast cancer and other malignancies. Subsequent to testing becoming publicly available in the late 1990s, organizations such as the National Comprehensive Cancer Network (NCCN) developed guidelines to aid in the identification of high-probability mutation carriers. It is unclear, however, how closely such guidelines are followed by healthcare providers, or what testing barriers may exist among patients. Furthermore, little is known about the clinical care and surveillance received by patients after testing positive for a mutation. The primary objective of this study is to assemble a cohort of BRCA-tested patients, in order to examine their demographic characteristics and clinical follow-up.

Background Almost 75% of breast cancer patients worldwide are treated with adjuvant therapy, primarily radiotherapy (RT). However, little is known about the long-term effects on cardiovascular health, particularly in older women.

Background/Aims Tamoxifen is a widely prescribed endocrine therapy for prevention and treatment of breast cancer in pre- and post-menopausal women and is commonly recommended for five years duration. While most people tolerate tamoxifen reasonably well, thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction or cerebrovascular accident can be serious complications. Study aims include evaluation of epidemiology of tamoxifen-related thromboembolic event in a large community setting, determination of rate and temporal distribution of thromboembolic events, description of patient clinical characteristics, analysis of time from tamoxifen initiation to first thromboembolic event, description of incidence of events among subgroups of patients related to antiplatelet, anticoagulant and statin medication use.

Background/Aims Surgical quality is typically measured using 30-day morbidity and mortality statistics – measures that are not very meaningful for procedures such as lumpectomies and mastectomies that have extremely high survival rates. The University of Vermont previously developed a single-site Breast Cancer Surgical Outcomes (BRCASO) database to capture meaningful quality measures such as breast conservation rates, positive margins rates, and number of procedures to complete breast cancer surgery. We extended the BRCASO database to three Cancer Research Network (CRN) institutions to study variation in breast cancer surgical quality across providers, facilities, and health plans.

Background/Aims Patient-centered communication (PCC) is a critical element of patient-centered care, which the Institute of Medicine (2001) promulgates as essential to improving healthcare delivery. The National Cancer Institute’s Strategic Plan for Leading the Nation (2008) calls for assessing the delivery of PCC in cancer care. However, no comprehensive measure of PCC exists, and stakeholders have different conceptualizations and assumptions about how to measure it. The purpose of our study was to develop a set of self-administered patient survey items for comprehensive PCC assessment.

Background/Aims Screening decreases colorectal cancer incidence and mortaility. However, almost half of eligible adults are not screened at recommended intervals. SOS: Systems of Support to Increase Colorectal Cancer Screening and Follow-up (R01CA121125) is a 4-arm randomized controlled trial that uses a systems-based approach to increase CRCS. We describe characteristics of patients who were not up-to-date compared to those current for CRCS and those who refused to participate in the study.

Background Advances in early detection and treatment of breast cancer has changed this disease from a fatal to chronic health condition. Recognition of informed decision-making and choices as the tenet of living well by the survivors motivates the development of credible and easily accessed information resources. Little is reported regarding the challenges specific to women in rural areas. Presently, available resources to encourage self-care are ineffective for women in our region, as evidenced by above the national average age- and stage-adjusted disease specific mortality rate. We have implemented a pilot project that leverages on technology to partner survivors and professionals that emphasize self regulation and health management

Background/Aims The U.S. mammography screening rate is higher than rates of other preventive services among women, perhaps because efforts to encourage regular mammography have been relatively more effective than efforts to encourage other types of preventive care. The purposes of this study were to investigate the rate at which female members of Scott & White Health Plan received mammography without a primary care physician visit, and to identify any short-term health consequences of receiving mammography without other primary care services.

Background/Aims Chemotherapy-related toxicity, while a major focus of randomized clinical trials, has been understudied in population-based research. Eight Cancer Research Network (CRN) sites used Virtual Data Warehouse (VDW) data to examine the risk of cardiotoxicity following chemotherapy for invasive breast cancer. However, information on VDW chemotherapy data validity is limited. This study assessed the validity of VDW data related to the reception and dosages of cardiotoxic chemotherapeutic agents among breast cancer (BC) patients.

Background Cancer providers strive to deliver high quality care, yet provider-patient communication breakdowns can occur and may contribute to adverse events and errors. A better understanding of cancer providers’ perceptions of communication breakdowns could improve patient and provider satisfaction and patient safety. This study investigated providers’ attitudes and experiences of communication breakdowns in cancer care.

Background Several studies have demonstrated that chemotherapy prolongs survival by upwards of 3 months in patients with advanced (stage IIIb–IV) non-small cell lung cancer (NSCLC), but often at considerable costs. Analyses of SEER-Medicare data suggests that only 25% of older patients receive chemotherapy, however, little is known about how these treatment rates compare to younger patients and to those receiving care in an HMO.

Genetic testing to inform health professionals and patients of disease risk, diagnostic, prognostic, or treatment information such as KRAS mutation testing to determine colorectal cancer (CRC) treatment is an evolving health care approach. KRAS, a pharmacogenomic marker normally expressed in wild type form, confers a lack of response to epidermal growth factor receptor (EGFR) inhibitor treatment in metastatic CRC when mutated. Mutations occur in 30–50% of CRC cases and a gap in knowledge exists regarding the impact of KRAS testing on treatment outcomes in metastatic CRC. The CERGEN-C (Comparative Effectiveness Research in Genomics & Personalized Medicine for Colorectal Cancer) study is a collaboration of eight Cancer Research Network members and four academic partners evaluating connections between evidence synthesis and evidence generation in cancer-related genomics and personalized medicine. We are conducting a comparative effectiveness study to evaluate overall survival in patients who received KRAS testing during routine medical care compared to those who did not before and after recommendations for KRAS testing were published in mid-2008. We identified 800 members from seven integrated health care organizations diagnosed with stage III (n=200) or IV (n=600) colorectal cancer from 1/1/05–7/31/2010. To date, 293 charts have been reviewed, 224 (76%) from pre-KRAS testing recommendations (pre-) and 69 (24%) from post-KRAS testing (post-) recommendations. All cases were Stage IV and the majority of cases were Caucasian, 133 (61%) pre and 51 (76%) post. A family history of any cancer was identified in 97 (43%) pre- and 29 (42%) post- cases and KRAS testing was performed in 60/293 (20%) of cases reviewed to date, 41 (18%) pre- and 19(26%) post-, respectively. Wild type KRAS was found in 28 tested cases, 21 pre- and 7 post- cases. Of the identified wild type cases, 17 pre- and 6 post- were treated with EGFR inhibitors. Overall, EGFR inhibitors were administered in 48 cases, 42 (18%) pre- and 6 (19%) post-. EGFR inhibitor treatment began with 3rd line therapy in those tested for KRAS compared to first line in those not tested. The most common chemotherapy regimen including an EGFR inhibitor was irinotecan and cetuximab, n=25 (52%).

Background Abstractor training is a key element in creating valid and reliable data collection procedures. The choice between in-person vs. remote or simultaneous vs. sequential abstractor training has significant consequences for time and resource utilization. We conducted a web-based (webinar) abstractor training session to standardize training across six individual Cancer Research Network (CRN) sites for a study of breast cancer treatment effects in older women (BOWII).

Background/Aims The HMO Cancer Research Network received a request from the National Cancer Institute to provide an empirical estimate of the medical care costs of diagnosing lung cancers within a typical HMO setting. This estimate had to be completed within 24 hours. This paper summarizes the methods and data we used to generate our response to this request. We assumed that services delivered during the 90 days prior to the date of the lung cancer diagnosis would provide an acceptable order-of-magnitude estimate of the costs of a diagnosis work-up. We further assumed that additional imaging procedures performed after the date of diagnosis represented treatment costs because their primary purpose was to assist physicians in developing treatment plans.

Background Reliable ascertainment of cancer recurrence is essential in order to evaluate therapeutic interventions to treat advanced disease. Specification of the timing of cancer recurrence using administrative claims from SEER-Medicare is challenging and has been limited to the use of algorithms based mainly on ICD9 diagnosis codes.

Background The richness of patients’ experiences warrants thoughtful and careful examination. While standardized surveys or other structured approaches can be useful when the goal is to count or summarize relatively uncomplicated experiences, they may be less appropriate when the objective is to study sensitive topics, such as medical errors during cancer care. This abstract describes and evaluates a flexible, patient-centered approach to interviewing patients.

Background/Aims Mastectomy and breast conserving surgery followed by radiotherapy are considered initial guideline therapies for early stage breast cancer with randomized trials demonstrating reduced risk of recurrence. However, older women and those with comorbidities frequently receive only breast conserving surgery. The interaction of age and comorbidity with breast cancer severity and their impact on receipt of guideline therapy have not been well studied.

Background/Aims Injectible low-molecular-weight heparin (LMWH) monotherapy is recommended over other anticoagulant therapies (e.g., oral warfarin + injectible anticoagulant) for venous thromboembolism (VTE) in cancer patients based on superior clinical outcomes. The aim of this retrospective study was to evaluate the extent of use of LMWH for cancer patients with incident post-cancer diagnosis VTE.

Background Research suggests physician-patient discussions about colonoscopies may be brief or absent. We sought to investigate men and women’s familiarity and experiences with colonoscopies, and perceived benefits and barriers.

Background/Aims Limited time and competing demands force primary care physicians and patients to prioritize among evidence-based preventive health services during periodic health examinations (PHE). We examined the rate of discussion of and recommendation for 19 USPSTF-endorsed preventive services during PHEs.

Background The association between cardiotoxic chemotherapy for breast cancer treatment and congestive heart failure has been well documented in clinical trials. However, clinical trial populations often contain young, otherwise healthy people, and these results may not represent true associations in community settings. We used electronic administrative data from the CRN VDW to estimate the association between chemotherapy with anthracycline and/or trastuzumab and heart failure in a cohort of women with breast cancer.

Background Adiposity is a well-accepted risk factor for post-menopausal breast cancer (PMBC). SNPs of the FTO gene, located on chromosome 16q12.2, have been associated with adiposity by lowering the activity of the enzyme lipase. This gene also encodes for a protein involved in DNA damage repair pathway. The current epidemiologic paradigm associates the risk of PMBC with increased aromatization of androstenedione to estradial in peripheral adipose tissue and increased serum levels of insulin-like growth-factors. The increased systemic inflammation because of adiposity motivates the inquiries for other plausible biochemical mechanism. We are conducting a pilot nested case-controls study to investigate the association between 3 SNPs of FTO gene with the risk of PMBC, adjusted for the major risk factors. Presently data are available from 50 cases and 202 controls from the cohort of MyCode Biobanking Project at Geisinger Health System.

KRAS mutation testing helps oncologists decide whether patients diagnosed with metastatic colorectal cancer (CRC) should be treated with epidermal growth factor receptor (EGFR) inhibitors. These drugs block the EGFR signaling pathway in tumor cells, and thus can slow tumor progression. Mutated KRAS is found in 30–45% of all CRC tumors, with mutations occurring at codons 12 and 13 being the most common. Patients with a mutated KRAS found in tumor tissue show limited clinical response to EGFR inhibitor therapy. Several factors can influence the results of KRAS mutation testing in tumor specimens. Variation can result from tumor heterogeneity, sample handling, DNA preparation, and differences in assay design and methodology. The purpose of this study was to evaluate comparability of KRAS test results among five labs currently used to determine KRAS mutation status of colorectal cancer specimens in a large multi-center study. Three commercial labs (Genzyme, Clarient, Quest Diagnostics), one clinical lab (Henry Ford Health System), and one research lab (Oregon Health Sciences University) were contracted to analyze KRAS mutational status; all are Clinical Laboratory Improvement Amendments (CLIA) certified. Twenty formalin-fixed paraffin-embedded (FFPE) human CRC samples that had been previously tested for KRAS mutations were selected based on mutation status (7 wild type samples, 7 with codon 12 mutations, and 6 with codon 13 mutations) from two clinical settings (Kaiser Permanente Colorado and Northwest). To ensure sufficient sample quantity, only surgical specimens from colon resections were used. Before being sent to each lab, the FFPE samples were reviewed by a pathologist to determine that the sample was of sufficient quality and quantity for testing. We asked each lab to use their standard clinical testing procedures. Clarient uses a polymerase chain reaction (PCR) method for mutation detection, Genzyme uses single nucleotide primer extension assay with fragment analysis by capillary electrophoresis, and the other three labs all use sequencing. Preliminary data (n=11 samples tested to date) suggests good agreement across laboratories despite differences in mutation detection methodologies.