Background: Racial disparities in breast cancer mortality in the United States are well documented. Non-Hispanic Black (NHB) women are more likely to die of their disease than their non-Hispanic White (NHW) counterparts. The disparity is most pronounced among women diagnosed with prognostically favorable tumors, which may result in part from variations in their receipt of guideline care. In this study, we sought to estimate the effect of guideline-concordant care (GCC) on prognosis, and to evaluate whether receipt of GCC modified racial disparities in breast cancer mortality. Patients and Methods: Using the Georgia Cancer Registry, we identified 2,784 NHB and 4,262 NHW women diagnosed with a stage I–III first primary breast cancer in the metropolitan Atlanta area, Georgia, between 2010 and 2014. Women were included if they received surgery and information on their breast tumor characteristics was available; all others were excluded. Receipt of recommended therapies (chemotherapy, radiotherapy, endocrine therapy, and anti-HER2 therapy) as indicated was considered GCC. We used Cox proportional hazards models to estimate the impact of receiving GCC on breast cancer mortality overall and by race, with multivariable adjusted hazard ratios (HRs). Results: We found that NHB and NHW women were almost equally likely to receive GCC (65% vs 63%, respectively). Failure to receive GCC was associated with an increase in the hazard of breast cancer mortality (HR, 1.74; 95% CI, 1.37–2.20). However, racial disparities in breast cancer mortality persisted despite whether GCC was received (HRGCC: 2.17 [95% CI, 1.61–2.92]; HRnon-GCC: 1.81 [95% CI, 1.28–2.91]). Conclusions: Although receipt of GCC is important for breast cancer outcomes, racial disparities in breast cancer mortality did not diminish with receipt of GCC; differences in mortality between Black and White patients persisted across the strata of GCC.

Over a decade ago, the Institute of Medicine called for a national cancer data system in the United States to support quality-of-care assessment and improvement, including research on effective interventions. Although considerable progress has been achieved in cancer quality measurement and effectiveness research, the nation still lacks a population-based data infrastructure for accurately identifying cancer patients and tracking services and outcomes over time. For compelling reasons, the most effective pathway forward may be the development of state-level cancer data systems, in which central registry data are linked to multiple public and private secondary sources. These would include administrative/claims files from Medicare, Medicaid, and private insurers. Moreover, such a state-level system would promote rapid learning by encouraging adoption of near-real-time reporting and feedback systems, such as the Commission on Cancer's new Rapid Quality Reporting System. The groundwork for such a system is being laid in the state of Georgia, and similar work is advancing in other states. The pace of progress depends on the successful resolution of issues related to the application of information technology, financing, and governance.

Objectives The aim of this study was to examine the potential cost-effectiveness of calcium chemoprevention post-polypectomy as a substitute or adjunct for surveillance. Methods We constructed a Markov model of post-polypectomy adenoma recurrence and colorectal cancer (CRC) development, calibrated to data from prospective chemoprevention trials of fiber, calcium, antioxidants, and aspirin. We modeled four scenarios for 50-year-old patients immediately after polypectomy: (i) natural history with no further intervention; (ii) elemental calcium 1,200 mg/day from age 50–80; (iii) surveillance colonoscopy from age 50–80 every 5 years, or 3 years for large adenoma; (iv) calcium + surveillance. Patients were followed up until age 100 or death. Results Calcium was cost-effective compared to natural history ($49,900/life-year gained). However, surveillance was significantly more effective than calcium (18.729 versus 18.654 life-years/patient; 76 percent versus 14 percent reduction in CRC incidence) at an incremental cost of $15,900/life-year gained. Calcium + surveillance yielded a very small benefit (0.0003 incremental life-years/patient) compared with surveillance alone, at a substantial incremental cost of $3,090,000/life-year gained. Conclusion Post-polypectomy calcium chemoprevention is unlikely to be a reasonable substitute for surveillance. It may be cost-effective in patients unwilling or unable to undergo surveillance.

Background Adjuvant radiation therapy (A-RT) for resected pancreatic adenocarcinoma (PAC) is controversial. We aim to determine if there is an association between overall survival (OS) and A-RT dose. Methods National Cancer Data Base (NCDB) data were obtained for all patients who underwent A-RT for resected PAC from 1998-2002. Univariate (UV) and multivariable (MV) survival analysis were performed along with Kaplan-Meier (KM) estimates for A-RT levels < 40 Gy, 40 to < 50 Gy, 50 to < 55 Gy, and ≥ 55 Gy. Results 1,385 patients met inclusion criteria. Median age was 64 (29-87); all patients underwent surgical resection and A-RT +/- chemotherapy. 231 patients were AJCC 5th edition stage I, 273 stage II, 734 stage III, and 126 stage IVA; 21 were unknown. Median A-RT dose was 45 Gy (1.63 Gy-69 Gy). Median OS was 21 months (95% CI 19 - 23). On MV analysis A-RT dose < 40 Gy (HR, 1.30 [95% CI 1.03-1.66]; p = 0.031), A-RT dose 40 to < 50 Gy (HR, 1.17 [95% CI 1.00-1.37]; p = 0.05), and A-RT dose ≥ 55 Gy (HR, 1.44 [95% CI 1.08-1.93]; p = 0.013) predicted worse OS when compared with the reference category of 50 to < 55 Gy. Conclusions A-RT doses of less than 40 Gy, 40 to < 50 Gy, and ≥ 55 Gy were associated with inferior OS. The dose of A-RT delivered appears to influence OS and a prospective study evaluating the addition of optimally delivered A-RT for resected PAC is needed.

Objective:Despite heterogeneous biology, similar surveillance schemas are utilized after resection of all pancreatic neuroendocrine tumors (PanNETs). Given concerns regarding excess radiation exposure and financial burden, our aim was to develop a prognostic score for disease recurrence to guide individually tailored surveillance strategies.Methods:All patients with primary nonfunctioning, nonmetastatic well/moderately differentiated PanNETs who underwent curative-intent resection at 9-institutions from 2000 to 2016 were included (n = 1006). A Recurrence Risk Score (RRS) was developed from a randomly selected derivation cohort comprised of 67% of patients and verified on the validation-cohort comprised of the remaining 33%.Results:On multivariable analysis, patients within the derivation cohort (n = 681) with symptomatic tumors (jaundice, pain, bleeding), tumors >2cm, Ki67 >3%, and lymph node (LN) (+) disease had increased recurrence. Each factor was assigned a score based on their weighted odds ratio that formed a RRS of 0 to 10: symptomatic = 1, tumor >2cm = 2, Ki67 3% to 20% = 1, Ki67 >20% = 6, LN (+) = 1. Patients were grouped into low-(RRS = 0-2; n = 247), intermediate-(RRS = 3-5; n = 204), or high (RRS = 6-10; n = 9)-risk groups. At 24 months, 33% of high RRS recurred, whereas only 2% of low and 14% of intermediate RRS recurred. This persisted in the validation cohort (n = 325).Conclusions:This international, novel, internally validated RRS accurately stratifies recurrence-free survival for patients with resected PanNETs. Given their unique recurrence patterns, surveillance intervals of 12, 6, and 3 months are proposed for low, intermediate, and high RRS patients, respectively, to minimize radiation exposure and optimize cost/resource utilization.

We conducted a population-based study of biologic, clinical, and sociodemographic factors associated with receipt of multi-agent systemic therapy (MAST) by people living with HIV (PLWH) who were diagnosed with non-Hodgkin lymphoma (NHL). Building on recent registry-based analyses, we linked records from the Georgia Cancer Registry, Georgia HIV/AIDS Surveillance Registry, and the Georgia Hospital Discharge Database to identify 328 PLWH adults (age ≥ 18) diagnosed with NHL within 2004–2012. Through logistic regression modeling, we examined factors associated with patients receiving MAST for NHL. Robust predictors included CD4 count ≥200 cells/mm3 around the time of cancer diagnosis, an advanced stage (III or IV) diagnosis of NHL, MSM HIV transmission, and having private health insurance. The strongest single predictor of MAST was CD4 count. Because there is now guideline-integrated evidence that PLWH receiving standard-of-care cancer therapy can achieve substantially improved outcomes, it is vital they have access to regimens routinely provided to HIV-negative cancer patients.

Background: Multiple studies have yielded important findings regarding the determinants of an advanced-stage diagnosis of breast cancer. We seek to advance this line of inquiry through a broadened conceptual framework and accompanying statistical modeling strategy that recognize the dual importance of access-tocare and biologic factors on stage. Methods: The Centers for Disease Control and Prevention-sponsored Breast and Prostate Cancer Data Quality and Patterns of Care Study yielded a seven-state, cancer registry-derived population-based sample of 9,142 women diagnosed with a first primary in situ or invasive breast cancer in 2004. The likelihood of advanced-stage cancer (American Joint Committee on Cancer IIIB, IIIC, or IV) was investigated through multivariable regression modeling, with base-case analyses using the method of instrumental variables (IV) to detect and correct for possible selection bias. The robustness of base-case findings was examined through extensive sensitivity analyses. Results: Advanced-stage disease was negatively associated with detection by mammography (P < 0.001) and with age < 50 (P < 0.001), and positively related to black race (P = 0.07), not being privately insured [Medicaid (P = 0.01), Medicare (P = 0.04), uninsured (P = 0.07)], being single (P = 0.06), body mass index > 40 (P= 0.001), a HER2 type tumor (P < 0.001), and tumor grade not well differentiated (P < 0.001). This IV model detected and adjusted for significant selection effects associated with method of detection (P=0.02). Sensitivity analyses generally supported these base-case results. Conclusions: Through our comprehensive modeling strategy andsensitivity analyses,weprovide newestimates of themagnitude androbustness of the determinants ofadvanced-stage breast cancer. Impact: Statistical approaches frequently used to address observational data biases in treatment-outcome studies can be applied similarly in analyses of the determinants of stage at diagnosis.

Introduction From 2012 through 2014, the US Preventive Services Task Force (USPSTF) recommended biennial mammography for women aged 50 to 75 and recommended against the prostate specific antigen (PSA) test for men of any age, emphasizing informed decision making for patients. Because of time constraints and other patient health priorities, health care providers often do not discuss benefits and risks associated with cancer screening. We analyzed the association between seeking information online about breast and prostate cancer and undergoing mammography and PSA screening. Methods We assessed guideline concordance in mammogram and PSA screening, according to USPSTF guidelines for those at average risk for disease. We used data on 4,537 survey respondents from the National Cancer Institute's Health Information National Trends Survey (HINTS) for 2012 through 2014 to assess online information-seeking, defined as whether people searched for cancer- related information online in the past 12 months. We used HINTS data to construct multivariable logistic regression models to isolate the effect of exposure to online information on the incidence of cancer screening. Results After controlling for available covariates, we found no significant association between online information-seeking and guidelineconcordant screening for breast or prostate cancer. Significant covariate values suggest that factors related to access to care were significantly associated with conformance to mammography guidelines for women recommended for screening and that physician discussion was significantly associated with nonconformance to guidelines for prostate-specific antigen screening (ie, having a PSA test in spite of the recommendation not to have it). Decomposition of differences between those who sought online information and those who did not indicated that uncontrolled confounders probably had little effect on findings. Conclusion We found little evidence that online information-seeking significantly affected screening for breast or prostate cancer in accordance with USPSTF guidelines among people at average risk.

Aims: To test the hypothesis that a 50-g oral glucose challenge test with 1-h glucose measurement would have superior performance compared with other opportunistic screening methods. Methods: In this prospective study in a Veterans Health Administration primary care clinic, the following test performances, measured by area under receiver-operating characteristic curves were compared: oral glucose challenge test; random glucose; and HbA1c level, using an oral glucose tolerance test as the ‘gold standard’. Results: The study population comprised 1535 people (mean age 56 years, BMI 30.3 kg/m2, 94% men, 74% black). By oral glucose tolerance test criteria, diabetes was present in 10% and high-risk prediabetes was present in 22% of the cohort. The plasma glucose challenge test provided area under receiver-operating characteristic curves of 0.85 (95% CI 0.78–0.91) to detect diabetes and 0.76 (95% CI 0.72–0.80) to detect high-risk dysglycaemia (diabetes or high-risk prediabetes), while area under receiver-operating characteristic curves for the capillary glucose challenge test were 0.82 (95% CI 0.75–0.89) and 0.73 (95% CI 0.69–0.77) for diabetes and high-risk dysglycaemia, respectively. Random glucose performed less well [plasma: 0.76 (95% CI 0.69–0.82) and 0.66 (95% CI 0.62–0.71), respectively; capillary: 0.72 (95% CI 0.65–0.80) and 0.64 (95% CI 0.59–0.68), respectively] and HbA1c performed even less well [0.67 (95% CI 0.57–0.76) and 0.63 (95% CI 0.58–0.68), respectively]. The cost of identifying one case of high-risk dysglycaemia with a plasma glucose challenge test would be $42 from a Veterans Affairs perspective, and $55 from a US Medicare perspective. Conclusions: Glucose challenge test screening, followed, if abnormal, by an oral glucose tolerance test, would be convenient and more accurate than other opportunistic tests. Use of glucose challenge test screening could improve management by permitting earlier therapy.

Ovarian cancer carries the highest fatality to case ratio for all gynecologic malignancies. In 2016, it is estimated that 22,280 women will be diagnosed with ovarian cancer, and 14,240 will die of this life-threatening disease [1]. Due to the aggressive nature of the disease and the lack of effective screening, over 2/3 of women with ovarian cancer are diagnosed in stages III and IV (http://seer.cancer.gov), which is conventionally treated with a combination of aggressive surgical cytoreduction and cytotoxic chemotherapy. However, controversy over the most effective treatment for newly diagnosed stage III ovarian cancer persists, specifically evaluating whether a combination of intraperitoneal (IP) and intravenous (IV) chemotherapy is superior to IV alone [2–6]. Taken together, results from these clinical trials require clinicians and patients to carefully evaluate the risks and outcomes associated with IP or IV treatment, particularly since at this time there is no clear guidance on which treatment is better for a given patient. Adding to the complexity of this decision is the observation that ovarian cancer patients utilize progression free survival (PFS) time to drive the preference of type of chemotherapy, although they are willing to trade significant PFS time for reductions in treatment-related toxicity [7]. Very few studies have examined the use of decision aids within the setting of ovarian cancer, although several authors have explicitly argued that there is a need to practice shared decision-making in order to elicit preferences and incorporate this information into the ovarian cancer treatment discussion [8–10]. In fact, when assessing preferences, those ovarian cancer patients with more serious illness desired more shared decision-making; and in total, >80% of women wanted detailed information about their disease, treatment, and care [11]. Perceived involvement in decision-making about ovarian cancer treatment has been associated with better quality of life [12], although the approach for involving patients in decision making has been debated [13–17], particularly in life-threatening cancer diagnoses. A review of patient preferences for shared decisions, drawing inferences from 43 cancer studies analyses, concluded that 77% of the respondents wanted to participate in decisions, rather than delegating the treatment choice to the physician [18]. In fact, there has been a substantial increase in the percent of cancer patients who wish to participate in medical decision-making, reaching 85% over the last decade [18] The purpose of this study was to develop and test the effectiveness of a Patient-Centered Outcome Aid (PCOA) compared to a control condition of usual care, as patients chose between IV or IP therapy for advanced ovarian cancer. We developed an internet-based decision aid to improve patient-centered outcomes and tested it within a randomized clinical trial. The purpose of this paper is to describe the clinical trial development and protocol.