Long-term quality of life after hematopoietic cell transplant for sickle cell disease in childhood: A STELLAR interim analysis.

We prospectively collected PROMIS©25 and PROMIS©29 surveys in the Sickle Cell Transplant Evaluation of Long Term and Late Effects Registry (STELLAR). Mobility and social participation T-scores were decreased; all other domains were within the norm.

Testing Theory-Based Messages to Encourage Women at Average Risk for Breast Cancer to Consider Biennial Mammography Screening.

BACKGROUND: The US Preventive Services Task Force does not recommend routine annual mammography screening for women aged 40-49 at average risk. Little research has been done to develop theory-based communication interventions to facilitate informed decision-making about reducing potentially low-value mammography screening. PURPOSE: Evaluate the effects of theory-based persuasive messages on women's willingness to consider delaying screening mammography until age 50 or have mammograms biennially. METHODS: We conducted a randomized controlled communication experiment online with a population-based sample of U.S. women aged 40-49 (N = 383) who screened to be at average risk for breast cancer. Women were randomly assigned to the following messaging summaries: annual mammography risks in 40s (Arm 1, n = 124), mammography risks plus family history-based genetic risk (Arm 2, n = 120), and mammography risks, genetic risk, and behavioral alternatives (Arm 3, n = 139). Willingness to delay screening or reduce screening frequency was assessed post-experiment by a set of 5-point Likert scale items. RESULTS: Women in Arm 3 reported significantly greater willingness to delay screening mammography until age 50 (mean = 0.23, SD = 1.26) compared with those in Arm 1 (mean = -0.17, SD = 1.20; p = .04). There were no significant arm differences in willingness to reduce screening frequency. Exposure to the communication messages significantly shifted women's breast cancer-related risk perceptions without increasing unwarranted cancer worry across all three arms. CONCLUSIONS: Providing women with screening information and options may help initiate challenging discussions with providers about potentially low-value screening.

The US Preventive Services Task Force does not recommend routine annual mammography screening for women aged 40­49 at average risk. This study aimed to assess the impact of theory-based persuasive messages on women's willingness to delay mammography screening until age 50 or opt for biennial screenings. In a randomized online experiment, 383 U.S. women aged 40­49 at average risk for breast cancer were assigned to three different message groups. The results showed that women exposed to messaging that included mammography risks, family history-based genetic risk, and behavioral alternatives were significantly more willing to delay screening until age 50. However, there were no significant differences in willingness to reduce screening frequency. The tested communication messages effectively shifted women's breast cancer-related risk perceptions without causing unnecessary worry. Providing women with screening information and options may help initiate challenging discussions with providers about potentially low-value screening.

Are children with sickle cell disease at particular risk from the harmful effects of air pollution? Evidence from a large, urban/peri-urban cohort.

INTRODUCTION: Pathophysiologic pathways of sickle cell disease (SCD) and air pollution involve inflammation, oxidative stress, and endothelial damage. It is therefore plausible that children with SCD are especially prone to air pollution's harmful effects. METHODS: Patient data were collected from a single-center, urban/peri-urban cohort of children with confirmed SCD. Daily ambient concentrations of particulate matter (PM2.5 ) were collected via satellite-derived remote-sensing technology, and carbon monoxide (CO), nitrogen dioxide (NO2 ), and ozone from local monitoring stations. We used multivariable regression to quantify associations of pollutant levels and daily counts of emergency department (ED) visits, accounting for weather and time trends. For comparison, we quantified the associations of pollutant levels with daily all-patient (non-SCD) ED visits to our center. RESULTS: From 2010 to 2018, there were 17,731 ED visits by 1740 children with SCD (64.8% HbSS/HbSß0 ). Vaso-occlusive events (57.8%), respiratory illness (17.1%), and fever (16.1%) were the most common visit diagnoses. Higher 3-day (lags 0-2) rolling mean PM2.5 and CO levels were associated with daily ED visits among those with SCD (PM2.5 incident rate ratio [IRR] 1.051 [95% confidence interval: 1.010-1.094] per 9.4 µg/m3 increase; CO 1.088 [1.045-1.132] per 0.5 ppm). NO2 showed positive associations in secondary analyses; ozone levels were not associated with ED visits. The comparison, all-patient ED visit analyses showed lower IRR for all pollutants. CONCLUSIONS: Our results suggest short-term air pollution levels as triggers for SCD events and that children with SCD may be more vulnerable to air pollution than those without SCD. Targeted pollution-avoidance strategies could have significant clinical benefits in this population.

Evaluating the impact of multicancer early detection testing on health and economic outcomes: Toward a decision modeling strategy.

Emerging data provide initial support for the concept that a single, minimally invasive liquid biopsy test, performed in conjunction with confirmatory radiologic or other diagnostic testing, when indicated, could be deployed on a broad scale to screen individuals for multiple types of cancer. Ideally, such a test could do this in a way that yields a clinically important percentage of true-positive indications of cancer while minimizing false-positive signals. Modern decision modeling approaches can and should be deployed to investigate the health and economic consequences of such multicancer early detection (MCED) testing within defined at-risk populations. In this paper, through small-scale analyses involving 3 hypothetical MCED-detectible cancers, the authors illustrate the potential for MCED testing to be cost-effective, along with the pivotal role of test-induced stage shift on results. The time is ripe for additional, prospective investigations of the clinical value of MCED testing, the benefits versus the risks for screened populations, and the overall projected impact on health outcomes and costs over time.

If it's information, it's not "bias": a scoping review and proposed nomenclature for future response-shift research.

BACKGROUND: The growth in response-shift methods has enabled a stronger empirical foundation to investigate response-shift phenomena in quality-of-life (QOL) research; but many of these methods utilize certain language in framing the research question(s) and interpreting results that treats response-shift effects as "bias," "noise," "nuisance," or otherwise warranting removal from the results rather than as information that matters. The present project will describe the various ways in which researchers have framed the questions for investigating response-shift issues and interpreted the findings, and will develop a nomenclature for such that highlights the important information about resilience reflected by response-shift findings. METHODS: A scoping review was done of the QOL and response-shift literature (n = 1100 articles) from 1963 to 2020. After culling only empirical response-shift articles, raters characterized how investigators framed and interpreted study research questions (n = 164 articles). RESULTS: Of 10 methods used, papers using four of them utilized terms like "bias" and aimed to remove response-shift effects to reveal "true change." Yet, the investigators' reflections on their own conclusions suggested that they do not truly believe that response shift is error to be removed. A structured nomenclature is proposed for discussing response-shift results in a range of research contexts and response-shift detection methods. CONCLUSIONS: It is time for a concerted and focused effort to change the nomenclature of those methods that demonstrated this misinterpretation. Only by framing and interpreting response shift as information, not bias, can we improve our understanding and methods to help to distill outcomes with and without response-shift effects.

A framework for cancer health economics research.

LAY SUMMARY: Cancer has substantial economic impacts for patients, their families and/or caregivers, employers, and the health care system. However, there is only limited understanding of how economic issues can affect access to cancer care services and the receipt of high-quality cancer care. Health economics research in cancer is particularly timely due to the large and increasing number of patients with cancer and cancer survivors, but there are many factors that may create barriers to performing cancer health economics research. This commentary has identified important topics and questions in cancer health economics research and will assist in the development of this critical field.

Receipt of Guideline-Concordant Care Does Not Explain Breast Cancer Mortality Disparities by Race in Metropolitan Atlanta.

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.

Optimal Surveillance Frequency After CRS/HIPEC for Appendiceal and Colorectal Neoplasms: A Multi-institutional Analysis of the US HIPEC Collaborative.

BACKGROUND: No guidelines exist for surveillance following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal and colorectal cancer. The primary objective was to define the optimal surveillance frequency after CRS/HIPEC. METHODS: The U.S. HIPEC Collaborative database (2000-2017) was reviewed for patients who underwent a CCR0/1 CRS/HIPEC for appendiceal or colorectal cancer. Radiologic surveillance frequency was divided into two categories: low-frequency surveillance (LFS) at q6-12mos or high-frequency surveillance (HFS) at q2-4mos. Primary outcome was overall survival (OS). RESULTS: Among 975 patients, the median age was 55 year, 41% were male: 31% had non-invasive appendiceal (n = 301), 45% invasive appendiceal (n = 435), and 24% colorectal cancer (CRC; n = 239). With a median follow-up time of 25 mos, the median time to recurrence was 12 mos. Despite less surveillance, LFS patients had no decrease in median OS (non-invasive appendiceal: 106 vs. 65 mos, p < 0.01; invasive appendiceal: 120 vs. 73 mos, p = 0.02; colorectal cancer [CRC]: 35 vs. 30 mos, p = 0.8). LFS patients had lower median PCI scores compared with HFS (non-invasive appendiceal: 10 vs. 19; invasive appendiceal: 10 vs. 14; CRC: 8 vs. 11; all p < 0.01). However, on multivariable analysis, accounting for PCI score, LFS was still not associated with decreased OS for any histologic type (non-invasive appendiceal: hazard ratio [HR]: 0.28, p = 0.1; invasive appendiceal: HR: 0.73, p = 0.42; CRC: HR: 1.14, p = 0.59). When estimating annual incident cases of CRS/HIPEC at 375 for non-invasive appendiceal, 375 invasive appendiceal and 4410 colorectal, LFS compared with HFS for the initial two post-operative years would potentially save $13-19 M/year to the U.S. healthcare system. CONCLUSIONS: Low-frequency surveillance after CRS/HIPEC for appendiceal or colorectal cancer is not associated with decreased survival, and when considering decreased costs, may optimize resource utilization.

A Novel Validated Recurrence Risk Score to Guide a Pragmatic Surveillance Strategy After Resection of Pancreatic Neuroendocrine Tumors: An International Study of 1006 Patients.

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 >2 cm, 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 >2 cm = 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.

Obesity and mortality after locoregional breast cancer diagnosis.

PURPOSE: Higher mortality after a breast cancer diagnosis has been observed among women who are obese. We investigated the relationships between body mass index (BMI) and all-cause or breast cancer-specific mortality after a diagnosis of locoregional breast cancer. METHODS: Women diagnosed in 2004 with AJCC Stage I, II, or III breast cancer (n = 5394) were identified from a population-based National Program of Cancer Registries (NPCR) patterns of care study (POC-BP) drawing from registries in seven U.S. states. Differences in overall and breast cancer-specific mortality were investigated using Cox proportional hazards regression models adjusting for demographic and clinical covariates, including age- and stage-based subgroup analyses. RESULTS: In women 70 or older, higher BMI was associated with lower overall mortality (HR for a 5 kg/m2 difference in BMI = 0.85, 95% CI 0.75-0.95). There was no significant association between BMI and overall mortality for women under 70. BMI was not associated with breast cancer death in the full sample, but among women with Stage I disease; those in the highest BMI category had significantly higher breast cancer mortality (HR for BMI ≥ 35 kg/m2 vs. 18.5-24.9 kg/m2 = 4.74, 95% CI 1.78-12.59). CONCLUSIONS: Contrary to our hypothesis, greater BMI was not associated with higher overall mortality. Among older women, BMI was inversely related to overall mortality, with a null association among younger women. Higher BMI was associated with breast cancer mortality among women with Stage I disease, but not among women with more advanced disease.

Association Between Online Information-Seeking and Adherence to Guidelines for Breast and Prostate Cancer Screening.

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 guideline-concordant 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.

Clinical risks and healthcare utilization of hematopoietic cell transplantation for sickle cell disease in the USA using merged databases.

Advances in allogeneic hematopoietic cell transplantation for sickle cell disease have improved outcomes, but there is limited analysis of healthcare utilization in this setting. We hypothesized that, compared to late transplantation, early transplantation (at age <10 years) improves outcomes and decreases healthcare utilization. We performed a retrospective study of children transplanted for sickle cell disease in the USA during 2000-2013 using two large databases. Univariate and Cox models were used to estimate associations of demographics, sickle cell disease severity, and transplant-related variables with mortality and chronic graft-versus-host disease, while Wilcoxon, Kruskal-Wallis, or linear trend tests were applied for the estimates of healthcare utilization. Among 161 patients with a 2-year overall survival rate of 90% (95% confidence interval [CI] 85-95%) mortality was significantly higher in those who underwent late transplantation versus early (hazard ratio (HR) 21, 95% CI 2.8-160.8, P=0.003) and unrelated compared to matched sibling donor transplantation (HR 5.9, 95% CI 1.7-20.2, P=0.005). Chronic graftversus host disease was significantly more frequent among those translanted late (HR 1.9, 95% CI 1.0-3.5, P=0.034) and those who received an unrelated graft (HR 2.5, 95% CI 1.2-5.4; P=0.017). Merged data for 176 patients showed that the median total adjusted transplant cost per patient was $467,747 (range: $344,029-$799,219). Healthcare utilization was lower among recipients of matched sibling donor grafts and those with low severity disease compared to those with other types of donor and disease severity types (P<0.001 and P=0.022, respectively); no association was demonstrated with late transplantation (P=0.775). Among patients with 2-year pre- and post-transplant data (n=41), early transplantation was associated with significant reductions in admissions (P<0.001), length of stay (P<0.001), and cost (P=0.008). Early transplant outcomes need to be studied prospectively in young children without severe disease and an available matched sibling to provide conclusive evidence for the superiority of this approach. Reduced post-transplant healthcare utilization inpatient care indicates that transplantation may provide a sustained decrease in healthcare costs over time.

The rationale for patient-reported outcomes surveillance in cancer and a reproducible method for achieving it.

Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

The development and acceptability of symptom management quality improvement reports based on patient-reported data: an overview of methods used in PROSSES.

PURPOSE: Patient experiences with symptom care need to be assessed and documented to ensure successful management of cancer-related symptoms. This paper details one method for creating symptom management quality improvement (SMQI) reports, including case-mix adjustment of patient-reported measures. Qualitative data regarding the acceptability of these reports at participating cancer centers (CCs) are also provided. METHODS: Data were collected from 2226 patients treated at 16 CCs via mailed/Web questionnaires. Twelve items assessing patient perceptions of symptom management-pain, fatigue, emotional distress-served as key quality indicators. Medico-demographic variables suitable for case-mix adjustment were selected using an index score combining predictive power and heterogeneity across CCs. SMQI reports were designed with staff feedback and produced for each CC, providing crude and adjusted CC-specific rates, along with study-wide rates for comparison purposes. RESULTS: Cancer type and participant educational level were selected for case-mix adjustment based upon high index scores. The Kendall rank correlation coefficient showed that case-mix adjustments changed the ranking of CCs on the key quality indicators (% Δ rank range: 5-22 %). The key quality indicators varied across CCs (all p < 0.02). SMQI reports were well received by CC staff, who described plans to share them with key personnel (e.g., cancer committee, navigator). CONCLUSIONS: This paper provides one method for creating hospital-level SMQI reports, including case-mix adjustment. Variation between CCs on key quality indicators, even after adjustment, suggested room for improvement. SMQI reports based on patient-reported data can inform and motivate efforts to improve care through professional/patient education and applying standards of care.

Disease characteristics, patterns of care, and survival in very elderly patients with diffuse large B-cell lymphoma.

BACKGROUND: Although the combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is considered standard therapy for diffuse large B-cell lymphoma (DLBCL), patterns of use and the impact of R-CHOP on survival in patients aged >80 years are less clear. METHODS: The Surveillance, Epidemiology, and End Results (SEER)-Medicare database was used to characterize presentation, treatment, and survival patterns in patients with DLBCL who were diagnosed between 2002 and 2009. Chi-square tests compared characteristics and initial treatments among patients with DLBCL who were aged >80 years and ≤80 years. Multivariable logistic regression models examined factors associated with treatment selection in patients aged >80 years; standard and propensity score-adjusted multivariable Cox proportional hazards models examined relationships between treatment regimen, treatment duration, and survival. RESULTS: Among 4635 patients with DLBCL, 1156 (25%) were aged >80 years. Patients aged >80 years were less likely to receive R-CHOP and more likely to be observed or receive the combination of rituximab, cyclophosphamide, vincristine, and prednisone (P<.0001 for both). Marital status, stage of disease, disease site, performance status, radiotherapy, and growth factor support were associated with initial R-CHOP in patients aged >80 years. In propensity score-matched multivariable Cox proportional hazards models examining relationships between treatment regimen and survival, R-CHOP was the only regimen found to be associated with improved overall survival (hazard ratio, 0.45; 95% confidence interval, 0.33-0.62) and lymphoma-related survival (hazard ratio, 0.58; 95% confidence interval, 0.38-0.88). CONCLUSIONS: Although patients with DLBCL who were aged >80 years were less likely to receive R-CHOP, this regimen conferred the longest survival and should be considered for this population. Further studies are needed to characterize the impact of treatment of DLBCL on quality of life among patients in this age group.

Patterns of locoregional treatment for nonmetastatic breast cancer by patient and health system factors.

BACKGROUND: The purpose of this study was to examine local definitive therapy for nonmetastatic breast cancer with the Patterns of Care Breast and Prostate Cancer (POCBP) study of the National Program of Cancer Registries (Centers for Disease Control and Prevention). METHODS: POCBP medical record data were re-abstracted in 7 state/regional registry systems (Georgia, North Carolina, Kentucky, Louisiana, Wisconsin, Minnesota, and California) to verify data quality and assess treatment patterns in the population. National Comprehensive Cancer Network clinical practice treatment guidelines were aligned with American Joint Committee on Cancer staging at diagnosis to appraise care. RESULTS: Six thousand five hundred five of 9142 patients with registry-confirmed breast cancer were coded as having primary disease with stage 0 to IIIA tumors and were included in the study. Approximately 88% received guideline-concordant locoregional treatment. However, this outcome varied by age group: 92% of women < age 50 versus 80% of women ≥ age 70 years old received guideline care (P < 0.01). Characteristics that best discriminated receipt (no/yes) of guideline-concordant care in receiver operating curve analyses were the receipt of breast-conserving surgery (BCS) versus mastectomy (C = 0.70), patient age (C = 0.62), a greater tumor stage (C = 0.60), public insurance (C = 0.58), and the presence of at least mild comorbidity (C = 0.55). Radiation therapy (RT) after BCS was the most omitted treatment component causing nonconcordance in the study population. In multivariate regression, the effects of the treatment facility, ductal carcinoma in situ, race, and comorbidity on nonconcordant care differed by age group. CONCLUSIONS: Patterns of underuse of standard therapies for breast cancer vary by age group and BCS use, with which there is a risk of omission of RT.

Stereotactic body radiation therapy versus no treatment for early stage non-small cell lung cancer in medically inoperable elderly patients: A National Cancer Data Base analysis.

BACKGROUND: Stereotactic body radiation therapy (SBRT) has demonstrated high rates of local control with low morbidity and has now emerged as the standard of care for medically inoperable, early stage non-small cell lung cancer (NSCLC). However, the impact of lung SBRT on survival in the elderly population is less clear given competing comorbid conditions. An analysis of the National Cancer Data Base (NCDB) was undertaken to determine whether definitive SBRT improves survival relative to observation alone patients ages 70 years and older. METHODS: The NCDB, a retrospective national database that captures approximately 70% of all patients treated for cancer, was queried for patients aged 70 years or older with early stage (T1-T3N0M0) NSCLC from 2003 to 2006. Overall survival was compared between patients who received stereotactic body radiotherapy alone and those who received no treatment. An extended Cox proportional hazards model was applied to estimate the treatment effect of SBRT. RESULTS: In total, 3147 patients met the selection criteria for this analysis. SBRT was delivered to 258 patients (8.2%), and 2889 patients (91.8%) received no treatment. There was no significant difference in the distribution of Charlson/Deyo comorbidity index scores between the 2 groups (P = .076). Multivariable analysis revealed improved overall survival with SBRT compared with observation for the entire cohort (hazard ratio, 0.64; P < .001). CONCLUSIONS: SBRT is associated with improved survival in elderly patients with early stage NSCLC who have concurrent comorbid conditions compared with observation alone. The current data support the use of SBRT for the treatment of elderly patients with early stage NSCLC who have limiting comorbid conditions.

Increased cardiovascular disease, resource use, and costs before the clinical diagnosis of diabetes in veterans in the southeastern U.S.

IMPORTANCE: Screening for diabetes might be more widespread if adverse associations with cardiovascular disease (CVD), resource use, and costs were known to occur earlier than conventional clinical diagnosis. OBJECTIVE: The purpose of this study was to determine whether adverse effects associated with diabetes begin prior to clinical diagnosis. DESIGN: Veterans with diabetes were matched 1:2 with controls by follow-up, age, race/ethnicity, gender, and VA facility. CVD was obtained from ICD-9 codes, and resource use and costs from VA datasets. SETTING: VA facilities in SC, GA, and AL. PARTICIPANTS: Patients with and without diagnosed diabetes. MAIN OUTCOME MEASURES: Diagnosed CVD, resource use, and costs. RESULTS: In this study, the 2,062 diabetic patients and 4,124 controls were 63 years old on average, 99 % male, and 29 % black; BMI was 30.8 in diabetic patients vs. 27.8 in controls (p<0.001). CVD prevalence was higher and there were more outpatient visits in Year -4 before diagnosis through Year +4 after diagnosis among diabetic vs. control patients (all p<0.01); in Year -2, CVD prevalence was 31 % vs. 24 %, and outpatient visits were 22 vs. 19 per year, respectively. Total VA costs/year/veteran were higher in diabetic than control patients from Year -4 ($4,083 vs. $2,754) through Year +5 ($8,347 vs. $5,700) (p<0.003) for each, reflecting underlying increases in outpatient, inpatient, and pharmacy costs (p<0.05 for each). Regression analysis showed that diabetes contributed an average of $1,748/year to costs, independent of CVD (p<0.001). CONCLUSIONS AND RELEVANCE: VA costs per veteran are higher--over $1,000/year before and $2,000/year after diagnosis of diabetes--due to underlying increases in outpatient, inpatient, and pharmacy costs, greater number of outpatient visits, and increased CVD. Moreover, adverse associations with veterans' health and the VA healthcare system occur early in the natural history of the disease, several years before diabetes is diagnosed. Since adverse associations begin before diabetes is recognized, greater consideration should be given to systematic screening in order to permit earlier detection and initiation of preventive management. Keeping frequency of CVD and marginal costs in line with those of patients before diabetes is currently diagnosed has the potential to save up to $2 billion a year.

Consensus in controversy: The modified Delphi method applied to Gynecologic Oncology practice.

OBJECTIVES: To determine the degree of consensus regarding the probabilities of outcomes associated with IP/IV and IV chemotherapy. METHODS: A survey was administered to an expert panel using the Delphi method. Ten ovarian cancer experts were asked to estimate outcomes for patients receiving IP/IV or IV chemotherapy. The clinical estimates were: 1) probability of completing six cycles of chemotherapy, 2) probability of surviving five years, 3) median survival, and 4) probability of ER/hospital visits during treatment. Estimates for two patients, one with a low comorbidity index (patient 1) and the other with a moderate index (patient 2), were included. The survey was administered in three rounds, and panelists could revise their subsequent responses based on review of the anonymous opinions of their peers. RESULTS: The ranges were smaller for IV compared with IP/IV therapy. Ranges decreased with each round. Consensus converged around outcomes related to IP/IV chemotherapy for: 1) completion of 6 cycles of therapy (type 1 patient, 62%, type 2 patient, 43%); 2) percentage of patients surviving 5 years (type 1 patient, 66%, type 2 patient, 47%); and 3) median survival (type 1 patient, 83 months, type 2 patient, 58 months). The group required three rounds to achieve consensus on the probabilities of ER/hospital visits (type 1 patient, 24%, type 2 patient, 35%). CONCLUSIONS: Initial estimates of survival and adverse events associated with IP/IV chemotherapy differ among experts. The Delphi process works to build consensus and may be a pragmatic tool to inform patients of their expected outcomes.

Association between urologist characteristics and radiation oncologist consultation for patients with locoregional prostate cancer.

BACKGROUND: Physicians managing patients with prostate cancer play a critical role in subsequent specialist consultations and initial treatment choice, especially in cases for which no consensus exists regarding optimal treatment strategy. The NCCN Guidelines for Prostate Cancer recommend radiation as a therapy option for patients with locoregional prostate cancer. PURPOSE: The authors examined the association of urologist characteristics with the likelihood that patients would consult radiation oncologists. METHODS: A retrospective cohort of 39,934 patients aged 66 years or older who were diagnosed with locoregional prostate cancer between 2004 and 2007, and the 2405 urologists who performed the patient diagnostic biopsies were constructed using the SEER-Medicare linked database and the American Medical Association Physician Masterfile. Logistic multilevel regression analysis was used to evaluate the influence of urologists' characteristics on radiation oncologist consultation within 9 months of locoregional prostate cancer diagnosis. RESULTS: Overall, 24,549 (61.5%) patients consulted a radiation oncologist. After adjusting for patient and urologist characteristics, patients diagnosed by urologists in noninstitutional settings (eg, physician office) were significantly more likely to consult a radiation oncologist (odds ratio [OR], 1.40; 95% CI, 1.17-1.67; P=.0002) compared with those diagnosed by urologists in institutional settings with a major medical school affiliation. In addition, patients diagnosed by urologists older than 57 years were significantly more likely to consult a radiation oncologist (OR, 1.21; 95% CI, 1.07-1.38, P=.003).