Modified Charlson Comorbidity Score Research Articles

Clinical phenotype of anaerobic bacteremia unaccompanied by detectable abscess lesion: a 10-year retrospective, multicenter, observational-cohort study.

Despite the importance of abscess lesions in clinical decisions regarding anaerobic bacteremia (AB), their impact on clinical characteristics remains unclear. Herein, we aimed to elucidate the clinical factors associated with AB that were unaccompanied by detectable abscess lesions during the initial phase of infection. This was a multicenter retrospective observational study involving patients with culture-proven AB at six tertiary hospitals in Japan between January 2012 and March 2022. Data on clinical characteristics, laboratory and radiological findings were collected, and their associations with the absence of detectable abscess lesions were analyzed. In total, 393 participants were included. Abscess lesions were absent in 42.7% of the entire cohort and detectable in the remaining patients. No differences were identified in the malignancy, severity, or 30-day mortality between patients with and without detectable abscess lesions. Multivariate logistic regression analysis adjusted for age and the modified Charlson comorbidity score revealed that the immunosuppressive status (febrile neutropenia or corticosteroid use), C-reactive protein (CRP) level ≤9.8mg/dL at onset, and the presence of gram-positive anaerobic rods (GPARs) were independently associated with AB unaccompanied by detectable abscess lesions [odds ratios (ORs) 3.24, 3.00, and 2.81, respectively; p<0.05]. This study elucidated distinctive clinical and microbiological characteristics of AB unaccompanied by detectable abscess lesions, with relatively lower CRP elevation, immunosuppressive status, and GPARs as the causative anaerobes.

Exploring the impact of traumatic injury on mortality: An analysis of the certified cause of death within one year of serious injury in the Scottish population

BackgroundFew studies effectively quantify the long-term incidence of death following injury.The absence of detailed mortality and underlying cause of death data results in limited understanding and a potential underestimation of the consequences at a population level. This study takes a nationwide approach to identify the one-year mortality following injury in Scotland, evaluating survivorship in relation to pre-existing comorbidities and incidental causes of death. Study DesignThis retrospective cohort study assessed the one-year mortality of adult trauma patients with an Injury Severity Score ≥ 9 during 2020 using the Scottish Trauma Audit Group (STAG) registry linked to inpatient hospital data and death certificate records. Patients were divided into three groups: trauma death, trauma-contributed death, and non-trauma death. Kaplan-Meier curves were used for survival analysis to evaluate mortality, and cox proportional hazards regression analysed risk factors linked to death. Results4056 patients were analysed with a median age 63 years (58–88) and male predominance (55.2 %). Falls accounted for 73.1 % of injuries followed by motor vehicle accidents (16.3 %) and blunt force (4.9 %). Extremity was the most commonly injured region overall followed by chest and head. However, head injury prevailed in those who died. The registry demonstrated a one-year mortality of 19.3 % with 55 % deaths occurring post-discharge. Of all deaths reported, 35.3 % were trauma deaths, and 47.7 % were trauma-contributed deaths. These groups accounted for over 70 % of mortality within 30 days of hospital admission and continued to represent the majority of deaths up to 6 months post-injury. Patients who died after 6 months were mainly the result of non-traumatic causes, frequently circulatory, neoplastic, and respiratory diseases (37.7 %, 12.3 %, 9.1 %, respectively). Independent risk factors for one-year mortality included a GCS ≤ 8, modified Charlson Comorbidity score >5, Injury Severity Score >25, serious head injury, age and sex. ConclusionWith a one-year mortality of 19.3 %, and post-discharge deaths higher than previously appreciated, patients can face an extended period of survival uncertainty.As mortality due to index trauma lasted up to 6 months post-admission, short-term outcomes fail to represent trauma burden and so cogent survival predictions should be avoided in clinical and patient settings.

Antimicrobial Use and Carbapenem-Resistant Enterobacterales in Korea: A Nationwide Case-Control Study With Propensity Score Matching.

Nationwide research on the association between carbapenem-resistant Enterobacterales (CREs) and antibiotic use is limited. This nested case-control study analyzed Korean National Health Insurance claims data from April 2017 to April 2019. Based on the occurrence of CRE, hospitalized patients aged ≥ 18 years were classified into CRE (cases) and control groups. Propensity scores based on age, sex, modified Charlson comorbidity score, insurance type, long-term care facility, intensive care unit stay, and acquisition of vancomycin-resistant Enterococci were used to match the case and control groups (1:3). After matching, the study included 6,476 participants (1,619 cases and 4,857 controls). Multivariable logistic regression analysis revealed that the utilization of broad-spectrum antibiotics, such as piperacillin/tazobactam (adjusted odds ratio [aOR], 2.178; 95% confidence interval [CI], 1.829-2.594), third/fourth generation cephalosporins (aOR, 1.764; 95% CI, 1.514-2.056), and carbapenems (aOR, 1.775; 95% CI, 1.454-2.165), as well as the presence of comorbidities (diabetes [aOR, 1.237; 95% CI, 1.061-1.443], hemiplegia or paraplegia [aOR, 1.370; 95% CI, 1.119-1.679], kidney disease [aOR, 1.312; 95% CI, 1.105-1.559], and liver disease [aOR, 1.431; 95% CI, 1.073-1.908]), were significantly associated with the development of CRE. Additionally, the CRE group had higher mortality (8.33 vs. 3.32 incidence rate per 100 person-months, P < 0.001) and a total cost of healthcare utilization per person-month (15,325,491 ± 23,587,378 vs. 5,263,373 ± 14,070,118 KRW, P < 0.001) than the control group. The utilization of broad-spectrum antibiotics and the presence of comorbidities are associated with increasing development of CRE. This study emphasizes the importance of antimicrobial stewardship in reducing broad-spectrum antibiotic use and CRE disease burden in Korea.

Adult-onset Still's disease in Western Australia: Epidemiology, comorbidity and long-term outcome.

Adult-onset Still's disease (ASD) is a rare, potentially life-threatening autoinflammatory condition. As reported prevalence shows regional variation and long-term outcome data are scarce, we investigated epidemiology and long-term health outcomes of ASD in Western Australia (WA). Population-based cohort study using longitudinally linked administrative health data from all WA hospitals between 1999 and 2013 for ASD patients (ICD-10-AM M06.1) and controls matched for age, gender, and index year. Rate ratios and odds ratios (RR/OR) with 95% confidence intervals (CI) compared ASD patients with controls. The average ASD incidence (n=52) was 0.22/100 000 with 2.4/100 000 point-prevalence as of December 31, 2013. ASD patients (median age 41.5 years, 59.6% female) had higher odds of previous liver disease (OR 2.67, 95% CI 1.31-5.45), fever (OR 54.10, 95% CI 6.60-433.0), rash (OR 15.70, 95% CI 4.08-60.80), and serious infections (OR 4.36, 95% CI 2.11-22.80) than controls. Despite biological disease-modifying antirheumatic drugs in 27% of patients, ASD patients had higher odds for joint replacement (n=7, 13.5%) (OR 45.5, 95% CI 4.57-93.70), osteoporosis (OR 31.3, 95% CI 3.43-97), and serious infections (RR 5.68; 95% CI 6.61-8.74) during follow up. However, crude mortality (11.5% vs 7.5%; P=0.34), survival at 1 and 5 years (P= 0.78), and last modified Charlson Comorbidity score (median 2 vs 2) were similar between groups. The epidemiology and demographics of ASD in Western Australia fall within the internationally reported range. ASD patients present increased rates of liver disease, rash, and serious infections before disease onset. Mortality following ASD was not increased for 5 years despite high rates of chronic arthritis requiring joint replacement, serious infections, and osteoporosis.

COVID-19 Trials: Who Participates and Who Benefits?

The coronavirus disease 2019 (COVID-19) pandemic has disproportionately afflicted vulnerable populations. Older adults, particularly residents of nursing facilities, represent a small percentage of the population but account for 40% of mortality from COVID-19 in the United States. Racial and ethnic minority individuals, particularly Black, Hispanic, and Indigenous Americans have experienced higher rates of infection and death than the White population. Although there has been an unprecedented explosion of clinical trials to examine potential therapies, participation by members of these vulnerable communities is crucial to obtaining data generalizable to those communities. We undertook an open-label, factorial randomized clinical trial examining hydroxychloroquine and/or azithromycin for hospitalized patients. Of 53 screened patients, 11 (21%) were enrolled. Ten percent (3/31) of Black patients were enrolled, 33% (7/21) of White patients, and 50% (6/12) of Hispanic patients. Forty-seven percent (25/53) of patients declined participation despite eligibility; 58%(18/31) of Black patients declined participation. Forty percent (21/53) of screened patients were from a nursing facility and 10% (2/21) were enrolled. Enrolled patients had fewer comorbidities than nonenrolled patients: median modified Charlson comorbidity score 2.0 (interquartile range 0-2.5), versus 4.0 (interquartile range 2-6) for nonenrolled patients (P = 0.006). The limitations of the study were the low participation rate and the multiple treatment trials concurrently recruiting at our institution. The high rate of nonparticipation in our trial of nursing facility residents and Black people emphasizes the concern that clinical trials for therapeutics may not target key populations with high mortality rates.

Disease Course and Outcomes of COVID-19 Among Hospitalized Patients With Gastrointestinal Manifestations

Background & AimsOur understanding of outcomes and disease time course of COVID-19 in patients with gastrointestinal (GI) symptoms remains limited. In this study we characterize the disease course and severity of COVID-19 among hospitalized patients with gastrointestinal manifestations in a large, diverse cohort from the Unites States. MethodsThis retrospective study evaluated hospitalized individuals with COVID-19 between March 11 and April 28, 2020 at two affiliated hospitals in New York City. We evaluated the association between GI symptoms and death, and also explored disease duration, from symptom onset to death or discharge. ResultsOf 2804 patients hospitalized with COVID-19, the 1,084 (38.7%) patients with GI symptoms were younger (aOR for age ≥75, 0.59; 95% CI, 0.45-0.77) and had more co-morbidities (aOR for modified Charlson comorbidity score ≥2, 1.22; 95% CI, 1.01-1.48) compared to those without GI symptoms. Individuals with GI symptoms had better outcomes, with a lower likelihood of intubation (aHR, 0.66; 95% CI, 0.55-0.79) and death (aHR, 0.71; 95% CI, 0.59-0.87), after adjusting for clinical factors. These patients had a longer median disease course from symptom onset to discharge (13.8 vs 10.8 days, log-rank p = .048; among 769 survivors with available symptom onset time), which was driven by longer time from symptom onset to hospitalization (7.4 vs 5.4 days, log-rank P < .01). ConclusionHospitalized patients with GI manifestations of COVID-19 have a reduced risk of intubation and death, but may have a longer overall disease course driven by duration of symptoms prior to hospitalization.

Lower Levels of Blood Zinc Associated with Intradialytic Hypertension in Maintenance Hemodialysis Patients

Intradialytic hypertension (iHTN) has been related with an increased risk of mortality, with imbalances in trace elements being frequent in maintenance hemodialysis (MHD) patients. The aim of this study was to analyze the relationships between the levels of blood trace elements and iHTN in MHD patients. A total of 144 MHD patients were enrolled in September, 2019 (66 females; 5616 hemodialysis treatments), with a mean age of 64.33 ± 13.39 years and median vintage of 33.50 (16.25–57.50) months. Patients exhibited an average peridialytic systolic blood pressure (SBP) change of − 4.18 ± 20.22 mm Hg in the next 3 months. Thirty-four (23.6%) patients had persistent iHTN (piHTN). These patients were characterized by older age, higher rate of hypozincemia, and modified Charlson comorbidity score, whereas lower blood zinc and hemoglobin, at the time of their recruitment. No significant difference in the levels of other blood trace elements was observed between groups. A general linear mixed (GLM) model showed that with every mg/L point lower mean blood zinc at baseline, the peridialytic SBP change was increased by 4.524 mm Hg (P < 0.001). Binary logistic model in modulate of the GLM model revealed that the lower level of blood zinc was associated with piHTN (OR = 0.433, 95 % CI 0.295 to 0.637, P < 0.001). Multivariate analysis confirmed both above results. Our study indicated that lower blood zinc was independently associated with piHTN in patients undergoing MHD, but prospective studies with larger population are still needed.

Transcervical Thymectomy Is the Most Cost-Effective Surgical Approach in Myasthenia Gravis

Extended thymectomy has been proven to improve the course of myasthenia gravis. Retrospective studies demonstrate that several techniques for thymectomy achieve overlapping remission rates. We therefore compared perioperative outcomes and costs among 3 approaches to thymectomy: sternotomy, video and/or robot assisted, and transcervical. To ensure similar study groups, we excluded patients with >4 cm or invasive tumors and those who underwent less than an extended thymectomy or concurrent procedures. Hospital costs were collected and analyzed by blinded finance personnel. The final study group consisted of 25 transcervical, 23 video/robot-assisted, and 14 sternotomy subjects. There was a higher incidence of myasthenia gravis in the transcervical and sternotomy groups (P < 0.001) and of thymoma in the video/robot-assisted and sternotomy groups (P = .002). Mean modified Charlson comorbidity score was higher for sternotomy (2.7 ± 2.1, mean ± SD) than transcervical (1.00 ± 0.58; P < .001) and video/robot-assisted (1.13 ± 0.97; P= .001) procedures. There was no difference in complication rates between approaches (P= 0.828). The cost of transcervical thymectomy was 45% of the cost of sternotomy (P < .001), and was 58% of the cost of video/robot-assisted (P= .018) approaches; these differences remained highly significant on multivariate analysis. Transcervical thymectomy had a shorter mean length of stay (1.2 ± 0.5 days) than median sternotomy (4.4 ± 3.5; P < .001), and video/robot-assisted thymectomy (2.4 ± 0.95; P= .045) and "bed cost" were major contributors to the cost difference between the groups. Transcervical thymectomy, which provides overlapping myasthenia gravis remission rates versus more invasive approaches, is equally safe and far less costly than sternotomy and video/robot-assisted approaches.

Long-term survival after endovascular and open repair of unruptured abdominal aortic aneurysm.

The aim of this study was to examine patterns of 10-year survival after elective repair of unruptured abdominal aortic aneurysms (AAAs) in different patient groups. Patients having open repair or endovascular aneurysm repair (EVAR) in the English National Health Service between January 2006 and December 2015 were identified from Hospital Episode Statistics data. Postoperative survival among patients of different age and Royal College of Surgeons of England (RCS) modified Charlson co-morbidity score profiles were analysed using flexible parametric survival models. The relationship between patient characteristics and risk of rupture after repair was also analysed. Some 37 138 patients underwent elective AAA repair, of which 15 523 were open and 21 615 were endovascular. The 10-year mortality rate was 38·1 per cent for patients aged under 70 years, and the survival trajectories for open repair and EVAR were similar when patients had no RCS-modified Charlson co-morbidity. Among older patients or those with co-morbidity, the 10-year mortality rate rose, exceeding 70 per cent for patients aged 80 years. Mean survival times over 10 years for open repair and EVAR were often similar in subgroups of older and more co-morbid patients, but their survival trajectories became increasingly dissimilar, with open repair showing greater short-term risk within 6 months but lower 10-year mortality rates. The risk of rupture over 9 years was 3·4 per cent for EVAR and 0·9 per cent for open repair, and was weakly associated with patient factors. Long-term survival patterns after elective open repair and EVAR for unruptured AAA vary markedly across patients with different age and co-morbidity profiles.

Financial burden among older, long-term cancer survivors: Results from the LILAC study.

BackgroundIncreasing attention is being paid to financial burdens of cancer survivorship, but little is known about the prevalence and predictors of these burdens in older, long‐term survivors.MethodsWe used data from 6012 participants diagnosed with cancer since enrolling in the Women's Health Initiative, and who participated in the Life and Longevity After Cancer (LILAC) ancillary study to estimate prevalence and identify predictors of financial burden. We used logistic regression to identify sociodemographic, socioeconomic, health‐ and cancer‐related factors associated with financial burden and backward selection to build a final multivariable model.ResultsAverage age at LILAC participation was 79 and 9.2 years had elapsed since cancer diagnosis. Overall, 6% experienced some form of financial burden, including having an insurance company refuse a claim (2.6%), being denied loans or insurance due to cancer history (2.2%), or experiencing significant indebtedness (1.8%, including facing large debts or bills or declaring bankruptcy). Eight predictors remained associated (P < 0.05) with financial burden in the fully‐adjusted model: younger age, shorter time since diagnosis, African‐American race, household income <$20 000/year, modified Charlson comorbidity score ≥2, receipt of chemotherapy, regional stage at diagnosis, and no private health insurance. Education, cancer site, social support, receipt of radiation, and receipt of hormone therapy were not associated with financial burden. Predictors differed between types of financial burden experienced and age at diagnosis (<65 vs 65+).ConclusionCancer‐related financial burden was rare in this population of older, female long‐term cancer survivors. The identification of several socioeconomic, health‐related and demographic predictors of financial burden may suggest targets of intervention to reduce financial burdens.PrecisFinancial burden was uncommon in older, female, long‐term survivors. Predictors of financial burden included age, race, income, comorbidities, time since diagnosis, stage, insurance, and receipt of chemotherapy.

Palliative radiation and fractionation in medicare patients with incurable non-small cell lung cancer

PurposePalliative radiation therapy (RT) can improve quality of life but also incurs time and financial costs. The aim of this study was to evaluate factors associated with use and intensity of palliative RT for incurable non-small cell lung cancer (NSCLC). Methods and materialsThis was a retrospective analysis of Medicare's Surveillance, Epidemiology and End Results data. We identified patients who were diagnosed with incurable (American Joint Committee on Cancer 6th edition stage IIIB with malignant effusion or stage IV) NSCLC between 2004 and 2011. Univariable and multivariable logistic regressions were used to identify factors associated with the receipt of palliative RT and the use of >10 fractions during the first course of radiation. Among patients who were treated with radiation, freestanding versus hospital-based center information was collected on the basis of the location of the RT delivery claim. ResultsAmong 55,258 patients with incurable NSCLC, 38% (21,053 patients) received palliative RT during the first year after diagnosis. Among patients who received RT, 56% (11,717 patients) received >10 fractions. On multivariable analysis, factors associated with greater RT use included younger age group (overall P < .01), lower modified Charlson comorbidity score (overall P < .01), female sex (odds ratio [OR]: 1.1; P < .01), marital status (OR: 1.1; P < .01), and chemotherapy use (OR: 3.6; P < .01). Predictors for >10 fractions were chemotherapy use (OR: 1.7; P < .01) and treatment at a freestanding versus hospital-based facility (58% vs 43%; OR: 1.7; P < .01). ConclusionsMore than a third of patients diagnosed with incurable lung cancer receive palliative RT and 56% received >10 fractions. The use of RT varied by region and patient characteristics, and patients treated at freestanding RT centers were more likely to receive >10 fractions. Further research into factors that influence treatment decisions including potential financial incentives may contribute to the high value and strategic utilization of palliative RT.

Prospective comorbidity-matched study of Parkinson's disease and risk of mortality among women

BackgroundIndividuals with Parkinson's disease (PD) may have an increased risk of overall mortality compared to the general population. Women may have lower mortality rates from PD than men; however, studies...

Treating Indolent Lymphoma in Older Adults: What Is the Right Way?

Introduction: The treatment of hematological malignancies in older adults is an emerging and important issue due to the aging population trend as well as drug-related toxicities in pts (pts) with comorbidities. Indolent lymphomas constitute a subgroup of incurable non-Hodgkin lymphomas characterized by multiple relapses. Anthracycline containing chemo-immunotherapy regimens (ACR) such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) are very active in indolent lymphomas, resulting in a long progression-free survival (PFS). Due to their high rate of associated toxicities, such regimens are less likely to be given to the elderly population. Currently, there is no consensus regarding the treatment of indolent lymphomas in older adults. The present study assessed overall survival (OS), time to next treatment (TNT) and treatment-associated toxicity in this distinctive subpopulation of pts with indolent lymphoma, aiming to develop an optimal approach to the management of such pts.Methods: This retrospective cohort analysis included pts with indolent lymphoma (histology diagnosis of follicular lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinaemia and indolent lymphoma not otherwise specified) aged ≥60 at therapy initiation (1st line) treated with either an ACR or a non-ACR at the Rambam Department of Hematology and Bone Marrow Transplantation between the years 2000 and 2012. All regimens included rituximab. OS, TNT and treatment-related toxicity (neutropenic fever and hospital admission due to noninfectious causes during the treatment period) were assessed.Results: Forty three pts treated with an ACR and 55 pts receiving a non-ACR were included in the analysis. Clinical characteristics, response to therapy and treatment modification data are presented in table 1. The median age was 67 years in the ACR group and 73 years in the non-ACR group; median duration of the follow-up was 4.3 years (range 0.1-11.9 years). No difference in terms of high risk co-morbidity score, defined as modified Charlson co-morbidity score ≥5 (Charlson et al, 1987), was found between the ACR group and the non-ACR group. Significantly more pts with follicular lymphoma were treated with ACR compared to non-follicular indolent lymphomas. There was no difference in CR rate between the ACR and non-ACR groups. In a univariate analysis, OS was found to be significantly higher in the ACR group, but in the multivariate analysis, OS appeared to be influenced only by age. The cause of death was disease-related in 8 pts (100% of deaths) in the ACR group and in 7 pts (64%) in the non-ACR group (data on the cause of death were available for 11 out of 18 pts from the non-ACR group). The median TNT was longer in the ACR cohort, but the difference did not reach statistical significance. No difference was found between the ACR and non-ACR groups in terms of major treatment-related toxicities assessed by the number of hospital admissions because of infection or other causes. Dose adjustments and treatment delays were far more frequent in the ACR cohort. This study is limited by its retrospective nature, the small number of patients and a significantly higher number of pts with follicular lymphoma treated in the ACR group.Conclusions: The present analysis of a cohort of older adults with indolent lymphoma treated with chemo-immunotherapy regimens in routine clinical practice has demonstrated that ACR was safe and efficacious. When approaching older adults suffering from indolent lymphoma, the considerations of quality of life (time without the need of further treatment, the minimal number of hospital admissions and minimal number of infections requiring hospitalization) should play a major role in treatment decision-making. In the current study, ACR was not inferior to non-ACR in terms of toxicity. A trend to an improved OS and longer TNT was demonstrated in the ACR group. The patient age should not deter physicians from using ACR in older adults.Table 1ParametersACR N=43Non-ACR N=55P valueAge, median67730.05Pts with modified Charlson comorbidity score ≥5 (%)7 (17)10 (19)0.55Pts with follicular lymphoma (%)33 (77)27 (49)0.007CR rate (%)30 (70)33 (60)0.44-year OS, %8167<0.04Median time to next treatment, months90550.2Dose adjustments65370.008Treatment delays57370.06 DisclosuresNo relevant conflicts of interest to declare.

Previous Agent Orange Exposure Is Correlated with Worse Outcome in Patients with Multiple Myeloma (MM)

Abstract BACKGROUND: Agent Orange (AO) is an herbicide that was previously used by the United States armed forces during the Vietnam conflict during the years 1961-1971. AO was contaminated with the potent carcinogen, 2, 3, 7, 8-tetrachlorodibenzodioxin (dioxin) , during the manufacturing process. Exposure to AO has previously been defined as a risk factor for the development of several malignancies including multiple myeloma (MM). While numerous studies have been evaluated the association between AO exposure and MM incidence, none have evaluated the association between AO exposure and survival. METHODS: Patients with MM were identified in the Veterans Health Administration (VHA) central cancer registry using International Classification of Diseases for Oncology, version 3, code 9732/3. Patients who did not receive treatment within 6 months of diagnosis were excluded in order to remove patients with monoclonal gammopathy or smoldering myeloma miscoded as MM (n=1,002). Data was linked to administrative data on AO exposure, through patient self-report and clinician report, for a total of 308 AO exposed patients. Data was also obtained on age, race, serum creatinine, co-morbid conditions calculated into a modified Charlson co-morbidity score, bisphosphonate use, year of diagnosis (before or after 2005), treatment with autologous stem cell transplantation, and body mass index (n=2968). Overall survival (OS) was calculated from date of MM diagnosis to death. Cox proportional hazards modeling was used to estimate the association between reported AO exposure and OS while controlling for potential confounding variables. RESULTS: Variables significantly associated with reduced hazard of death included obese BMI (HR = 0.79, 95% CI 0.71-0.88), overweight BMI (0.85, CI 0.77-0.93), bisphosphonate use (HR 0.850, CI 0 .779-0.927), use of autologous transplantation (HR 0, 52, CI 0.44-0.67), and diagnosis after 2005 (HR 0.84, CI 0.78-0.92). Race was associated with a non-significant trend towards reduced hazard of death (HR - 0.92 CI 0.84 - 1.01) Variables significantly associated with increased hazard of death included underweight BMI (HR 1.61 CI 1.28-2.04), advanced age (HR 1.02, CI 1.02-1.-3); higher co-morbidity score (HR 1.07 CI 1.06-1.09), creatinine greater than 2 mg/dl (HR 1.40 CI 1.28-1.56), and reported AO exposure (HR 1.29 CI 1.07-1.40). CONCLUSIONS: This is the largest reported study of the association between AO exposure and OS in patients diagnosed with MM, and it suggests a statistically significant worsening of OS in those exposed. Whether this is due to the development of higher risk cytogenetic profiles in those exposed to AO could not be determined for this study, but is worthy of further research. A major limitation is the inability to objectively confirm the history of AO exposure. However, it is unlikely that a systematic bias would drive patients with poorer prognosis MM to aberrantly claim AO exposure. It is important to highlight that regardless of the detriment in estimated OS after AO exposure, MM remains an incurable disease that results in a disease-related death in most patients. Disclosures No relevant conflicts of interest to declare.

Is Body Mass Index Related to the Progression of Monoclonal Gammopathy of Unknown Significance to Multiple Myeloma?

Introduction: Multiple Myeloma (MM) is a hematologic malignancy that is universally preceded by Monoclonal Gammopathy of Undetermined Significance (MGUS). Obesity is the only known modifiable risk factor for the development of MM, though it is unclear if this is due to increased MGUS incidence or transition of MGUS to MM. In an effort to better understand how obesity may influence the progression of MGUS to MM, we analyzed patient data from the U.S. Veterans Health Administration (VHA).Methods: The VHA database was used to identify patients diagnosed with MGUS between October 1, 1999 and December 31, 2009 using ICD-9 code 273.1. Data was obtained on patient demographics, myeloma direct treatments, weight, height, and other clinical characteristics. Transition to MM was identified using two occurrences of ICD-9 code 203.0 or use of myeloma directed therapy within six months of a single use of ICD-9 code 203.0. Additionally, two investigators reviewed patient records to confirm the diagnosis and verify the diagnosis date. The World Health Organization (WHO) Body Mass Index (BMI) classification (normal-weight: 18.5≤BMI<25, overweight: 25≤BMI<30, and obese: BMI>30) was utilized to categorize BMI. Weight recorded closest to the MGUS diagnosis date was used for BMI calculations. Multivariate survival analysis (controlling for sex, race, BMI, marital status, estimated household income level, modified Charlson co-morbidity score, and creatinine level) was conducted by parametric accelerated failure time left-censored analysis with Weibull-modeled survival time.Results: There were 9,430 unique MGUS patients identified in the VHA database. Progression to MM was noted in 501 (5.3%) patients overall, with a frequency of 98/2139 (4.6%), 236/3932 (6.0%), and 167/3359 (5.0%) of the normal weight, overweight and obese BMI groups, respectively. Survival analysis revealed a statistically significant difference in progression from MGUS to MM in overweight and obese patients compared to normal-weight patients. After controlling for other variables, multivariate analysis demonstrated that obese (HR: 1.53; 95% CI 1.19-1.98) and overweight (HR: 1.45; 95% CI 1.14-1.84) patients were at increased risk of progression from MGUS to MM. Black patients (HR: 1.78; 95% CI 1.46-2.17) were also at increased risk of progression to MM.Conclusions: Patients with Monoclonal Gammopathy of Unknown Significance who are overweight or obese at the time of MGUS diagnosis are at increased risk of progression to Multiple Myeloma compared to normal weight counterparts. Also the data is suggestive that an obese BMI is associated with a higher risk of progression to MM compared to being overweight. Elevated BMI is a modifiable risk factor for progression of MGUS to MM and weight loss is a potential strategy to decrease the risk of progression. DisclosuresCarson:Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Millennium: Consultancy, Research Funding.

THU0115 Factors Associated with Methotrexate Treatment Duration, Including Subcutaneous Use, in Patients with Rheumatoid Arthritis: Observations from the Veterans Affairs Database

BackgroundMethotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment, however, limitations of systemic exposure of oral MTX can affect its efficacy. The bioavailability of subcutaneous (SC) MTX is greater...

Treatment (tx) patterns and drug (Rx) costs for patients (pts) with metastatic renal cell carcinoma (mRCC) in the United States.

457 Background: The tx paradigm for mRCC has rapidly morphed from cytokine-based and cytotoxic tx to targeted therapy (TT). Five oral (O) and two intravenous (IV) TTs are approved for mRCC. No consensus exists on the sequence of TT use. This study aimed to examine the evolution of 1st through 3rd line tx patterns since 2004 and their associated costs. Methods: LifeLink Health Plan Claims Database (October 1, 2003-March 31, 2011), a commercial claims database, was used to create a cohort of age ≥ 18 yo, mRCC pts with at least 12 months of continuous enrollment. We examined tx patterns and sequences by year. When evaluating cost, we limited analysis to pts &lt;65 yo because the database does not have information on claims paid by Medicare. We described pt characteristics and tx patterns over time and applied a nonparametric bootstrapping method to compare costs. Results: 1,561 mRCC pts met the inclusion criteria with 71% men and a mean age of 62 yo (SD=11); 39% were from the South; 57% had a modified Charlson comorbidity score of zero. In 2010: 9 unique Rx regimens were used for 1st line tx, 8 for 2nd, 8 for 3rd; most common 1st/2nd/3rd line tx was sunitinib (44%)/temsirolimus (24%)/everolimus=sunitinib (26%); most common sequence was VEGF-&gt;mTOR for the 1st switch and VEGF-&gt;VEGF-&gt;VEGF for 2nd switch. From 2004 to 2011, 1st line cytotoxic tx decreased from 47% to 6%, IFN-α from 47% to 3%, bevacizumab from 33% to 9%. Over time, more pts were able to go from 1st to 2nd line tx (p=0.01) and 2nd to 3rd line tx (p=0.025). Median time to switch (TTS) from 1st to 2nd line was 175 days (SD 103) with a longer TTS if started on O vs. IV tx (188 vs. 143 days) (p&lt;0.001). For 959 pts &lt;65 yo, stratifying by whether the 1st line tx was O or IV, mean total 1st-yr tx cost/pt was $130,962 (IV) vs. $121,676 (O) (P=0.18) and total 1st-yr Rx cost was $36,636 (IV) vs. $54,596 (O) (p&lt;0.001). Also, costs increased by the number of switches, from $108,428 for no switch to $190,976 for &gt; 1 switch. Conclusions: The results support a drastic shift in the tx of mRCC with wide heterogeneity in tx patterns, reflecting a lack of clear guidelines. Over the years, more pts are able to receive more lines of tx, TTS was longer with initial O tx, but 1st-yr Rx costs were lower with initial IV tx.

Abstract 4803: Metabolic syndrome is associated with an increased risk of Barrett's esophagus in those without symptomatic reflux.

Abstract Background: Obesity is known to increase the propensity for gastroesophageal reflux, a discrete inflammatory effect which may lead to the development of an esophageal metaplasia termed Barrett's esophagus (BE). BE is a precancerous lesion that drastically increases the risk of esophageal adenocarcinoma. Obesity is also associated with BE independent of reflux, through unknown pathways. Metabolic syndrome (MetS) is an exposure closely aligned with obesity and represents one possible pathway. MetS produces a global inflammatory state which could increase the risk of BE. Methods: We used the SEER-Medicare linked database to evaluate the association between MetS and BE with comparison to two control groups- a general Medicare group and an endoscopy BE-negative group. MetS was defined as diagnosis of at least three of the following conditions: obesity, dyslipidemia, hypertension, and impaired fasting glucose. Multivariable logistic regression was used to estimate adjusted odds ratios (OR) and 95% confidence intervals (95%CI). All analyses were adjusted for age, sex, SEER registry, smoking-related conditions, Medicaid dual enrollment, reflux, and a modified Charlson comorbidity score. Results: We identified 2,212 incident Barrett's esophagus cases among 251,196 eligible beneficiaries. MetS increased the risk of BE [OR 1.20; 95%CI 1.07, 1.36] compared with Medicare controls. However, reflux status modified the association; among those without a prior reflux diagnosis, MetS was associated with a 35% increased risk of BE [OR 1.35; 95%CI 1.18, 1.55], but no association was observed among those with a history of reflux [OR 0.97; 95%CI 0.65, 1.43]. Assessment of individual components of MetS reiterated these findings. MetS was not associated with an increased risk of BE compared with endoscopy controls [OR 0.99; 95%CI 0.88, 1.10]. Conclusions: MetS was positively associated with BE; however not in a reflux population or compared to endoscopy BE-negative controls. Our findings may be explained by a saturated inflammatory state in which MetS global inflammation contributes little to the risk of BE in the presence of discrete inflammatory effects conferred by gastroesophageal reflux. Conversely, in individuals without reflux, the effects of MetS global inflammation in relation to BE are detectable. Citation Format: Jennifer Drahos, Winnie Ricker, Ruth M. Pfiffer, Joan L. Warren, Michael B. Cook. Metabolic syndrome is associated with an increased risk of Barrett's esophagus in those without symptomatic reflux. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 4803. doi:10.1158/1538-7445.AM2013-4803

Sublobar Resection Versus Definitive Radiation in Patients With Stage IA Non-Small Cell Lung Cancer

Many patients with resectable non-small cell lung cancer (NSCLC) are unfit for lobectomy owing to comorbidity. Surgical outcomes are biased by preoperative selection factors and upstaging that occurs during surgery. This study compares outcomes between sublobar pulmonary resection and traditional external beam radiation therapy. This cohort study utilizes Surveillance, Epidemiology, and End Results-Medicare data (1998 to 2005). Patients with stage IA NSCLC treated with either radiotherapy or sublobar resection were compared. The bias of clinical staging in the radiation group versus pathologic staging in the surgical group was addressed by including only sublobar resections without lymph node sampling. Medicare claims data were used to calculate a modified Charlson comorbidity score for each patient. In all, 878 patients received radiotherapy and 657 underwent sublobar resection without lymph node sampling. Radiation patients were older (77.0 versus 75.5 years, p<0.0001) and had larger tumors (22.8 versus 17.9 mm, p<0.0001). There was no difference in comorbidity scores between groups (p=0.21). Three-year overall survival favored sublobar resection (56% versus 35%; p<0.0001). Predictors of earlier death were radiation, age, comorbidity score, tumor size, male sex, and prior malignancy (all p<0.05). Propensity analysis matched 319 radiation patients and 319 sublobar resection patients. In this subgroup, 3-year overall survival favored sublobar resection (52% versus 41%; p<0.001). Sublobar resection without lymph node sampling appears to be superior to radiotherapy for clinical stage IA NSCLC. For patients with prohibitive risk for lobectomy, sublobar resection may be preferable to radiotherapy. Radiotherapy results in current and future patients are likely to be better.

Recruitment and Training for Home Hemodialysis

We assessed perceived barriers and incentives to home hemodialysis and evaluated potential correlates with the duration of home hemodialysis training. Surveys were sent to the principal investigator and study coordinator for each clinical center in the Frequent Hemodialysis Network Nocturnal Trial. Baseline data were obtained on medical comorbidities, cognitive and physical functioning, sessions required for home hemodialysis training, and costs of home renovations. The most commonly perceived barriers included lack of patient motivation, unwillingness to change from in-center modality, and fear of self-cannulation. The most common incentives were greater scheduling flexibility and reduced travel time. The median costs for home renovations varied between $1191 and $4018. The mean number of home hemodialysis training sessions was 27.7 +/- 10.4 (11-59 days). Average training time was less for patients with experience in either self-care or both self-care and cannulation. The number of training sessions was unrelated to the score on the Modified Mini Mental Status or Trailmaking B tests or patient's education level. Training time also did not correlate with the SF-36 Physical Function subscale but did with the modified Charlson comorbidity score and older patient age. Lack of patient or family motivation and fear of the dialysis process are surmountable barriers for accepting home hemodialysis as a modality for renal replacement therapy. Formal education and scores on cognitive function tests are not predictors of training time.