Patterns of erythropoiesis-stimulating agent use among Medicare beneficiaries with myelodysplastic syndromes and consistency with clinical guidelines.
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SUBMITTER: Davidoff AJ
PROVIDER: S-EPMC3694576 | biostudies-literature | 2013 Jun
REPOSITORIES: biostudies-literature
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Patterns of erythropoiesis-stimulating agent use among Medicare beneficiaries with myelodysplastic syndromes and consistency with clinical guidelines.
Davidoff Amy J AJ Weiss Sheila R SR Baer Maria R MR Ke Xuehua X Hendrick Franklin F Zeidan Amer A Gore Steven D SD
Leukemia research 20130321 6
Erythropoiesis-stimulating agents (ESA) are used commonly to reduce symptomatic anemia in patients with myelodysplastic syndromes (MDS). We assessed population-based patterns of ESA use relative to treatment guidelines using data from the Surveillance, Epidemiology, and End Results (SEER) registries, with linked Medicare claims providing detailed treatment data from 2001 through 2005. The study found widespread use (62%) of ESA in Medicare beneficiaries with MDS. Similar ESA use rates regardless ...[more]
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Project description:A randomized phase-II study was performed in low/int-1 risk MDS (IPSS) to study efficacy and safety of lenalidomide without (arm A) or with (arm B) ESA/G-CSF. In arm B, patients without erythroid response (HI-E) after 4 cycles received ESA; G-CSF was added if no HI-E was obtained by cycle 9. HI-E served as primary endpoint. Flow cytometry and next-generation sequencing were performed to identify predictors of response. The final evaluation comprised 184 patients; 84% non-del(5q), 16% isolated del(5q); median follow-up: 70.7 months. In arm A and B, 39 and 41% of patients achieved HI-E; median time-to-HI-E: 3.2 months for both arms, median duration of-HI-E: 9.8 months. HI-E was significantly lower in non-del(5q) vs. del(5q): 32% vs. 80%. The same accounted for transfusion independency-at-week 24 (16% vs. 67%), but similar in both arms. Apart from presence of del(5q), high percentages of bone marrow lymphocytes and progenitor B-cells, a low number of mutations, absence of ring sideroblasts, and SF3B1 mutations predicted HI-E. In conclusion, lenalidomide induced HI-E in patients with non-del(5q) and del(5q) MDS without additional effect of ESA/G-CSF. The identified predictors of response may guide application of lenalidomide in lower-risk MDS in the era of precision medicine. (EudraCT 2008-002195-10).
| S-EPMC10997501 | biostudies-literature
Project description:BackgroundErythropoiesis-stimulating agents (erythropoietin and darbepoietin) have been approved to reduce the number of blood transfusions required during chemotherapy; however, concerns about the risks of venous thromboembolism and mortality exist.MethodsWe identified patients who were aged 65 years or older in the Surveillance, Epidemiology, and End Results-Medicare database; who were diagnosed with colon, non-small cell lung, or breast cancer or with diffuse large B-cell lymphoma from January 1, 1991, through December 31, 2002; and who received chemotherapy. The main outcome measures were claims for use of an erythropoiesis-stimulating agent, blood transfusion, venous thromboembolism (ie, deep vein thrombosis or pulmonary embolism), and overall survival. We used multivariable logistic regression models to analyze the association of erythropoiesis-stimulating agent use with clinical and demographic variables. We used time-dependent Cox proportional hazards models to analyze the association of time to receipt of first erythropoiesis-stimulating agent with venous thromboembolism and overall survival. All statistical tests were two-sided.ResultsAmong 56,210 patients treated with chemotherapy from 1991 through 2002, 15,346 (27%) received an erythropoiesis-stimulating agent. The proportion of patients receiving erythropoiesis-stimulating agents increased from 4.8% in 1991 to 45.9% in 2002 (P < .001). Use was associated with more recent diagnosis, younger age, urban residence, comorbidities, receipt of radiation therapy, female sex, and metastatic or recurrent cancer. The rate of blood transfusion per year during 1991-2002 remained constant at 22%. Venous thromboembolism developed in 1796 (14.3%) of the 12,522 patients who received erythropoiesis-stimulating agent and 3400 (9.8%) of the 34,820 patients who did not (hazard ratio = 1.93, 95% confidence interval = 1.79 to 2.07). Overall survival was similar in both groups.ConclusionUse of erythropoiesis-stimulating agent increased rapidly after its approval in 1991, but the blood transfusion rate did not change. Use of erythropoiesis-stimulating agents was associated with an increased risk of venous thromboembolism but not of mortality.
| S-EPMC2786918 | biostudies-literature
Project description:ObjectiveIn 2011, the Centers for Medicare and Medicaid Services (CMS) replaced fee-for-service reimbursement for erythropoiesis stimulating agents (ESAs) with a fixed-sum bundled payment for all dialysis-related care and pay-for-performance incentives to discourage maintaining patients' hematocrits above 36 percent. We examined the impact of the new payment policy on the use of ESAs.Data sourcesCMS's Renal Information Management System.Study designRegression discontinuity design assessing the use of ESAs by hematocrit level before and after the implementation of the payment policy change.Data extractionSecondary data from 424,163 patients receiving hemodialysis treatment between January 2009 and June 2011.Principal findingsThe introduction of bundled payments with pay-for-performance initiatives was associated with an immediate and substantial decline in the use of ESAs among patients with hematocrit >36 percent and little change in the use of ESAs among patients with hematocrit ≤36 percent. In the first two quarters of 2011, the use of ESAs during dialysis fell by about 7-9 percentage points among patients with hematocrit levels >36 percent. No statistically significant differences in ESA use were observed at the thresholds of 30 or 33 percent.ConclusionsCMS's payment reform for dialysis care reduced the use of ESAs in patients who may not benefit from these agents.
| S-EPMC4450930 | biostudies-literature
Project description:BackgroundLenalidomide is approved for the treatment of anemia with transfusion dependence (TD) in patients with lower-risk myelodysplastic syndrome (MDS) with 5q deletion (del5q-MDS), but its "real-life" use and effect on transfusion needs are unclear. In the current study, the authors examined its use in the Medicare population.MethodsPatients with MDS who were enrolled in Medicare Parts A, B, and D were identified using International Classification of Diseases 9-Clinical Modification (ICD-9) codes from 100% Medicare claims from 2006 through 2008. Patients were followed until the end of the study or death. Claims were used to determine time to initiation of lenalidomide, daily dose, duration, and other MDS therapies. Transfusion status was defined each week based on transfusion use in rolling 8-week period: TD, required transfusions during 2 weeks, separated by ≥ 3 weeks; transfusion user (TU), 1 transfusion; and transfusion independence (TI), no transfusions.ResultsA total of 753 of 23,855 patients (3.2%) received lenalidomide, including 31% of 470 patients with del5q-MDS. At the time of lenalidomide initiation, 33% of patients were TD, 31% were TU, and 36% were TI. The median time to lenalidomide initiation was shorter for patients with del5q-MDS than for other lower-risk patients (8 weeks vs 20 weeks; P < .01). The percentage of patients with del5q-MDS receiving lenalidomide increased over time. Lenalidomide initiation was found to be negatively associated with older age and baseline diabetes, stroke, and renal disease. During the observation period, 44% of TU/TD patients (53% of the patients with del5q-MDS) achieved reductions in transfusion use; among TD patients receiving ≥ 3 cycles, 77% reduced their transfusion use and 40% achieved TI.ConclusionsTo the authors' knowledge, the current study is the first report of lenalidomide use in a large Medicare-enrolled population with MDS. Reductions in transfusion rates were overall consistent with data from clinical trials. Response rates were higher when ≥ 3 lenalidomide cycles were received.
| S-EPMC3805757 | biostudies-literature
Project description:OBJECTIVES:To characterize the patterns of transitions in care and factors associated with multiple transitions in the last 6 months of life of U.S. decedents (N = 660,132). DESIGN:Retrospective study. SETTING:United States. PARTICIPANTS:Medicare beneficiaries aged 66 and older who died from July to December 2011. MEASUREMENTS:Transitions between healthcare settings (e.g., hospital, skilled nursing facility, inpatient hospice, home hospice, home without hospice) in the last 6 months of life. A count variable for number of transitions was summarized, and Sankey diagrams were produced to illustrate the sequences of healthcare transitions. Multivariable analyses were used to identify factors associated with likelihood of having four or more transitions. RESULTS:More than 80% decedents (n = 556,437) had at least one transition within the last 6 months of life; 218,731 had four or more transitions within the last 6 months of life. The most-frequent transition pattern (19.3% of all decedents; n = 127,435) was home to hospital, back to home or skilled nursing facility, to hospital again, and then to settings other than hospital, ending with four or more transitions. The average number of transitions in the last 6 months of life varied substantially across states, ranging from 1.8 in Alaska to 3.1 in New Jersey. Transitions became more intensive for decedents approaching death. In multivariable analyses, women, blacks, individuals younger than 85, and individuals without dementia were more likely to have four or more transitions (all P < .05). CONCLUSION:Approximately one-third of the Medicare beneficiaries who died in 2011 had four or more transitions within their last 6 months of life. Identifying interventions that can facilitate care transitions consistent with beneficiaries' preferences is warranted.
| S-EPMC5507734 | biostudies-literature
Project description:Established cell culture systems have failed to accurately recapitulate key features of terminal erythroid maturation, hampering our ability to in vitro model and treat diseases with impaired erythropoiesis such as myelodysplastic syndromes with ring sideroblasts (MDS-RS). We developed an efficient and robust three-dimensional (3D) scaffold culture model supporting terminal erythroid differentiation from both mononuclear (MNC) or CD34+-enriched primary bone marrow cells from healthy donors and MDS-RS patients. While CD34+ cells did not proliferate beyond two weeks in 2D suspension cultures, the 3D scaffolds supported CD34+ and MNC erythroid proliferation over four weeks demonstrating the importance of the 3D environment. CD34+ cells cultured in 3D facilitated the highest expansion and maturation of erythroid cells, including generation of erythroblastic islands and enucleated erythrocytes, while MNCs supported multi-lineage hemopoietic differentiation and cytokine secretion relevant for MDS-RS. Importantly, MDS-RS 3D-cultures supported de novo generation of ring sideroblasts and maintenance of the mutated clone. The 3D cultures effectively model a clonal disease characterized by terminal erythroid failure and can be used to assess therapeutic compounds.
| S-EPMC7214248 | biostudies-literature
Project description:CD95, a member of the death receptor family initiates a caspase-dependent apoptosis, when activated by its ligand CD95L, thought to negatively regulate erythrocyte production in the bone marrow. We have previously shown that CD95 is overexpressed in two thirds of patients with a lower risk myelodysplastic syndrome (MDS) and that resistance to erythropoiesis-stimulating agents (ESA) is linked to poor residual erythropoiesis. In the present study, we show that CD95 overexpression and previous transfusion are independent predictive factors of ESA resistance. To investigate an alternative therapeutic strategy of anemia in ESA-resistant patients, we have conducted a preclinical study of the effects of APG101, a fusion protein consisting of the extracellular domain of human CD95 and the Fc region of human IgG1 on MDS erythropoiesis in vitro. APG101 increases the number of burst-forming unit-erythroid (BFU-E) progenitors derived from CD34+ progenitors in liquid culture and improves overall proliferation rate of erythroid precursors by inhibiting apoptosis. APG101 rescues BFU-E growth in MDS patients presenting with attrition of erythroid progenitors at baseline, independently of CD95 or CD95L expression level. Our data show that overexpression of CD95 at diagnosis is a hallmark of ESA resistance and that severe impairment of erythropoiesis is predictive of erythroid response to APG101 in vitro. These data provide a rationale for further clinical investigation of APG101 in an attempt to treat anemia in lower risk MDS patients.
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Project description:ImportanceA growing proportion of the population is enrolling in Medicare Advantage (MA), which typically offers additional benefits compared with traditional Medicare (TM).ObjectiveTo determine whether frailty and frailty trajectories differ between MA enrollees and TM enrollees.Design, setting, and participantsThis retrospective cohort study used data from the National Health and Aging Trends Study (2015-2016). Analyses were conducted from August 2023 to March 2024. Participants were community-dwelling Medicare beneficiaries aged 65 years and older.ExposureEnrollment in MA vs TM.Main outcomes and measuresFrailty was calculated by a frailty index (FI) (range, 0-1, with higher values indicating greater frailty) and the Fried Frailty Phenotype (FFP) score (range, 0-5, with higher values indicating greater frailty). Physical performance, including Short Physical Performance Battery (SPPB) score (range, 0-12, with higher values indicating better performance), and gait speed (meters per second) were measured. The primary outcome was the difference in FI and FFP scores from the 2015 baseline assessment to the 2016 follow-up assessment. Secondary outcomes include the 1-year changes in SPPB and gait speed.ResultsThe final cohort consisted of 7063 participants (2775 [23.1%] aged >80 years; 4040 [54.7%] female), representing a sample of the 38.8 million beneficiaries. There were 2583 (35.0%) MA enrollees (13.6 million) and 4480 (65.0%) TM enrollees (25.2 million). At baseline, the FI score was similar between MA and TM enrollees (mean [SD], 0.22 [0.15] vs 0.21 [0.14]), although MA enrollees had worse phenotypic frailty (496 participants [15.2%] vs 811 participants [13.7%] considered frail by FFP score), SPPB scores (mean [SD], 6.91 [3.34] vs 7.21 [3.27]), and gait speed (0.79 [0.24] m/s vs 0.82 [0.23] m/s) than TM enrollees. One year later, there were no differences between MA and TM enrollees in the 1-year change in FI score (mean [SD], 0.016 [0.071] vs 0.014 [0.066]; adjusted mean difference, 0.001 [95% CI, -0.004 to 0.005]), FFP score (mean [SD], 0.017 [1.004] vs 0.007 [0.958]; adjusted mean difference, -0.009 [95% CI, -0.067 to 0.049]), SPPB score (mean [SD], -0.144 [2.064] vs -0.211 [1.968]; adjusted mean difference, 0.068 [95% CI, -0.076 to 0.212]), and gait speed (mean [SD], -0.0160 [0.148] m/s vs -0.007 [0.148] m/s; adjusted mean difference, -0.010 m/s [95% CI, -0.067 to 0.049 m/s]).Conclusions and relevanceIn this cohort study of Medicare beneficiaries from 2015, MA enrollees experienced similar declines in frailty over 1 year compared with TM enrollees. Future work should examine whether the specific types of services covered by health insurance can impact frailty and health trajectories for older adults.
| S-EPMC11365002 | biostudies-literature
Project description:Ferric citrate (FC) is a phosphate binder with shown efficacy and additional effects on iron stores and use of intravenous (iv) iron and erythropoiesis-stimulating agents (ESAs). We provide detailed analyses of changes in iron/hematologic parameters and iv iron/ESA use at time points throughout the active control period of a phase 3 international randomized clinical trial. In all, 441 subjects were randomized (292 to FC and 149 to sevelamer carbonate and/or calcium acetate [active control (AC)]) and followed for 52 weeks. Subjects on FC had increased ferritin and transferrin saturation (TSAT) levels compared with subjects on AC by week 12 (change in ferritin, 114.1±29.35 ng/ml; P<0.001; change in TSAT, 8.62%±1.57%; P<0.001). Change in TSAT plateaued at this point, whereas change in ferritin increased through week 24, remaining relatively stable thereafter. Subjects on FC needed less iv iron compared with subjects on AC over 52 weeks (median [interquartile range] dose=12.9 [1.0-28.9] versus 26.8 [13.4-47.6] mg/wk; P<0.001), and the percentage of subjects not requiring iv iron was higher with FC (P<0.001). Cumulative ESA over 52 weeks was lower with FC than AC (median [interquartile range] dose=5303 [2023-9695] versus 6954 [2664-12,375] units/wk; P=0.04). Overall, 90.3% of subjects on FC and 89.3% of subjects on AC experienced adverse events. In conclusion, treatment with FC as a phosphate binder results in increased iron parameters apparent after 12 weeks and reduces iv iron and ESA use while maintaining hemoglobin over 52 weeks, with a safety profile similar to that of available binders.
| S-EPMC4587699 | biostudies-literature
Project description:BackgroundThe role of pre-transplant erythropoiesis-stimulating agent (ESA) responsiveness in affecting post-transplant outcomes is not clear.MethodsLinking the 5-year patient data of a large dialysis organization to the 'Scientific Registry of Transplant Recipients', we identified 8795 hemodialyzed patients who underwent first kidney transplantation. Mortality or graft failure, delayed graft function (DGF) and acute rejection risks were estimated by Cox regression [hazard ratio (HR)] and logistic regression, respectively.ResultsPatients were 48 ± 14 years old and included 38% women and 36% diabetics. Compared to renal allograft recipients who were in the first quartile of pre-transplant ESA responsiveness index (ERI), i.e. ESA dose divided by hemoglobin and weight, recipients in second, third and fourth quartiles had higher adjusted graft-censored death HR (and 95% confidence intervals) of 1.7 (1.0-2.7), 1.8 (1.1-2.9) and 2.3 (1.4-3.9) and higher death-censored graft failure HR of 1.6 (1.0-2.5), 2.0 (1.2-3.1) and 1.6 (0.9-2.6), respectively. No significant association between pre-transplant ERI and post-transplant DGF or acute rejection was detected.ConclusionsHigher pre-transplant ERI during the hemodialysis treatment period was associated with worse post-transplant long-term outcomes including increased all-cause death and higher risk of graft failure.
| S-EPMC3408941 | biostudies-literature