Dataset Information

A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer.

ABSTRACT:

Introduction

Since sipuleucel-T approval in 2010, the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC) now includes the androgen-receptor signaling pathway inhibitors (ASPIs) abiraterone acetate or enzalutamide. In 2013 and 2014, these oral agents were approved for use in men with metastatic prostate cancer who had minimal to no symptoms. We compared overall survival (OS) in men who received their first mCRPC treatment using the Medicare Fee-for-Service 100% administrative claims research dataset with patient-level linkage to the National Death Index.

Methods

This retrospective cohort analysis (January 2013 to December 2017) included men who were chemo-naïve at treatment start in 2014 and who had continuous Medicare Parts A, B, and D eligibility during the 3-year observation period. We compared: first-line sipuleucel-T vs. first-line ASPIs and any-line sipuleucel-T vs. any-line ASPIs (without sipuleucel-T). We used a multivariable regression model to help control for potentially confounding factors while assessing survival outcomes.

Results

The model included 6044 eligible men (average age 75-78 years) with similar disease severity;?>?80% were white. Median OS, presented as sipuleucel-T vs. ASPI, was 35.2 vs. 20.7 months (n, 906 vs. 5092; any-line cohort) and 34.9 vs. 21.0 months (n, 647 vs. 4810; first-line cohort). Model outcomes indicated sipuleucel-T was associated with significantly prolonged OS compared with ASPIs: adjusted hazard ratio, 0.59 (95% CI 0.527-0.651) and 0.56 (0.494-0.627) for the any-line and first-line cohorts, respectively.

Conclusion

This analysis suggests use of sipuleucel-T at any time was associated with improved OS compared with ASPI use alone. Of note, these analyses are intended as descriptive rather than definitive as this dataset contains limited data on key clinical factors. While selection bias is a risk in secondary claims data, this research provides important insight into real-world treatment outcomes.

SUBMITTER: McKay RR

PROVIDER: S-EPMC7596004 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer.

McKay Rana R RR Hafron Jason M JM Ferro Christine C Wilfehrt Helen M HM Fitch Kate K Flanders Scott C SC Fabrizio Michael D MD Schweizer Michael T MT

Advances in therapy 20201007 12

<h4>Introduction</h4>Since sipuleucel-T approval in 2010, the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC) now includes the androgen-receptor signaling pathway inhibitors (ASPIs) abiraterone acetate or enzalutamide. In 2013 and 2014, these oral agents were approved for use in men with metastatic prostate cancer who had minimal to no symptoms. We compared overall survival (OS) in men who received their first mCRPC treatment using the Medicare Fee-for-Service 100 ...[more]

PMID: 33029725

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Project description:IntroductionThe treatment landscape for metastatic castration-resistant prostate cancer (mCRPC) continues to evolve. Sipuleucel-T was the first immunotherapy approved by the US Food and Drug Administration (FDA) to treat asymptomatic or minimally symptomatic mCRPC. The androgen receptor-targeting agents (ARTAs) abiraterone acetate and enzalutamide were initially approved to treat mCRPC. Looking at chemotherapy-naïve men with mCRPC, we compared survival outcomes between the sipuleucel-T + ARTA cohort (men who received either sipuleucel-T or an ARTA in the first line, and then the other in the second line within 6 months) and the ARTA monotherapy cohort (men who only received ARTA monotherapy).MethodsThis retrospective cohort analysis used longitudinal, adjudicated claims data from the US Medicare Fee-for-Service 100% research identifiable dataset that includes both urologic and oncologic practice settings. Eligible men started their first mCRPC treatment with either sipuleucel-T or ARTA in either 2014 or 2015 and had continuous Medicare Parts A, B, and D eligibility for the subsequent 3 years. A multivariable Cox proportional hazards regression model was used to analyze overall survival (OS), both overall and by index year, and to control for differences.ResultsThe sipuleucel-T + ARTA and ARTA monotherapy cohorts comprised 773 and 4642 men, respectively, with different characteristics at treatment start. The most commonly used ARTAs were enzalutamide in the former and abiraterone in the latter cohort. Median OS was 30.4 and 14.3 months in the sipuleucel-T + ARTA and ARTA monotherapy cohorts, respectively, with the sipuleucel-T + ARTA cohort having a 28.3% lower risk of death than the ARTA monotherapy cohort (hazard ratio 0.717; 95% CI 0.648, 0.793; p < 0.01).ConclusionsThis real-world study of mCRPC treatment indicates that men receiving sipuleucel-T and ARTAs had a longer median OS than patients receiving treatment with an ARTA alone, suggesting that leveraging mechanisms of action can be beneficial in treating patients with mCRPC.

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.

Project description:BackgroundAbiraterone and enzalutamide are high-cost oral therapies that increasingly are used to treat patients with advanced prostate cancer; these agents carry the potential for significant financial consequences to patients. In the current study, the authors investigated coping and material measures of the financial hardship of these therapies among patients with Medicare Part D coverage.MethodsThe authors performed a retrospective cohort study on a 20% sample of Medicare Part D enrollees who underwent treatment with abiraterone or enzalutamide between July 2013 and June 2015. The authors described the variability in adherence rates and out-of-pocket payments among hospital referral regions in the first 6 months of therapy and determined whether adherence and out-of-pocket payments were associated with patient factors and the socioeconomic characteristics of where a patient was treated.ResultsThere were 4153 patients who filled abiraterone or enzalutamide prescriptions through Medicare Part D in 228 hospital referral regions. The mean adherence rate was 75%. The median monthly out-of-pocket payment for abiraterone and enzalutamide was $706 (range, $0-$3505). After multilevel, multivariable adjustment for patient and regional factors, adherence was found to be lower in patients who were older (69% for patients aged ≥85 years vs 76% for patients aged <70 years; P < .01) and in those with low-income subsidies (69% in those with a subsidy vs 76% in those without a subsidy; P < .01). Both Hispanic ethnicity and living in a hospital referral region with a higher percentage of Hispanic beneficiaries were found to be independently associated with higher out-of-pocket payments for abiraterone and enzalutamide.ConclusionsThere were substantial variations in the adherence rate and out-of-pocket payments among Medicare Part D beneficiaries who were prescribed abiraterone and enzalutamide. Sociodemographic patient and regional factors were found to be associated with both adherence and out-of-pocket payments.

Project description:ObjectiveThis study was undertaken to characterize antiseizure medication (ASM) treatment pathways in Medicare beneficiaries with newly treated epilepsy.MethodsThis was a retrospective cohort study using Medicare claims. Medicare is the United States' federal health insurance program for people aged 65 years and older plus younger people with disabilities or end-stage renal disease. We included beneficiaries with newly treated epilepsy (International Classification of Diseases codes for epilepsy/convulsions 2014-2017, no ASM in the previous 2 years). We displayed the sequence of ASM fills using sunburst plots overall, then stratified by mood disorder, age, and neurologist prescriber. We tabulated drug costs for each pathway.ResultsWe included 21 458 beneficiaries. Levetiracetam comprised the greatest number of pill days (56%), followed by gabapentin (11%) and valproate (8%). There were 22 288 unique treatment pathways. The most common pathways were levetiracetam monotherapy (43%), gabapentin monotherapy (10%), and valproate monotherapy (5%). Gabapentin was the most common second- and third-line ASM. Whereas only 2% of pathways involved first-line lacosamide, those pathways accounted for 19% of cost. Gabapentin and valproate use was increased and levetiracetam use was decreased in beneficiaries with mood disorders compared to beneficiaries without mood disorders. Levetiracetam use was increased and gabapentin, valproate, lamotrigine, and topiramate use was decreased in beneficiaries aged >65 years compared with those aged 65 years or less. Lamotrigine, levetiracetam, and lacosamide use was increased and gabapentin use was decreased in beneficiaries whose initial prescriber was a neurologist compared to those whose prescriber was not a neurologist.SignificanceLevetiracetam monotherapy was the most common pathway, although substantial heterogeneity existed. Lacosamide accounted for a small percentage of ASMs but a disproportionately large share of cost. Neurologists were more likely to prescribe lamotrigine compared with nonneurologists, and lamotrigine was prescribed far less frequently than may be endorsed by guidelines. Future work may explore patient- and physician-driven factors underlying ASM choices.

Dataset Information

A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer.

Introduction

Methods

Results

Conclusion

Publications

A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer.

Similar Datasets

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