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

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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.

Electronic Supplementary Material

The online version of this article (10.1007/s12325-020-01509-5) contains supplementary material, which is available to authorized users.

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Most cited references 35

Record: found
Abstract: found
Article: not found

Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases

R Deyo (1992)

Administrative databases are increasingly used for studying outcomes of medical care. Valid inferences from such data require the ability to account for disease severity and comorbid conditions. We adapted a clinical comorbidity index, designed for use with medical records, for research relying on International Classification of Diseases (ICD-9-CM) diagnosis and procedure codes. The association of this adapted index with health outcomes and resource use was then examined with a sample of Medicare beneficiaries who underwent lumbar spine surgery in 1985 (n = 27,111). The index was associated in the expected direction with postoperative complications, mortality, blood transfusion, discharge to nursing home, length of hospital stay, and hospital charges. These associations were observed whether the index incorporated data from multiple hospitalizations over a year's time, or just from the index surgical admission. They also persisted after controlling for patient age. We conclude that the adapted comorbidity index will be useful in studies of disease outcome and resource use employing administrative databases.

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Record: found
Abstract: found
Article: not found

A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.

P Pompei, M Charlson, Tippi MacKenzie … (1986)

The objective of this study was to develop a prospectively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies. A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients. The 1-yr mortality rates for the different scores were: "0", 12% (181); "1-2", 26% (225); "3-4", 52% (71); and "greater than or equal to 5", 85% (82). The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up. The percent of patients who died of comorbid disease for the different scores were: "0", 8% (588); "1", 25% (54); "2", 48% (25); "greater than or equal to 3", 59% (18). With each increased level of the comorbidity index, there were stepwise increases in the cumulative mortality attributable to comorbid disease (log rank chi 2 = 165; p less than 0.0001). In this longer follow-up, age was also a predictor of mortality (p less than 0.001). The new index performed similarly to a previous system devised by Kaplan and Feinstein. The method of classifying comorbidity provides a simple, readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies. Further work in larger populations is still required to refine the approach because the number of patients with any given condition in this study was relatively small.

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Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

Philip Kantoff, Celestia Higano, Neal Shore … (2010)

Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)

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Author and article information

Contributors

Rana R. McKay: rmckay@ucsd.edu

Journal

Journal ID (nlm-ta): Adv Ther

Journal ID (iso-abbrev): Adv Ther

Title: Advances in Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 0741-238X

ISSN (Electronic): 1865-8652

Publication date (Electronic): 7 October 2020

Publication date PMC-release: 7 October 2020

Publication date (Print): 2020

Volume: 37

Issue: 12

Pages: 4910-4929

Affiliations

[1 ]GRID grid.266100.3, ISNI 0000 0001 2107 4242, Moores Cancer Center, , University of California San Diego, ; San Diego, CA USA

[2 ]GRID grid.261277.7, ISNI 0000 0001 2219 916X, William Beaumont School of Medicine, , Oakland University, ; Auburn Hills, MI USA

[3 ]GRID grid.467453.7, Milliman Inc, ; New York, NY USA

[4 ]Department of Medical Affairs, Dendreon Pharmaceuticals, LLC, Seattle, WA USA

[5 ]GRID grid.255414.3, ISNI 0000 0001 2182 3733, Department of Urology, , Eastern Virginia Medical School, ; Virginia Beach, VA USA

[6 ]GRID grid.478121.9, Urology of Virginia, PLLC, ; Virginia Beach, VA USA

[7 ]GRID grid.34477.33, ISNI 0000000122986657, Division of Medical Oncology, , University of Washington, ; Seattle, WA USA

[8 ]GRID grid.270240.3, ISNI 0000 0001 2180 1622, Clinical Research Division, , Fred Hutchinson Cancer Research Center, ; Seattle, WA USA

Article

Publisher ID: 1509

DOI: 10.1007/s12325-020-01509-5

PMC ID: 7596004

PubMed ID: 33029725

SO-VID: bc628ba9-f217-4140-be29-1abbd7f43aa2

License:

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 1 August 2020

Date accepted : 16 September 2020

Funding

Funded by: Dendreon Pharmaceuticals, LLC

Custom metadata

Keywords: abiraterone,androgen-receptor signaling pathway inhibitors,castration-resistant prostate cancer,claims,enzalutamide,immunotherapy,metastatic,multivariable analysis,sipuleucel-t

Data availability:

Keywords: abiraterone, androgen-receptor signaling pathway inhibitors, castration-resistant prostate cancer, claims, enzalutamide, immunotherapy, metastatic, multivariable analysis, sipuleucel-t

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

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Abstract

Introduction

Methods

Results

Conclusion

Electronic Supplementary Material

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Most cited references 35

Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases

A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.

Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

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