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Value of treatment in clinical trials versus the real world : the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden

Svensson, Johanna; Andersson, Emelie; Persson, Ulf; Edekling, Thomas; Ovanfors, Anna and Ahlgren, Göran LU (2016) In Scandinavian Journal of Urology2013-01-01+01:00
Abstract

Objective: In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga®) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective. Materials and methods: A retrospective chart review was conducted using data from three Swedish hospitals. Data were retrieved from 119... (More)

Objective: In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga®) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective. Materials and methods: A retrospective chart review was conducted using data from three Swedish hospitals. Data were retrieved from 119 eligible patients diagnosed with mCRPC, treated during 2013 and 2014. Swedish real-world evidence sample characteristics, treatment patterns and duration, and overall survival were compared to the clinical trial data. Results: Analyses of the data showed that patients were treated for a median of 5.6 months, which was significantly shorter than the treatment duration in the clinical trial (7.3 months). A comparison indicated that the Swedish patients were similar to patients included in the clinical trial in observed patient characteristics, but perhaps less likely to benefit from treatment owing to prior ketoconazole treatment and possibly higher Eastern Cooperative Oncology Group performance status. Despite this, the Swedish patients had non-significantly longer overall survival and significantly shorter treatment duration. Conclusion: Swedish patients could expect the same overall survival as patients randomized to abiraterone in the clinical trial despite shorter treatment duration, leading to a more cost-effective use of the treatment in the real world compared to the clinical trial.

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author
organization
publishing date
type
Contribution to journal
publication status
in press
subject
keywords
Abiraterone acetate, clinical practice, external validity, metastatic castration-resistant prostate cancer
in
Scandinavian Journal of Urology2013-01-01+01:00
pages
6 pages
publisher
Taylor & Francis
external identifiers
  • Scopus:84964474433
ISSN
2168-1805
DOI
10.3109/21681805.2016.1172254
language
English
LU publication?
yes
id
50374295-98a1-4c20-862e-955abd8580d4
date added to LUP
2016-06-02 12:16:00
date last changed
2016-11-14 12:43:47
@misc{50374295-98a1-4c20-862e-955abd8580d4,
  abstract     = {<p>Objective: In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga<sup>®</sup>) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective. Materials and methods: A retrospective chart review was conducted using data from three Swedish hospitals. Data were retrieved from 119 eligible patients diagnosed with mCRPC, treated during 2013 and 2014. Swedish real-world evidence sample characteristics, treatment patterns and duration, and overall survival were compared to the clinical trial data. Results: Analyses of the data showed that patients were treated for a median of 5.6 months, which was significantly shorter than the treatment duration in the clinical trial (7.3 months). A comparison indicated that the Swedish patients were similar to patients included in the clinical trial in observed patient characteristics, but perhaps less likely to benefit from treatment owing to prior ketoconazole treatment and possibly higher Eastern Cooperative Oncology Group performance status. Despite this, the Swedish patients had non-significantly longer overall survival and significantly shorter treatment duration. Conclusion: Swedish patients could expect the same overall survival as patients randomized to abiraterone in the clinical trial despite shorter treatment duration, leading to a more cost-effective use of the treatment in the real world compared to the clinical trial.</p>},
  author       = {Svensson, Johanna and Andersson, Emelie and Persson, Ulf and Edekling, Thomas and Ovanfors, Anna and Ahlgren, Göran},
  issn         = {2168-1805},
  keyword      = {Abiraterone acetate,clinical practice,external validity,metastatic castration-resistant prostate cancer},
  language     = {eng},
  month        = {04},
  pages        = {6},
  publisher    = {ARRAY(0xa19f530)},
  series       = {Scandinavian Journal of Urology2013-01-01+01:00},
  title        = {Value of treatment in clinical trials versus the real world : the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden},
  url          = {http://dx.doi.org/10.3109/21681805.2016.1172254},
  year         = {2016},
}