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Quantitative imaging by automated bone scan index (BSI) as a response biomarker in standard clinical care of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide

Anand, Aseem ; Lindgren Belal, Sarah LU orcid ; Reza Felix, Mariana LU ; Edenbrandt, Lars LU and Bjartell, Anders LU (2015) American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium In Journal of Clinical Oncology 33(7 Suppl). p.288-288
Abstract
Background: Enzalutamide (ENZ), an androgen receptor antagonist therapy, was approved for patients (pts) with mCRPC. However, in standard of care for mCRPC pts, change in prostate specific antigen (PSA) is not accepted as an efficacy response measurement and the radiological change is inadequately measured in an interpreter-dependent subjective analysis of bone scan. Therefore, an objective efficacy response biomarker is warranted. In this registry study, we evaluated BSI as a quantitative analysis of bone scintigraphy, to access response in mCRPC pts being treated with ENZ.

Methods: Pts with mCRPC, at Skåne University Hospital (SUH), Sweden, who initiated treatment with ENZ after failing chemotherapy were eligible... (More)
Background: Enzalutamide (ENZ), an androgen receptor antagonist therapy, was approved for patients (pts) with mCRPC. However, in standard of care for mCRPC pts, change in prostate specific antigen (PSA) is not accepted as an efficacy response measurement and the radiological change is inadequately measured in an interpreter-dependent subjective analysis of bone scan. Therefore, an objective efficacy response biomarker is warranted. In this registry study, we evaluated BSI as a quantitative analysis of bone scintigraphy, to access response in mCRPC pts being treated with ENZ.

Methods: Pts with mCRPC, at Skåne University Hospital (SUH), Sweden, who initiated treatment with ENZ after failing chemotherapy were eligible for the study. Primary objective was to associate the change in BSI and PSA, after 12 weeks (wks) of treatment with EZN, with overall survival (OS). Automated BSI generated by EXINI boneBSI platform is quantitative representation of tumor burden as a percent of total skeletal mass. Bivariate cox regression analysis was used to evaluate the association of BSI and PSA with OS.

Results: Thirty-five pts, who initiated ENZ treatment at (SUH), were eligible for the BSI analysis. Follow-up scans for the BSI analysis were available from 24 pts. Median baseline BSI value was 2.92 (range: 0.0-11.72) and at follow-up the median BSI value was 2.83 (range: 0.0-12.65). OS was associated with BSI at both baseline and at follow-up as opposed to that of PSA (table 1). The change in BSI between baseline and follow-up was also significantly associated with OS, whereas the change in PSA was not.

Conclusions: Automated BSI and its relative change were observed to be associated with OS in mCRPC pts receiving ENZ as standard of care treatment. The result deserves further validation, in controlled investigational studies, of BSI as a quantitative imaging biomarker indicative of efficacy response to second-line treatment in mCRPC pts. (Less)
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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Clinical Oncology
volume
33
issue
7 Suppl
pages
288 - 288
publisher
American Society of Clinical Oncology
conference name
American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium
conference location
Orlando, United States
conference dates
2015-02-26 - 2015-02-28
ISSN
0732-183X
DOI
10.1200/jco.2015.33.7_suppl.288
language
English
LU publication?
yes
id
164b0720-ceb5-43f9-b0f2-80e998cfb49a
date added to LUP
2022-12-13 21:34:04
date last changed
2023-05-10 14:02:53
@misc{164b0720-ceb5-43f9-b0f2-80e998cfb49a,
  abstract     = {{<b>Background:</b> Enzalutamide (ENZ), an androgen receptor antagonist therapy, was approved for patients (pts) with mCRPC. However, in standard of care for mCRPC pts, change in prostate specific antigen (PSA) is not accepted as an efficacy response measurement and the radiological change is inadequately measured in an interpreter-dependent subjective analysis of bone scan. Therefore, an objective efficacy response biomarker is warranted. In this registry study, we evaluated BSI as a quantitative analysis of bone scintigraphy, to access response in mCRPC pts being treated with ENZ.<br/><br/><b>Methods:</b> Pts with mCRPC, at Skåne University Hospital (SUH), Sweden, who initiated treatment with ENZ after failing chemotherapy were eligible for the study. Primary objective was to associate the change in BSI and PSA, after 12 weeks (wks) of treatment with EZN, with overall survival (OS). Automated BSI generated by EXINI boneBSI platform is quantitative representation of tumor burden as a percent of total skeletal mass. Bivariate cox regression analysis was used to evaluate the association of BSI and PSA with OS.<br/><b><br/>Results:</b> Thirty-five pts, who initiated ENZ treatment at (SUH), were eligible for the BSI analysis. Follow-up scans for the BSI analysis were available from 24 pts. Median baseline BSI value was 2.92 (range: 0.0-11.72) and at follow-up the median BSI value was 2.83 (range: 0.0-12.65). OS was associated with BSI at both baseline and at follow-up as opposed to that of PSA (table 1). The change in BSI between baseline and follow-up was also significantly associated with OS, whereas the change in PSA was not.<br/><br/><b>Conclusions:</b> Automated BSI and its relative change were observed to be associated with OS in mCRPC pts receiving ENZ as standard of care treatment. The result deserves further validation, in controlled investigational studies, of BSI as a quantitative imaging biomarker indicative of efficacy response to second-line treatment in mCRPC pts.}},
  author       = {{Anand, Aseem and Lindgren Belal, Sarah and Reza Felix, Mariana and Edenbrandt, Lars and Bjartell, Anders}},
  issn         = {{0732-183X}},
  language     = {{eng}},
  month        = {{03}},
  note         = {{Conference Abstract}},
  number       = {{7 Suppl}},
  pages        = {{288--288}},
  publisher    = {{American Society of Clinical Oncology}},
  series       = {{Journal of Clinical Oncology}},
  title        = {{Quantitative imaging by automated bone scan index (BSI) as a response biomarker in standard clinical care of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide}},
  url          = {{http://dx.doi.org/10.1200/jco.2015.33.7_suppl.288}},
  doi          = {{10.1200/jco.2015.33.7_suppl.288}},
  volume       = {{33}},
  year         = {{2015}},
}