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Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy

Abrahamsson, Per-Anders LU ; Boccon-Gibod, Laurent ; Morote, Juan ; de Jong, Igle Jan ; Malmberg, Anders ; Neijber, Anders and Albers, Peter (2017) In European Urology Focus 3(4-5). p.470-479
Abstract

Background: Intermittent androgen deprivation therapy (IAD) is commonly used in prostate cancer because of the benefits of the off-treatment period (OTP). The off-treatment time for patients depends on cancer progression, often measured as a rise in prostate-specific antigen (PSA). Objective: To evaluate if certain factors can predict OTP duration following 7-mo degarelix therapy. Design, setting, and participants: This multivariable analysis included 191 prostate cancer patients with baseline PSA 4–50 ng/ml or PSA doubling time <24 mo entering the first OTP with PSA ≤4 ng/ml and testosterone <0.5 ng/ml. OTP continued until disease progression, measured as PSA >4 ng/ml. Despite a study-defined OTP maximum of 24 mo, a 50%... (More)

Background: Intermittent androgen deprivation therapy (IAD) is commonly used in prostate cancer because of the benefits of the off-treatment period (OTP). The off-treatment time for patients depends on cancer progression, often measured as a rise in prostate-specific antigen (PSA). Objective: To evaluate if certain factors can predict OTP duration following 7-mo degarelix therapy. Design, setting, and participants: This multivariable analysis included 191 prostate cancer patients with baseline PSA 4–50 ng/ml or PSA doubling time <24 mo entering the first OTP with PSA ≤4 ng/ml and testosterone <0.5 ng/ml. OTP continued until disease progression, measured as PSA >4 ng/ml. Despite a study-defined OTP maximum of 24 mo, a 50% failure rate was not observed within certain strata. A Weibull distribution was used to estimate median time to PSA >4 ng/ml adjusted for the following variables: age; baseline (or end of induction period [EOI]) PSA; baseline testosterone; cancer stage/previous curative treatment; and Gleason score. According to the results and the utility of these factors in clinical practice, the model was reduced in a stepwise manner. Time to testosterone recovery (testosterone >0.5 and >2.2 ng/ml) was estimated in a similar manner. Results: The full five-factor model showed that baseline PSA (p < 0.0001), age (p = 0.004), prostate cancer stage/previous therapy (p = 0.023), and baseline testosterone (p = 0.039) influenced OTP. A reduced two-factor model (baseline PSA, age) showed that only baseline PSA influenced OTP (p < 0.0001), and patients with baseline PSA ≤4 ng/ml had the longest OTP. In addition, EOI PSA (p < 0.0001) and age (p = 0.050) significantly influenced OTP. The times to testosterone >0.5 and >2.2 ng/ml were longer for older patients and those with lower baseline testosterone levels. Conclusion: Patients with lower baseline and EOI PSA, and older patients can stay off therapy longer and therefore may benefit more from degarelix IAD. These factors may help in proposing an algorithm to predict the OTP and optimise visit frequency. Patient summary: We describe extended analysis results for a trial in which patients with prostate cancer received intermittent androgen deprivation treatment. Prostate-specific antigen levels at baseline and at the end of the induction period, as well as older age, predicted the duration of the off-treatment period. Testosterone recovery was slower in older patients and in patients who had lower pretreatment testosterone levels. These factors may help in deciding whether to choose continuous or intermittent treatment as a strategy. Trial registration: Clinicaltrials.gov NCT00801242 Age and prostate-specific antigen levels before and at the end of active treatment seem to predict off-treatment duration for degarelix as intermittent androgen deprivation treatment (ADT). This information could be valuable in proposing an algorithm to predict the off-treatment period, optimise visit schedules, and set the restart sate for ADT.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Intermittent androgen deprivation, Off-treatment period, Predictive factors, Prostate cancer
in
European Urology Focus
volume
3
issue
4-5
pages
470 - 479
publisher
Elsevier
external identifiers
  • scopus:85041564585
  • pmid:28753747
ISSN
2405-4569
DOI
10.1016/j.euf.2015.12.008
language
English
LU publication?
yes
id
57c03969-2953-4244-ac0a-4929fa1b346d
date added to LUP
2018-02-23 12:27:22
date last changed
2024-01-14 15:42:36
@article{57c03969-2953-4244-ac0a-4929fa1b346d,
  abstract     = {{<p>Background: Intermittent androgen deprivation therapy (IAD) is commonly used in prostate cancer because of the benefits of the off-treatment period (OTP). The off-treatment time for patients depends on cancer progression, often measured as a rise in prostate-specific antigen (PSA). Objective: To evaluate if certain factors can predict OTP duration following 7-mo degarelix therapy. Design, setting, and participants: This multivariable analysis included 191 prostate cancer patients with baseline PSA 4–50 ng/ml or PSA doubling time &lt;24 mo entering the first OTP with PSA ≤4 ng/ml and testosterone &lt;0.5 ng/ml. OTP continued until disease progression, measured as PSA &gt;4 ng/ml. Despite a study-defined OTP maximum of 24 mo, a 50% failure rate was not observed within certain strata. A Weibull distribution was used to estimate median time to PSA &gt;4 ng/ml adjusted for the following variables: age; baseline (or end of induction period [EOI]) PSA; baseline testosterone; cancer stage/previous curative treatment; and Gleason score. According to the results and the utility of these factors in clinical practice, the model was reduced in a stepwise manner. Time to testosterone recovery (testosterone &gt;0.5 and &gt;2.2 ng/ml) was estimated in a similar manner. Results: The full five-factor model showed that baseline PSA (p &lt; 0.0001), age (p = 0.004), prostate cancer stage/previous therapy (p = 0.023), and baseline testosterone (p = 0.039) influenced OTP. A reduced two-factor model (baseline PSA, age) showed that only baseline PSA influenced OTP (p &lt; 0.0001), and patients with baseline PSA ≤4 ng/ml had the longest OTP. In addition, EOI PSA (p &lt; 0.0001) and age (p = 0.050) significantly influenced OTP. The times to testosterone &gt;0.5 and &gt;2.2 ng/ml were longer for older patients and those with lower baseline testosterone levels. Conclusion: Patients with lower baseline and EOI PSA, and older patients can stay off therapy longer and therefore may benefit more from degarelix IAD. These factors may help in proposing an algorithm to predict the OTP and optimise visit frequency. Patient summary: We describe extended analysis results for a trial in which patients with prostate cancer received intermittent androgen deprivation treatment. Prostate-specific antigen levels at baseline and at the end of the induction period, as well as older age, predicted the duration of the off-treatment period. Testosterone recovery was slower in older patients and in patients who had lower pretreatment testosterone levels. These factors may help in deciding whether to choose continuous or intermittent treatment as a strategy. Trial registration: Clinicaltrials.gov NCT00801242 Age and prostate-specific antigen levels before and at the end of active treatment seem to predict off-treatment duration for degarelix as intermittent androgen deprivation treatment (ADT). This information could be valuable in proposing an algorithm to predict the off-treatment period, optimise visit schedules, and set the restart sate for ADT.</p>}},
  author       = {{Abrahamsson, Per-Anders and Boccon-Gibod, Laurent and Morote, Juan and de Jong, Igle Jan and Malmberg, Anders and Neijber, Anders and Albers, Peter}},
  issn         = {{2405-4569}},
  keywords     = {{Intermittent androgen deprivation; Off-treatment period; Predictive factors; Prostate cancer}},
  language     = {{eng}},
  month        = {{10}},
  number       = {{4-5}},
  pages        = {{470--479}},
  publisher    = {{Elsevier}},
  series       = {{European Urology Focus}},
  title        = {{Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy}},
  url          = {{http://dx.doi.org/10.1016/j.euf.2015.12.008}},
  doi          = {{10.1016/j.euf.2015.12.008}},
  volume       = {{3}},
  year         = {{2017}},
}