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Clinical outcomes and testosterone levels following continuous androgen deprivation (CAD) in patients with relapsing or locally advanced prostate cancer (PC): A post hoc analysis of the ICELAND study

Date

09 Oct 2016

Session

Poster display

Presenters

Bertrand Tombal

Citation

Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372

Authors

B.F. Tombal1, E. Cornel2, V. Matveev3, T.L. Tammela4, J. Schraml5, W. Warnack6, R. Persad7, A. Stari8, F.G. Veiga9, C. Schulman10

Author affiliations

  • 1 Urology, Cliniques universitaires Saint Luc, 1200 - Brussels/BE
  • 2 Urology, Ziekenhuis Groep Twente, Hengelo/NL
  • 3 Urology, N. N. Blokhin Russian Cancer Research Center, Moscow/RU
  • 4 Urology, Tampere University hospital (Tays), Tampere/FI
  • 5 Urology And Robotic Surgery, Masaryk Hospital and University of J.E. Purkyně, Usti nad Labem/CZ
  • 6 Urology, Warnack Private Practice, Hagenow/DE
  • 7 Urology/surgery, University of Bristol and Bristol Urological Institute, Bristol/GB
  • 8 Medical Affairs, Astellas Pharma Inc., London/GB
  • 9 Urology, Hospital Universitario de Salamanca, Salamanca/ES
  • 10 Urology, Clinic Edith Cavell - University of Brussels, B-1180 - Brussels/BE
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Background

ICELAND is a large multicentre EU study demonstrating similar efficacy, tolerability and QOL with CAD and intermittent androgen deprivation (IAD) with leuprorelin (Eligard®) in non-metastatic PC. This post hoc analysis investigated if patients (pts) achieving serum testosterone (T) levels of ≤20 ng/dL within the 1st year of CAD have improved cause-specific survival (CSS) and time to PSA [castrate-resistant prostate cancer (CRPC)] progression.

Methods

Pts with locally advanced or relapsing non-metastatic PC following radical prostatectomy or radiotherapy were enrolled in this prospective, phase IIIb, open-label, randomised study (NCT00378690). After a 6-month induction with leuprorelin (Eligard®) 3-month depot 22.5 mg (plus bicalutamide 50 mg/day for 1 month), pts with PSA levels ≤1 ng/mL were randomised 1:1 to CAD (n = 361) or IAD (n = 340) with leuprorelin (Eligard®) for 36 months. Pts receiving CAD therapy were stratified by min, median and max T levels achieved during the 1st year of therapy into ≤20, 20-50 and >50 ng/dL T subgroups. CSS and time to PSA (CRPC) progression were analysed by Kaplan-Meier analyses and Cox proportional hazards regression model.

Results

A total of 90.1%, 83.5% and 74.5% of pts receiving CAD achieved minimum, median and maximum serum T levels of ≤20 ng/dL, respectively. CSS rates and time to PSA (CRPC) progression did not differ significantly between T subgroups (table).

Testosterone level (ng/dL) N Time to cause-specific survival Time to PSA (CRPC) progression
% (95% CI) HR (95% CI) p valuea % (95% CI) HR (95% CI) p valuea
Minimum
≤20 311 90.5 (87.2–93.8) 1 99.0 (97.9–100.0) 1
>20 − ≤50 33 86.7 (74.5–100.0) 0.89 (0.4–1.8) 0.849 92.4 (83.3–100.0) 5.06 (1.3–16.1) 0.062
>50 1 100.0 (100.0–100.0) NE 100.0 (100.0–100.0) NE
Median
≤20 288 90.2 (86.8–93.7) 1 98.9 (97.8–100.0) 1
>20 − ≤50 54 89.1 (80.6–98.9) 0.84 (0.4–1.6) 0.598 95.4 (89.8–100.0) 3.92 (1.2–12.3) 0.083
>50 3 83.3 (56.7–100.0) 2.74 (0.2–12.7) 100.0 (100.0–100.0) NE
Maximum
≤20 257 90.6 (87.0–94.2) 1 99.2 (98.1–100.0) 1
>20 − ≤50 78 87.8 (80.3–95.5) 1.13 (0.6–1.9) 0.196 96.8 (92.9–100.0) 2.79 (0.8–9.3) 0.165
>50 10 83.3 (59.5–100.0) 3.59 (0.9–10.0) 95.0 (85.7–100.0) 4.57 (0.2–26.8)

CI, confidence interval; HR, hazard ratio; CRPC, castrate-resistant prostate cancer; NE, not estimable; PSA, prostate-specific antigen. aLikelihood ratio test.

Conclusions

In pts receiving CAD, CSS and time to PSA (CRPC) progression did not differ according to T levels in the 1st year of therapy. This finding may have been due, at least in part, to the effectiveness of leuprorelin (Eligard®) in lowering T, as maximum T levels ≤20 ng/dL were achieved in 75% of pts over the 1st year of CAD.

Legal entity responsible for the study

Astellas Pharma, Inc. and Medivation, Inc.

Funding

Astellas Pharma, Inc. and Medivation, Inc.

Disclosure

B. Tombal: Advisory board member: Astellas, Bayer, Medivation, Ferring, Amgen, Sanofi. Aventis. Corporate-sponsored research: Astellas, Bayer, Medivation, Ferring, Amgen, Sanofi Aventis.

T.L. Tammela: Advisory board member: Astellas, Orion Pharma, Bayer. Corporate-sponsored research: Astellas, Orion Pharma, Medivation, Jansen-Cilag, Bayer, Ferring, Camurus Ab, Lidds Ab.

All other authors have declared no conflicts of interest.

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