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Prognostic factors in men with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide (ENZA) or bicalutamide (BIC) in TERRAIN

Date

09 Oct 2016

Session

Poster display

Presenters

Axel Heidenreich

Citation

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

Authors

A. Heidenreich1, N. Shore2, A. Villers3, L. Klotz4, D.R. Siemens5, S. van Os6, B. Baron7, F. Wang8, S. Chowdhury9

Author affiliations

  • 1 Urology, Cologne University, 50937 - Cologne/DE
  • 2 Urology, Carolina Urologic Research Center, Myrtle Beach/US
  • 3 Urology, Lille University, Lille/FR
  • 4 Urology, Sunnybrook Health Sciences Centre, M4N 3M5 - Toronto/CA
  • 5 Urology, Centre for Applied Urological Research, Queen’s University, Kingston/CA
  • 6 Global Development Oncology, Astellas Pharma, Inc., Leiden/NL
  • 7 Data Science, Astellas Pharma, Inc., Leiden/NL
  • 8 Clinical Development, Medivation, Inc., San Francisco/US
  • 9 Medical Oncology, Guy’s, King’s and St. Thomas’ Hospitals, London/GB
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Resources

Abstract 3089

Background

In TERRAIN, men with mCRPC who had progressed during luteinising hormone receptor hormone agonist/antagonist (LHRHa) treatment or after bilateral orchiectomy were randomised to ENZA or BIC. This post hoc analysis explores pre-treatment factors associated with progression-free survival (PFS) and time to prostate serum antigen (PSA) progression (TTP) and a risk group classification model based on the statistically and clinically predictive value of these factors.

Methods

Data from randomised men in TERRAIN were analysed. Cox regression analysis was used to identify pre-treatment factors associated with PFS and TTP as single or multiple variables in the model and to determine a risk group classification. PSA, testosterone, lactate dehydrogenase (LDH), alkaline phosphatase (ALP), albumin (ALB), haemoglobin, neutrophil-lymphocyte ratio (NLR), LHRHa/orchiectomy start date relative to diagnosis of metastasis, ECOG performance status, Gleason score, disease location and prior anti-androgen use were used as continuous or categorical variables. Models were stratified by study treatment.

Results

Data from 375 men were analysed. PSA, LDH, ALP, ALB and disease location were prognostic factors for PFS and/or TTP in single and multiple variable models. NLR, haemoglobin and LHRHa start were prognostic factors in single variable models. For PFS and TTP, an efficient risk group classification with three prognostic risk groups was derived based on ALP, PSA and ALB (table). Median PFS for the best risk group (0–1) was 16.6 months vs 3.3 months for the worst risk group (4) [hazard ratio, 5.7; 95% confidence interval 4.0, 8.2].

Baseline parameter Total score Risk group
ALP PSA ALB
ALP

Conclusions

Three baseline laboratory parameters defined risk groups in a classification system and explained differential clinical benefits for men in TERRAIN, including the ENZA-treated subgroup.

Legal entity responsible for the study

Astellas Pharma, Inc. and Medivation, Inc.

Funding

Astellas Pharma, Inc. and Medivation, Inc.

Disclosure

A. Heidenreich: Advisory board member: Astellas, Bayer, Dendreon, Jansen, Sanofi. Corporate-sponsored research: Astellas, Bayer.

N. Shore: Advisory board member: Astellas, Bayer, Dendreon, Ferring, Janssen, Sanofi, Takeda.

A. Villers: Advisory board member: Astellas (2015).

L. Klotz: Advisory board member: Astellas, Medivation, Janssen, Amgen, Genomic Health, Abbvie, Ferring.

D.R. Siemens: Study investigator: Astellas

S. van Os: Employee of Astellas.

B. Baron: Employee of Astellas

F. Wang: Employee of Medivation. Owns Medivation stock.

S. Chowdhury: Advisory board member: Sanofi, Astellas, Novartis, Janssen, Bayer, Essa, Pfizer and Clovis. Corporate - sponsored research: Sanofi and Astellas.

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