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 ConclusionsThree 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 studyAstellas Pharma, Inc. and Medivation, Inc. FundingAstellas Pharma, Inc. and Medivation, Inc. DisclosureA. 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. Resources from the same session3713 - ZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract 3305 - ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract 3222 - ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract 1560 - Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract 2335 - Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract 3291 - Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract 3607 - What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract 1963 - What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract 3503 - Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract 1997 - Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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