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 session2354 - The clinicopathologic features and treatment of 607 hindgut neuroendocrine tumor (NET) patients at a single institutionPresenter: Seung Tae Kim Session: Poster Display Resources: Abstract 2594 - Neuroendocrine carcinomas of the colorectal origin - Polish experiencePresenter: Agnieszka Kolasińska-Ćwikła Session: Poster Display Resources: Abstract 2539 - Neuroendocrine neoplasms of the appendix including goblet cell carcinoidsPresenter: Agnieszka Kolasinska-Cwikla Session: Poster Display Resources: Abstract 1245 - Prognostic validity of AJCC staging system in neuroendocrine tumors of the appendixPresenter: Amir Mehrvarz Sarshekeh Session: Poster Display Resources: Abstract 3902 - Enhancer of zest homolog 2 (EZH2) expression in well and moderately differentiated pancreatic neuroendocrine tumor (pNET)Presenter: Riccardo Marconcini Session: Poster Display Resources: Abstract 3882 - Differential clinical and pathological characteristics of hereditary neuroendocrine pancreatic tumours (NEPT)Presenter: Gema Marín Zafra Session: Poster Display Resources: Abstract 2296 - Natural course of thyroid cancer nodules compared with benign thyroid nodulesPresenter: Kyung-Jin Yun Session: Poster Display Resources: Abstract 4083 - Reassessment of proliferative activity at disease progression in neuroendocrine neoplasmsPresenter: Noemi Cicchese Session: Poster Display Resources: Abstract 3866 - 18F-FDG-PET to predict disease progression in advanced digestive neuroendocrine neoplasmsPresenter: Maria Rinzivillo Session: Poster Display Resources: Abstract 3651 - UK phase IV, observational study to assess quality of life in patients (pts) with pancreatic neuroendocrine tumours (pNETS) receiving treatment with everolimus: The “real-world” OBLIQUE studyPresenter: John Ramage 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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