In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 5013-5013
Abstract:
5013 Background: COU-AA-301 was a multinational, randomized, controlled, phase III trial comparing AA + prednisone (P) (n = 797) versus placebo + P (n = 398) in mCRPC pts post-docetaxel. Using data from that trial, we developed a prognostic model for predicting OS in pts treated with AA post-chemotherapy, with a focus on readily assessable clinical parameters. Methods: The analyses used data from pts treated with AA in the COU-AA-301 trial for whom relevant baseline data were available (n = 729). Baseline variables were assessed for association with OS through a univariate Cox proportional hazards regression model. High/low values for accepted normal ranges were used for laboratory parameters. The Cox proportional hazards regression was used with a stepwise procedure to identify independent prognostic factors for OS. The model was subject to sensitivity analyses and the C-index was utilized as a measure of model accuracy. Results: The following risk factors were associated with a poor prognosis: ECOG performance status (only pts with scores of ≤ 2 were eligible for this trial) of 2 (HR = 2.19, p 〈 0.0001), presence of liver metastases (HR = 2.00, p 〈 0.0001), time from start of initial LHRH agonist therapy to start of AA treatment ≤ 36 months (HR = 1.30, p = 0.0078), low albumin (HR = 1.54, p 〈 0.0001), high ALP (HR = 1.38, p = 0.0016), and high LDH (HR = 2.31, p 〈 0.0001). Patients were categorized into 3 risk groups (good prognosis, n = 369; intermediate prognosis, n = 321; poor prognosis, n = 107) based on total number of risk factors and median OS calculated for each group (table). The C-index was 0.74 (95% CI: 0.68, 0.80). Conclusions: This prognostic model uses readily available clinical parameters to conveniently assess risk for mCRPC pts previously treated with docetaxel and initiating treatment with AA + P. If validated, the model will be useful in clinical practice and clinical trials. Clinical trial information: NCT00638690. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.5013
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
detail.hit.zdb_id:
604914-X
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