British Columbia Cancer Agency, Vancouver, BC, Canada
Kim N. Chi , Thian San Kheoh , Charles J. Ryan , Arturo Molina , Joaquim Bellmunt , Nicholas J. Vogelzang , Dana E. Rathkopf , Karim Fizazi , Philip W. Kantoff , Jinhui Li , Johann Sebastian De Bono , Howard I. Scher
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.
Number of risk factors | Median OS, mos (95% CI) | HR (95% CI) |
---|---|---|
0 or 1 (good) | 21.3 (19.4, 27.1) | - |
2 or 3 (intermediate) | 13.9 (11.7, 14.8) | 2.30a (1.89, 2.81) |
4 to 6 (poor) | 6.1 (4.8, 7.2) | 6.19a (4.76, 8.05) |
aVersus patients with good prognosis.
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