The effect of corticosteroids on prostate cancer outcome following treatment with enzalutamide: A multivariate analysis of the phase III AFFIRM Trial Journal Article
| Authors: | Zhao, J. L.; Fizazi, K.; Saad, F.; Chi, K. N.; Taplin, M. E.; Sternberg, C. N.; Armstrong, A. J.; de Bono, J. S.; Duggan, W. T.; Scher, H. I. |
| Article Title: | The effect of corticosteroids on prostate cancer outcome following treatment with enzalutamide: A multivariate analysis of the phase III AFFIRM Trial |
| Abstract: | Purpose: The clinical impact of concurrent corticosteroid use (CCU) on enzalutamide-treated patients with metastatic castrationresistant prostate cancer (mCRPC) is unknown. We investigated the association of CCU with overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) in post-chemotherapy, enzalutamide- treated patients with mCRPC. Patients and Methods: Post hoc analysis of AFFIRM (NCT00974311) with patients (n = 1,199) randomized 2:1 to enzalutamide 160 mg/day or placebo. Treatment group, CCU, and known prognostic factors were evaluated for impact on OS, rPFS, and TTPP using a multivariate Cox proportional hazards model. CCU was defined as "baseline"(use started at baseline) or "on-study"(baseline plus use that was started during the trial). Results: Enzalutamide significantly improved OS, rPFS, and TTPP independent of baselineCCUbut was associated with inferior clinical outcomes when compared with no baseline CCU, including a shorter OS [10.8 months vs. not reached (NR); HR for use vs. no use, 2.13;95%confidence interval (CI), 1.79-2.54], rPFS (5.2 months vs. 8.0 months; HR, 1.49; 95% CI, 1.29-1.72], and TTPP (4.6 months vs. 5.7 months; HR, 1.50; 95% CI, 1.25-1.81). These findings held in a multivariate analysis adjusting for baseline prognostic factors wherein baselineCCUwas independently associated with decreased OS (HR, 1.71; 95% CI, 1.43-2.04; P < 0.0001) and rPFS (HR, 1.28; 95% CI, 1.11-1.48; P = 0.0007). Conclusions: Patients with mCRPC benefited from enzalutamide treatment independent of CCU, but CCU was associated with worse baseline prognostic factors and outcomes. © 2021 The Authors. |
| Journal Title: | Clinical Cancer Research |
| Volume: | 28 |
| Issue: | 5 |
| ISSN: | 1078-0432 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 2022-03-01 |
| Start Page: | 860 |
| End Page: | 869 |
| Language: | English |
| DOI: | 10.1158/1078-0432.Ccr-21-1090 |
| PUBMED: | 34965947 |
| PROVIDER: | scopus |
| PMCID: | PMC9366341 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2022 -- Source: Scopus |
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