BACKGROUND: With an hypothesis that post-chemotherapy changes in serum prostate-specific antigen (PSA) levels might serve as a surrogate marker for assessing prostate cancer outcome (i.e., survival), we studied the relationship between pretherapy and post-therapy prognostic factors and survival in patients with androgen-independent prostate cancer. METHODS: A prognostic model for survival based on pretherapy and post-therapy parameters was developed from the clinical data on 254 patients with androgen-independent prostate cancer treated with 11 different protocol therapies at Memorial Sloan-Kettering Cancer Center. The model was validated by use of an independent dataset of 541 patients enrolled in two randomized phase III trials. RESULTS: In multivariate analysis, a post-therapy decline in PSA levels of 50% achieved in 12 weeks was a statistically significant factor associated with survival (two-sided P = .0012). A similar outcome was obtained with the use of an 8-week time frame. Elevated pretherapy level of serum lactate dehydrogenase (two-sided P = .0001), lower pretherapy level of hemoglobin (P = .0001), and younger age (two-sided P = .0430) had a statistically significant negative impact on outcome. Median survival times were 23, 17, and 9 months for low-, intermediate-, and high-risk groups of patients defined by the prognostic model, respectively. CONCLUSION: This study confirms the prognostic value of a post-therapy decline in PSA of 50% or greater from baseline in relation to survival in patients with androgen-independent prostate cancer treated with a variety of therapies. Two consecutive determinations at 4-week intervals can be used as an end point for efficacy in phase II trials of therapies in this disease.
RCT Entities:
BACKGROUND: With an hypothesis that post-chemotherapy changes in serum prostate-specific antigen (PSA) levels might serve as a surrogate marker for assessing prostate cancer outcome (i.e., survival), we studied the relationship between pretherapy and post-therapy prognostic factors and survival in patients with androgen-independent prostate cancer. METHODS: A prognostic model for survival based on pretherapy and post-therapy parameters was developed from the clinical data on 254 patients with androgen-independent prostate cancer treated with 11 different protocol therapies at Memorial Sloan-Kettering Cancer Center. The model was validated by use of an independent dataset of 541 patients enrolled in two randomized phase III trials. RESULTS: In multivariate analysis, a post-therapy decline in PSA levels of 50% achieved in 12 weeks was a statistically significant factor associated with survival (two-sided P = .0012). A similar outcome was obtained with the use of an 8-week time frame. Elevated pretherapy level of serum lactate dehydrogenase (two-sided P = .0001), lower pretherapy level of hemoglobin (P = .0001), and younger age (two-sided P = .0430) had a statistically significant negative impact on outcome. Median survival times were 23, 17, and 9 months for low-, intermediate-, and high-risk groups of patients defined by the prognostic model, respectively. CONCLUSION: This study confirms the prognostic value of a post-therapy decline in PSA of 50% or greater from baseline in relation to survival in patients with androgen-independent prostate cancer treated with a variety of therapies. Two consecutive determinations at 4-week intervals can be used as an end point for efficacy in phase II trials of therapies in this disease.
Authors: Lawrence T Dauer; Matthew J Williamson; John Humm; Joseph O'Donoghue; Rashid Ghani; Robert Awadallah; Jorge Carrasquillo; Neeta Pandit-Taskar; Anne-Kirsti Aksnes; Colin Biggin; Vigdis Reinton; Michael Morris; Jean St Germain Journal: Health Phys Date: 2014-04 Impact factor: 1.316
Authors: Anne F Schott; William E Barlow; Kathy S Albain; Helen K Chew; James L Wade; Keith S Lanier; Danika L Lew; Daniel F Hayes; Julie R Gralow; Robert B Livingston; Gabriel N Hortobagyi Journal: Oncologist Date: 2012-01-20
Authors: G L Smith; A P Doherty; L M Banks; J Dutton; L W Hanham; T J Christmas; R J Epstein Journal: Clin Exp Metastasis Date: 2000 Impact factor: 5.150
Authors: Michael J Morris; Timothy Akhurst; Steven M Larson; Marisa Ditullio; Elaina Chu; Karen Siedlecki; David Verbel; Glenn Heller; W Kevin Kelly; Susan Slovin; Lawrence Schwartz; Howard I Scher Journal: Clin Cancer Res Date: 2005-05-01 Impact factor: 12.531