作者: Howard I Scher , WM Kevin Kelly , Zuo-Feng Zhang , Peter Ouyang , Min Sun
关键词: Prostate cancer 、 Internal medicine 、 Gynecology 、 Prostate-specific antigen 、 Survival analysis 、 Multivariate analysis 、 Cancer 、 Surrogate endpoint 、 Prostate 、 Oncology 、 Radiation therapy 、 Medicine
摘要: 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 survival patients with androgen-independent cancer. Methods: A model based on parameters was developed from clinical data 254 androgenindependent treated 11 different protocol therapies at Memorial Sloan-Kettering Cancer Center. The validated by use of independent dataset 541 enrolled two randomized phase III trials. Results: In multivariate analysis, decline PSA 50% achieved 12 weeks statistically significant factor associated (two-sided P = .0012). similar obtained 8-week time frame. Elevated level lactate dehydrogenase .0001), lower hemoglobin (P younger age .0430) had negative impact outcome. Median times were 23, 17, 9 months low-, intermediate-, high-risk groups defined model, respectively. Conclusion: This study confirms value or greater baseline relation to variety therapies. Two consecutive determinations 4-week intervals can be used end point efficacy II trials this disease. [J Natl Inst 1999;91:244‐51]