Intermediate end point for prostate cancer-specific mortality following salvage hormonal therapy for prostate-specific antigen failure

被引:28
作者
D'Amico, AV
Moul, JW
Carroll, PR
Cote, K
Sun, L
Lubeck, D
Renshaw, AA
Loffredo, M
Chen, MH
机构
[1] Brigham & Womens Hosp, Dept Radiat Oncol, ASBI, Boston, MA 02115 USA
[2] Brigham & Womens Hosp, Dept Pathol, Boston, MA 02115 USA
[3] Dana Farber Canc Inst, Boston, MA 02115 USA
[4] Uniformed Serv Univ Hlth Sci, Dept Surg, Bethesda, MD 20814 USA
[5] Uniformed Serv Univ Hlth Sci, Ctr Prostate Dis Res, Urol Serv, Bethesda, MD 20814 USA
[6] Walter Reed Army Med Ctr, Bethesda, MD USA
[7] Univ Calif San Francisco, Dept Urol, San Francisco, CA 94143 USA
[8] Univ Connecticut, Dept Stat, Storrs, CT 06269 USA
来源
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE | 2004年 / 96卷 / 07期
关键词
D O I
10.1093/jnci/djh086
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Whether the prostate-specific antigen (PSA) response to salvage hormonal therapy can act as an intermediate end point for prostate cancer-specific mortality (PCSM) remains unclear. Therefore, we evaluated whether PSA response, defined as the absolute value of the ratio of the rate of PSA change after salvage hormonal therapy to the rate of PSA change before salvage therapy, is associated with the time to PCSM following salvage hormonal therapy. Methods: A single-institution and two pooled multi-institution databases containing baseline, treatment, and follow-up information on men who received salvage hormonal therapy for PSA failure following surgery or radiation therapy from January 1, 1988, to January 1, 2002, formed the study (n = 199) and validation cohorts (n = 1255), respectively. The ability of PSA response and its constituents (i.e., pre-salvage hormonal therapy PSA slope and post-salvage hormonal therapy PSA slope) to predict time to PCSM following salvage hormonal therapy was assessed using Cox regression analysis. For illustrative purposes, PSA response was analyzed as a dichotomous variable with a breakpoint for the ratio of PSA response of 1. All statistical tests were two-sided. Results: PSA response was statistically significantly associated with time to PCSM following salvage hormonal therapy in both the study (P-Cox = .0014) and validation (P-Cox < .001) cohorts; however, its constituents were not (pre-salvage hormonal therapy PSA Slope: PCox-study = .97, PCox-validation = .57; post-salvage hormonal therapy PSA slope: PCox-study = .27, PCox-validation = .31). Patients with a PSA response that was less than or equal to 1 had a statistically significantly shorter time to PCSM than patients with a PSA response of greater than 1 in both the study (hazard ratio [HR] = 3.6, 95% confidence interval [CI] = 1.3 to 10.3; P-Cox = .01) and validation (HR = 12.8, 95% CI = 6.2 to 26.3; P-Cox < .001) cohorts. Conclusion: The PSA response to salvage hormonal therapy can serve as an intermediate end point for PCSM in patients with a rising PSA level following surgery or radiation therapy.
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页码:509 / 515
页数:7
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