Radical Prostatectomy versus Observation for Localized Prostate Cancer

被引：1395
|
作者：
Wilt, Timothy J. [1 ,2 ]
Brawer, Michael K. [3 ]
Jones, Karen M. [4 ]
Barry, Michael J. [6 ]
Aronson, William J. [7 ]
Fox, Steven [5 ]
Gingrich, Jeffrey R. [10 ,11 ]
Wei, John T. [12 ]
Gilhooly, Patricia [13 ]
Grob, B. Mayer [9 ]
Nsouli, Imad [14 ]
Iyer, Padmini [8 ]
Cartagena, Ruben [16 ]
Snider, Glenn [17 ]
Roehrborn, Claus [18 ]
Sharifi, Roohollah [21 ]
Blank, William [15 ]
Pandya, Parikshit [19 ]
Andriole, Gerald L. [22 ]
Culkin, Daniel [23 ]
Wheeler, Thomas [20 ]
机构：
[1] Univ Minnesota, Ctr Chron Dis Out comes Res, Minneapolis Vet Affairs VA, Hlth Care Syst, Minneapolis, MN 55455 USA
[2] Univ Minnesota, Sch Med, Sect Gen Med, Minneapolis, MN 55455 USA
[3] Urol IDEA, Seattle, WA USA
[4] Coordinating Ctr, VA Cooperat Studies Program, Perry Point, MD USA
[5] Agcy Healthcare Res & Qual, Rockville, MD USA
[6] Massachusetts Gen Hosp, Div Gen Med, Boston, MA 02114 USA
[7] Greater Angeles Healthcare Syst, VA Med Ctr, Los Angeles, CA USA
[8] VA Med Ctr, Long Beach, CA USA
[9] Richmond VA Med Ctr, Richmond, VA USA
[10] Univ Pittsburgh, Dept Urol, Pittsburgh, PA USA
[11] VA Pittsburgh Hlth Care Syst, Pittsburgh, PA USA
[12] Univ Michigan, Ann Arbor, MI 48109 USA
[13] VA New Jer sey Hlth Care Syst, E Orange, NJ USA
[14] VA Med Ctr Syracuse, Syracuse, NY USA
[15] Brooklyn VA Med Ctr, Brooklyn, NY USA
[16] VA Western New York Hlth Syst, Buffalo, NY USA
[17] Louis Johnson VA Med Ctr, Clarksburg, WV USA
[18] Univ Texas Dallas, SW Med Ctr, Dept Urol, Dallas, TX USA
[19] Temple VA Med Ctr, Temple, TX USA
[20] Baylor Coll Med, Houston, TX 77030 USA
[21] Jesse Brown VA Med Ctr, Chicago, IL USA
[22] Washington Univ, St Louis, MO USA
[23] Univ Oklahoma, Norman, OK 73019 USA
来源：
NEW ENGLAND JOURNAL OF MEDICINE | 2012年 / 367卷 / 03期
基金：
美国医疗保健研究与质量局;
关键词：
POSITIVE SURGICAL MARGINS; QUALITY-OF-LIFE; RANDOMIZED-TRIAL; PROGNOSTIC-SIGNIFICANCE; ACTIVE SURVEILLANCE; MEN; SPECIMENS; OUTCOMES; TRENDS; MANAGEMENT;
D O I：
10.1056/NEJMoa1113162
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
BACKGROUND The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known. METHODS From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality. RESULTS During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P = 0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P = 0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P = 0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P = 0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death. CONCLUSIONS Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.)
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页码：203 / 213
页数：11
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