Mäkinen Tuukka, Tammela Teuvo L J, Stenman Ulf-Håkan, Määttänen Liisa, Aro Jussi, Juusela Harri, Martikainen Paula, Hakama Matti, Auvinen Anssi
Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.
Clin Cancer Res. 2004 Apr 1;10(7):2231-6. doi: 10.1158/1078-0432.ccr-03-0338.
Large randomized trials provide the only valid means of quantifying the benefits and drawbacks of prostate-specific antigen (PSA) screening, but the follow-up of ongoing studies is still too short to allow evaluation of mortality. We report here the intermediate indicators of screening efficacy from the second round of the Finnish trial.
The Finnish trial, with approximately 80,000 men in the target population, is the largest component in the European Randomized Study of Screening for Prostate Cancer. The first round was completed in 1996-1999. Each year 8,000 men 55-67 years of age were randomly assigned to the screening arm, and the rest formed the control arm. Men randomized to the screening arm in 1996 were reinvited 4 years later, in 2000, and PSA was determined.
Of the eligible 6415 men, 4407 (69%) eventually participated in the second round of screening. Of the first-round participants, up to 84% (3833 of 4556) attended rescreening. A total of 461 screenees (10.5%) had PSA levels of > or = 4 microg/liter. Altogether, 97 cancers were found, yielding an overall detection rate of 2.2% (97 of 4407). Seventy-nine cases were found among the 3833 second-time screenees (detection rate 2.1%) and 18 in those 574 men (3.1%) who had not participated previously. A PSA of > or = 4 microg/liter, but negative biopsy in the first screening round was associated with an up to 9-fold risk of cancer in rescreening relative to those with lower PSA levels at baseline. Ninety-one (94%) of all of the detected cancers were clinically localized.
As surrogate measures of an effective screening program, both compliance as well as the overall and advanced prostate cancer detection rates remained acceptable. Men defined as screen-positive but with a negative confirmation of cancer at prevalence screen formed a high-risk group at rescreening.
大型随机试验是量化前列腺特异性抗原（PSA）筛查利弊的唯一有效方法，但目前正在进行的研究随访时间仍过短，无法评估死亡率。我们在此报告芬兰试验第二轮筛查效果的中间指标。
芬兰试验针对约80000名目标人群男性，是欧洲前列腺癌筛查随机研究的最大组成部分。第一轮于1996 - 1999年完成。每年将8000名55 - 67岁男性随机分配至筛查组，其余构成对照组。1996年随机分配至筛查组的男性在4年后的2000年被再次邀请进行PSA检测。
在符合条件的6415名男性中，4407名（69%）最终参与了第二轮筛查。第一轮参与者中，高达84%（4556名中的3833名）参加了复查。共有461名筛查对象（10.5%）PSA水平≥4微克/升。总共发现97例癌症，总体检出率为2.2%（4407名中的97名）。在3833名二次筛查对象中发现79例（检出率2.1%），在之前未参与筛查的574名男性中有18例（3.1%）。第一轮筛查时PSA≥4微克/升但活检阴性者，复查时患癌风险相对于基线PSA水平较低者高达9倍。所有检测出的癌症中，91例（94%）为临床局限性癌。
作为有效筛查计划的替代指标，依从性以及前列腺癌总体和进展期检出率仍可接受。在初筛时被定义为筛查阳性但癌症确诊阴性的男性在复查时构成高危组。
