[欧洲前列腺癌筛查随机研究(ERSPC)中前列腺特异性抗原的结果及参与因素:塔恩省和埃罗省的法国部门]
[Results and participation factors to the European Randomized study of Screening for Prostate Cancer (ERSPC) with Prostate Specific Antigen: French departments of Tarn and Hérault].
作者信息
Jegu J, Tretarre B, Grosclaude P, Rebillard X, Bataille V, Malavaud B, Iborra F, Salama G, Rischmann P, Villers A
机构信息
Registre des cancers du Tarn, Albi, Toulouse, 81000 France.
出版信息
Prog Urol. 2009 Jul;19(7):487-98. doi: 10.1016/j.purol.2009.03.001. Epub 2009 Apr 28.
INTRODUCTION
Mass screening modalities remained controversial and made necessary large studies. The European Randomized study of Screening for Prostate cancer (ERSPC) was initiated in 1994. Eight countries including France are participating.
METHODS
ERSPC is a multicentric randomised study and started with the aim to determine whether a 20% reduction in prostate cancer mortality can be achieved with PSA-based screening. Men aged 50-74 and living in the Tarn or Hérault were included. After randomization and exclusion of men who died or had a prostate cancer were invited to participate by giving their consent and had a PSA test. In case of PSA greater than or equal to 3 ng/ml, biopsy was recommended. Included men in both screening and control group were followed through cancer registries. Objective was to present first round results of French participation to ERSPC, to determine factors of participation and to compare detected cancers cases between both groups.
RESULTS
Population of men included was 84,781 and were randomized in screening (n=42,590) or control (n=42,191) group. Participation rate was 36.9% in Tarn and 24.3% in Hérault. PSA was greater than or equal to 3 ng/ml in 15,4% of cases (n=1812) and 45.9% of men (n=832) who were biopsied. Age, previous PSA performed within two years prior to invitation, health insurance and department of residence were significantly associated to participation rate. Cumulated incidence with a four years follow-up was 2.48% (n=1053) in screening and 1.99% (n=840) in control group, with a relative risk (RR) of 1.242. Corresponding RR for Tarn and Hérault were 1.37 and 1.20 respectively. Clinical parameters and treatments modalities were similar between both screening and control groups (radical prostatectomy 68% and radiation therapy 20%).
CONCLUSION
Participation rate at first round was modest. Profile of men who participated compared to men who did not were different. The control group was probably contaminated by PSA testing outside study protocol. Consequences at ERSPC level of this low participation rate on final analysis remain to be determined.
引言
大规模筛查方式仍存在争议,因此有必要开展大型研究。欧洲前列腺癌筛查随机研究(ERSPC)于1994年启动。包括法国在内的八个国家参与其中。
方法
ERSPC是一项多中心随机研究,旨在确定基于前列腺特异性抗原(PSA)的筛查能否使前列腺癌死亡率降低20%。纳入了年龄在50 - 74岁且居住在塔恩省或埃罗省的男性。随机分组后,排除了死亡或患有前列腺癌的男性,邀请其余男性在获得其同意后参与研究并进行PSA检测。若PSA大于或等于3 ng/ml,则建议进行活检。通过癌症登记处对筛查组和对照组的纳入男性进行随访。目的是呈现法国参与ERSPC的首轮结果,确定参与因素,并比较两组中检测出的癌症病例。
结果
纳入的男性人群为84,781人,随机分为筛查组(n = 42,590)和对照组(n = 42,191)。塔恩省的参与率为36.9%,埃罗省为24.3%。15.4%的病例(n = 1812)和45.9%接受活检的男性(n = 832)的PSA大于或等于3 ng/ml。年龄、在邀请前两年内曾进行过的PSA检测、医疗保险和居住省份与参与率显著相关。四年随访的累积发病率在筛查组为2.48%(n = 1053),对照组为1.99%(n = 840),相对风险(RR)为1.242。塔恩省和埃罗省相应的RR分别为1.37和1.20。筛查组和对照组的临床参数及治疗方式相似(根治性前列腺切除术68%,放射治疗20%)。
结论
首轮参与率较低。参与研究的男性与未参与的男性特征不同。对照组可能因研究方案外的PSA检测而受到影响。这种低参与率在ERSPC最终分析中的后果仍有待确定。