Kobayashi H, Yamada Y, Sado T, Sakata M, Yoshida S, Kawaguchi R, Kanayama S, Shigetomi H, Haruta S, Tsuji Y, Ueda S, Kitanaka T
Department of Obstetrics and Gynecology, Nara Medical University, Nara, Japan.
Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20. doi: 10.1111/j.1525-1438.2007.01035.x. Epub 2007 Jul 21.
Ovarian cancer is common in women from developed countries. We designed a prospective randomized controlled trial of ovarian cancer screening to establish an improved strategy for the early detection of cancers. Asymptomatic postmenopausal women were randomly assigned between 1985 and 1999 to either an intervention group (n = 41,688) or a control group (n = 40,799) in a ratio of 1:1, with follow-up of mean 9.2 years, in Shizuoka district, Japan. The original intention was to offer women in the intervention group annual screens by gynecological examination (sequential pelvic ultrasound [US] and serum CA125 test). Women with abnormal US findings and/or raised CA125 values were referred for surgical investigation by a gynecological oncologist. In December 2002, the code was broken and the Shizuoka Cohort Study of Ovarian Cancer Screening and Shizuoka Cancer Registry were searched to determine both malignant and nonmalignant diagnoses. Twenty-seven cancers were detected in the 41,688-screened women. Eight more cancers were diagnosed outside the screening program. Detection rates of ovarian cancer were 0.31 per 1000 at the prevalent screen and 0.38-0.74 per 1000 at subsequent screens; they increased with successive screening rounds. Among the 40,779 control women, 32 women developed ovarian cancer. The proportion of stage I ovarian cancer was higher in the screened group (63%) than in the control group (38%), which did not reach statistical significance (P = 0.2285). This is to our knowledge the first prospective randomized report of the ovarian cancer screening. The rise in the detection of early-stage ovarian cancer in asymptomatic postmenopausal women is not significant, but future decisions on screening policy should be informed by further follow-up from this trial.
卵巢癌在发达国家女性中很常见。我们设计了一项卵巢癌筛查的前瞻性随机对照试验，以确立一种改进的癌症早期检测策略。1985年至1999年期间，日本静冈地区将无症状绝经后女性按1:1的比例随机分为干预组（n = 41,688）或对照组（n = 40,799），平均随访9.2年。最初的意图是为干预组女性提供每年一次的妇科检查（序贯盆腔超声[US]和血清CA125检测）筛查。超声检查结果异常和/或CA125值升高的女性被转介给妇科肿瘤学家进行手术检查。2002年12月，编码被破解，对静冈卵巢癌筛查队列研究和静冈癌症登记处进行了检索，以确定恶性和非恶性诊断。在41,688名接受筛查的女性中检测到27例癌症。在筛查项目之外又诊断出8例癌症。卵巢癌的检出率在初次筛查时为每1000人0.31例，在后续筛查中为每1000人0.38 - 0.74例；随着筛查轮次的增加而上升。在40,779名对照女性中，有32名女性患卵巢癌。筛查组中I期卵巢癌的比例（63%）高于对照组（38%），但未达到统计学显著性（P = 0.2285）。据我们所知，这是第一份关于卵巢癌筛查的前瞻性随机报告。无症状绝经后女性早期卵巢癌检测率的上升并不显著，但该试验的进一步随访结果应为未来的筛查政策决策提供参考。
