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一项III期多中心随机对照试验(SHIP0804)当代系列中前列腺活检的中心病理学审查结果。

Results of central pathology review of prostatic biopsies in a contemporary series from a phase III, multicenter, randomized controlled trial (SHIP0804).

作者信息

Sasaki Hiroshi, Kido Masahito, Miki Kenta, Aoki Manabu, Takahashi Hiroyuki, Dokiya Takushi, Yamanaka Hidetoshi, Fukushima Masanori, Egawa Shin

机构信息

Department of Urology, Jikei University School of Medicine, Tokyo, Japan.

出版信息

Pathol Int. 2015 Apr;65(4):177-82. doi: 10.1111/pin.12260. Epub 2015 Feb 24.

DOI:10.1111/pin.12260
PMID:25707702
Abstract

To investigate contemporary rates of variation in the biopsy Gleason grading in prostate cancer, between local and central pathologists, based on central review of the pathological slides from Seed and Hormone for Intermediate-risk Prostate Cancer (SHIP) 0804, a phase III, multicenter, randomized, controlled study. From April 2008 to May 2011, 18 Japanese institutions participated. All H&E slides were reviewed independently, without clinical information, and a tumor grade was assigned according to the modified Gleason grading system proposed by the International Society of Urological Pathology (ISUP). Prostate biopsy specimens of 642 cases were available for evaluation. An exact concordance rate of Gleason score (GS) between local and central pathologists was determined to be 65.3%; with the under-grading and over-grading of grades to be 14.6% and 20.1%, respectively. The central review resulted in numbers of tumor-bearing cores reassigned in 99 of 616 cases in which such information by the local pathologists was available (16.1%). Discordance in biopsy Gleason grading was still found in one third of the cases in the SHIP0804 study. This information is valuable in extrapolating the diagnostic error range in contemporary clinical studies conducted without central pathological review.

摘要

基于对中危前列腺癌种子与激素治疗(SHIP)0804(一项III期、多中心、随机对照研究)病理切片的中心复审,调查当地与中心病理学家之间前列腺癌活检Gleason分级的当代变异率。2008年4月至2011年5月,18家日本机构参与其中。所有苏木精-伊红(H&E)切片均在无临床信息的情况下独立复审,并根据国际泌尿病理学会(ISUP)提出的改良Gleason分级系统指定肿瘤分级。642例前列腺活检标本可供评估。当地与中心病理学家之间Gleason评分(GS)的精确一致率确定为65.3%;分级过低和过高的比例分别为14.6%和20.1%。中心复审导致在当地病理学家提供此类信息的616例中的99例(16.1%)重新分配了有肿瘤的核心数量。在SHIP0804研究中,仍有三分之一的病例存在活检Gleason分级不一致的情况。该信息对于推断在无中心病理复审的当代临床研究中的诊断误差范围很有价值。

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