Department of Pathology, Johns Hopkins University, Baltimore, Maryland 21231, USA.
Urology. 2011 May;77(5):1155-60. doi: 10.1016/j.urology.2010.08.031. Epub 2010 Dec 13.
To determine the agreement between the local pathologist findings and central pathologist findings using data from the TAX 3501 trial. TAX 3501 was a randomized, multinational trial comparing the outcomes of patients with high-risk prostate cancer treated with androgen deprivation with or without docetaxel after radical prostatectomy (RP). Patient eligibility was determined by a minimal 5-year progression-free survival estimate of 60% using Kattan's nomogram.
The pathologic findings were reassessed in 257 consecutive RP specimens by 2 central pathologists and compared with the local pathologist data.
For the Gleason score, agreement was found in 181 (70%) of 257 cases, upgrading in 57 (75%), and downgrading in 25% of the RP specimens The most frequent upgrade was from Gleason score 7 to 8 or 9 and downgrading from Gleason score 8 to 7. Of the upgrades and downgrades, 37% and 21% were of 2 Gleason score points, respectively. For the tumor extent, agreement was found in 179 (70%) of 256 specimens, with upstaging in 70 (91%) and downstaging in 9%. The most frequent upstage was from focal to extensive extraprostatic extension (45%). For seminal vesicle invasion, agreement was found for 238 (93%) of 256 RP specimens Almost equal rates of underdiagnosing and overdiagnosing seminal vesicle invasion was observed. For margin status, agreement was present for 229 (89%) of 256 cases. The central pathologist review led to reclassification as a positive margin in 17 cases and a negative margin in 10. For lymph node status, 2 (1%) of 210 RP specimens had positive nodes identified only by the central pathologist. Agreement was observed in 154 negative and 54 positive cases.
Significant interobserver variations were found between the central and local pathologists. From the central pathologist review, the progression-free survival estimates were altered in 31 patients (13%), including 22 who were reassigned a greater risk estimate, rendering them study eligible. Thus, interobserver variability affected prognostication and trial accrual.
利用 TAX 3501 试验的数据，确定局部病理学家和中心病理学家的发现之间的一致性。TAX 3501 是一项随机、多中心试验，比较了接受根治性前列腺切除术（RP）后雄激素剥夺治疗加或不加多西紫杉醇的高危前列腺癌患者的结局。患者的入选标准是使用 Kattan 列线图估计 5 年内无进展生存率至少为 60%。
由 2 名中心病理学家对 257 例连续的 RP 标本进行病理复查，并与局部病理学家的数据进行比较。
对于 Gleason 评分，在 257 例病例中有 181 例（70%）达成一致，升级 57 例（75%），降级 25%。最常见的升级是从 Gleason 评分 7 到 8 或 9，从 Gleason 评分 8 降级到 7。在升级和降级中，分别有 37%和 21%为 2 个 Gleason 评分点。对于肿瘤范围，在 256 例标本中有 179 例（70%）达成一致，分期上调 70 例（91%），分期下调 9 例。最常见的分期上调是从局限性到广泛的前列腺外延伸（45%）。对于精囊侵犯，在 256 例 RP 标本中有 238 例（93%）达成一致。几乎相等的低估和高估精囊侵犯的发生率。对于切缘状态，在 256 例病例中有 229 例（89%）达成一致。中心病理学家的复查导致 17 例病例重新分类为阳性切缘，10 例病例重新分类为阴性切缘。在 154 例阴性和 54 例阳性病例中观察到一致。
局部病理学家和中心病理学家之间存在显著的观察者间差异。从中心病理学家的复查结果来看，有 31 例（13%）患者的无进展生存率估计发生了改变，其中 22 例被重新分配了更高的风险估计，使他们有资格参加研究。因此，观察者间的差异影响了预后和试验入组。
