Sarosdy Michael F, Kahn Paul R, Ziffer Mark D, Love William R, Barkin Jack, Abara Emmanuel O, Jansz Ken, Bridge Julia A, Johansson Sonny L, Persons Diane L, Gibson Jane S
South Texas Urology and Urologic Oncology, 4499 Medical #218, San Antonio, TX 78229, USA.
J Urol. 2006 Jul;176(1):44-7. doi: 10.1016/S0022-5347(06)00576-3.
We evaluated the multitarget UroVysion fluorescence in situ hybridization assay for the diagnosis of bladder cancer in patients with hematuria and no history of bladder cancer.
A multicenter, blinded trial was performed to compare the sensitivity of the fluorescence in situ hybridization assay to that of voided cytology in patients with gross or microscopic hematuria. Confirmation of hematuria was required. Voided urine was sent to a central laboratory for each study before cystoscopy. Suspicious lesions on cystoscopy were biopsied or resected. A centrally reviewed histopathological interpretation was used to confirm cancer and assign grade and stage.
A total of 497 patients were enrolled at 23 centers and in 473 (95.2%) fluorescence in situ hybridization and cytology results were interpretable. Bladder cancer was diagnosed histologically in 50 patients (10.1%) and ureteral cancer was diagnosed in 1. Fluorescence in situ hybridization assay detected 69% of cases and cytology detected 38% (95% CI 25 to 52). When low grade, low stage (TaG1) tumors were excluded, fluorescence in situ hybridization detected 25 of 30 cancers (84%), while cytology detected only 15 (50%). Of 265 current or past smokers with hematuria and positive fluorescence in situ hybridization assay findings bladder cancer was detected in 65% with a history of greater than 40 pack-years compared to 13.6% to 24.2% in those with no, less than a 20 or a 20 to 40-pack-year smoking history.
The UroVysion fluorescence in situ hybridization assay is significantly more sensitive than voided cytology for detecting bladder cancer in patients evaluated for gross or microscopic hematuria for all grades and stages. Based on these data UroVysion was approved by the Food and Drug Administration for use in patients with hematuria.
我们评估了多靶点UroVysion荧光原位杂交检测法在诊断血尿且无膀胱癌病史患者膀胱癌中的应用。
开展一项多中心、盲法试验，比较荧光原位杂交检测法与尿脱落细胞学检查对肉眼血尿或镜下血尿患者的敏感性。血尿需经确认。在膀胱镜检查前，将每份研究的晨尿送至中心实验室。膀胱镜检查中可疑病变进行活检或切除。采用集中审核的组织病理学解释来确诊癌症并确定分级和分期。
23个中心共纳入497例患者，473例（95.2%）的荧光原位杂交和细胞学检查结果可解读。经组织学诊断膀胱癌50例（10.1%），输尿管癌1例。荧光原位杂交检测法检出69%的病例，细胞学检查检出38%（95%可信区间25至52）。排除低级别、低分期（TaG1）肿瘤后，荧光原位杂交检测出30例癌症中的25例（84%），而细胞学检查仅检出15例（50%）。在265例血尿且荧光原位杂交检测结果为阳性的现吸烟者或既往吸烟者中，吸烟史超过40包年的患者膀胱癌检出率为65%，而无吸烟史、吸烟史少于20包年或吸烟史为20至40包年的患者检出率为分别为13.6%至24.2%。
对于所有分级和分期的肉眼血尿或镜下血尿评估患者，UroVysion荧光原位杂交检测法在检测膀胱癌方面显著比尿脱落细胞学检查更敏感。基于这些数据，UroVysion被美国食品药品监督管理局批准用于血尿患者。
