García Peñalver C, Pérez Barrios A, Leiva Galvis O
Servicio de Urología, Hospital 12 de Octubre, Madrid.
Actas Urol Esp. 2005 Jun;29(6):535-41. doi: 10.1016/s0210-4806(05)73293-9.
The overall objective of this study was to carry out a prospective investigation of the usefulness of the IMMUNOCYT commercial kit in the follow-up of patients treated for bladder cancer and to evaluate its utility as a complement to urinary cytology and a possible tool for reducing the number of follow-up cystoscopies required.
From September 2001 to December 2002, the ImmunoCyt test and urinary cytology were performed in urine simples from a total of 136 patients (115 with a history or suspicion of bladder cancer and 21 patients with other urological pathologies). Urine simples were fixed with an equal volume of 50% alcohol. Urinary cytology and the ImmunoCyt test were interpreted by a cytopathologist unacquainted with the result of the corresponding cytology and bladder biopsy report. Samples were staged and graded using the 1997 TNM classification of the UICC and the 1998 WHO/ISUP classification. Histopathological confirmation of lesions was available for 111 patients (81.6%).
The gender distribution was 89% men and 11% women. Mean age was 71.68 years (range 27 to 98 years). Overall sensitivity and specificity were 77.9% and 92.3% for the ImmunoCyt test and 47.9% and 100% for urinary cytology, respectively. The positive (PPV) and negative predictive values (NPV) were 96.4% and 61.7%, respectively, for the ImmunoCyt test and 100% and 36.7% for cytology. In Ta and low-grade carcinomas, the sensitivity of the ImmunoCyt test was 70% (n=20) and 76.4% (n=34) respectively, whereas it was 25% (n=28) and 29.7% (n=37), respectively, for urinary cytology. The differences observed between the sensitivities of the ImmunoCyt test and cytology were statistically significant (X2 p<0.05) overall and for Ta and low-grade carcinomas. The sensitivity and specificity of the combination of both tests were 86.8% and 96.2%, respectively. The sensitivity of the combination of both tests for Ta and low-grade carcinomas was 80% (n=20) and 82.3% (n=34), respectively. The ImmunoCyt test was diagnostic in 36.2% of tumors overall.
In view of the results obtained, we decided to change our follow-up protocol to reduce the number of follow-up cystoscopies by 32.2% in the first 5 years of postoperative follow-up (in a cohort of 140 patients who undergo surgery annually). This benefits patients by reducing the number of urinary infections and iatrogenesis originated by follow-up cystoscopy. In addition, this 32.2% reduction in the number of cystoscopies in 5 years will yield a savings of approximately 35,560 EUR to the health care system in 5 years.
本研究的总体目标是对IMMUNOCYT商业试剂盒在膀胱癌治疗患者随访中的实用性进行前瞻性调查，并评估其作为尿液细胞学补充手段的效用以及作为减少所需随访膀胱镜检查次数的可能工具的效用。
2001年9月至2002年12月，对总共136例患者（115例有膀胱癌病史或疑似膀胱癌，21例有其他泌尿系统疾病）的尿液样本进行了免疫细胞检测和尿液细胞学检查。尿液样本用等体积的50%酒精固定。尿液细胞学检查和免疫细胞检测由一位不了解相应细胞学检查结果和膀胱活检报告的细胞病理学家进行解读。样本根据国际抗癌联盟（UICC）1997年TNM分类和世界卫生组织/国际泌尿病理学会（WHO/ISUP）1998年分类进行分期和分级。111例患者（81.6%）有病变的组织病理学确诊结果。
性别分布为男性89%，女性11%。平均年龄为71.68岁（范围27至98岁）。免疫细胞检测的总体敏感性和特异性分别为77.9%和92.3%，尿液细胞学检查的总体敏感性和特异性分别为47.9%和100%。免疫细胞检测的阳性预测值（PPV）和阴性预测值（NPV）分别为96.4%和61.7%，细胞学检查的阳性预测值和阴性预测值分别为100%和36.7%。在Ta期和低级别癌中，免疫细胞检测的敏感性分别为70%（n = 20）和76.4%（n = 34），而尿液细胞学检查的敏感性分别为25%（n = 28）和29.7%（n = 37）。免疫细胞检测和细胞学检查敏感性之间观察到的差异在总体上以及Ta期和低级别癌中具有统计学意义（卡方检验p < 0.05）。两种检测方法联合的敏感性和特异性分别为86.8%和96.2%。两种检测方法联合对Ta期和低级别癌的敏感性分别为80%（n = 20）和82.3%（n = 34）。免疫细胞检测对总体肿瘤的诊断率为36.2%。
鉴于所获得的结果，我们决定改变随访方案，在术后随访的前5年将随访膀胱镜检查次数减少32.2%（在每年接受手术的140例患者队列中）。这对患者有益，因为减少了随访膀胱镜检查引起的泌尿系统感染和医源性疾病的数量。此外，5年内膀胱镜检查次数减少32.2%将在5年内为医疗保健系统节省约35,560欧元。
