Fine-needle aspiration (FNA) cytology has been widely used for the diagnosis of breast cancer lesions with the objective of differentiating benign from malignant masses. However, the occurrence of unsatisfactory samples and false-negative rates remains a matter of concern. Major improvements have been made thanks to the implementation of rapid on-site evaluation (ROSE) in multidisciplinary and integrated medical settings such as one-stop clinics (OSCs). In these settings, clinical and radiological examinations are combined with a morphological study performed by interventional pathologists. The aim of our study was to assess the diagnostic accuracy of the on-site cytopathology advance report (OSCAR) procedure on breast FNA cytologic samples in our breast OSC during the first three years (April 2004 till March 2007) of its implementation. To this goal, we retrospectively analyzed a series of 1820 breast masses (1740 patients) radiologically classified according to the American College of Radiology (ACR) BI-RADS lexicon (67.6% being either BI-RADS 4 or 5), sampled by FNA and immediately diagnosed by cytomorphology. The clinicoradiological, cytomorphological, and histological characteristics of all consecutive patients were retrieved from the hospital computerized medical records prospectively registered in the central information system. Histopathological analysis and ultrasound (US) follow-up (FU) were the reference diagnostic tests of the study design. In brief, we carried out either a histopathological verification or an 18-month US evaluation when a benign cytology was concordant with the components of the triple test. Overall, histology was available for 1138 masses, whereas 491 masses were analyzed at the 18-month US-FU. FNA specimens were morphologically nondiagnostic in 3.1%, false negatives were observed in 1.5%, and there was only one false positive (0.06%). The breast cancer prevalence was 62%. Diagnostic accuracy measures of the OSCAR procedure with their 95% confidence intervals (95% CI) were the following: sensitivity (Se) = 97.4% (96.19–98.31); specificity (Sp) = 94.98% (92.94–96.56); positive predictive value (PPV) = 96.80% (95.48–97.81); negative predictive value (NPV) = 95.91% (94.02–97.33); positive likelihood ratio (LR+) = 19.39 (13.75–27.32); negative predictive ratio (LR−) = 0.03 (0.02–0.04), and; accuracy = 96.45% (95.42–97.31). The respective positive likelihood ratio (LR+) for each of the four categories of cytopathological diagnoses (with their 95% CI) which are malignant, suspicious, benign, and nondiagnostic were 540 (76–3827); 2.69 (1.8–3.96); 0.03 (0.02–0.04); and 0.37 (0.2–0.66), respectively. In conclusion, our study demonstrates that the OSCAR procedure is a highly reliable diagnostic approach and a perfect test to select patients requiring core-needle biopsy (CNB) when performed by interventional cytopathologists in a multidisciplinary and integrated OSC setting. Besides drastically limiting the rate of nondiagnostic specimens and diagnostic turn-around time, OSCAR is an efficient and powerful first-line diagnostic approach for patient-centered care.
细针穿刺细胞学检查已广泛应用于乳腺癌病变的诊断，旨在鉴别良恶性肿块。然而，样本不满意率和假阴性率仍是值得关注的问题。通过在一站式门诊等多学科整合医疗环境中实施快速现场评估，该技术已取得重大改进。在此类医疗模式下，临床与放射学检查可与介入病理医师执行的形态学分析相结合。本研究旨在评估乳腺一站式门诊实施前三年（2004年4月至2007年3月）期间，现场细胞病理学即时报告程序对乳腺细针穿刺细胞学样本的诊断准确性。为此，我们回顾性分析了1820例乳腺肿块（1740例患者）的系列数据，所有病例均按美国放射学会乳腺影像报告和数据系统词典进行放射学分类（其中67.6%为BI-RADS 4或5类），经细针穿刺取样后立即进行细胞形态学诊断。所有连续患者的临床放射学、细胞形态学及组织学特征均从医院计算机化医疗记录中提取，这些数据已前瞻性录入中央信息系统。组织病理学分析和超声随访是本研究的参考诊断标准。简言之，当良性细胞学检查结果与三联评估体系的其他组成部分一致时，我们进行组织病理学验证或18个月超声随访评估。总体而言，1138例肿块获得组织学结果，491例肿块通过18个月超声随访进行分析。细针穿刺标本中形态学无法诊断者占3.1%，假阴性率为1.5%，仅出现1例假阳性（0.06%）。乳腺癌患病率为62%。现场细胞病理学即时报告程序的诊断准确性指标及其95%置信区间如下：敏感性=97.4%（96.19-98.31）；特异性=94.98%（92.94-96.56）；阳性预测值=96.80%（95.48-97.81）；阴性预测值=95.91%（94.02-97.33）；阳性似然比=19.39（13.75-27.32）；阴性似然比=0.03（0.02-0.04）；准确度=96.45%（95.42-97.31）。细胞病理学诊断四个类别（恶性、可疑、良性及无法诊断）对应的阳性似然比及其95%置信区间分别为：540（76-3827）；2.69（1.8-3.96）；0.03（0.02-0.04）；0.37（0.2-0.66）。综上所述，本研究证实当由介入细胞病理医师在多学科整合的一站式门诊环境中实施时，现场细胞病理学即时报告程序是高度可靠的诊断方法，可作为筛选需要空心针穿刺活检患者的理想检测手段。该程序不仅能显著降低无法诊断标本率、缩短诊断周转时间，更是以患者为中心医疗服务中高效且强有力的首选诊断方案。
肿瘤(癌症)患者之家