COMBINED FINE-NEEDLE ASPIRATION, PHYSICAL-EXAMINATION AND MAMMOGRAPHYIN THE DIAGNOSIS OF PALPABLE BREAST MASSES - THEIR RELATION TO OUTCOME FOR WOMEN WITH PRIMARY BREAST-CANCER

OBJECTIVE: To examine the combined and individual predictive values of fine-needle aspiration (FNA), physical examination (PE) of the breast and mammography (the ''triple test'') in diagnosing breast cancer in relation to the results of open surgical biopsy. DESIGN: A Study of th e records of patients who received both FNA and open surgical biopsy f or the same palpable breast lump. The results of diagnostic assessment and open surgical biopsy were categorized as positive or negative. Co ncordance (percentage of tests found to be correct at biopsy), sensiti vity, specificity (percentage of patients without breast cancer for wh om the diagnostic test was negative) and positive predictive value (pe rcentage of patients with a positive test found to have breast cancer) were determined for the triple test for each diagnostic modality. In addition, prognostic variables (tumour size, node positivity, estrogen and progesterone receptor status) and outcomes were assessed in patie nts with a diagnosis of breast cancer. SETTING: A university-affiliate d general hospital with a special focus on women's health. PATIENTS: O f 290 patients who had both FNA and open surgical biopsy, 191 underwen t all three diagnostic procedures. MAIN OUTCOME MEASURES: The diagnost ic accuracy of FNA, PE and mammography to permit preoperative definiti ve therapy or to allow obser ation without mandating open surgical bio ps). RESULTS: In 81 patients all three diagnostic modalities were in a greement for a diagnosis of either benign or malignant disease; the co ncordance for the triple test was 98.8%, specificity was 100% and sens itivity was 95.5%. Nodal status, tumour size and outcome were similar whether or not the triple test was positive, but, interestingly, when the triple-test results were positive, estrogen ip < 0.05) and progest erone (P < 0.03) receptor values were more likely to be negative. CONC LUSIONS: When all three diagnostic modalities were in agreement for a diagnosis of malignant disease, the combination of FNA, PE and mammogr aphy had excellent concordance with the results of open surgical biops y, and in this situation definitive treatment may be carried out. If a ll three modalities are in agreement for a diagnosis of benign disease , a period of close observation with repetition of FNA may be safely e ntertained. Lack of concordance of the three diagnostic modalities man dates biopsy. Triple-test positivity does not predict a worse outcome.