Total EWBC Data
In 1995, the EWBC saw three categories of patients and performed further diagnostic and/or interventional procedures when indicated on: 1) 31,694 women who underwent screening mammograms, 2) 12,423 women with clinical problems such as palpable masses or nipple discharge, and 3) 1527 women referred to the clinic for a second opinion after evaluation at another diagnostic radiologic facility. Of these women, 20% had clinical problems. The remainder had aberrations on their screening mammograms.
All patients evaluated at the EWBC clinic in 1995 were followed from 1 to 2 years until the end of 1996, to determine the number of 1-year-interval missed breast carcinomas. A carcinoma emerged within 1 year of a negative evaluation in 40 women, accounting for 9% of all the carcinomas diagnosed on EWBC patients. Lymph node metastases were present in 20% of these patients. During 1995, a false-negative FNAC was obtained from 50 of 320 patients with breast carcinoma (15.6%). In all but three of these patients, the radiologist was sufficiently concerned regarding the radiographic and/or clinical appearance to proceed to CB or to recommend OSB despite the negative FNAC results. In each of the remaining 3 patients, the false-negative FNAC resulted in a delayed diagnosis of 3 to 4 months. CBs were performed on 28 of the patients whose FNACs were false-negative; these all were interpreted correctly as suspicious of carcinoma or frankly malignant. Of the total of 155 patients with breast carcinoma on whom CB was performed, there were 11 false-negative interpretations (7%). The radiologist was sufficiently concerned regarding the clinical and/or radiographic appearance to recommend OSB despite the negative CB interpretation in all but three of these patients. The diagnosis of breast carcinoma on these three patients was delayed by 4 months, 8 months, and 1 year, respectively. The sensitivity of FNAC was 87% and its specificity was 98%. The sensitivity of CB was 93% and its specificity was 95%.
Of the 385 CBs performed on women without breast carcinoma, there were 15 false-positive interpretations (3.9%). OSBs performed on these women revealed ductal hyperplasia in all cases except for one woman with apocrine metaplasia and one woman with a radial scar. Of the 3155 FNACs performed on women without breast carcinoma, there were 65 false-positive interpretations (2%). Thirty-three fibroadenomas were diagnosed after performing 15 OSBs and 18 CBs. The remaining 32 lesions, diagnosed after 11 CBs and 21 OSBs, primarily were comprised of ductal hyperplasia without atypia (24), apocrine metaplasia (3), papilloma (2), gynecomastia (2), and a radial scar (1). None of the false-positive CBs was performed on women with false-positive FNACs. All the women who had false-positive CBs or FNACs were free of abnormalities 2-3 years later.
Of all the EWBC patients with breast carcinoma, there were four patients for whom the histopathologic interpretations of their OSBs were benign (1% false-negative). In one of these patients, the OSB did not yield the suspicious lesion. Repeat OSB resulted in successful removal of the carcinoma. Repeat OSBs were not necessary for the other three patients, because the histopathologic diagnoses were changed to carcinoma on review and correlation with the CB results. We were unable to obtain the false-negative rate incurred by all other physicians in the city of Rochester.
During 1995, FNAC performed as a cross-check on "probably benign" lesions detected 11 breast carcinomas. CB performed on "probably benign" lesions detected 38 breast carcinomas. Of these 49 FNAC- and CB-detected lesions, only 3 (6%) had metastatic lymph node involvement.
When the EWBC unequivocally established the diagnosis of breast carcinoma with FNAC or CB, the surgeons performed only one open surgical procedure (treatment) on 73% of the patients (Table 1). However, if the EWBC did not perform FNAC or CB and therefore did not establish the diagnosis of breast carcinoma, the surgeons found it necessary to perform > 1 open surgical procedure on 71% of the patients (diagnosis then treatment).
Table 1. FNAC/CB Results of the 421 Breast Carcinomas Identified at The Elizabeth Wende Breast Clinic in 1995
|FNAC||CB||No. total||No. 1 OSP||%||No. >1 OSP||%|
|If no FNAC/CB performed||35||10||29%||25||71%|
|If definite breast carcinoma diagnosis obtained with either FNAC and/or CB||268||195||73%||73||27%|
The differences between screening patients and patients with clinical problems are shown in Table 2. There were disproportionately more FNACs performed on patients with clinical problems because the majority of these patients had palpable areas believed to be normal variations. There were disproportionately more CBs performed on patients with screening abnormalities because many of these patients had calcifications or small masses that were neither clinically palpable nor ultrasonographically visible. The OSB/Ca ratio of screening patients was 1.3 compared with a 1.7 ratio of patients with clinical problems. The larger percentage of benign OSBs in women with clinical problems was attributed mostly to OSBs on 59 patients with ductogram abnormalities (mostly papillomas), and 44 patients with fibroadenomas (false-positive FNACs, growth spurts, and patients who preferred removal).
Table 2. The Elizabeth Wende Breast Clinic 1995 Open Surgical Biopsy/Breast Carcinoma Ratios (Screening vs. Clinical Problems)
| ||Screening||Clinical problems|
|No. of patients||31,694||13,950|
|No. of FNAC||636||2,823|
|No. of CB||426||111|
|No. of OSB||313||323|
|No. of diagnosed breast carcinomas||231||190|
|% diagnosed breast carcinomas||0.73%||1.3%|
|No. 1-year-interval missed breast carcinomas||28||11|
|% 1-year-interval missed breast carcinomas||11.1%||5.6%|
The EWBC 1-year-interval missed breast carcinoma rate for screening patients (Table 2) was 11%, which compares favorably with the 11-25% rates described in the literature.9-11 The clinic was unable to compare its 6% 1-year-interval missed breast carcinoma rate in symptomatic patients because we were unable to find any information in the medical literature regarding the missed rate of breast carcinoma in symptomatic patients by radiologists utilizing FNAC and CB.
The advantage of FNAC and CB utilization was reflected in the changed recommendations among many of the 1527 women referred to the EWBC for a second opinion in 1995. Approximately 80% of these women had mammographically detected lesions. The remaining 20% were patients with clinical problems, usually palpable abnormalities. Of the 1107 patients whose mammographic and/or clinical findings were considered benign by outside facilities, 27 carcinomas were diagnosed when the EWBC recommended 46 OSBs after performing 38 FNACs and 27 CBs. The FNACs yielded 17 carcinomas and the CBs yielded 10 carcinomas in these 27 patients. Because of the suspicion of carcinoma OSB was recommended by outside facilities in 420 of the patients referred for a second opinion. The EWBC originally canceled 263 of these OSBs, but performed 62 FNACs and 59 CBs to be certain its opinion was correct. The FNACs yielded 3 carcinomas and the CBs yielded 12 carcinomas. The revised total of canceled OSBs was 248. After performing FNAC and/or CB, the EWBC recommended OSBs on the remaining 172 women, verifying the diagnosis of 120 carcinomas.
The costs of the procedures are summarized in Table 3. In 1995 the EWBC recommended 462 lumpectomies in women from Rochester who were seen at its clinic; of these patients, 310 breast carcinomas were diagnosed for an OSB/Ca ratio of 1.5. The physicians in the remainder of the city recommended 2036 OSBs; of these patients, 513 breast carcinomas were diagnosed for an OSB/Ca ratio of 4.0. If the EWBC OSB/Ca ratio had been 4.0, the clinic would have recommended 778 additional OSBs for a total cost of $1,712,082.
Table 3. Cost Figures for FNAC, CB, and OSB
|$42.00 AvR for procedure x 2594 EWBC patients||$108.948|
|$43.00 AvR for cytopathologic interpretation x 2594 EWBC patients||$111,542|
|Total cost of 2594 EWBC FNAC||$220,490|
|$95.00 AvR for <1 year follow-up ultrasound x 1582 EWBC patients (61% of 2594)||$150,290|
|Total cost of EWBC FNAC plus follow-up||$370,780|
|Offset by $85.00 AvR for procedure x 1347 patients done elsewhere in Rochester||-$114,495|
|Total cost of FNAC incurred above and beyond the rest of the city||$256,285|
|$437.00 AvR for procedure x 403 EWBC patients||$176,111|
|$134.00 AvR for histopathologic interpretation x 403 EWBC patients||$54,002|
|Total cost of 403 CB||$230,113|
|$55.00 AvR for <1 year follow-up unilateral mammogram x 403 EWBC patients||$22,165|
|Total cost of CB plus follow-up||$252,278|
|Total cost FNAC + CB||$508,563|
|$441.00 AvR for surgeon x 778 patients||$343,098|
|$878.00 AvR for operating room x 778 patients||$683,084|
|$667.00 AvR for anesthesiologist for 1 hour x 778 patients||$518,926|
|$134.00 AvR for histopathologic interpretation x 778 patients||$104,252|
|Total cost 778 OSBs||$1,649,360|
|$55.00 AvR for <1 year follow-up unilateral mammogram x 54 patients (7% of 778 patients)||$2,970|
|$194.00 AvR for preoperative wire loc. x 308 (39.6% of 778 patients)||$59,752|
|Total cost of OSB plus follow-up||$1,712,082|
|Total cost 778 OSBs||$1,712,082|
|Minus (-) total cost CB, extra FNAC, and short term follow-up||-$508,563|
|Total savings for 1995||$1,203,519|
During 1995 in Rochester, the EWBC performed 2594 FNACs, for a total cost of $370,780. Elsewhere in Rochester, surgeons and a few radiologists performed 1347 FNACs at a total cost of $114,495; when that amount was subtracted from the EWBC's FNAC costs, the remaining amount ($256,285) represented the EWBC's extra FNAC costs above and beyond that of the remainder of the city. The clinic performed 403 CBs (361 stereotactic biopsies, 30 ultrasonographically guided biopsies, and 12 clinically guided biopsies), for a total cost of $252,278. No CBs were performed elsewhere in Rochester in 1995. When the EWBC's extra costs of the FNACs and CBs were subtracted from the cost of the 778 fewer OSBs recommended by the clinic, the savings during 1995 amounted to $1,203,519.
There most likely were additional savings, but the EWBC was unable to obtain the data to calculate the exact amount. Some of these savings were due to fewer open surgical procedures in the patients for whom the EWBC established the diagnosis of breast carcinoma with FNAC and CB (Table 1). There were other savings because, in contrast to elsewhere in the Rochester community, only a few of the patients whom the EWBC determined to have benign conditions obtained surgical consultations.
The percentage of lymph node metastases in the EWBC patients with diagnosed breast carcinoma was compared with the rate of lymph node metastases in the women with diagnosed breast carcinoma in the remainder of the city of Rochester to determine whether the fewer OSBs recommended by the EWBC resulted in the diagnosis of carcinoma at a later stage. The lymph node metastasis rate of the carcinomas diagnosed by the EWBC was 19%, identical to that of the remainder of the city.