Core Needle Biopsy Rate for New Breast Cancer Diagnosis
Core Needle Biopsy Rate for New Breast Cancer Diagnosis
Three hundred sixty new cancers were diagnosed in 352 patients ranging from 26 to 91 years old, with a mean age of 63 years. Ninety-nine percent (349/352) of the cancers occurred inwomen. Left and right-sided cancers occurred at similar rates, 182/360 (50.6%) and 178/360 (49.4%), respectively (P = 0.833; Table 1).
The diagnosis of cancer was made by minimally invasive techniques in 350 (97%) of 360 cancers. Of these 350 cancers diagnosed by minimally invasive techniques, 339 (97%) were made by a needle biopsy, with 63 (18.5%) of the 339 needle biopsies requiring vacuum assistance. Overall, the majority of cancers were diagnosed by ultrasound-guided biopsy (277/360; 77%), followed by stereotacticguided needle biopsy (54/360; 15%). Nineteen percent of the needle biopsies (63/339)were performed with vacuum assistance; 8 (13%) of the 63 were ultrasound-guided biopsies and 54 (86%) of the 63 were stereotactic-guided biopsies. Most needle biopsies were performed with 14- or 18-gauge needles under ultrasound guidance (72.5%; 261/360), with 3.8 ± 1.5 and 3.0 ± 1.5 mean number of tissue acquisition attempts, respectively, per biopsy (P = 0.002). When vacuum assistance was used, a mean of 8.3 ±2.9 tissue acquisition attempts weremade per biopsy compared to 3.3 ± 1.3 attempts when vacuum assistance was not utilized (P < 0.0001).
Surgical diagnosis occurred in 10/360 patients, representing 2.8% of all cancers diagnosed. Surgical diagnosis occurred in these patients for 1 of 2 reasons: the needle biopsy was either performed but failed to make the diagnosis (n = 4) or a needle biopsy was not attempted (n = 6). Thus, for 40% (4/10) of patients diagnosed surgically, the cancer was not identified after an initial attempt at needle biopsy. One of these 4 patients had surgery with an indication of micropapillomas with florid epithelial hyperplasia. Three had surgery with an indication of "atypia" on the needle biopsy, which was subsequently upgraded to cancer after an excisional biopsy. One of these 3 patients had an atypical apocrine lesion and 2 of the 3 patients with atypia on CNB had ADH. The 2 cases of ADH underwent a later secondary pathologic review by our subspecialty breast pathologist. By this secondary pathologic review, no cancer patient in this study with ADH on CNB assessment was retrospectively upgraded to in situ or invasive cancer based on the initial CNB alone. Of the remaining 6 patients diagnosed by surgery, a needle biopsy was not attempted: one had suspicious microcalcifications (BIRAD 4b) in a lower inner quadrant close to the chest wall that was "inaccessible" to our stereotactic methods; one was incidentally found in a prophylactic contralateral mastectomy; one was found after excision of a recurrent cyst; two were found after excision of an intraductal mass with bloody nipple discharge; and one presented with mammographically detected microcalcifications, undetectable on ultrasound, in a patient who could not tolerate prone positioning for stereotactic biopsy. Although surgical diagnosis occurred in 10 patients, minimally invasive biopsy as the first diagnostic step was attempted in 354 (98%) of 360 cancers. Upstaging from DCIS on needle biopsy to invasive cancer on surgical biopsy occurred in 8 (16%) of 50 patients. One (12.5%) of these 8 patients was upstaged to T1mi (less than or equal to 1 mm) invasive disease. The remainder had upstaging to T1 disease.
For cancers diagnosed with ultrasound-guided CNB, the reported postbiopsy tumor size was larger on average compared to the reported prebiopsy size, but this difference was insignificant (1.34mm ± 18.1; P = 0.300; n = 198). Likewise, for cancers diagnosed with stereotactic-guided needle biopsy, which was generally performed with larger bore needles and with more biopsy attempts, as noted earlier, the size estimates were again insignificantly larger on average in the postbiopsy size estimates compared with the prebiopsy measures (1.48 mm ± 6.3; P = 0.117; n = 46; P = 0.932).
Seven hundred fifty-six patients underwent an initialminimally invasive breast biopsy (MIBB) during the study period. The positive biopsy rate (number of MIBB's identifying cancer divided by the number of MIBB's) was 46% (350/756). The sensitivity, specificity, PPV,NPV, and the Kappa agreement statistic ofMIBBare described in Table 2. The overall accuracy ofMIBBis99%(752/756). Patientswho had a benign MIBB had 2.7- and 2.8-year mean and median followup, respectively. Seven patients were lost to follow-up. Four hundred two patients had their initial MIBB demonstrate benign histology. In follow-up, only one of these patients developed breast cancer. This patient's initial CNB identified a fibroadenoma. One year later, she developed newmammographically detected microcalcifications 4-cm distant from the stable fibroadenoma. A stereotactic-guided biopsy of the microcalcifications revealed DCIS. This patient was therefore not considered to have a false negative MIBB.
Finally, after diagnosis and treatment, patientswere specifically questioned regarding pain related to the needle biopsy procedure and satisfaction with timeliness of care through our postal survey. Overall response rate for the surveys mailed in the years 2007-2008 was 48% (172/357). One hundred fifty-four patients responded to the question "Was your pain well controlled during your needle biopsy?" One hundred thirty-one (85%) of 154 patients responded, "Yes, definitely," 17 (11%) responded "Yes, somewhat," and 6 (4%) responded, "No."One hundred forty-seven patients responded to the question "was your pain controlled during your pre-op needle localization." This included patients undergoing both open excisional biopsy and formal lumpectomy, as the anonymization process made it impossible to separate the 2 groups. One hundred twenty (82%) of 147 patients responded "Yes, definitely," 21 (14%) responded, "Yes, somewhat," and 6 (4%) responded "No. After tissue diagnosis, patients were referred for interdisciplinary treatment counseling, aided by specialty breast center nurse navigators. Newly diagnosed breast cancer patients were offered appointments within 48 hours and surgery within 1 week. The actual duration of time from pathology reporting to an appointment with a surgeon averaged 6.4 ± 15.5 days, and the subsequent actual time interval from first surgery consultation to date of surgery averaged 19.8 ± 33.7 days. Overall, a mean of 25.7 ± 36.3 days elapsed between pathologic confirmation of a tissue diagnosis to the date of surgery, with 90% being within 38 days. When asked if expectations for timeliness were met for the interval from cancer diagnosis to surgeon appointment, 154/156 (99%) responded, "Yes." When asked if timeliness expectations were met for the interval from an appointment with a surgeon to the day of surgery, 141/151 (93%) responded, "Yes." (Not all responders answered all questions.) Specific details of our institution's timeliness of care and patient satisfaction have been described previously, and these results are consistent with those trends.
Results
Three hundred sixty new cancers were diagnosed in 352 patients ranging from 26 to 91 years old, with a mean age of 63 years. Ninety-nine percent (349/352) of the cancers occurred inwomen. Left and right-sided cancers occurred at similar rates, 182/360 (50.6%) and 178/360 (49.4%), respectively (P = 0.833; Table 1).
The diagnosis of cancer was made by minimally invasive techniques in 350 (97%) of 360 cancers. Of these 350 cancers diagnosed by minimally invasive techniques, 339 (97%) were made by a needle biopsy, with 63 (18.5%) of the 339 needle biopsies requiring vacuum assistance. Overall, the majority of cancers were diagnosed by ultrasound-guided biopsy (277/360; 77%), followed by stereotacticguided needle biopsy (54/360; 15%). Nineteen percent of the needle biopsies (63/339)were performed with vacuum assistance; 8 (13%) of the 63 were ultrasound-guided biopsies and 54 (86%) of the 63 were stereotactic-guided biopsies. Most needle biopsies were performed with 14- or 18-gauge needles under ultrasound guidance (72.5%; 261/360), with 3.8 ± 1.5 and 3.0 ± 1.5 mean number of tissue acquisition attempts, respectively, per biopsy (P = 0.002). When vacuum assistance was used, a mean of 8.3 ±2.9 tissue acquisition attempts weremade per biopsy compared to 3.3 ± 1.3 attempts when vacuum assistance was not utilized (P < 0.0001).
Surgical diagnosis occurred in 10/360 patients, representing 2.8% of all cancers diagnosed. Surgical diagnosis occurred in these patients for 1 of 2 reasons: the needle biopsy was either performed but failed to make the diagnosis (n = 4) or a needle biopsy was not attempted (n = 6). Thus, for 40% (4/10) of patients diagnosed surgically, the cancer was not identified after an initial attempt at needle biopsy. One of these 4 patients had surgery with an indication of micropapillomas with florid epithelial hyperplasia. Three had surgery with an indication of "atypia" on the needle biopsy, which was subsequently upgraded to cancer after an excisional biopsy. One of these 3 patients had an atypical apocrine lesion and 2 of the 3 patients with atypia on CNB had ADH. The 2 cases of ADH underwent a later secondary pathologic review by our subspecialty breast pathologist. By this secondary pathologic review, no cancer patient in this study with ADH on CNB assessment was retrospectively upgraded to in situ or invasive cancer based on the initial CNB alone. Of the remaining 6 patients diagnosed by surgery, a needle biopsy was not attempted: one had suspicious microcalcifications (BIRAD 4b) in a lower inner quadrant close to the chest wall that was "inaccessible" to our stereotactic methods; one was incidentally found in a prophylactic contralateral mastectomy; one was found after excision of a recurrent cyst; two were found after excision of an intraductal mass with bloody nipple discharge; and one presented with mammographically detected microcalcifications, undetectable on ultrasound, in a patient who could not tolerate prone positioning for stereotactic biopsy. Although surgical diagnosis occurred in 10 patients, minimally invasive biopsy as the first diagnostic step was attempted in 354 (98%) of 360 cancers. Upstaging from DCIS on needle biopsy to invasive cancer on surgical biopsy occurred in 8 (16%) of 50 patients. One (12.5%) of these 8 patients was upstaged to T1mi (less than or equal to 1 mm) invasive disease. The remainder had upstaging to T1 disease.
For cancers diagnosed with ultrasound-guided CNB, the reported postbiopsy tumor size was larger on average compared to the reported prebiopsy size, but this difference was insignificant (1.34mm ± 18.1; P = 0.300; n = 198). Likewise, for cancers diagnosed with stereotactic-guided needle biopsy, which was generally performed with larger bore needles and with more biopsy attempts, as noted earlier, the size estimates were again insignificantly larger on average in the postbiopsy size estimates compared with the prebiopsy measures (1.48 mm ± 6.3; P = 0.117; n = 46; P = 0.932).
Seven hundred fifty-six patients underwent an initialminimally invasive breast biopsy (MIBB) during the study period. The positive biopsy rate (number of MIBB's identifying cancer divided by the number of MIBB's) was 46% (350/756). The sensitivity, specificity, PPV,NPV, and the Kappa agreement statistic ofMIBBare described in Table 2. The overall accuracy ofMIBBis99%(752/756). Patientswho had a benign MIBB had 2.7- and 2.8-year mean and median followup, respectively. Seven patients were lost to follow-up. Four hundred two patients had their initial MIBB demonstrate benign histology. In follow-up, only one of these patients developed breast cancer. This patient's initial CNB identified a fibroadenoma. One year later, she developed newmammographically detected microcalcifications 4-cm distant from the stable fibroadenoma. A stereotactic-guided biopsy of the microcalcifications revealed DCIS. This patient was therefore not considered to have a false negative MIBB.
Finally, after diagnosis and treatment, patientswere specifically questioned regarding pain related to the needle biopsy procedure and satisfaction with timeliness of care through our postal survey. Overall response rate for the surveys mailed in the years 2007-2008 was 48% (172/357). One hundred fifty-four patients responded to the question "Was your pain well controlled during your needle biopsy?" One hundred thirty-one (85%) of 154 patients responded, "Yes, definitely," 17 (11%) responded "Yes, somewhat," and 6 (4%) responded, "No."One hundred forty-seven patients responded to the question "was your pain controlled during your pre-op needle localization." This included patients undergoing both open excisional biopsy and formal lumpectomy, as the anonymization process made it impossible to separate the 2 groups. One hundred twenty (82%) of 147 patients responded "Yes, definitely," 21 (14%) responded, "Yes, somewhat," and 6 (4%) responded "No. After tissue diagnosis, patients were referred for interdisciplinary treatment counseling, aided by specialty breast center nurse navigators. Newly diagnosed breast cancer patients were offered appointments within 48 hours and surgery within 1 week. The actual duration of time from pathology reporting to an appointment with a surgeon averaged 6.4 ± 15.5 days, and the subsequent actual time interval from first surgery consultation to date of surgery averaged 19.8 ± 33.7 days. Overall, a mean of 25.7 ± 36.3 days elapsed between pathologic confirmation of a tissue diagnosis to the date of surgery, with 90% being within 38 days. When asked if expectations for timeliness were met for the interval from cancer diagnosis to surgeon appointment, 154/156 (99%) responded, "Yes." When asked if timeliness expectations were met for the interval from an appointment with a surgeon to the day of surgery, 141/151 (93%) responded, "Yes." (Not all responders answered all questions.) Specific details of our institution's timeliness of care and patient satisfaction have been described previously, and these results are consistent with those trends.
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