Core Needle Biopsy Rate for New Breast Cancer Diagnosis
Core Needle Biopsy Rate for New Breast Cancer Diagnosis
Institutional review board approval was obtained for this study. The study occurred at an interdisciplinary breast center, which is integrated into a multispecialty clinic and tertiary care hospital that serves as an academic teaching campus for nurses, physician assistants, and residents. Both surgical and medical residents participate in services through the breast center. The breast center is accredited by the National Accreditation Program for Breast Centers and has been named a Center of Excellence by the National Consortium of Breast Centers (NCBC) and the American College of Radiology (ACR). Approximately 25,000 screening mammography examinations are performed and interpreted and approximately 200 new breast cancer patients are treated annually at this site. The structure and care pathways of this center have been described elsewhere.
This study represents a single institution retrospective review of three independent hospital databases—the breast center registry, the hospital cancer registry, and the hospital pathology registry. Data are prospectively entered into the breast center and pathology databases. All breast cancers, invasive and in situ, and all needle biopsies, benign ormalignant, diagnosed in 2007 and 2008 were included. A secondary pathology review was performed for all needle biopsies. Data were collected for each unique cancer identified and analyzed by the method of diagnosis for that particular tumor. When patients presented with more than one tumor, each cancer diagnosis was analyzed uniquely. Patients treated at our institution but diagnosed elsewhere were excluded. The study also included all patients in 2007 and 2008 that had a needle biopsy of the breast that demonstrated a benign histology. Patients with a benign finding on biopsy underwent concordance assessment, which usually included presentation at a weekly imaging—pathology conference. Concordance assessment at our institution has been described elsewhere. After concordance assessment, these patients were followed with scheduled 6, 12, and 24 month follow-up appointments or they underwent open surgical biopsy. If atypical ductal hyperplasia (ADH) was identified on CNB, then surgical biopsy was offered. Atypical ductal hyperplasia was diagnosed on CNB with stringent diagnostic criteria supported in the breast pathology literature. Accordingly, if ADH had similar cytologic and architectural features of low-grade ductal carcinoma in situ (DCIS), but measured less than 2 mm or the atypia was not noted to involve multiple terminal ductal lobular units, then it was categorized as ADH.
Evaluation of a new breast complaint or an abnormal screening mammogram typically began with a clinical breast radiologist. Breast surgeons were also present in the diagnostic breast center. Image-guided tissue sampling was almost always performed by clinical breast radiologists; however, it is this institution's policy to first attempt minimally invasive biopsy regardless of the initial provider accessed. Usual methods of tissue acquisition were employed, including ultrasound-guided or stereotactic-guided CNB with or without vacuum assistance, fine needle aspiration, skin punch biopsy, freehanded CNB, and magnetic resonance image–guided needle biopsy. Image guidance for needle biopsy was usually employed, regardless of lesion palpability. Patients who did not receive a diagnosis of cancer by minimally invasive techniques had the diagnosis made with an open surgical biopsy.
The mode of percutaneous biopsy used was dependent upon the presenting lesion. The ACR guidelines for image-guided biopsy were followed. Ultrasound-guided core needle biopsy was used preferentially for all palpable and nonpalpable lesions visible with this modality. A Philips/ATL 5000 HDI SonoCT (Bothell, WA) with an L5-12 50 mm probe was used. Approximately 4 cores were taken per lesion with either an 18-gauge or a 14-gauge needle. Vacuum assistance was selectively used with ultrasound-guided CNB based on tumor characteristics, most often for tumors less than 5 mm in size. Stereotactic-guided biopsy was utilized for nonpalpable lesions not seen on ultrasonography, typically formicrocalcifications or other imaging abnormalities seen on initial mammography but not identified with ultrasound. These biopsies were performed using the Lorad/HologicMultiCare Platinum (Danbury, CT) prone biopsy system. Vacuum assistancewas usedwith stereotactic biopsies using the Suros (9 gauge) system, taking 6 to 12 cores per lesion. If the target lesion contained calcifications, a specimen radiograph was used to confirm the presence of calcifications in the cores. Ultrasound-guided fine needle aspiration was performed with a 21-gauge aspiration, relying on a cytopathologist to confirm when an adequate sample had been obtained. Analgesia for needle biopsies was accomplished with approximately 4 to 12 mL of buffered 1% lidocaine using a 26-gauge needle to anesthetize a cone of tissue around the lesion, as well as the needle track and associated skin. Skin punch biopsywas typically performed with a 4-mm instrument, reapproximating the margins with a single suture.
Open surgical biopsy was performed with or without needle localization, depending on tumor characteristics. For nonpalpable or image-detected lesions, needle localized open surgical biopsy was performed with image-guided localization, using either ultrasound or stereotactic techniques. Depending on the lesion, localization was performed with either single needle hookwires or multiple needle hookwires for bracketing. Skin markings were made over ultrasound visible lesions by the radiologist. Surgeons then utilized ultrasound in the operating room to identify the relationship between the needle hook wire and the intended target lesion and to aid in planning of site of skin incision and site of parenchyma excision. The biopsy specimen was marked by the surgeon for orientation with sutures along with a defined color of ink applied to each margin. For mammographydetectable lesions, tissue was then placed in a specimen container for anatomically oriented biplanar specimen radiography to assess for both presence of the lesion and margin status before final wound closure.
Documentation of palpable breast abnormalities was available in a shared electronic medical record at the time of the initial clinical breast radiologist's examination and initial biopsy and at the time of the initial surgeon's examination. Thus, the reported size of palpable breast abnormalities from pre-CNB to post-CNB records was available for evaluation.
Finally, as part of an institutional quality of care initiative, a postal survey of patient satisfaction was conducted for all patients. This survey has been described elsewhere. The surveys were batch mailed in June to patients diagnosed with breast cancer in the previous calendar year. The patient's care had been transitioned to postsurgical care providers by the date they received the survey unless the patient had an ongoing postoperative problem. The patient survey instrument was blinded for patient identifiers. This anonymity was intentional, to encourage patients to provide honest responses. Patients were asked if pain control for the needle biopsy procedures and needle localizations procedures was adequate and if timeliness expectations were met.
Methods
Institutional review board approval was obtained for this study. The study occurred at an interdisciplinary breast center, which is integrated into a multispecialty clinic and tertiary care hospital that serves as an academic teaching campus for nurses, physician assistants, and residents. Both surgical and medical residents participate in services through the breast center. The breast center is accredited by the National Accreditation Program for Breast Centers and has been named a Center of Excellence by the National Consortium of Breast Centers (NCBC) and the American College of Radiology (ACR). Approximately 25,000 screening mammography examinations are performed and interpreted and approximately 200 new breast cancer patients are treated annually at this site. The structure and care pathways of this center have been described elsewhere.
This study represents a single institution retrospective review of three independent hospital databases—the breast center registry, the hospital cancer registry, and the hospital pathology registry. Data are prospectively entered into the breast center and pathology databases. All breast cancers, invasive and in situ, and all needle biopsies, benign ormalignant, diagnosed in 2007 and 2008 were included. A secondary pathology review was performed for all needle biopsies. Data were collected for each unique cancer identified and analyzed by the method of diagnosis for that particular tumor. When patients presented with more than one tumor, each cancer diagnosis was analyzed uniquely. Patients treated at our institution but diagnosed elsewhere were excluded. The study also included all patients in 2007 and 2008 that had a needle biopsy of the breast that demonstrated a benign histology. Patients with a benign finding on biopsy underwent concordance assessment, which usually included presentation at a weekly imaging—pathology conference. Concordance assessment at our institution has been described elsewhere. After concordance assessment, these patients were followed with scheduled 6, 12, and 24 month follow-up appointments or they underwent open surgical biopsy. If atypical ductal hyperplasia (ADH) was identified on CNB, then surgical biopsy was offered. Atypical ductal hyperplasia was diagnosed on CNB with stringent diagnostic criteria supported in the breast pathology literature. Accordingly, if ADH had similar cytologic and architectural features of low-grade ductal carcinoma in situ (DCIS), but measured less than 2 mm or the atypia was not noted to involve multiple terminal ductal lobular units, then it was categorized as ADH.
Evaluation of a new breast complaint or an abnormal screening mammogram typically began with a clinical breast radiologist. Breast surgeons were also present in the diagnostic breast center. Image-guided tissue sampling was almost always performed by clinical breast radiologists; however, it is this institution's policy to first attempt minimally invasive biopsy regardless of the initial provider accessed. Usual methods of tissue acquisition were employed, including ultrasound-guided or stereotactic-guided CNB with or without vacuum assistance, fine needle aspiration, skin punch biopsy, freehanded CNB, and magnetic resonance image–guided needle biopsy. Image guidance for needle biopsy was usually employed, regardless of lesion palpability. Patients who did not receive a diagnosis of cancer by minimally invasive techniques had the diagnosis made with an open surgical biopsy.
The mode of percutaneous biopsy used was dependent upon the presenting lesion. The ACR guidelines for image-guided biopsy were followed. Ultrasound-guided core needle biopsy was used preferentially for all palpable and nonpalpable lesions visible with this modality. A Philips/ATL 5000 HDI SonoCT (Bothell, WA) with an L5-12 50 mm probe was used. Approximately 4 cores were taken per lesion with either an 18-gauge or a 14-gauge needle. Vacuum assistance was selectively used with ultrasound-guided CNB based on tumor characteristics, most often for tumors less than 5 mm in size. Stereotactic-guided biopsy was utilized for nonpalpable lesions not seen on ultrasonography, typically formicrocalcifications or other imaging abnormalities seen on initial mammography but not identified with ultrasound. These biopsies were performed using the Lorad/HologicMultiCare Platinum (Danbury, CT) prone biopsy system. Vacuum assistancewas usedwith stereotactic biopsies using the Suros (9 gauge) system, taking 6 to 12 cores per lesion. If the target lesion contained calcifications, a specimen radiograph was used to confirm the presence of calcifications in the cores. Ultrasound-guided fine needle aspiration was performed with a 21-gauge aspiration, relying on a cytopathologist to confirm when an adequate sample had been obtained. Analgesia for needle biopsies was accomplished with approximately 4 to 12 mL of buffered 1% lidocaine using a 26-gauge needle to anesthetize a cone of tissue around the lesion, as well as the needle track and associated skin. Skin punch biopsywas typically performed with a 4-mm instrument, reapproximating the margins with a single suture.
Open surgical biopsy was performed with or without needle localization, depending on tumor characteristics. For nonpalpable or image-detected lesions, needle localized open surgical biopsy was performed with image-guided localization, using either ultrasound or stereotactic techniques. Depending on the lesion, localization was performed with either single needle hookwires or multiple needle hookwires for bracketing. Skin markings were made over ultrasound visible lesions by the radiologist. Surgeons then utilized ultrasound in the operating room to identify the relationship between the needle hook wire and the intended target lesion and to aid in planning of site of skin incision and site of parenchyma excision. The biopsy specimen was marked by the surgeon for orientation with sutures along with a defined color of ink applied to each margin. For mammographydetectable lesions, tissue was then placed in a specimen container for anatomically oriented biplanar specimen radiography to assess for both presence of the lesion and margin status before final wound closure.
Documentation of palpable breast abnormalities was available in a shared electronic medical record at the time of the initial clinical breast radiologist's examination and initial biopsy and at the time of the initial surgeon's examination. Thus, the reported size of palpable breast abnormalities from pre-CNB to post-CNB records was available for evaluation.
Finally, as part of an institutional quality of care initiative, a postal survey of patient satisfaction was conducted for all patients. This survey has been described elsewhere. The surveys were batch mailed in June to patients diagnosed with breast cancer in the previous calendar year. The patient's care had been transitioned to postsurgical care providers by the date they received the survey unless the patient had an ongoing postoperative problem. The patient survey instrument was blinded for patient identifiers. This anonymity was intentional, to encourage patients to provide honest responses. Patients were asked if pain control for the needle biopsy procedures and needle localizations procedures was adequate and if timeliness expectations were met.
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