Table E14Surgical procedures avoided

ReferenceDesign of StudyNumber of PatientsBiopsy MethodsConclusion
Friese et al. 2009592Analysis of data from the SEER data of women diagnosed with DCIS or stage I/II breast cancer between 1991 and 199945,542Needle or surgicalNeedle biopsy use was associated with a reduced likelihood of multiple breast surgeries (odds ratio 0.35, 95% CI: 0.34 to 0.37)
Altomare et al. 2005145Retrospective chart review of patients with nonpalpable breast lesions who underwent core-needle biopsy between January 2001-January 2004.591US- or stereotactic-guided vacuum-assisted biopsy (Mammotome) 11-gauge needle or ABBICore-needle biopsy spared a surgical procedure for 128 cancer patients and 134 non-cancer patients, but did not spare a procedure in 17 women
Bolivar et al. 2005497Prospective case series of patients with non-palpable suspicious breast lesions who underwent core-needle biopsy from August 1997–August 2001.198US-guided (7.5 MHz linear array transducer) using a freehand technique with patient in supine or supine oblique position.Core-needle biopsy spared 155/198 (or 78%) women a surgical procedure.
Chapellier et al. 2005494Prospective case series of the first 318 aspiration-guided macrobiopsy procedures performed at one institution. The majority of patients had microcalcifications; approximately 50% were BIRADS 4 while 35% were BIRADS 3 but had risk factors.301Fischer stereotactic imaging table, vacuum-assisted biopsy (AND).128 BIRADS 4 patients and six BIRADS 5 patients were spared an additional operation by use of core-needle biopsy.
Carmon et al. 2004176Retrospective chart review of patients with nonpalpable breast lesions who were ultimately operated on for primary breast carcinoma between 1997-mid-2001.167Percutaneous image-guided core biopsyFrom 1997 to 2001, the percent of patients requiring a second operation decreased from 56.2% to 11.1%, with increased availability of a preoperative diagnosis. 79.2% of subjects with a preoperative diagnosis of invasive duct carcinoma had axillary lymph node dissection vs. 37.7% of those without a preoperative CNB diagnosis.
Apesteguia et al. 2002518Prospective consecutive case series of patients with nonpalpable breast lesions non-visible or non-accessible by US.126Vacuum-assisted core biopsy on a digital stereotaxic table with an 11-gauge needle.Second surgical procedures due to involved margins were required in 17.4% of cases and 5 additional lymphadenectomy procedures were needed based on core-needle biopsy’s inability to predict invasion.
Liberman et al. 2002522Retrospective study. Rate of spared surgical procedures was compared for those whose lesion was completely excised compared to those whose lesion was only sampled.800 (565 calcifications, 194 mass, 41 both)Vacuum-assisted core biopsy (Mammotome) with 11-gauge needle466 lesions were totally removed by the core-needle procedure. Surgery was spared in 80.6% of lesions. There was not a significant difference between the excised versus sampled lesion groups in spared surgery rates (81.5% vs. 82%, p = 0.95).
Becker et al. 2001527Retrospective chart review of lesions with indeterminate microcalcifications218DMR regular mammography machine plus either a Stereotix 2 conventional add-on unit or a SenoVision digital add-on unit. Core-needle biopsy was performed with a 14-gauge needle in all but 5 cases (in which a 16-gauge needle was used)Open biopsy was avoided in 78 (69.6%) of patients in the conventional treatment group and in 78 (73.6%) of the digital treatment group.
Liberman et al. 2001298Retrospective review of women with calcifications highly suggestive of malignancy who underwent a diagnostic biopsy procedure from 1993–2000.139Stereotactic vacuum-assisted biopsy with 11 or 14-gauge needleThe mean number of surgical procedures was 1.2 and 1.6 for core-needle biopsy vs. surgical biopsy. 62% of surgical biopsy patients overall and 83.8% of diagnostic surgical biopsy with cancer needed two procedures. The likelihood of requiring a single operation was greater for women who had core-needle biopsy. A surgical procedure was spared in 58.4% of this group.
Perez-Fuentes et al. 2001534Prospective case series of patients seen between August 1998-December 2000 with palpable or nonpalpable breast masses83US-guided vacuum-assisted biopsy (Mammotome) with 11-gauge needleOf the 83 patients studied, 79 were spared a surgical procedure (95.2%).
Verkooijen et al. 2001593Prospective comparison of patients with nonpalpable breast lesions164Patient prone, 14-gauge needleIn 75% of core-needle cases, only a single surgical procedure was needed, while this was true in only 16% of open biopsy cases (p <0.001). Mean number of surgical procedures was 1.31 vs. 1.91 (p <0.001) in the core-needle and open biopsy groups, respectively.
Liberman et al. 2000542Retrospective chart review of patients with breast masses that were palpable on physical examination from 1992 to 1998.107Stereotactic- or US-guided core biopsy with a 14-gauge needle.Core-needle biopsy spared 74% of subjects in this study an additional diagnostic tissue sampling
Morrow et al. 2000305Prospective nonrandomized comparative study of patients with nonpalpable mammographically-detected abnormalities1,550Core-needle or open biopsyAmong those with cancer, a single procedure was performed in 33% of the excisional biopsy subjects versus 84% of the core-needle group (p <0.001). The core-needle group consistently had a larger proportion of subjects treated with a single procedure, regardless of lesion type: for architectural distortions 71% vs. 46% and for highly suspicious lesions 83% vs. 45%.
Al-Sobhi et al. 1999346Retrospective review of patients found to have cancer67Vacuum-assisted with an 11 or 14-gauge needleThe number of surgical procedures performed in an operating room differed significantly for the two groups overall (CNB mean 1.1 ±0.3 and wire localization mean 1.8 ±0.4). For the subset who underwent breast-conserving treatment a significant difference between groups was also evident, mean surgical procedures were 1.2 ±0.4 and 2.1 ±0.2, respectively.
Williams et al. 1999384Prospective case series of patients with impalpable breast lesions diagnosed by stereotactic CNB on a prone table vs. a historical cohort of patients with similar lesions diagnosed prior to the use of prone stereotactic CNB.222Stereotactic prone core-needle with Mammotest and 14-gauge needle.More patients in the prone group required only a single operation (p <0.03). The average number of operations was 1.33 (SE 0.053) vs.1.47 (SE 0.054) in the prone and control groups, respectively.
Johnson et al. 1998395Retrospective review of patients with malignant-appearing microcalcifications without an associated parenchymal abnormality on mammography.167Stereotactic biopsy was performed using Lorad Stereotactic prone biopsy table with 14-gauge needle. Digital mammography was used to localize the lesions. US biopsies were performed using a 7.5 MHz probe with real-time imaging using the same CNB device.The mean number of procedures required until definitive treatment was 2.4 and 1.7 for the initial IGBB and initial NLOB, respectively (p = 0.0002)
Kaufman et al. 1998396Retrospective review of consecutive mammographically-detected nonpalpable breast lesions ultimately diagnosed as in situ or invasive carcinoma.113Core-needle or open biopsyNegative margins were achieved twice as often in the core-needle group as in the open biopsy group after the first surgical procedure (77% vs. 38%, p <0.001). A one-stage surgical procedure was possible in many more of the core-needle patients than in the open biopsy group (79% vs. 21%, p <0.001). On average, 2.2 procedures (surgery and biopsy) were needed in the core-needle group vs. 1.8 among the open biopsy patients. However, the average number of surgeries was 50% higher in the open biopsy group (1.8 vs. 1.2).
Liberman et al. 1998556Retrospective review of patients with nonpalpable breast masses.151US-guided biopsy was performed in the supine or supine oblique position using high resolution (7.5 MHz linear array transducer) equipment with a 14-gauge cutting needle.85% of patients in this study were spared a surgical procedure by use of core-needle biopsy.
Lind et al. 1998402Retrospective review of patients with mammographically-detected breast cancer that underwent breast-conserving surgery117Biopsies were performed on a dedicated prone table with 14-gauge needleOnly 6% of patients in the core-needle group had positive margins vs. 55% of the open biopsy patients (p <0.01). One patient with positive margins in the core-needle group was re-excised vs. 34/38 of those with positive margins in the open group (p <0.01).
Fenoglio et al. 1997419Retrospective chart review of patients with mammographically-detected breast cancer4014-gauge long throw Biopty gun plus Mammotest Stereotactic SystemAll 20 patients diagnosed with core-needle biopsy required one surgical procedure only whereas among the 20 initially diagnosed with open biopsy a total of 41 procedures were required to diagnose and treat their cancers
Liberman et al. 1997428Retrospective chart review of nonpalpable breast cancers197Stereotactic CNB were done with patient in prone position using StereoGuide; sonographically-guided CNB were done with patients in supine or supine oblique using a 7.5 MHz linear array transducer and high resolution sonographic equipment; all CNB used a 14-gauge needle or an ultra-core biopsy needle.84% of patients in the CNB group underwent a single surgical procedure vs. 29% of those diagnosed by surgical biopsy (p <0.00001). 16% of the CNB patients required two surgical procedures while 66% of the open-biopsy patients needed two surgeries and 5% underwent three surgical procedures.
Smith et al. 1997433Retrospective review.677US-guided Mammotest (67) or wire localized excisional biopsy (610)On average, 1.25 surgical procedures were required by the core-needle group versus 2.01 in the surgical biopsy group (p <0.001).
Sutton et al. 1997568Retrospective review of patients with nonpalpable mammographic abnormalities detected at routine screening in a community-based clinic.200Biopsies were performed on a dedicated prone stereotactic table (Mammotest) with an autoguide attachment and 14-gauge 22 mm-throw Bard Biopty-cut needles held in a Bard Biopty gun.The authors estimated that open biopsy was avoided in 82% of cases by using core-needle biopsy for diagnosis.
Whitten et al. 1997435Retrospective review171Stereotactic- or US-guided biopsy with a 14-gauge needleAmong the 86 subjects diagnosed by image-guided core-needle biopsy, 98 surgical procedures were completed (1.1 surgeries per patient) compared with 1.9 operations on average for the 85 patients undergoing a diagnostic needle localized biopsy (157 surgeries total in 85 subjects).
Yim et al. 1996454Retrospective review52Stereotactic biopsy with a 14-gauge needle was performed on a dedicated prone tableAt the time of excision, surgical margins were more frequently positive in the open biopsy group (55%) vs. the CNB group (0%); the distance of the tumor from the surgical margin was greater for the CNB vs. open biopsy patients among the negative margins; and, among those having breast conservation surgery, the rate of re-excision was higher for the open biopsy group (74%) vs. no patients in the CNB treatment group.
Liberman et al. 1995458Retrospective chart review of patients with impalpable speculated masses.43Biopsies were performed with patients prone on a dedicated table using either a 14-gauge Bard Biopty needle or a 14-gauge Manan needle and either a Bard Biopty gun with 23 mm throw or Manan ProMag 2.2 gun with a 22 mm throw.The use of core-needle biopsy in the diagnosis of breast cancer reduced the number of procedures required in 33 (77%) patients.
Strong et al. 1995463Prospective study of patients with mammographically-detected, asymptomatic, nonpalpable breast lesions97Mammotest stereotactic device using 14-gauge Manan needle.In eight benign cases, open biopsy was performed, adding an extra procedure to the diagnostic protocol for these patients. However, 74 women (76%) were spared an open biopsy by core-needle biopsy. As the 15 women with carcinoma went directly to mastectomy without an open biopsy, core- needle biopsy did not add a diagnostic procedure in these cases.
Elliott et al. 1992479Retrospective review of 12-month period of patients with nonpalpable breast lesions.115Mammotest II with 18-gauge Bard biopsy needle using Bard Biopty gunCore-needle biopsy spared 97 patients an open surgical biopsy.

From: Appendix E, Evidence Tables

Cover of Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions
Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet].
Comparative Effectiveness Reviews, No. 19.
Bruening W, Schoelles K, Treadwell J, et al.

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