Stereotactic Large-core Needle Biopsy Research Articles

Abstract P2-14-03: Development and evaluation of a prediction model based on routine clinicopathological variables for predicting underestimated invasive breast cancer in women with ductal carcinoma in situ at stereotactic large core needle biopsy

Abstract Purpose: To develop a multivariable model for prediction of underestimated invasiveness in women with ductal carcinoma in situ (DCIS) at stereotactic large core needle biopsy (LCNB), that can be used to select patients for sentinel node biopsy (SNB) at primary surgery. Methods: From the literature, we selected potential preoperative predictors of underestimated invasive breast cancer. Data of patients with nonpalpable breast lesions who were diagnosed with DCIS at stereotactic LCNB, drawn from the COBRA (Core Biopsy after RAdiological localization) and COBRA2000 studies, were used to fit the multivariable model and assess its overall performance, discrimination, and calibration. Results: 348 women with LCNB-proven DCIS were available for analysis. In 100 (28.7%) patients invasive carcinoma was found at subsequent surgery. Nine predictors were included in the model. In the multivariable analysis, the predictors with the strongest association were lesion size (OR 1.12 per cm, 95% CI 0.98-1.28), the number of cores retrieved at biopsy (OR per core 0.87, 95% CI 0.75-1.01), presence of lobular cancerization (OR 5.29, 95% CI 1.25-26.77), and microinvasion (OR 3.75, 95% CI 1.42-9.87). The overall performance of the multivariable model was poor with an explained variation of 9% (Nagelkerke's R2), mediocre discrimination with area under the receiver operating characteristic curve of 0.66 (95% confidence interval 0.58-0.73), and fairly good calibration. Conclusion: The evaluation of our multivariable prediction model in a large, clinically representative study population, proves that routine clinical and pathological variables are not suitable to select patients with LCNB-proven DCIS for SNB during primary surgery. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-14-03.

Development and Evaluation of a Prediction Model for Underestimated Invasive Breast Cancer in Women with Ductal Carcinoma In Situ at Stereotactic Large Core Needle Biopsy

BackgroundWe aimed to develop a multivariable model for prediction of underestimated invasiveness in women with ductal carcinoma in situ at stereotactic large core needle biopsy, that can be used to select patients for sentinel node biopsy at primary surgery.MethodsFrom the literature, we selected potential preoperative predictors of underestimated invasive breast cancer. Data of patients with nonpalpable breast lesions who were diagnosed with ductal carcinoma in situ at stereotactic large core needle biopsy, drawn from the prospective COBRA (Core Biopsy after RAdiological localization) and COBRA2000 cohort studies, were used to fit the multivariable model and assess its overall performance, discrimination, and calibration.Results348 women with large core needle biopsy-proven ductal carcinoma in situ were available for analysis. In 100 (28.7%) patients invasive carcinoma was found at subsequent surgery. Nine predictors were included in the model. In the multivariable analysis, the predictors with the strongest association were lesion size (OR 1.12 per cm, 95% CI 0.98-1.28), number of cores retrieved at biopsy (OR per core 0.87, 95% CI 0.75-1.01), presence of lobular cancerization (OR 5.29, 95% CI 1.25-26.77), and microinvasion (OR 3.75, 95% CI 1.42-9.87). The overall performance of the multivariable model was poor with an explained variation of 9% (Nagelkerke’s R 2), mediocre discrimination with area under the receiver operating characteristic curve of 0.66 (95% confidence interval 0.58-0.73), and fairly good calibration.ConclusionThe evaluation of our multivariable prediction model in a large, clinically representative study population proves that routine clinical and pathological variables are not suitable to select patients with large core needle biopsy-proven ductal carcinoma in situ for sentinel node biopsy during primary surgery.

Diagnostic performance of stereotactic large core needle biopsy for nonpalpable breast lesions in routine clinical practice

The COBRA (COre Biopsy after RAdiological localization) study showed that in a controlled study setting, stereotactic large core needle biopsy (LCNB) is as reliable for diagnosing nonpalpable breast lesions as open surgical biopsy. In the present study, we evaluated the diagnostic performance of stereotactic LCNB in routine clinical practice. Between February 2000 and June 2002, data on all patients (n = 955) with nonpalpable breast lesions referred for LCNB were collected. High risk underestimate rate, ductal carcinoma in situ (DCIS) underestimate rate and sensitivity rate after 2 years were calculated. The usefulness of the COBRA guidelines in clinical practice was determined. Nine hundred five successful biopsies were performed in 874 patients. Of the high-risk lesions, 27% were found to be carcinomas on open biopsy, which is comparable to the results of the COBRA study (23%). The DCIS underestimate rate (28%) was higher than found in the COBRA study (17%). No carcinomas were missed after a follow-up period of 2 years. Ninety-six percent of patients were treated according to the COBRA guidelines. The diagnostic performance of stereotactic LCNB in patients with nonpalpable breast lesions seems to be comparable in a controlled study setting and routine clinical practice.

Vacuum-assisted large-core needle biopsy (VLNB) improves the management of patients with breast microcalcifications – Analysis of 1009 cases

To evaluate the surgical management of patients who underwent VLNB for breast microcalcifications. This retrospective study compared the histological results and the surgical procedures in two groups of patients, group 1: large-core needle biopsy n=1009, and group 2: surgical biopsy n=270. After VLNB, 54% patients were not operated on after stereotactic large-core needle biopsy, 42% underwent one operation, 4% underwent two operations and 0.2% underwent three operations. No surgery was performed for 95% of benign lesions. Multiples operations were necessary in 12% of patients with malignant lesions of VLNB group compared to 45% in the surgical biopsy group. The rate of underdiagnosis of borderline lesions and ductal carcinomas in situ was 16% by the large-core biopsy technique. VLNB constitutes an alternative to surgical biopsy. This procedure avoids surgery for most benign lesions and reduces the number of surgical procedures in malignant lesions.

Is stereotactic large-core needle biopsy beneficial prior to surgical treatment in BI-RADS 5 lesions?

Introduction. Due to screening mammography, more nonpalpable mammographic lesions warrant histological evaluation. Stereotactic large-core needle biopsy (SLCNB) has been shown to be as effective in diagnosing these lesions as diagnostic surgical excision, and has become the preferred diagnostic procedure for most mammographic lesions. Since radiologically malignant BI-RADS 5 lesions are almost always carcinoma, some centers advocate prompt diagnostic surgical excision for these lesions instead of SLCNB. For some patients this diagnostic surgical intervention may serve as definitive treatment. We set out to find a subgroup of mammographic BI-RADS 5 lesions for which surgical biopsy might be preferable.

Ductal carcinoma in situ presenting as microcalcifications: the effect of stereotactic large-core needle biopsy on surgical therapy

The aim of this investigation was to study the efficacy of surgical therapy in patients with non-palpable ductal carcinoma in situ (DCIS) presenting as microcalcifications diagnosed by means of stereotactic large-core needle biopsy (SCNB). This is a retrospective study with a historical control group within a 12-year period. Two groups of consecutive patients diagnosed with DCIS (1991-2002) by means of needle-localised open breast biopsy (NLBB, n=49) and SCNB (n=51) were studied. Both groups were comparable for clinical, radiological and pathological characteristics. The therapeutic interval (time from presentation to definitive of therapy) was 62-days in the SCNB group versus 32-days in the NLBB group (p<0.001). In the SCNB group fewer surgical procedures were required for completion of surgical therapy (p=0.006) and after local excision the surgical margins were more often tumour free (p=0.002). It is postulated that the need for fewer surgical procedures and the greater frequency of tumour-free margins after local excision may be attributable to SCNB.

Cost-effectiveness of stereotactic large-core needle biopsy for nonpalpable breast lesions compared to open-breast biopsy.

This paper demonstrates that the introduction of large-core needle biopsy (LCNB) replacing needle-localised breast biopsy (NLBB) for nonpalpable (screen-detected) breast lesions could result in substantial cost savings at the expense of a possible slight increase in breast cancer mortality. The cost-effectiveness of LCNB and NLBB was estimated using a microsimulation model. The sensitivity of LCNB (0.97) and resource use and costs of LCNB and NLBB were derived from a multicentre consecutive cohort study among 973 women who consented in getting LCNB and NLBB, if LCNB was negative. Sensitivity analyses were performed. Replacing NLBB with LCNB would result in approximately six more breast cancer deaths per year (in a target population of 2.1 million women), or in 1000 extra life-years lost from breast cancer (effect over 100 years). The total costs of management of breast cancer (3% discounted) are estimated at £4676 million with NLBB; introducing LCNB would save £13 million. The incremental cost-effectiveness ratio of continued NLBB vs LCNB would be £12 482 per additional life-year gained (3% discounted); incremental costs range from £-21 687 (low threshold for breast biopsy) to £74 378 (high sensitivity of LCNB).

Interobserver variability between general and expert pathologists during the histopathological assessment of large-core needle and open biopsies of non-palpable breast lesions

The purpose of this study was to assess whether general pathologists are able to make as accurate and reproducible a diagnosis on large-core needle biopsies as on open breast biopsy specimens. A total of 688 patients underwent a stereotactic large-core (14G) needle biopsy and subsequent surgical excision of 718 non-palpable breast lesions. Forty-two pathologists from 10 departments of pathology (generalists) made a diagnosis on both the needle and open biopsy specimens. Afterwards, three pathologists and two radiologists with extensive experience in breast pathology (experts) diagnosed all of the biopsy specimens. The general pathologists made a similar histological diagnosis as the experts in 632 (88%) of the needle biopsies and 649 (90%) of the open biopsy specimens. Accordingly, the interobserver agreement for the diagnosis of large-core needle biopsies between the general and experts pathologists was excellent (kappa 0.83) and not significantly different from the interobserver agreement for the diagnosis of open breast biopsies (kappa 0.86). However, many inconsistencies were observed in the category of borderline lesions: only 24% of the large-core needle biopsies and 43% of the open biopsies with an expert diagnosis of ‘borderline’ were diagnosed similarly by the general pathologists. Additionally, the risk of benign/malignant inconsistencies between general pathologists and experts was approximately 1 in 55 for both needle and open biopsies.

Stereotactic large core needle biopsy for all nonpalpable breast lesions?

Stereotactic large-core needle biopsy (SLCNB) is a minimally invasive method for histological diagnosis of nonpalpable breast disease. We studied differences in cancer prevalence between a group of women referred through the national screening program and a non-screening group, and assessed whether the validity of SLCNB differed between these groups. A group of non-selective, consecutive patients presenting with a nonpalpable mammographic lesion, who participated in a recently conducted multicenter study regarding the accuracy of SLCNB in The Netherlands, were the basis for this study. Prevalence of carcinoma, predictive value of a benign diagnosis, sensitivity, and specificity rate of SLCNB were compared between the two groups. Of the 1029 lesions in 972 patients included, 858 were evaluable. In 850/858 lesions (99.1%) the reason for referral was clear. The prevalence of cancer in the screening group (n = 511 lesions) was 64.0% (95%CI 59.8-68.2), versus 49.6% in the non-screening group (n = 339) (95%CI 44.2-54.9). Respective predictive values of a benign diagnosis on SLCNB were 97.0 versus 94.8% (non-significant). The sensitivity rates of SLCNB were 98.5% (screening; 95%CI 96.5-99.5) versus 95.2% (non-screening; 95%CI 90.8-97.9). Specificity rates were 97.8 (95%CI 94.5-99.4) and 99.4% (95%CI 96.8-100), respectively. Despite a significant difference in the prevalence of carcinoma, the accuracy of SLCNB did not show a statistically significant difference between both patient groups. Therefore, SLCNB appears accurate in diagnosing nonpalpable breast lesions both in screening and non-screening patient groups.

Diagnosing non-palpable breast disease: short-term impact on quality of life of large-core needle biopsy versus open breast biopsy

Background: One of the alleged advantages of stereotactic large-core needle biopsy of non-palpable breast lesions is that it entails less inconvenience for the patient. In this prospective study, the quality of life of patients undergoing large-core needle biopsy was compared with that of patients undergoing open breast biopsy prior to learning the definitive diagnosis. Methods: Thirty patients with non-palpable breast lesions underwent stereotactic large-core needle biopsy as initial diagnostic procedure (needle biopsy group). Quality of life as perceived by these patients was compared with that of 27 patients who underwent open breast biopsy as initial diagnostic procedure (control group). Both groups completed quality of life questionnaires (EuroQol and SF-36) 1 day before and 4 days after the diagnostic intervention. Results: One day before the diagnostic procedure, the overall estimate for quality of life (measured with the EuroQol) was slightly higher in the needle biopsy group than in the control group (73 versus 69 resp.). Four days after the diagnostic procedure, the quality of life score remained approximately unchanged in the needle biopsy group, but was reduced in the control group (71 versus 61 resp.). Results of the SF-36 questionnaire demonstrated that patients in the needle biopsy group had higher quality of life scores on physical functioning, physical performance, pain and social performance after the diagnostic intervention. Conclusion: Stereotactic large-core needle biopsy seems to affect quality of life to a lesser extent than open breast biopsy. This difference is mainly attributable to a reduction of physical discomfort and pain.

Risk factors for cancellation of stereotactic large core needle biopsy on a prone biopsy table.

Among patients undergoing stereotactic needle biopsy of the breast on a prone biopsy table, a substantial proportion of planned procedures are terminated prematurely. This study was undertaken to identify risk factors for cancellation of these procedures and to derive a clinical rule for predicting cancellation. Risk factors for cancellation were assessed in a group of 476 consecutive patients with non-palpable lesions planned for large core needle biopsy. 64 (13%) of these planned procedures were cancelled. Multivariate regression analysis was applied to identify independent risk factors for cancellation. Validation took place by applying the logistic rule on a validation set, including 5 cancelled and 35 successful biopsy procedures. Mammograms that were difficult to interpret owing to extremely dense breast tissue, axillary location of the non-palpable lesion, body mass index below 20, less than 15 mm distance from the lesion to the chest wall or the presence of more than one non-palpable lesion were identified as independent risk factors. The logistic rule discriminated patients with successful and cancelled biopsy procedures with a receiver operator characteristic (ROC) area of 0.72. In the validation set, the area under the ROC curve was 0.92. The prediction rule, based on mammographic and clinical findings, discriminated patients with successful and cancelled needle biopsy procedures to a certain extent. The risk of cancellation of the stereotacic biopsy procedure is considerable in cases of very dense breast tissue or the presence of multiple risk factors.

Impact of stereotactic large-core needle biopsy on diagnosis and surgical treatment of non-palpable breast cancer

Introduction Stereotactic large-core needle biopsy is increasingly replacing needle-localized breast biopsy for the diagnosis of nonpalpable breast disease. In this prospective study, the impact of the introduction of this technique on diagnosis and surgical treatment of nonpalpable breast cancer was assessed in two hospitals in The Netherlands. Patients and methods A total of 84 patients with nonpalpable breast cancer, diagnosed by means of stereotactic large-core needle biopsy (needle biopsy group) were compared with 80 patients diagnosed with nonpalpable breast cancer before the introduction of large-core needle biopsy. These patients were diagnosed by means of needle-localized open breast biopsy (control group). Clinical outcome measures evaluated included: duration of diagnostic and therapeutic intervals and number of surgical procedures required for complete surgical treatment. Subgroup analysis was performed for the category of microcalcifications without tissue distortion.Results For the needle biopsy group, the median interval between initial referral to the surgeon and the availability of histological diagnosis was 9 days and the interval between initial referral and complete surgical treatment was 31 days. These intervals were significantly longer for the control group (19 days and 44 days respectively); 75% of patients in the needle biopsy group were treated in a single step surgical procedure compared to 16% of the patients in the control group (67vs 25% respectively for the subgroup). The mean number of surgical procedures required to complete surgical treatment was 1.31 for needle biopsy group vs 1.91 for the open biopsy group (1.46 vs 1.84 for the subgroup).Conclusion Introduction of stereotactic large-core needle biopsy leads to a reduction of the time to diagnosis and the time to complete surgical treatment of nonpalpable breast cancer. It also reduces the number of surgical procedures required for complete surgical treatment of nonpalpable breast cancer. The benefits of large-core needle biopsy may also be anticipated for patients with microcalcifications without tissue distortion.