The comparison of efficacy and safety evaluation of vacuum-assisted Elite 10-G system and the traditional BARD 14-G core needle in breast diagnosis: an open-label, parallel, randomized controlled trial.

BACKGROUND: Vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) are both widely used methods in diagnosing breast lesions. We aimed to determine whether the Elite 10-gauge VAB achieves higher accuracy than the BARD spring-actuated 14-gauge CNB. MATERIALS AND METHODS: This was a phase 3, open-label, parallel, randomized controlled trial (NCT04612439). In total, 1470 patients with ultrasound (US)-visible breast lesions requiring breast biopsy were enrolled from April to July 2021 and randomized at a 1 : 1 ratio to undergo VAB or CNB. All patients underwent surgical excision after needle biopsy. The primary outcome was accuracy, defined as the proportion of patients who had a consistent qualitative diagnosis between the biopsy and surgical pathology results. The underestimation rate, false-negative rate and safety evaluations were the secondary endpoints. RESULTS: A total of 730 and 732 patients were evaluable for endpoints in the VAB and CNB groups, respectively. The accuracy of VAB surpassed that of CNB in the whole population (94.8 vs. 91.1%, P =0.009). The overall malignant underestimation rate was significantly lower in the VAB group than in the CNB group (21.4 vs. 30.9%, P =0.035). Additionally, significantly more false-negative events were noted in the CNB group (4.9 vs. 7.8%, P =0.037). In patients who presented with accompanying calcification, the accuracy of VAB surpassed that of CNB (93.2 vs. 88.3%, P =0.022). The potential superiority of VAB was indicated in patients with heterogeneous echo on US. CONCLUSIONS: In general, the 10-G VAB procedure is a reasonable alternative to the 14-G CNB procedure with higher accuracy. We recommend the use of VAB for lesions with accompanying calcification or heterogeneous echo on US.

CACA Guidelines for Holistic Integrative Management of Breast Cancer.

Purpose: Breast cancer is now the most common malignant tumor worldwide. About one-fourth of female cancer patients all over the world suffer from breast cancer. And about one in six female cancer deaths worldwide is caused by breast cancer. In terms of absolute numbers of cases and deaths, China ranks first in the world. The CACA Guidelines for Holistic Integrative Management of Breast Cancer were edited to help improve the diagnosis and comprehensive treatment in China. Methods: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to classify evidence and consensus. Results: The CACA Guidelines for Holistic Integrative Management of Breast Cancer include the epidemiology of breast cancer, breast cancer screening, breast cancer diagnosis, early breast cancer treatment, advanced breast cancer treatment, follow-up, rehabilitation, and traditional Chinese medicine treatment of breast cancer patients. Conclusion: We to standardize the diagnosis and treatment of breast cancer in China through the formulation of the CACA Guidelines.

Value of stereotactic 11-gauge vacuum-assisted breast biopsy in non-palpable suspicious calcifications: an eight-year single institution experience with 587 patients.

BACKGROUND: Vacuum-assisted breast biopsy (VABB) has been routinely recommended for stereotactic intervention in cases of isolate mammographically-detected calcifications. Herein we aimed to evaluate and compare the diagnostic consistency and accuracy of calcified and noncalcified specimens obtained from same sites of sampling on mammography-visible calcifications. In addition, we presented the biopsy procedure and retrospectively evaluated the usefulness of VABB as well as the complications of this technique over an eight-year experience in our centre. METHODS: This single-institution observational cohort study included 587 patients referred for stereotactic 11-gauge VABB of 594 mammographically-detected calcifications between January 2010 and December 2018. The rate of histopathological underestimation, the false negative, the diagnostic consistency and accuracy between calcified and noncalcified specimens of VABB were comprehensively evaluated based on the surveillance data and final histopathological result of the surgical specimens. RESULTS: In total, 594 biopsy procedures were performed in 587 patients (mean age 46 years, range, 21-80 years). The average number of biopsy specimens was 14.7 (range, 9-21) per lesion. VABB pathological results revealed 471 (79.3%) benign, 39 (6.6%) high-risk, and 84 (14.1%) malignant cases. The diagnostic inconsistency between calcified and noncalcified specimens was 14.6% (105/123) for high-risk and malignant lesions. Furthermore, calcified specimens exhibited higher diagnostic accuracy of malignant lesion as compared with the noncalcified specimens (97.7% versus 82.6%, respectively). Underestimation rate for high-risk lesions and in situ carcinoma was 5.1% and 54.1%, respectively, along with a false negative rate of 6.25%. In addition, mild complications were reported with high patient tolerance. CONCLUSIONS: Stereotactic 11G-VABB might be preferred for the investigation of non-palpable mammographically-detected calcifications in terms of accuracy and safety profile. The high prevalence of diagnostic discordance between the specimens with and without calcifications revealed a higher value of calcified specimens in diagnosing high-risk and malignant calcifications.

The use of a second core needle biopsy to predict response to neoadjuvant chemotherapy in breast cancer patients, especially in the HER2-positive population.

BACKGROUND: Early and accurate assessment of the response to neoadjuvant chemotherapy offers the potential to optimize treatment to obtain improved responses. We aimed to predict the response to neoadjuvant chemotherapy using a second breast core needle biopsy after a median of 2 cycles of neoadjuvant chemotherapy. METHODS: We evaluated 805 consecutive patients undergoing neoadjuvant chemotherapy who had a second core needle biopsy between 2013 and 2017. The second core needle biopsy was performed after a median of 2 cycles of neoadjuvant chemotherapy. Pathologic response was evaluated after completion of all the chemotherapy cycles. Diagnostic values were compared and evaluated between the second core needle biopsy and contrast-enhanced magnetic resonance imaging in both the whole and the human epidermal growth factor receptor 2-positive populations. RESULTS: Overall, 653 patients were eligible and underwent a median of 6 chemotherapy cycles. The second core needle biopsy predicted residual breast cancer earlier than the final contrast-enhanced magnetic resonance imaging, with a greater positive predictive value (positive predictive value: 0.856 vs 0.802, P = .028). Multivariate analysis revealed that a estrogen receptor status, human epidermal growth factor receptor 2 positivity, findings on the final contrast-enhanced magnetic resonance imaging and the pathologic findings of the second core needle biopsy pathology were independent predictive factors for treatment response. The superiority in diagnostic value of a second core needle biopsy pathology in human epidermal growth factor receptor 2-positive patients was consistent with that in the whole population, with a positive predictive value of 0.785 (95% confidence interval: 0.707-0.847). The second core needle biopsy predicted the response to neoadjuvant chemotherapy as early as after 2 cycles, but the accuracy increased from 0.744 to 0.872 if the procedure was performed after more cycles (P = .002). CONCLUSION: The second core needle biopsy predicted the response to neoadjuvant chemotherapy after 2 cycles quite well, especially in human epidermal growth factor receptor 2-positive patients. The ability of the prediction of response improved if the second biopsy was performed after 3 or 4 cycles.

Development and Validation of a Simple-to-Use Nomogram for Predicting the Upgrade of Atypical Ductal Hyperplasia on Core Needle Biopsy in Ultrasound-Detected Breast Lesions.

BACKGROUND: The rate of carcinoma upgrade for atypical ductal hyperplasia (ADH) diagnosed on core needle biopsy (CNB) is variable on open excision. The purpose of the present study was to develop and validate a simple-to-use nomogram for predicting the upgrade of ADH diagnosed with ultrasound (US)-guided core needle biopsy in patients with US-detected breast lesions. METHODS: Two retrospective sets, the training set (n = 401) and the validation set (n = 186), from Fudan University Shanghai Cancer Center between January 2014 and December 2019 were retrospectively analyzed. Clinicopathological and US features were selected using univariate and multivariable logistic regression, and the significant features were incorporated to build a nomogram model. Model discrimination and calibration were assessed in the training set and validation set. RESULTS: Of the 587 ADH biopsies, 67.7% (training set: 267/401, 66.6%; validation set: 128/186, 68.8%) were upgraded to cancers. In the multivariable analysis, the risk factors were age [odds ratio (OR) 2.739, 95% confidence interval (CI): 1.525-5.672], mass palpation (OR 3.008, 95% CI: 1.624-5.672), calcifications on US (OR 4.752, 95% CI: 2.569-9.276), ADH extent (OR 3.150, 95% CI: 1.951-5.155), and suspected malignancy (OR 4.162, CI: 2.289-7.980). The model showed good discrimination, with an area under curve (AUC) of 0.783 (95% CI: 0.736-0.831), and good calibration (p = 0.543). The application of the nomogram in the validation set still had good discrimination (AUC = 0.753, 95% CI: 0.666-0.841) and calibration (p = 0.565). Instead of surgical excision of all ADHs, if those categorized with the model to be at low risk for upgrade were surveillanced and the remainder were excised, then 63.7% (37/58) of surgeries of benign lesions could have been avoided and 78.1% (100/128) malignant lesions could be treated in time. CONCLUSIONS: This study developed a simple-to-use nomogram by incorporating clinicopathological and US features with the overarching goal of predicting the probability of upgrade in women with ADH. The nomogram could be expected to decrease unnecessary surgery by nearly two-third and to identify most of the malignant lesions, helping guide clinical decision making with regard to surveillance versus surgical excision of ADH lesions.

Intraoperative Touch Imprint Cytology in Targeted Axillary Dissection After Neoadjuvant Chemotherapy for Breast Cancer Patients with Initial Axillary Metastasis.

BACKGROUND: For breast cancer patients, a false-negative rate lower than 10% can be achieved if targeted axillary dissection (TAD) is performed, which includes the excision of both biopsy-proven positive lymph nodes (BxLNs) and sentinel lymph nodes (SLNs). However, little evidence exists on the accuracy of intraoperative touch imprint cytology (ITPC) applied in TAD after neoadjuvant chemotherapy (NAC) for breast cancer patients with initial axillary metastasis. This study aimed to investigate the accuracy of ITPC in TAD after NAC. METHODS: Breast cancer patients with biopsy-confirmed nodal metastasis were prospectively enrolled in the study. After completion of NAC, all patients underwent TAD followed by axillary lymph node dissection (ALND). Then ITPC was performed to evaluate BxLNs and SLNs. The accuracy of TAD and ITPC was calculated in comparison with hematoxylin and eosin (H&E) staining of ALNs. The results of ITPC during 6 months at our center in the adjuvant setting were used for comparison . RESULTS: Overall, the false-negative rate of TAD was 10.8%. In a test with 92 patients, ITPC had an accuracy of 92.4%, a sensitivity of 87.9%, and a specificity of 94.9%. In the non-NAC group, ITPC showed similar accuracy (91.2%) and specificity (97.9%) but significantly lower sensitivity (68.9%; P = 0.03). CONCLUSIONS: The use of ITPC was feasible for TAD among breast cancer patients with biopsy-confirmed axillary metastasis who were treated with NAC. All the misses in the ITPC involved patients with micrometastases or isolated tumor cells. Use of ITPC can help decrease the number of second operations for patients with residual disease in ALNs after NAC.

Changing attitudes toward needle biopsies of breast cancer in Shanghai: experience and current status over the past 8 years.

Diagnostic patterns in breast cancer have greatly changed over the past few decades, and core needle biopsy (CNB) has become a reliable procedure for detecting breast cancer without invasive surgery. To estimate the changing diagnostic patterns of breast cancer in urban Shanghai, 11,947 women with breast lesions detected by preoperative needle biopsy between January 1995 and December 2012 were selected from the Shanghai Cancer Data base, which integrates information from approximately 50% of breast cancer patients in Shanghai. The CNB procedure uses an automated prone unit, biopsy gun, and 14-gauge needles under freehand or ultrasound guidance and was performed by experienced radiologists and surgeons specializing in needle biopsies. Diagnosis and classification for each patient were independently evaluated by pathologists. Over the indicated 8-year period, biopsy type consisted of 11,947 ultrasound-guided core needle biopsies (UCNBs), 2,015 ultrasound-guided vacuum-assisted biopsies (UVABs), and 654 stereotactic X-ray-guided vacuum-assisted biopsies (XVABs). For all the 11,947 women included in this study, image-guided needle biopsy was the initial diagnostic procedure. Approximately 81.0% of biopsied samples were histopathologically determined to be malignant lesions, 5.5% were determined to be high-risk lesions, and 13.5% were determined to be benign lesions. The number of patients choosing UCNB increased at the greatest rate, and UCNB has become a standard procedure for histodiagnosis because it is inexpensive, convenient, and accurate. The overall false-negative rate of CNB was 1.7%, and the specific false-negative rates for UCNB, UVAB, and XVAB, were 1.7%, 0%, and 0%, respectively. This study suggests that the use of preoperative needle biopsy as the initial breast cancer diagnostic procedure is acceptable in urban Shanghai. Preoperative needle biopsy is now a standard procedure in the Shanghai Cancer Center because it may reduce the number of surgeries needed to treat breast cancer.

Association between a novel polymorphism (rs2046210) of the 6q25.1 locus and breast cancer risk.

The novel single nucleotide polymorphism (SNP), rs2046210, was identified in a breast cancer genome-wide association study of Chinese women. The SNP is located on 6q25.1 in proximity to the C6orf97 and estrogen receptor 1 (ESR1) genes. To replicate this susceptibility, a number of case-control studies have been conducted in various populations. However, some results were inconclusive due to the restriction of sample size or ethnic diversity. To derive a more precise estimation of the relationship between rs2046210 and genetic risk of breast cancer, we performed the first comprehensive meta-analysis which included 121,494 cases and 119,295 controls from 14 published studies. Overall, significant increased risk between the A allele of rs2046210 and breast cancer was found in the total population (allelic model: OR = 1.16, 95 %CI = 1.11-1.21, P heterogeneity < 0.0001; dominant model: OR = 1.22, 95 %CI = 1.14-1.29, P heterogeneity < 0.0001; recessive model: OR = 1.21, 95 %CI = 1.13-1.29, P heterogeneity < 0.0001). When stratified by ethnicity, significant elevated risk was found among Europeans and Asians. However, no significant association was detected in African descent population. In the subgroup analyses according to estrogen receptor (ER) positive/negative status, our results suggested that this polymorphism tended to increase breast cancer risk in ER negative tumors by a greater magnitude compared to ER positive tumors. In addition, our subgroup analysis also indicated that this SNP was significantly associated with the risk of breast cancer for BRCA1 mutation carriers and exhibited weaker association with the risk for BRCA2 mutation carriers. Substantial heterogeneity was present in the overall analysis, but largely disappeared after stratification by ethnicity. Despite some limitations, this meta-analysis demonstrates that the rs2046210 polymorphism may be a risk factor associated with increased breast cancer risk. However, the association varies in different ethnicities.