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BackgroundAbout 40 % of women with breast cancer achieve a pathologic complete response in the breast after neoadjuvant systemic treatment (NST). To identify these women, vacuum-assisted biopsy (VAB) was evaluated to facilitate risk-adaptive surgery. In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%). This analysis aimed to improve the ability of VAB to exclude residual cancer in the breast reliably by identifying key characteristics of false-negative cases.MethodsUni- and multivariable logistic regressions were performed using data of a prospective multicenter trial (n= 398) to identify patient and VAB characteristics associated with false-negative cases (no residual cancer in the VAB but in the surgical specimen). Based on these findings FNR was exploratively re-calculated.ResultsIn the multivariable analysis, a false-negative VAB result was significantly associated with accompanying ductal carcinoma in situ (DCIS) in the initial diagnostic biopsy [odds ratio (OR), 3.94;p p = 0.066), and age (OR, 1.03;p = 0.034). Exclusion of women with DCIS or multicentric disease (n = 114) and classication of VABs that did not remove the clip marker as uncertain representative VABs decreased the FNR to 2.9% (3/104).ConclusionFor patients without accompanying DCIS or multicentric disease, performing a distinct representative VAB (i.e., removing a well-placed clip marker) after NST suggests that VAB might reliably exclude residual cancer in the breast without surgery. This evidence will inform the design of future trials evaluating risk-adaptive surgery for exceptional responders to NST.

In breast cancer, completion axillary lymph node dissection (cALND) was previously recommended for patients with at least one tumour-affected sentinel lymph node (SLN). Several prospective trials predominantly in patients undergoing breast-conserving surgery showed no benefit and increased arm morbidity with this procedure. We report the influence of these trials on clinical practice of patients undergoing mastectomy. We analysed prospectively collected data from patients with primary invasive breast cancer treated at German breast cancer units between January 2008 and December 2015. Time trends of cALND rates were analysed in patients undergoing mastectomy for T1/2N0M0 breast cancer with one or two tumour-involved SLNs. Multivariable logistic regression was used to determine factors influencing the decision not to perform cALND. Among the entire study cohort of 166,074 patients treated at 179 breast cancer units, 4093 patients (2%) had T1/2N0M0 breast cancer with one or two tumour-involved SLNs and underwent mastectomy. cALND rates decreased from 89.9% in 2010 to 55.5% in 2015 (p

Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.

The objective of this study was to analyze heterogeneous responses of axillary lymph node metastasis to neoadjuvant chemotherapy and to determine to what extent they differ between tumor subtypes (TN, HER2+, HR+/HER2−). This retrospective, monocenter study included 72 consecutive, histologically node-positive breast cancers (cT1–4 cN1–3 cM0) diagnosed in the period from January 2015 to December 2016, who had received axillary lymph node dissection following neoadjuvant chemotherapy. All individual lymph node specimens were re-evaluated for the presence of tumor cells and chemotherapy effects to assess their response to neoadjuvant chemotherapy on an individual lymph node level according to the Sataloff classification. Heterogeneous axillary responses to neoadjuvant chemotherapy occurred in 47.2% of the included 72 patients. The partial response rate was significantly higher in HR+/HER2− tumors (74.2%) than in TN (28.6%) and HER2+ tumors (25.0%) (p

To explore whether patients after a reexcision due to involved or close margins have the same risk of local recurrence (LR) than those after a one-step breast-conserving surgery (BCS); to learn whether the presence of residual cancer in the reexcision specimen influences the probability of LR. We reviewed demographic, clinical, radiologic, and pathologic records of a cohort of women diagnosed with invasive cancer or carcinoma-in situ who underwent BCS surgery as final surgical treatment between January 1, 2003, and December 31, 2011. Univariable and multivariable Cox regression analyses were used to evaluate influencing factors of LR. A total of 2657 patients were eligible for inclusion onto this study. LR was observed in 67 patients (2.5 %) after a median follow-up of 52 months. Reexcision surgery was performed in 486 patients (18.3 %). The 5-year LR-free survival rate was 94.5 % in the reexcision group and 98.0 % in the group with one-step BCS surgery (p

This study evaluated breast imaging procedures for predicting pathologic complete response (pCR = ypT0) after neoadjuvant chemotherapy (NACT) for breast cancer to challenge surgery as a diagnostic procedure after NACT. This retrospective, exploratory, monocenter study included 150 invasive breast cancers treated by NACT. The patients received magnetic resonance imaging (MRI), mammography (MGR), and ultrasound (US). The results were classified in three response subgroups according to response evaluation criteria in solid tumors. To incorporate specific features of MRI and MGR, an additional category [clinical near complete response (near-cCR)] was defined. Residual cancer in imaging and pathology was defined as a positive result. Negative predictive values (NPVs), false-negative rates (FNRs), and false-positive rates (FPRs) of all imaging procedures were analyzed for the whole cohort and for triple-negative (TN), HER2-positive (HER2+), and HER2-negative/hormone-receptor-positive (HER2−/HR+) cancers, respectively. In 46 cases (31 %), pCR (ypT0) was achieved. Clinical complete response (cCR) and near-cCR showed nearly the same NPVs and FNRs. The NPV was highest with 61 % for near-cCR in MRI and lowest with 44 % for near-cCR in MGR for the whole cohort. The FNRs ranged from 4 to 25 % according to different imaging methods. The MRI performance seemed to be superior, especially in TN cancers (NPV 94 %; FNR 5 %). The lowest FPR was 10 % in MRI, and the highest FPR was 44 % in US. Neither MRI nor MGR or US can diagnose a pCR (ypT0) with sufficient accuracy to replace pathologic diagnosis of the surgical excision specimen.

Disseminated tumor cells (DTC) in the bone marrow (BM) of primary breast cancer (BC) patients are a promising surrogate marker of micrometastatic spread and an independent predictor of poor prognosis for disease-free survival (DFS) and overall survival (OS). The present study aims to analyze DTCs as an independent prognostic factor for DFS/OS in tumor biology and bisphosphonate treatment. A total of 504 patients with operable primary BC and a median observation time of 72.3 months [lower quartile (LQ) 58.1; upper quartile (UQ) 82.8] have been included. DTCs were detected via immunohistochemistry as MUC-1 positive cells in the BM of 59.13 % (298 of 504) of the patients. The immunophenotyping of cancer cells was achieved immunohistochemically as well. For luminal A/B carcinoma patients, we observed a significant benefit of BM DTC negativity with respect to DFS (luminal A, P = 0.0498; luminal B, P = 0.0224). In triple-negative patients, DTC-negative BM was associated with a longer OS (P = 0.0326). In a multivariate Cox survival analysis relating to DFS and OS, the DTC status was identified as an independent prognostic factor for DFS in luminal A/B BC (P = 0.0071). A multivariate Cox survival analysis among DTC-positive patients with luminal immunophenotype showed bisphosphonate application (P = 0.0326) to be an independent prognostic factor for DFS. The findings of our multivariate analyses reveal BM DTC positivity as an independent risk factor for DFS particularly in luminal A/B BC patients. This might be a novel criterion for the identification of candidates most likely to benefit from additional adjuvant therapy possibly including bisphosphonates.

Analysis of mastectomy rates in breast cancer patients diagnosed between 2006 and 2010 in Germany with focus on impact of breast magnetic resonance imaging (MRI), immediate breast reconstruction (IBR) rates, and hospital volume as possible influencing factors of mastectomy rates. Data of a voluntary monitored benchmarking project were used to evaluate mastectomy trends across time in an unselected cohort of breast cancer patients. We used univariate and multivariate logistic regression analysis to identify predictive factors of mastectomy. A total of 142.863 cases were included into the analysis. There was an overall decrease of 5.9 % (95 % confidence interval 5.1–6.7) in mastectomy trend from 36.5 % in 2006 to 30.6 % in 2010 (P

Reexcision is a clinically relevant aspect of oncological breast conservation surgery. The influence of reexcision on aesthetic outcome is described differently in the literature. Our aim was to analyze this question in a well-defined cohort with standardized study instruments. A total of 439 patients from a prospectively followed cohort were included in this analysis. Aesthetic results were assessed by the Breast Cancer Treatment Outcome Scale (BCTOS) aesthetic status. Dates of assessments were shortly after surgical interventions and before surgery. Group comparison was performed between patients with reexcisions (80 cases; 18%) and patients without reexcision (359 cases; 82%). We considered variables of differing distribution between the two groups that could hypothetically influence BCTOS aesthetic status in a nonparametric analysis of covariance (ANCOVA). The aesthetic status of patients with reexcisions was found to be significantly worse than for patients with a single breast conservation surgery (P

To analyze the relationship of objective and subjective evaluation tools of breast aesthetics, we compare the results of the BCCT.core (breast cancer conservative treatment.cosmetic results) software, a semiautomated objective symmetry evaluation tool, with those of the Aesthetic Status of the BCTOS (Breast Cancer Treatment Outcome Scale) patient questionnaire.We included 128 patients with one-sided, primary breast cancer, treated conservatively in a prospective, exploratory study in order to assess the inter-rater reliability of the BCCT.core and the agreement between the BCCT.core and the BCTOS preoperatively, shortly and 1 year after surgery. Therefore, we use agreement rates, multiple (mk), and weighted (wk) kappa coefficients as statistical methods. Furthermore, we analyzed patient-, tumor-, and therapy-related variables as possible covariates to explain agreement.The inter-rater reliability for the semiautomated BCCT.core is very good with agreement rates up to 84% (mk = 0.80). The agreement rates of the BCCT.core and the BCTOS Aesthetic Status range between 35 and 44% subject to the different times of assessment (wk = 0.34 at best). Moreover, the patients judge their aesthetic outcome more positively than the software. None of the considered patient-, tumor-, and therapy-related covariates turned out to explain agreement.The BCCT.core is a reliable instrument that shows fair agreement with patient's perspective.

We analyzed the change of aesthetic outcome (AO) over time and explored factors characterizing poor AO after breast-conserving surgery (BCS).This prospective single-center cohort study included 849 patients preoperatively planned for BCS between September 2007 and December 2011. Long-term follow-up was made once in 2013. AO was measured by the Aesthetic Status (AS) of the Breast Cancer Treatment Outcome Scale questionnaire. Clinical, surgical, and pathologic variables were evaluated to identify predictors of poor AO. We applied single factor variance analyses and univariable logistic regression analyses for outcome analysis.The long-term follow-up rate in 2013 was 73 % (621 nonrecurrent with final BCS). A poor or fair AO was reported in 30 (4.8 %) and 98 (15.8 %) of these 621 patients, respectively. Single factor variance analysis showed a negative impact of higher specimen weight on AO (p 0.001). Univariable logistic regression analysis revealed the following risk factors for poor AO: radial breast incision [odds ratio (OR) 1.97], periareolar incision (OR 1.85), fishmouth-shaped incision with resection of the nipple-areola complex (OR 8.12), impaired wound healing (OR 3.14), and seroma (OR 2.16). No patient rating her AO as fair or poor shortly after BCS improved in the long-term follow-up.The incidence of poor AO is relatively rare but increases in the long-term follow-up. Patients experiencing poor AO after BCS are likely to remain unsatisfied with the outcome over time. Factors predicting unfavorable AO can assist preoperative planning with regards to the choice between simple breast conserving techniques or more complex oncoplastic procedures.

We evaluated whether a supplementary preoperative breast MRI in patients with invasive lobular breast cancer (ILC) has changed number and methods of primary and number of secondary surgical interventions.This was a retrospective controlled single-center analysis of 178 ILC patients. The 2 study groups consisted of 92 patients with breast MRI (MRI group) and of 86 patients without breast MRI (non-MRI group). We investigated the primary and final surgical procedures and factors that influenced the number of secondary surgical interventions.A total of 40 primary mastectomies (38%) have been performed in the MRI group, compared with 27 (30%) in the non-MRI group (P = .119).There have been more bilateral surgical interventions in the MRI group (14 vs 3 patients; P = .002). The 2 groups did not differ with respect to secondary surgery rates (P = .429). The MRI and non-MRI group were significantly different with respect to age and breast density (P = .003 and P = .002). Yet, both variables seemed not to influence secondary surgery rates (P = .516 and P = .788, respectively).The implementation of preoperative breast MRI tended to result in more primary mastectomies and bilateral surgeries and did not seem to decrease the secondary surgery rate.