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Presents guidelines of Standards, Options and Recommendations for nonmetastatic breast cancer. Pathological examination and classification of frozen sections of tumors; Investigation for the detection of metastatic disease; Histological classification of breast cancer.

Purpose: We evaluated the addition of breast magnetic resonance imaging (MRI) to standard radiologic evaluation on the re-intervention rate in women with ductal carcinoma in situ (DCIS) undergoing breast-conserving surgery., Patients and Methods: Women with biopsy-proven DCIS corresponding to a unifocal microcalcification cluster or a mass less than 30 mm were randomly assigned to undergo MRI or standard evaluation. The primary end point was the re-intervention rate for positive or close margins (< 2 mm) in the 6 months after randomization ( ClinicalTrials.gov identifier: NCT01112254)., Results: A total of 360 patients from 10 hospitals in France were included in the study. Of the 352 analyzable patients, 178 were randomly assigned to the MRI arm, and 174 were assigned to the control arm. In the intent-to-treat analysis, 82 of 345 patients with the assessable end point were reoperated for positive or close margins within 6 months, resulting in a re-intervention rate of 20% (35 of 173) in the MRI arm and 27% (47 of 172) in the control arm. The absolute difference of 7% (95% CI, -2% to 16%) corresponded to a relative reduction of 26% (stratified odds ratio, 0.68; 95% CI, 0.41 to 1.1; P = .13). When considering only the per-protocol population with an assessable end point, the difference was 9% (stratified odds ratio, 0.59; 95% CI, 0.35 to 1.0; P = .05). Total mastectomy rates were 18% (31 of 176) in the MRI arm and 17% (30 of 173) in the control arm (stratified P = .93). For 100 lesions seen on MRI, nonmass-like enhancement was more predominant (82%) than mass enhancement (20%). Nevertheless, no specific morphologic and kinetic parameters for DCIS were identified., Conclusion: The study did not show sufficient surgical improvement with the use of preoperative MRI to be clinically relevant in DCIS staging. However, this could be reconsidered with the improvement of new MRI sequences and new modalities in magnetic resonance techniques.

Introduction: The aim of this study was to examine changes in therapeutic practices for early breast cancer T0-2 N0 managed by upfront surgery and SLNB., Population: Between 1999 and 2012, 15.508 patients were treated. Four periods were determined: 1999-2003, 2004-2006, 2007-2009 and > 2009. Five tumor subtypes were defined according to hormonal receptors (HR) and Her2: Luminal A (HR + Her2- Grade 1-2), Her2 (Her2+ HR-), Triple-negative (HR- Her2-), Luminal B Her2- (HR + Her2- Grade 3), Luminal B Her2+ (HR + HER2+)., Methods: Rates of axillary lymph node dissection (ALND), adjuvant chemotherapy ± trastuzumab, endocrine treatment, mastectomy and post mastectomy radiotherapy (PMRT) were analyzed according to treatment periods with univariate and multivariate analysis. Overall and disease-free survivals were analyzed according to treatment periods adjusted for HR and then for tumor subtypes., Results: Rates of ALND, adjuvant chemotherapy and endocrine treatment varied significantly according to treatment periods, for HR positive and negative tumors. ALND rate decreased for all tumor subtypes with a decrease of adjuvant chemotherapy rate for Luminal A tumors and an increase for Luminal B Her2+ and Her2-tumors. Endocrine treatment rate decreased for Luminal A and increased for Luminal B Her2+ tumors. In multivariate analysis, these modifications with time remained significant. Mastectomy and PMRT rates increased. In multivariate analysis, overall and disease-free survivals increased during successive periods., Conclusion: A global therapeutic de-escalation in ALND and adjuvant systemic treatment, combined with an actual escalation in some specific subsets was demonstrated, but without negative impact on survival., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Purpose: Benefit of adjuvant trastuzumab-based chemotherapy for node-positive and/or >1 cm human epidermal growth factor receptor 2-positive (HER2+) breast carcinomas has been clearly demonstrated in randomized clinical trials. Yet, evidence that adjuvant chemotherapy with or without trastuzumab is effective in pT1abN0 HER2+ tumors is still limited. The primary objective of this study was to investigate the impact of adjuvant chemotherapy ± trastuzumab on outcome in this subpopulation., Patients and Methods: A total of 356 cases of pT1abN0M0 HER2 + breast cancers were retrospectively identified from a large cohort of 22,334 patients, including 1248 HER2+ patients who underwent primary surgery at 17 French centers, between December 1994 and January 2014. The primary end point was disease-free survival (DFS). A multivariate Cox model was built, including adjuvant chemotherapy, tumor size, hormone receptor status, and Scarff Bloom Richardson (SBR) grade., Results: A total of 138 cases (39%) were treated with trastuzumab-based chemotherapy, 29 (8%) with chemotherapy alone, and 189 (53%) received neither trastuzumab nor chemotherapy. Adjuvant chemotherapy ± trastuzumab was associated with a significant DFS benefit (3-year 99 vs. 90%, and 5-year 96 vs. 84%, Hazard ratio, HR 0.26 [0.10-0.67]; p = 0.003, logrank test) which was maintained in multivariate analysis (HR 0.19 [0.07-0.52]; p = 0.001). Metastasis-free survival was also increased (HR 0.25 [0.07-0.86]; p = 0.018, logrank test) at 3-year (99 vs. 95%) and 5-year (98 vs. 89%) censoring. Exploratory subgroup analysis found DFS benefit to be significant in hormone receptor-negative, hormone receptor-positive, and pT1b tumors, but not in pT1a tumors., Conclusions: Adjuvant chemotherapy ± trastuzumab is associated with a significantly reduced risk of recurrence in subcentimeter node-negative HER2+ breast cancers. Most of the benefit may be driven by pT1b tumors.

Background: To estimate the proportion of elderly patients (>70 years) with breast cancer eligible for an Exclusive IntraOperative RadioTherapy (E-IORT) and to evaluate their local recurrence-free survival rate., Methods: This retrospective study examining two cohorts focuses on patients over 70 years old: a multi-centric cohort of 1411 elderly patients and a mono-centric cohort of 592 elderly patients. All patients underwent conservative surgery followed by external radiotherapy for T0-T3 N0-N1 invasive breast cancer, between 1980 and 2008., Results: Within each cohort two groups were identified according to the inclusion criteria of the RIOP trial (R group) and TARGIT E study (T group). Each group was divided into two sub-groups, patients eligible (E) or non-eligible (nE) for IORT. The population of patients that were eligible in the TARGIT E study but not in the RIOP trial were also studied in both cohorts. The proportion of patients eligible for IORT was calculated, according to the eligibility criteria of each study. A comparison of the 5-year local or locoregional recurrence-free survival rate between eligible vs non-eligible patients was made. In both cohorts, the proportion of patients eligible according to the RIOP trial's eligibility criteria was 35.4 and 19.3%, and according to the TARGIT E study criteria was 60.9 and 45.3%. The 5-year locoregional recurrence-free survival rate was not significantly different between RE and RnE groups, TE and TnE groups. In both cohorts RE and (TE-RE) groups were not significantly different., Conclusions: Our results encourage further necessary studies to define and to extend the eligibility criteria for per operative exclusive radiotherapy.

Background: Omission of completion axillary lymph node dissection (ALND) is a standard practice in patients with breast cancer (BC) and negative sentinel nodes (SNs) but has shown insufficient evidence to be recommended in those with SN invasion., Methods: A retrospective analysis of a cohort of patients with BC and micrometastases (Mic) or isolated tumour cells (ITCs) in SN. Factors associated with ALND were identified, and patients with ALND were matched to patients without ALND. Overall survival (OS) and recurrence-free survival (RFS) were estimated in the overall population, in Mic and in ITC cohorts., Findings: Among 2009 patients analysed, 1390 and 619 had Mic and ITC in SN, respectively. Factors significantly associated with ALND were SN status, histological type, age, number of SN harvested and absence of adjuvant chemotherapy. After a median follow-up of 60.4 months, ALND omission was independently associated with reduced OS (hazard ratio [HR] 2.41, 90 confidence interval [CI] 1.36-4.27, p = 0.0102), but not with increased RFS (HR 1.21, 90 CI 0.74-2.0, p = 0.52) in the overall population. In matched patients, the increased risk of death in case of ALND omission was found only in the Mic cohort (HR 2.88, 90 CI 1.46-5.69), not in the ITC cohort. The risk of recurrence was also significantly increased in the subgroup of matched Mic patients (HR 1.56, 90 CI 0.90-2.73)., Interpretation: A separate analysis of Mic and ITC groups, matched for the determinants of ALND, suggested that patients with Mic had increased recurrence rates and shorter OS when ALND was not performed. Our results are consistent with those of previous studies for patients with ITC but not for those with Mic. Randomised controlled clinical trials are still warranted to show with a high level of evidence if ALND can be safely omitted in patients with micrometastatic disease in SN., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Triple-negative breast cancers (TNBCs) are the most deadly form of breast cancer (BC) subtypes. Axillary lymph node involvement (ALNI) has been described to be prognostic in BC taken as a whole, but its prognostic value in each subtype is unclear. We explored the prognostic impact of ALNI and especially of small size axillary metastases in early TNBCs., Methods: We analysed in this multicentre study all patients treated for early TNBC in 12 French cancer centres. We explored the correlation between clinicopathological data and ALNI, with a specific focus on the dichotomisation between macrometastases and occult metastases, which is defined as the presence of isolated tumour cells or micrometastases. The prognostic value of ALNI both in terms of disease-free survival (DFS) and overall survival (OS) was also explored., Results: We included 1237 TNBC patients. Five-year DFS and OS were 83.7% and 88.5%, respectively. The identified independent prognostic features for DFS were tumour size >20 mm (hazard ratio (HR)=1.86; 95% CI: 1.11-3.10, P=0.018), lymphovascular invasion (HR=1.69; 95% CI: 1.21-2.34, P=0.002) and ALNI both in case of macrometastases (HR=1.97; 95% CI: 1.38-2.81, P<0.0001) and occult metastases (HR=1.72; 95% CI: 1.1-2.71, P=0.019). DFS and OS were similar between tumours with occult metastases and macrometastases. Tumours presenting at least two pejorative features (out of ALNI, lymphovascular invasion and large tumour size) displayed a significantly poorer DFS in both the training set and validation set, independently of chemotherapy administration. Tumours with no more than one of the above-cited pejorative features had a 5-year OS of ⩾90% vs 70% for other cases (P<0.0001)., Conclusions: Axillary lymph node involvement is a key prognostic feature for early TNBC when isolated tumour cells were identified in lymph nodes. This impact is independent of chemotherapy use.

Purpose: Rapid diagnosis is a key issue in modern oncology, for which one-stop breast clinics are a model. We aimed to assess the diagnosis accuracy and procedure costs of a large-scale one-stop breast clinic., Patients and Methods: A total of 10,602 individuals with suspect breast lesions attended the Gustave Roussy's regional one-stop breast clinic between 2004 and 2012. The multidisciplinary clinic uses multimodal imaging together with ultrasonography-guided fine needle aspiration for masses and ultrasonography-guided and stereotactic biopsies as needed. Diagnostic accuracy was assessed by comparing one-stop diagnosis to the consolidated diagnosis obtained after surgery or biopsy or long-term monitoring. The medical cost per patient of the care pathway was assessed from patient-level data collected prospectively., Results: Sixty-nine percent of the patients had masses, while 31% had micro-calcifications or other non-mass lesions. In 75% of the cases (87% of masses), an exact diagnosis could be given on the same day. In the base-case analysis (i.e. considering only benign and malignant lesions at one-stop and at consolidated diagnoses), the sensitivity of the one-stop clinic was 98.4%, specificity 99.8%, positive and negative predictive values 99.7% and 99.0%. In the sensitivity analysis (reclassification of suspect, atypical and undetermined lesions), diagnostic sensitivity varied from 90.3% to 98.5% and specificity varied from 94.3% to 99.8%. The mean medical cost per patient of one-stop diagnostic procedure was €420., Conclusions: One-stop breast clinic can provide timely and cost-efficient delivery of highly accurate diagnoses and serve as models of care for multiple settings, including rapid screening-linked diagnosis., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Purpose: Controversy exists about the prognosis of breast cancer in young women. Our objective was to describe clinicopathological and prognostic features to improve adjuvant treatment indications., Methods: We conducted a retrospective multi centre study including fifteen French hospitals. Disease-free survival's data, clinical and pathological criteria were collected., Results: 5815 patients were included, 15.6% of them where between 35 and 40 years old and 8.7% below 35. In 94% of the cases, a palpable masse was found in patients ≤35 years old. Triple negative and HER2 tumors were predominantly found in patients ≤35 (22.2% and 22.1%, p < 0.01). A young age ≤40 years (p < 0.001; hazard ratio [HR]: 2.05; 95% confidence limit [CL]: 1.60-2.63) or ≤35 years (p < 0.001; [HR]: 3.86; 95% [CL]: 2.69-5.53) impacted on the indication of chemotherapy. Age ≤35 (p < 0.001; [HR]: 2.01; 95% [CL]: 1.36-2.95) was a significantly negative factor on disease-free survival. Chemotherapy (p < 0.006; [HR]: 0.6; 95% [CL]: 0.40-0.86) and positive hormone receptor status (p < 0.001; [HR]: 0.6; 95% [CL]: 0.54-0.79) appeared to be protector factors. Patients under 36, had a significantly higher rate of local recurrence and distant metastasis compared to patients >35-40 (21.5 vs. 15.4% and 21.8 vs. 12.6%, p < 0.01)., Conclusion: Young women present a different distribution of molecular phenotypes with more luminal B and triple negative tumors with a higher grade and more lymph node involvement. A young age, must be taken as a pejorative prognostic factor and must play a part in indication of adjuvant therapy., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Objective: The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection., Setting: This prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres., Participants: All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure., Interventions: Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner., Primary and Secondary Outcome Measures: The primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph., Results: Ninety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia., Conclusions: With this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised., Trial Registration: ClinicalTrials.gov NCT01356862.

Background: The rate of axillary recurrence (AR) after sentinel lymph node biopsy is usually low but few studies investigated its impact on survival. Our aim was to determine the rate and predictive factors of AR in a large cohort of breast cancer patients and its impact on survival., Patients and Methods: From 1999 to 2013, 14,095 patients who underwent surgery for clinically N0 previously untreated breast cancer and had sentinel lymph node biopsy were analysed. A simplified score predictive of AR was established., Results: Median follow-up was 55.2 months. AR was observed in 0.51% of cases, with a median time to onset of 43.4 months. In multivariate analysis, the occurrence of AR was significantly correlated with grade 2 or 3 disease, absence of radiotherapy and tumour subtype (hormonal receptor [HR]- / human estrogen receptor [HER]+). AR rates were 1% for triple-negative tumours, 2.8% for HER2-positive tumours, 0.4% for luminal A tumours, 0.9% for HER2-negative luminal B tumours, and 0.5% for HER2-positive luminal B tumours. A simplified score predictive of the occurrence of AR was established. Patients could be divided into three different score groups (p < 0.0001). In multivariate analysis, overall survival was significantly lower in cases of AR (p < 0.0001), age >50, lymphovascular invasion, grade 3 disease, sentinel node (SN) macrometastases, tumour size >20 mm, absence of chemotherapy and triple-negative phenotype. Survival in patients with AR was significantly lower in case of early-onset (2 years) AR (p = 0.017)., Conclusions: Isolated AR is more common in Her2-positive/HR-negative triple-negative tumours with a more severe prognosis in triple-negative and Her2-positive/HR-negative tumours, and represents an independent adverse factor justifying an indication for systemic treatment for AR treatment. However, the benefit of any systemic treatment remains to be proven., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Objective: We aimed at examining the potential benefits of blue dye in sentinel node biopsy (SNB) in comparison with its proven drawbacks., Patients and Methods: In 2007, 203 T1 primary breast carcinomas had been operated on in our institute. The patients had undergone a lumpectomy and SNB. Sentinel node (SN) detection was exclusively isotopic (ISO) in 77 patients and performed with blue dye combined with a radioactive isotope (COMBI) in 126 patients. We compared the number of SNs and the rate of SN positivity in both groups., Results: The detection rate was 99% in both groups: 76/77 in the ISO group and 125/126 in the COMBI group. The mean number of SNs was 2.14 and 1.91 in the ISO group and the COMBI group, respectively (difference not significant (NS)). SN positivity was found in 26.1% and 24.6% in the ISO group and the COMBI group, respectively (NS). Only 1 SN had been removed in 26% of the patients in the ISO group versus 45.2% of the patients in the COMBI group (p = 0.004). No significant differences were observed in the tumor characteristics., Conclusion: The systematic use of patent blue dye combined with isotopic detection does not appear to increase the overall performance of the SNB technique in this retrospective study.

Background: When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The primary aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients. The secondary aim was to determine DCIS factors associated with microinvasion or invasion., Methods: The SLN procedure was performed during mastectomy, and for positive SLN an ALND was performed during the same intervention. A tissue microarray containing DCIS lesions from the mastectomy specimens was subsequently performed., Results: From May 2008 to December 2010, 228 patients were enrolled from 14 French cancer centers, including 192 eligible patients with pure DCIS on VAB and successful SLN procedures. ALND was avoided for 51 [67 %; 95 % confidence interval (CI), 56-77 %] of all the patients who had microinvasive DCIS or DCIS associated with invasive carcinoma at mastectomy and a negative SLN. Of the 192 patients, 76 (39 %) with VAB-diagnosed DCIS were upgraded after mastectomy to micro (n = 20) or invasive disease (n = 56). The rate of positive SLN for patients with DCIS on VAB was 14 %. High nuclear grade of DCIS was associated with greater risk of microinvasion and invasion, and HER2-amplified DCIS was associated with greater risk of invasion., Conclusions: Underestimation of invasive components is high when DCIS is diagnosed by VAB in patients undergoing mastectomy. Upfront SLN for patients with VAB-diagnosed extensive DCIS avoids unnecessary ALND for two-thirds of patients with micro or invasive disease on mastectomy.

Objectives: To assess the prognostic factors of T1 and T2 infiltrating lobular breast cancers, and to investigate predictive factors of axillary lymph node involvement., Methods: This is a retrospective multicentric study, conducted from 1999 to 2008, among 13 french centers. All data concerning patients with breast cancer who underwent a primary surgical treatment including a sentinel lymph node procedure have been collected (tumors was stage T1 or T2). Patients underwent partial or radical mastectomy. Axillary lymph node dissection was done systematically (at the time of sentinel procedure evaluation), or in case of sentinel lymph node involvement. Among all the 8100 patients, 940 cases of lobular infiltrating tumors were extracted. Univariate analysis was done to identify significant prognosis factors, and then a Cox regression was applied. Analysis interested factors that improved disease free survival, overall survival and factors that influenced the chemotherapy indication. Different factors that may be related with lymph node involvement have been tested with univariate than multivariate analysis, to highlight predictive factors of axillary involvement., Results: Median age was 60 years (27-89). Most of patients had tumours with a size superior to 10mm (n=676, 72%), with a minority of high SBR grade (n=38, 4%), and a majority of positive hormonal status (n = 880, 93, 6%). The median duration of follow-up was 59 months (1-131). Factors significantly associated with decreased disease free survival was histological grade 3 (hazard ratio [HR]: 3,85, IC 1,21-12,21), tumour size superior to 2cm (HR: 2,85, IC: 1,43-5,68) and macrometastatic lymph node status (HR: 3,11, IC: 1,47-6,58). Concerning overall survival, multivariate analysis demonstrated a significant impact of age less than 50 years (HR: 5,2, IC: 1,39-19,49), histological grade 3 (HR: 5,03, IC: 1,19-21,25), tumour size superior to 2cm (HR: 2,53, IC: 1,13-5,69). Analysis concerning macrometastatic lymph node status nearly reached significance (HR: 2,43, IC: 0,99-5,93). There was no detectable effect of chemotherapy regarding disease free survival (odds ratio [OR] 0,8, IC: 0,35-1,80) and overall survival (OR: 0,72, IC: 0,28-1,82). Disease free survival was similar between no axillary invasion (pN0) and isolated tumor cells (pNi+), or micrometastatic lymph nodes (pNmic). There were no difference neither between one or more than one macromatastatic lymph node. But disease free survival was statistically worse for pN1 compared to other lymph node status (pN0, pNi+ or pNmic). Factors associated with lymph node involvement after logistic regression was: age from 51 to 65 years (OR: 2,1, IC 1,45-3,04), age inferior to 50 years (OR 3,2, IC: 2,05-5,03), Tumour size superior to 2cm (OR 4,4, IC: 3,2-6,14), SBR grading 2 (OR 1,9, IC: 1,30-2,90) and SBR grade 3 (OR 3,5, IC: 1,61-7,75)., Conclusion: The analysis of this series of 940 T1 and T2 lobular invasive breast carcinomas offers several information: factors associated with axillary lymph node involvement are age under 65 years, tumor size greater than 20mm, and a SBR grade 2 or 3. The same factors were significantly associated with the OS and DFS. The macrometastatic lymph node involvement has a significant impact on DFS and OS, which is not true for isolated cells and micrometastases, which seem to have the same prognosis as pN0., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: The current retrospective study was intended to obtain up-to-date and comprehensive data on surgical practice for breast cancer throughout France, including neoadjuvant chemotherapy (NAC) and the more recent surgical techniques of oncoplastic surgery (OPS)., Methods: In June 2011, e-mail surveys were sent to 33 nationally renowned breast cancer surgeons from French public or private hospitals. The questionnaire focused on all the new cases of breast cancer treated in 2010. It included questions regarding surgical practices, with special emphases on NAC and OPS and other surgical characteristics., Results: The overall response rate for the survey was 72.7 %. The total number of breast cancer cases from the survey was 13,762, which constitutes 26.2 % of the total incidence in 2010. Breast-conserving surgery (BCS) was performed for 71.0 % of the patients, and the results were similar throughout the types of practices. Of these patients, 13.9 % received OPS, either upfront or after NAC. Mastectomy was performed for 29.0 % of the patients, which is consistent with French official numbers. Among all patients, 16.3 % underwent surgery after NAC., Conclusion: To the authors' knowledge, there are no publications of national figures on NAC or OPS rates to date. They are convinced that this study offers real-life surgical care information on a large population and covers France's breast cancer surgical landscape. Mastectomy rates in France remain stable and consistent with those in other European countries. However, additional large-scale retrospective studies are required to confirm these figures and further explore NAC and OPS rates as well as surgical practice characteristics.

Background: Drainage duration and seroma formation occurring after mastectomy with or without axillary surgery lengthens hospitalization and delays adjuvant treatment. The aim of the study was to evaluate the effect of quilting in the prevention of seroma after mastectomy for breast cancer., Patients and Methods: Eighty-two breast cancer patients about to undergo mastectomy with or without axillary surgery lymphadenectomy were enrolled in the study. We conducted an observational comparison between 41 patients in whom quilting with closed suction drainage was used and 41 patients in whom drainage only was used., Results: The mean drained volume was significantly lower in the quilting group compared with the control group on days 1 and 2 (day 1: 107.1 mL vs. 156.5 mL; P = .02; day 2: 108.4 mL vs. 162.8 mL; P = .01). The mean drainage period was shorter in the quilting group (4.6 vs. 5.3 days; P = .046). There were fewer needle aspirations for seroma in the padding group (n = 14, 34.1% vs. n = 24, 58.5%; P = .03)., Conclusion: The use of padding after mastectomy seems to reduce seroma formation, volume drained, and length of drainage time., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Oncoplastic surgery (OPS) consists of breast-conserving surgery (BCS) that allows for oncologically safe breast conservation and breast remodeling, thus reducing postoperative deformities. The purpose of the present study was to identify factors determining the risk of re-excision and complications after OPS., Patients and Methods: A retrospective analysis was conducted on patients who underwent OPS between 2009 and 2013, regardless of whether neoadjuvant chemotherapy was administered. Clinical and pathological factors were evaluated. Recursive partitioning analysis (RPA) was used to build regression trees for the prediction of re-excision., Results: Amongst the 129 patients treated by OPS procedures, 30.3% required re-excision. Predictive factors for re-excision were: being overweight (p=0.02), the presence of microcalcifications on mammography (p=0.003), and tumor multifocality (p=0.03). The RPA identified five terminal nodes based on microcalcifications on mammography, being overweight and the presence of ductal carcinoma in situ. Another model included minimal invasive margins (p<0.001), being overweight (p=0.02) and the presence of microcalcifications (p=0.01) on mammography yielded a model with an area under the receiver operating characteristic curve of 0.875., Conclusion: Microcalcifications, tumor multifocality and being overweight were the factors identified as predictors of re-excision after OPS. These factors can serve as decisional tools before surgery., (Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Background and Purpose: The aim of this study is to assess the toxicity and cosmetic outcome of preoperative accelerated partial breast irradiation (PAPBI) for breast cancer patients with low risk on local recurrence., Material and Methods: Women aged ⩾60years with an invasive, unifocal ⩽3cm on MRI, (non-lobular) adenocarcinoma of the breast and a negative sentinel node received PAPBI (40Gray in 10 fractions over 2 weeks). Six weeks after radiotherapy a wide local excision was performed., Results: 70 patients with a median follow-up of 23 months (3-44 months) were evaluated. The overall postoperative infection rate was 11%. At 1, 2 and 3 years of follow-up respectively 89%, 98% and 100% of patients had no or mild induration-fibrosis. Fibrosis was only found in a small volume of the breast. The global cosmetic outcome was good to excellent in 77% at 6 months to 100% at 3 years. Two patients developed a local recurrence., Conclusion: Our first results show limited fibrosis in a small volume and good to excellent cosmetic outcome. In selected patients, preoperative radiotherapy appears to be a good option for breast conserving therapy., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

Background: We wished to estimate the proportion of patients with breast cancer eligible for an exclusive targeted intraoperative radiotherapy (TARGIT) and to evaluate their survival without local recurrence., Methods: We undertook a retrospective study examining two cohorts. The first cohort was multicentric (G3S) and contained 7580 patients. The second cohort was monocentric (cohort 2) comprising 4445 patients. All patients underwent conservative surgery followed by external radiotherapy for invasive breast cancer (T0-T3, N0-N1) between 1980 and 2005. Within each cohort, two groups were isolated according to the inclusion criteria of the TARGIT A study (T group) and RIOP trial (R group).In the multicentric cohort (G3S) eligible patients for TARGIT A and RIOP trials were T1E and R1E subgroups, respectively. In cohort number 2, the corresponding subgroups were T2E and R2E. Similarly, non-eligible patients were T1nE, R1nE and T2nE, and R2nE.The eligible groups in the TARGIT A study that were not eligible in the RIOP trial (TE-RE) were also studied. The proportion of patients eligible for TARGIT was calculated according to the criteria of each study. A comparison was made of the 5-year survival without local or locoregional recurrence between the TE versus TnE, RE versus RnE, and RE versus (TE-RE) groups., Results: In G3S and cohort 2, the proportion of patients eligible for TARGIT was, respectively, 53.2% and 33.9% according the criteria of the TARGIT A study, and 21% and 8% according the criteria of the RIOP trial. Survival without five-year locoregional recurrence was significantly different between T1E and T1nE groups (97.6% versus 97% [log rank=0.009]), R1E and R1nE groups (98% versus 97.1% [log rank=0.011]), T2E and T2nE groups (96.6% versus 93.1% [log rank<0. 0001]) and R2E and R2nE groups (98.6% versus 94% [log rank=0.001]). In both cohorts, no significant difference was found between RE and (TE-RE) groups., Conclusions: Almost 50% of T0-2 N0 patients could be eligible for TARGIT.

To define the prognostic value of isolated tumor cells (ITC), micrometastases (pN1mi) and macrometastases in early stage breast cancer (ESBC). We conducted a retrospective multicenter cohort study at 13 French sites. All the eligible patients who underwent SLNB from January 1999 to December 2008 were identified, and appropriate data were extracted from medical records and analyzed. Among 8001 patients, including 70% node-negative (n = 5588), 4% ITC (n = 305), 10% pN1mi (n = 794) and 16% macrometastases (n = 1314) with a median follow-up of 61.3 months, overall survival (OS) and recurrence-free survival (RFS) rates at 84 months were not statistically different in ITC or pN1mi compared to tumor-free nodes. Axillary recurrence (AR) was significantly more frequent in ITC (1.7%) and pN1mi (1.5%) compared to negative nodes (0.6%). Survival and AR rates of single macrometastases were not different from those of ITC or pN1mi. In case of 2 macrometastases or more, survival rates decreased and recurrence rates increased significantly. Micrometastases and ITC do not have a negative prognostic value. Single macrometastases might have an intermediate prognostic value while 2 macrometastases or more are associated with poorer prognosis., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Nipple-sparing mastectomy (NSM) is increasingly popular for the treatment of select breast cancers and prophylactic mastectomy. This study aimed to analyze the authors' 11-year experience with NSM and breast reconstruction in cases of ductal carcinoma in situ (DCIS) with an emphasis on indications, complications, and cancer recurrence rate., Methods: Between January 2000 and December 2010, 41 NSMs were performed in 41 women for DCIS. The mean age of the women was 49.7±8.7 years (range, 33-66 years). The indications for NSM were tumor size greater than 3 cm (18 cases), multifocal tumor (16 cases), and tumor recurrence (7 cases). In all cases, the tumor was located more than 2 cm from the nipple-areola complex (NAC), as shown by preoperative radiologic imaging. Histologic results, secondary NAC resection, complications, and cancer recurrence rates were recorded., Results: The NAC was lost in seven cases (17%) due to postoperative necrosis. In another 10 patients (25%), the NAC was secondarily removed due to proximity of the tumor to the resection margin. Five patients were lost to follow-up evaluation (12%). The authors report the long-term follow-up data for the remaining 19 patients (46%). In this group, they observed one local recurrence (5.3%) and one case of ovarian cancer., Conclusion: Despite the low locoregional recurrence rate for DCIS, NSM remains controversial because of the nipple necrosis observed and the irradical tumor excisions. Given the ethical impossibility of conducting randomized controlled studies to compare NSM with conventional or skin-sparing mastectomy in DCIS, only long-term follow-up evaluations can demonstrate the safety of NSM., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background: A subgroup of T1N0M0 breast cancer (BC) carries a high potential of relapse, and thus may require adjuvant systemic therapy (AST)., Patients and Methods: Retrospective analysis of all patients with T1 BC, who underwent surgery from January 1999 to December 2009 at 13 French sites. AST was not standardized., Results: Among 8100 women operated, 5423 had T1 tumors (708 T1a, 2208 T1b and 2508 T1c 11-15 mm). T1a differed significantly from T1b tumors with respect to several parameters (lower age, more frequent negative hormonal status and positive HER2 status, less frequent lymphovascular invasion), exhibiting a mix of favorable and poor prognosis factors. Overall survival was not different between T1a, b or c tumors but recurrence-free survival was significantly higher in T1b than in T1a tumors (P = 0.001). In multivariate analysis, tumor grade, hormone therapy and lymphovascular invasion were independent prognostic factors., Conclusion: Relatively poor outcome of patients with T1a tumors might be explained by a high frequency of risk factors in this subgroup (frequent negative hormone receptors and HER2 overexpression) and by a less frequent administration of AST (endocrine treatment and chemotherapy). Tumor size might not be the main determinant of prognosis in T1 BC.

Objective: The purpose of this study was to evaluate the benefit of Oncoplastic Breast Conserving Surgery (BCS) compared to standard BCS after primary CT, in terms of oncologic safety and cosmetic outcomes., Background: The development of new drugs has led to greater use of primary chemotherapy (CT) for bulky breast cancer (BC) and has allowed wider indications for conservative surgery., Patients and Methods: We identified 259 patients consecutively treated with BCS for primary BC from January 2002 to November 2010. All patients had undergone Oncoplastic Breast Surgery (OBS) or standard BCS after primary CT. Mastectomy rates, and oncological and cosmetic outcomes were compared., Results: A total of 45 OBS and 214 standard BCS were analyzed. The median tumor size was 40 mm in the two groups (p = 0.66). The median operative specimen volumes were larger in the OBS group than in the standard group (respectively, 180 cm3 and 98 cm3, p < 0.0001). Re-excision (9% vs. 2%) and mastectomy (24% vs. 18%) rates were similar (p = 0.22 and p = 0.30) in the standard BCS group and in the OBS group respectively. At a median follow-up of 46 months, local relapse (p = 0.23) and distant relapse (p = 0.35) rates were similar., Conclusion: OBS allows excision of larger volumes of residual tumor after primary CT. OBS outcomes results were similar to those of standard BCS. Oncoplastic Breast Conserving Surgery (BCS) after primary chemotherapy allows wider breast resection than standard BCS. Survival and relapse probabilities are similar in both groups., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The aim of this study was to evaluate the accuracy and safety of breast lesion excision system (BLES) procedure with an Intact system device, under stereotactic and ultrasound guidance. Retrospective data review of 32 breast lesions BI-RADS 4 or 5 underwent Intact procedures, from March 2010 to January 2012. Underestimation rates of atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) were evaluated; percentage of complete radiologic and histologic removal of the breast lesion were analyzed, as were the complications due to procedure. Complete radiologic excision of the target lesion was achieved in all masses and 58.6% of calcifications. Lesion size was less than 11 mm (mean size 5.6 mm). Underestimation of ADH and DCIS was 0% and 10%, respectively. Low complication rate was noted: only one hematoma. BLES appears an accurate and safe biopsy system for sampling nonpalpable breast lesions, especially in case of microcalcifications clusters categorized as BI-RADS 4 and 5., (© 2013 Wiley Periodicals, Inc.)

Background: The increased rate of ductal carcinoma in situ (DCIS) is associated with a rise in indications for mastectomy and immediate breast reconstruction (IBR). The purpose of our study was to evaluate the factors affecting the indications for IBR and its modalities., Study Design: Data concerning two hundred and thirty-eight consecutive patients with DCIS who had undergone modified radical mastectomy and a sentinel lymph node biopsy (SLNB) between 2005 and 2011 were extracted from our database. We then conducted a comparative study between patients who had undergone IBR and those who had not, to determine which factors affected the decision to offer IBR (LOE II)., Results: About 57.1% had IBR and 42.9% had no reconstruction. The most common reason why IBR had not been performed was that it had not been proposed by the surgeon (33.4%). Of the 136 patients offered IBR, an implant had been proposed to the majority of them (81.6%). The IBR rate was highest among women under 50 years (52.2%), and was lower among women with diabetes (0.7%) or obesity (8.8%). The choice of reconstruction was not affected by tobacco use or positive SLNB results., Conclusion: Factors predictive of the IBR reflect the influence of surgeon counselling and, to a lesser extent, consideration of patient comorbidities. However, there is a need to improve patient information and physician referral., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: The purpose of our study was to evaluate the surgical treatment and outcome of breast cancer according to molecular subtypes., Methods: We identified 1,194 patients consecutively treated for primary breast cancer from 2004 to 2010. The type of surgery, pathological findings, local recurrence, and distant metastasis were evaluated for 5 molecular subtypes: luminal A and B, luminal HER2 (Human Epidermal Growth Factor Receptor 2), HER2 , and triple negative., Results: Breast-conserving surgery (BCS) was performed more frequently in luminal A (70.6%), triple-negative (66.2%), and luminal HER2 tumors (60.9%) (P < .001). A sentinel node biopsy was performed more frequently in luminal A (60%), and luminal HER2 (29.3%) types (P < .001). Among the 791 BCS, positive nodes were observed more often in HER2 (50%) and luminal B (44.9%) types (P = .0003). The number of local recurrences was higher in the node-negative luminal B subtype (3.4%)., Conclusions: Molecular subtypes exert an impact on BCS and nodal surgery rates. The local relapse rates are influenced by the molecular subtypes according to the nodal status., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: For patients with breast cancer and metastases in the sentinel nodes, axillary dissection has been standard treatment. However, for patients with limited sentinel-node involvement, axillary dissection might be overtreatment. We designed IBCSG trial 23-01 to determine whether no axillary dissection was non-inferior to axillary dissection in patients with one or more micrometastatic (≤2 mm) sentinel nodes and tumour of maximum 5 cm., Methods: In this multicentre, randomised, non-inferiority, phase 3 trial, patients were eligible if they had clinically non-palpable axillary lymph node(s) and a primary tumour of 5 cm or less and who, after sentinel-node biopsy, had one or more micrometastatic (≤2 mm) sentinel lymph nodes with no extracapsular extension. Patients were randomly assigned (in a 1:1 ratio) to either undergo axillary dissection or not to undergo axillary dissection. Randomisation was stratified by centre and menopausal status. Treatment assignment was not masked. The primary endpoint was disease-free survival. Non-inferiority was defined as a hazard ratio (HR) of less than 1·25 for no axillary dissection versus axillary dissection. The analysis was by intention to treat. Per protocol, disease and survival information continues to be collected yearly. This trial is registered with ClinicalTrials.gov, NCT00072293., Findings: Between April 1, 2001, and Feb 28, 2010, 465 patients were randomly assigned to axillary dissection and 469 to no axillary dissection. After the exclusion of three patients, 464 patients were in the axillary dissection group and 467 patients were in the no axillary dissection group. After a median follow-up of 5·0 (IQR 3·6-7·3) years, we recorded 69 disease-free survival events in the axillary dissection group and 55 events in the no axillary dissection group. Breast-cancer-related events were recorded in 48 patients in the axillary dissection group and 47 in the no axillary dissection group (ten local recurrences in the axillary dissection group and eight in the no axillary dissection group; three and nine contralateral breast cancers; one and five [corrected] regional recurrences; and 34 and 25 distant relapses). Other non-breast cancer events were recorded in 21 patients in the axillary dissection group and eight in the no axillary dissection group (20 and six second non-breast malignancies; and one and two deaths not due to a cancer event). 5-year disease-free survival was 87·8% (95% CI 84·4-91·2) in the group without axillary dissection and 84·4% (80·7-88·1) in the group with axillary dissection (log-rank p=0·16; HR for no axillary dissection vs axillary dissection was 0·78, 95% CI 0·55-1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3-4) included one sensory neuropathy (grade 3), three lymphoedema (two grade 3 and one grade 4), and three motor neuropathy (grade 3), all in the group that underwent axillary dissection, and one grade 3 motor neuropathy in the group without axillary dissection. One serious adverse event was reported, a postoperative infection in the axilla in the group with axillary dissection., Interpretation: Axillary dissection could be avoided in patients with early breast cancer and limited sentinel-node involvement, thus eliminating complications of axillary surgery with no adverse effect on survival., Funding: None., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Surgical and systemic treatment modalities for breast cancer (BC) patients with micrometastatic disease in the sentinel lymph node biopsy (SNB) are controversial. The aim of this study was to evaluate decisional factors associated with assignment of adjuvant chemotherapy (CT)., Patients and Methods: In a retrospective multicentric European study we evaluated cases of primary BC patients who underwent SNB. Logistic regression (LR) and recursive partitioning analyses (RPA) were performed to determine factors associated with CT., Results: Of the 172 patients with micrometastatic disease, 39.5% received adjuvant CT. In the group treated with CT, patients tended to be younger (P = 0.001), with higher grade (P = 0.001) and HER2 positive tumors (P = 0.006) compared to patients without CT. In multivariate LR, age (P = 0.0027), high grading (P = 0.01) HER2 positivity (P = 0.03), and positive non-SN status (P = 0.03) were significantly associated with CT. RPA demonstrated that tumor grade, and not the non-SN status, was the first split in the partition tree followed by HER2 status, and non-SN status influencing the probability for CT administration., Conclusion: High tumor grade is the main decisional factor followed by HER2 positivity and then by the positive non-SN status for CT in micrometastatic disease in the SN., (Copyright © 2012 Wiley Periodicals, Inc.)

Breast conserving treatment (breast conserving surgery followed by whole breast irradiation) has commonly been used in early breast cancer since many years. New radiation modalities have been recently developed in early breast cancers, particularly accelerated partial breast irradiation. Three-dimensional conformal accelerated partial breast irradiation is the most commonly used modality of radiotherapy. Other techniques are currently being developed, such as intensity-modulated radiotherapy, arctherapy, and tomotherapy. The present article reviews the indications, treatment modalities and side effects of accelerated partial breast irradiation., (Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

Objective: Recent recommendations regarding indications of accelerated partial breast irradiation (APBI) have been put forward for selected breast cancer (BC) patients. However, some treatment planning parameters, such as total dose, are not yet well defined. The Institut Gustave Roussy has initiated a dose escalation trial at the 40 Gy/10 fractions/5 days and at a further step of total dose (TD) of 42 Gy/10 fractions/ 5 days. Here, we report early results of the latest step compared with the 40 Gy dose level., Methods and Materials: From October 2007 to March 2010, a total of 48 pT1N0 BC patients were enrolled within this clinical trial: 17 patients at a TD of 42 Gy/10f/5d and 31 at a TD of 40 Gy/10f/5d. Median follow-up was 19 months (min-max, 12-26). All the patients were treated by APBI using a technique with 2 minitangents and an "enface" electrons delivering 20% of the total dose. Toxicities were systematically assessed at 1; 2; 6 months and then every 6 months., Results: Patients' recruitment of 42 Gy step was ended owing to persistent grade 3 toxicity 6 months after APBI completion (n = 1). Early toxicities were statistically higher after a total dose of 42 Gy regarding grade ≥2 dry (p = 0.01) and moist (p = 0.05) skin desquamation. Breast pain was also statistically higher in the 42 Gy step compared to 40 Gy step (p = 0.02). Other late toxicities (grade ≥2 fibrosis and telangectasia) were not statistically different between 42 Gy and 40 Gy., Conclusions: Early toxicities were more severe and higher rates of late toxicities were observed after 42 Gy/10 fractions/5 days when compared to 40 Gy/10 fractions/5 days. This data suggest that 40 Gy/10 fractions/ 5 days could potentially be the maximum tolerance for PBI although longer follow-up is warranted to better assess late toxicities.

BACKGROUND: After lymphadenectomy for early breast cancer, seroma formation is a constant event requiring a suction drainage. This drainage is the strongest obstacle to reducing the hospital stay. Axillary padding without drainage appears to be a valuable option amid the various solutions for reducing the hospital stay. METHODS: We conducted a comparison between 114 patients with padding and 185 patients with drainage. Data were obtained from 2 successive prospective studies. RESULTS: The mean hospital stay was 2.4 days (range 1-4) in the padding group and 4.2 days (range 2-9) in the drainage group (p < 0.05). There were fewer needle aspirations for seroma in the padding group (8.8 vs. 23%, p < 0.05). At 6 weeks, only 28% (32/114) of the patients in the padding group reported pain versus 51% (94/185) in the drainage group. The mean pain intensity at 6 weeks was 3 and 4.3 respectively (p < 0.0001). CONCLUSION: Axillary padding without drainage was associated with a better post-operative course than suction drainage in this historical comparison, and the hospital stay was significantly shortened. There are only few series published on this new technique but they all indicate good feasibility and good tolerance. A large randomised multicentric evaluation is now warranted.

Introduction: The present study prospectively reported both physicians' and patients' assessment for toxicities, cosmetic assessment and patients' satisfaction after 3D-conformal accelerated partial breast irradiation (APBI)., Materials and Methods: From October 2007 to September 2009, 30 early breast cancer patients were enrolled in a 3D-conformal APBI Phase II trial (40 Gy/10 fractions/5 days). Treatment related toxicities and cosmetic results were assessed by both patients and physicians at each visit (at 1, 2, 6 months, and then every 6 months). Patient satisfaction was also scored., Results: After a median follow-up of 27.7 months, all patients were satisfied with APBI treatment, regardless of cosmetic results or late adverse events. Good/excellent cosmetic results were noticed by 80% of patients versus 92% of cases by radiation oncologists. Breast pain was systematically underestimated by physicians (8-20% vs. 16.6-26.2%; Kappa coefficient KC=0.16-0.44). Grade 1 and 2 fibrosis and/or breast retraction occurred in 7-12% of patients and were overestimated by patients (KC=0.14-0.27)., Conclusions: Present results have shown discrepancies between patient and physician assessments. In addition to the assessment of efficacy and toxicity after 3D-conformal APBI, patients' cosmetic results consideration and satisfaction should be also evaluated., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Purpose: The risk of non sentinel node (NSN) involvement varies in function of the characteristics of sentinel nodes (SN) and primary tumor. Our aim was to determine and validate a statistical tool (a nomogram) able to predict the risk of NSN involvement in case of SN micro or sub-micrometastasis of breast cancer. We have compared this monogram with other models described in the literature., Methods: We have collected data on 905 patients, then 484 other patients, to build and validate the nomogram and compare it with other published scores and nomograms., Results: Multivariate analysis conducted on the data of the first cohort allowed us to define a nomogram based on 5 criteria: the method of SN detection (immunohistochemistry or by standard coloration with HES); the ratio of positive SN out of total removed SN; the pathologic size of the tumor; the histological type; and the presence (or not) of lympho-vascular invasion. The nomogram developed here is the only one dedicated to micrometastasis and developed on the basis of two large cohorts. The results of this statistical tool in the calculation of the risk of NSN involvement is similar to those of the MSKCC (the similarly more effective nomogram according to the literature), with a lower rate of false negatives., Conclusion: this nomogram is dedicated specifically to cases of SN involvement by metastasis lower or equal to 2 mm. It could be used in clinical practice in the way to omit ALND when the risk of NSN involvement is low., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objectives: This study sought to investigate long-term cardiovascular mortality and its relationship to the use of radiotherapy for breast cancer., Background: Cardiovascular diseases are among the main long-term complications of radiotherapy, but knowledge is limited regarding long-term risks because published studies have, on average, <20 years of follow-up., Methods: A total of 4,456 women who survived at least 5 years after treatment of a breast cancer at the Institut Gustave Roussy between 1954 and 1984 were followed up for mortality until the end of 2003, for over 28 years on average., Results: A total of 421 deaths due to cardiovascular diseases were observed, of which 236 were due to cardiac disease. Women who had received radiotherapy had a 1.76-fold (95% confidence interval [CI]: 1.34 to 2.31) higher risk of dying of cardiac disease and a 1.33-fold (95% CI: 0.99 to 1.80) higher risk of dying of vascular disease than those who had not received radiotherapy. Among women who had received radiotherapy, those who had been treated for a left-sided breast cancer had a 1.56-fold (95% CI: 1.27 to 1.90) higher risk of dying of cardiac disease than those treated for a right-sided breast cancer. This relative risk increased with time since the breast cancer diagnosis (p = 0.05)., Conclusions: This study confirmed that radiotherapy, as delivered until the mid-1980s, increased the long-term risk of dying of cardiovascular diseases. The long-term risk of dying of cardiac disease is a particular concern for women treated for a left-sided breast cancer with contemporary tangential breast or chest wall radiotherapy. This risk may increase with a longer follow-up, even after 20 years following radiotherapy., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Invasive ductal carcinoma with osteoclast-like giant cells (OGCs) is a very rare breast tumor the main characteristic of which is the presence of multinucleated cells of histiocytic nature., Methods: The authors report a study of 8 consecutive cases of fine-needle aspiration cytopathology (FNAC) of breast nodules in which OGCs and malignant epithelial cells were associated and diagnosed as mammary carcinoma with OGCs. These cases were selected over a period of 5 years from more than 6000 patients who were examined during a weekly, single-day, multidisciplinary breast clinic. The corresponding biopsies and surgical specimens were examined histologically in an immunohistochemical study using a histiocytic marker (cluster of differentiation 68 [CD68])., Results: Conventional histologic analysis made it possible to diagnose 5 of the 8 cases as mammary carcinoma with OGCs; whereas, in the other 3 cases, OGCs were not detected without the help of immunohistochemistry., Conclusions: FNAC appeared to be a very efficient way to diagnose breast carcinoma with OGCs, because it detected forms with only a few OGCs that usually are not observed at histologic diagnosis. Consequently, the current results indicated that mammary carcinoma with OGCs may be more frequent than reported previously., (Copyright © 2010 American Cancer Society.)

Purpose: Since 2009, accelerated partial breast irradiation (APBI) in North America has been allowed to be used for selected group of patients outside a clinical trial according to the ASTRO consensus statement. In France, accelerated partial breast irradiation is still considered investigational, several clinical trials have been conducted using either intraoperative (Montpellier) or Mammosite(®) (Lille) or brachytherapy modality (PAC GERICO/FNCLCC). Here, we report the original dosimetric results of this technique., Patients and Methods: Since October 2007, Institut Gustave-Roussy has initiated a phase II trial using 3D-conformal accelerated partial breast irradiation (40 Gy in 10 fractions BID in 1 week). Twenty-five patients with pT1N0 breast cancer were enrolled and were treated by two minitangent photons beams (6MV) and an "en face" electron beam (6-22 MeV)., Results: The mean clinical target volume and planning target volume were respectively 15.1cm(3) (range: 5.2-28.7 cm(3)) and 117 cm(3) (range: 52-185 cm(3)). The planning target volume coverage was adequate with at least a mean of 99% of the volume encompassed by the isodose 40 Gy. The mean dose to the planning target volume was 41.8 Gy (range: 41-42.4 Gy). Dose inhomogeneity did not exceed 5%. Mean doses to the ipsilateral lung and heart were 1.6 Gy (range: 1.0-2.3 Gy) and 1.2 Gy (range: 1.0-1.6 Gy), respectively., Conclusion: The 3D conformal accelerated partial breast irradiation using two minitangent and "en face" electron beams using a total dose of 40 Gy in 10 fractions BID over 5 days achieves appropriate planning target volume coverage and offers significant normal-tissue sparing (heart, lung). Longer follow-up is needed to evaluate the tissue tolerance to this radiation dose., (Copyright © 2010 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

Purpose: To determine to what extent the placement of surgical clips helps delineate the cavity in three-dimensional conformal accelerated partial-breast irradiation., Patients and Methods: Planning CT images of 100 lumpectomy cavities were reviewed in a cohort of 100 consecutive patients. The cavities were determined and categorized by two radiation oncologists according to cavity visualization score criteria and the breast density score. The two physicians first attempted to delineate the lumpectomy cavity without clips and then with clips., Results: In the case of high-density mammary tissue, the breast remodeling done during surgery does not enable the lumpectomy cavity to be sufficiently visualized. The use of surgical clips significantly improved the ability to visualize the lumpectomy cavity, with a 69% rate of concordance between physicians regardless of the breast tissue density., Conclusion: The placement of surgical clips at lumpectomy enables visualization of the lumpectomy cavity and allows upgrading of the cavity visualization score on CT scans obtained for accelerated partial-breast irradiation treatment planning.

Background: Accurate localisation of the lumpectomy cavity (LC) volume is one of the most critical points in 3D-conformal Partial breast irradiation (3D-APBI) treatment planning because the irradiated volume is restricted to a small breast volume. Here, we studied the role of the placement of surgical clips at the 4 cardinal points of the lumpectomy cavity in target delineation., Methods: Forty CT-based 3D-APBI plans were retrieved on which a total of 4 radiation oncologists, two trainee and two experienced physicians, outlined the lumpectomy cavity. The inter-observer variability of LC contouring was assessed when the CTV was defined as the delineation that encompassed both surgical clips and remodelled breast tissue., Results: The conformity index of tumour bed delineation was significantly improved by the placement of surgical clips within the LC (median at 0.65). Furthermore, a better conformity index of LC was observed according to the experience of the physicians (median CI = 0.55 for trainee physicians vs 0.65 for experienced physicians)., Conclusions: The placement of surgical clips improved the accuracy of lumpectomy cavity delineation in 3D-APBI. However, a learning curve is needed to improve the conformity index of the lumpectomy cavity.

Purpose: Predictive factors of non-sentinel lymph node (NSN) involvement at axillary lymph node dissection (ALND) have been studied in the case of sentinel node (SN) involvement, with validation of a nomogram. This nomogram is not accurate for SN micrometastasis. The purpose of our study was to determine a nomogram for predicting the likelihood of NSN involvement in breast cancer patients with a SN micrometastasis., Methods: We collated 909 observations of SN micrometastases with additional ALND. Characteristics of the patients, tumours and SN were analysed., Results: Involvement of SN was diagnosed 490 times (53.9%) with standard staining (HES) and 419 times solely on immunohistochemical analysis (IHC) (46.1%). NSN invasion was observed in 114 patients (12.5%), whereas 62.3% (71) had only one NSN involved and 37.7% (43) two or more NSN involved. In multivariate analysis, significant predictive factors were: tumour size (pT stage < or = 10 mm or >11 and < or = 20 or >20 mm [odds ratio (OR) 2.1 and 3.43], micrometastases detected by HES or IHC [OR 1.64], presence or absence of lymphovascular invasion (LVI) [OR 1.76], tumour histological type mixed or not [OR 2.64]. The rate and probability of NSN involvement with the model are given for 24 groups, with a representation by a nomogram., Conclusion: One group, corresponding to 10.1% of the patients, was associated with a risk of NSN involvement of less than 5%, and five groups, corresponding to 29.8% of the patients, were associated with a risk < or = 10%. Omission of ALND could be proposed with minimal risk for a low probability of NSN involvement.

CEDM is a recent development of digital mammography using the intra-venous injection of an iodinated contrast agent in conjunction with a mammography examination. Two techniques have been developed to perform CEDM examinations: the temporal subtraction technique with acquisition of high-energy images before and after contrast medium injection and the dual energy technique with acquisition of a pair of low and high-energy images only after contrast medium injection. The temporal subtraction technique offered the possibility to analyze the kinetic curve of enhancement of breast lesions, similarly to breast MRI. The dual energy technique do not provide information about the kinetic of tumor enhancement but allows the acquisition of multiples views of the same breast or bilateral examination and is less sensitive to patient motion than temporal CEDM. Initial clinical experience has shown the ability of CEDM to map the distribution of neovasculature induced by cancer using mammography. Moreover, previous studies have shown a superiority of MX+CEDM, either for the assessment of the probability of malignancy than for BIRADS assessment comparing to MX alone. The potential clinical applications are the clarification of mammographically equivocal lesions, the detection of occult lesions on standard mammography, particularly in dense breast, the determination of the extent of disease, the assessment of recurrent disease and the monitoring of the response to chemotherapy. CEDM should result in a simple way to enhance the detection and the characterization of breast lesions.

Imaging of angiogenesis is a challenge for modern imaging. Velocimetry in malignant breast lesions and density of malignant vessels are very low. In breast imaging, first results of contrast-enhanced ultrasound (CEUS) were disappointing. Microbubbles are fragile when examined with high frequency US, commonly used in breast imaging. Second-generation contrast agents increase intensively the signal level of breast lesions and new sequences like CPS (Coherence Pulse Sequencing) might be accurate to detect malignant vessels in breast lesions for characterization, to assess the extent of infiltrative breast carcinoma or to evaluate the tumor response after chemotherapy. Another interesting clinical application is the differentiation between post-operative changes and recurrences. In this review, we detail the main results obtained with contrast ultrasonography in a characterization study. In malignant lesions, enhancement was fast, starting with less than 20s. Compared to MR, enhancement appeared faster. Malignant vessels were predominant in the external ring of the nodule, conversely vessels were seen in the center of the lesion in benign nodules. Malignant vessels were also seen outside the lesion. This knowledge could lead the surgeon to perform a larger lumpectomy in these cases, to obtain sane margins and to reduce recurrences.

Background: The role of radiofrequency (RF) ablation to treat local recurrence of breast cancer is unknown., Methods: We conducted a two-stage phase II clinical trial. Eligible patients had a histologically confirmed noninflammatory and < or =3 cm ipsilateral breast tumor recurrence. The tumor site was identified by intraoperative sonography. A LeVeen needle electrode (RadioTherapeutics Corp, Mountain View, Calif) was inserted into a single site within the tumor and radiofrequency ablation was performed using a RF-2000 generator (RadioTherapeutics Corp). After completion of radiofrequency, a mastectomy was performed. Conventional staining and nicotinamide adenine dinucleotide-diaphorase (NADH-diaphorase) cell viability staining were performed., Results: During the first stage, procedures were uneventful. Conventional, cytokeratin, and NADH-diaphorase staining identified persistent viable tumor cells in the RF-ablated region in three patients. This phase II trial was stopped after completion of the first stage because of insufficient efficacy., Conclusion: We demonstrate in this study that RF ablation is a potential technique to destroy local recurrence of breast tumors but the technique we tested in this phase II clinical trial had insufficient efficacy to recommend its use in routine.