Postoperative Outcomes of Pre-Pectoral Versus Sub-Pectoral Implant Immediate Breast Reconstruction.

INTRODUCTION: Immediate breast reconstruction (IBR) techniques are rapidly evolving. We compared the results from a single-center implant IBR cohort between subpectoral and prepectoral implants with and without a mesh. METHODS: We analyzed all complications and grade 2-3 complications, the implant loss rate, the surgery time, the length of stay (LOS), patient satisfaction, the interval time to adjuvant therapy and cost, with a comparison between subpectoral and prepectoral implant IBR. RESULTS: Subpectoral implant IBR was carried out in 529 mastectomies (62.0%) and prepectoral in 324, with a significant increase in prepectoral placement in recent years. Mesh was used in 176 prepectoral placements (54.3%). Any grade of complication was reported in 147 mastectomies (17.2%), with a significantly higher rate for prepectoral implant IBR (p = 0.036). Regression analysis showed that prepectoral implant was not significantly associated with any grade of complication or with grade 2-3 complications. Prepectoral implant IBR was associated with a significantly shorter operative time and lower LOS. Grade 2-3 complications were significantly associated with lower satisfaction. Higher costs were significantly associated with the subpectoral placement and mesh. A complication rate predictive score identified five groups with a significant increase in grade 2-3 complications. CONCLUSIONS: Prepectoral-M-IBR increased over time with no difference in complication rates compared to subpectoral-M-IBR. Prepectoral implant placement can be considered a safe technique.

Does Breast Surgery Type Alter Incidental Axillary Irradiation? A Dosimetric Analysis of the "Sentinel Envahi et Randomisation du Curage" SERC Trial.

BACKGROUND: An incidental axillary dose of adjuvant radiotherapy using tangential beams is usually given after breast-conserving surgery for breast cancer. The goal of this sub-study was to evaluate this incidental dose in the setting of post-mastectomy radiotherapy (PMRT) according to two different radiotherapy techniques. METHODS: Patients participating in a randomized SERC trial who received PMRT in a single center were included. We collected the incidental axillary dose delivered to the Berg level 1 using different dosimetric parameters and compared two techniques using Student's t-test: three-dimensional conformal radiotherapy (3D-CRT) and volumetric arc therapy (VMAT). RESULTS: We analyzed radiotherapy plans from 52 patients who received PMRT from 2012 to 2021. The mean dose delivered to the Berg level 1 was 37.2 Gy. It was significantly higher with VMAT than with 3D-CRT-43.6 Gy (SD = 3.1 Gy) versus 34.8 Gy (SD = 8.6 Gy) p < 0.001. Eighty-four percent of the Berg level 1 was covered by 40 Gy isodose in the VMAT group versus 55.5% in the 3D-CRT group p < 0.001. CONCLUSIONS: On the Berg level 1, PMRT gives a dose at least equivalent to the one given by post-breast-conserving surgery radiotherapy, making it possible to limit completion axillary lymph node dissections in select pN1a patients treated with a mastectomy. Modern radiotherapy techniques like VMAT tend to increase this incidental dose.

Neoadjuvant chemotherapy for breast cancer: Pathologic response rates but not tumor size, has an independent prognostic impact on survival.

AIM: We investigated the pathologic complete response rates (pCR) and survival outcomes of early breast cancer patients who underwent neoadjuvant chemotherapy (NAC) over 14 years at a French comprehensive cancer center and reported pCR and survival outcomes by tumor subtypes and size. METHODS: From January 2005 to December 2018, 1150 patients receiving NAC were identified. Correlations between cT stage, breast tumor response, axillary lymph node response, pCR, surgery, and outcomes were assessed. pCR was defined as (ypT0/ypTis) and (ypN0/pN0sn). RESULTS: A pCR was reached in 31.7% (365/1150) of patients and was strongly associated with tumor subtypes, but not with tumor size (pretreatment cT category). Luminal-B Her2-negative and triple-negative (TN) subtypes, cN1 status, older age, and no-pCR had an independent negative prognostic value. Overall survival (OS), relapse-free survival (RFS), and metastasis-free survival (MFS) were not significantly different for cT0-1 compared to cT2 stages. In Cox-model adjusted on in-breast pCR and pN status, ypN1 had a strong negative impact (OS, RFS, and MFS: HR = 3.153, 4.677, and 6.133, respectively), higher than no in-breast pCR (HR = 2.369, 2.252, and 2.323). A negative impact of no pCR on OS was observed for cN0 patients and TN tumors (HR = 4.972) or HER2-positive tumors (HR = 11.706), as well as in Luminal-B Her2-negative tumors on MFS (HR = 2.223) and for Luminal-A on RFS (HR = 4.465) and MFS (HR = 4.185). CONCLUSION: Achievement of pCR, but not tumor size (pretreatment cT category), has an independent prognostic impact on survival. These results suggest potential NAC benefits in patients with small tumors (<2 cm), even in absence of clinically suspicious lymph nodes. Residual lymph node disease after NAC is the most powerful adverse prognostic factor.

Negative Survival Impact of Occult Lymph Node Involvement in Small HER2-Positive Early Breast Cancer Treated by Up-Front Surgery.

(1) Background: The independent negative prognostic value of isolated tumor cells or micro-metastases in axillary lymph nodes has been established in triple-negative breast cancers (BC). However, the prognostic significance of pN0(i+) or pN1mi in HER2-positive BCs treated by primary surgery remains unexplored. Therefore, our objective was to investigate the impact of pN0(i+) or pN1mi in HER2-positive BC patients undergoing up-front surgery on their outcomes. (2) Methods: We retrospectively analyzed 23,650 patients treated in 13 French cancer centers from 1991 to 2013. pN status was categorized as pN0, pN0(i+), pN1mi, and pNmacro. The effect of pN0(i+) or pN1mi on outcomes was investigated both in the entire cohort of patients and in pT1a-b tumors. (3) Results: Of 1771 HER2-positive BC patients included, pN status distributed as follows: 1047 pN0 (59.1%), 60 pN0(i+) (3.4%), 118 pN1mi (6.7%), and 546 pN1 macro-metastases (30.8%). pN status was significantly associated with sentinel lymph node biopsy, axillary lymph node dissection, age, ER status, tumor grade, and size, lymphovascular invasion, adjuvant systemic therapy (ACt), and radiation therapy. With 61 months median follow-up (mean 63.2; CI 95% 61.5-64.9), only pN1 with macro-metastases was independently associated with a negative impact on overall, disease-free, recurrence-free, and metastasis-free survivals in multivariate analysis. In the pT1a-b subgroup including 474 patients, RFS was significantly decreased in multivariate analysis for pT1b BC without ACt (HR 2.365, 1.04-5.36, p = 0.039) and for pN0(i+)/pN1mi patients (HR 2.518, 1.03-6.14, p = 0.042). (4) Conclusions: Survival outcomes were not adversely affected by pN0(i+) and pN1mi in patients with HER2-positive BC. However, in the case of pT1a-b HER2-positive BC, a negative impact on RFS was observed specifically for patients with pN0(i+) and pN1mi diseases, particularly among those with pT1b tumors without ACt. Our findings highlight the importance of considering the pN0(i+) and pN1mi status in the decision-making process when discussing trastuzumab-based ACt for these patients.

Early breast cancer in women aged 35 years or younger: A large national multicenter French population-based case control-matched analysis.

BACKGROUND: There is a scarcity of data exploring early breast cancer (eBC) in very young patients. We assessed shared and intrinsic prognostic factors in a large cohort of patients aged ≤35, compared to a control group aged 36 to 50. METHODS: Patients ≤50 were retrospectively identified from a multicentric cohort of 23,134 eBC patients who underwent primary surgery between 1990 and 2014. Multivariate Cox analyses for DFS and OS were built. To assess the independent impact of age, 1 to 3 case-control analysis was performed by matching ≤35 and 36-50 years patients. RESULTS: Of 6481 patients, 556 were aged ≤35, and 5925 from 36 to 50. Age ≤35 was associated with larger tumors, higher grade, ER-negativity, macroscopic lymph node involvement (pN + macro), lymphovascular invasion (LVI), mastectomy, and chemotherapy (CT) use. In multivariate analysis, age ≤35 was associated with worse DFS [HR 1.56, 95% CI 1.32-1.84; p < 0.001], and OS [HR 1.29, 95% CI 1.03-1.60; p = 0.025], as were high grade, large tumor, LVI, pN + macro, ER-negativity, period of diagnostic, and absence of ET or CT (for DFS). Adverse prognostic impact of age ≤35 was maintained in the case control-matched analysis for DFS [HR 1.56, 95%CI 1.28-1.91, p < 0.001], and OS [HR 1.33, 95%CI 1.02-1.73, p = 0.032]. When only considering patients ≤35, ER, tumor size, nodal status, and LVI were independently associated with survival in this subgroup. CONCLUSIONS: Age ≤35 is associated with less favorable presentation and more aggressive treatment strategies. Our results support the poor prognosis value of young age, which independently persisted when adjusting for other prognostic factors and treatments.

The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases.

BACKGROUND: Results of IBCSG-23-01-trial which included breast cancer patients with involved sentinel nodes (SN) by isolated-tumor-cells or micro-metastases supported the non-inferiority of completion axillary-lymph-node-dissection (cALND) omission. However, current data are considered insufficient to avoid cALND for all patients with SN-micro-metastases. METHODS: To investigate the impact of cALND omission on disease-free-survival (DFS) and overall survival (OS), we analyzed a cohort of 1421 patients <75 years old with SN-micro-metastases who underwent breast conservative surgery (BCS). We used inverse probability of treatment weighting (IPTW) to obtain adjusted Kaplan-Meier estimators representing the experience in the analysis cohort, based on whether all or none had been subject to cALND omission. RESULTS: Weighted log-rank tests comparing adjusted Kaplan-Meier survival curves showed significant differences in OS (p-value = 0.002) and borderline significant differences in DFS (p-value = 0.090) between cALND omission versus cALND. Cox's regression using stabilized IPTW evidenced an average increase in the risk of death associated with cALND omission (HR = 2.77, CI95% = 1.36-5.66). Subgroup analyses suggest that the rates of recurrence and death associated with cALND omission increase substantially after a large period of time in the half sample of women less likely to miss cALND. CONCLUSIONS: Using IPTW to estimate the causal treatment effect of cALND in a large retrospective cohort, we concluded cALND omission is associated with an increased risk of recurrence and death in women of <75 years old treated by BCS in the absence of a large consensus in favor of omitting cALND. These results are particularly contributive for patients treated by BCS where cALND omission rates increase over time.

Triple-negative and Her2-positive breast cancer in women aged 70 and over: prognostic impact of age according to treatment.

Background: Elderly breast cancer (BC) patients have been underrepresented in clinical trials whereas ~60% of deaths from BC occur in women aged 70 years and older. Only limited data are available on the prognostic impact of age according to treatment, especially in the triple-negative (TN) and Her2-positive because of the lower frequency of these subtypes in elderly patients. We report herein the results of a multicenter retrospective study analyzing the prognostic impact of age according to treatment delivered in TN and Her2-positive BC patients of 70 years or older, including comparison by age groups. Methods: The medical records of 31,473 patients treated from January 1991 to December 2018 were retrieved from 13 French cancer centers for retrospective analysis. Our study population included all ≥70 patients with TN or Her2-positive BC treated by upfront surgery. Three age categories were determined: 70-74, 75-80, and > 80 years. Results: Of 528 patients included, 243 patients were 70-74 years old (46%), 172 were 75-80 years (32.6%) and 113 were >80 years (21.4%). Half the population (51.9%, 274 patients) were TN, 30.1% (159) Her2-positive/hormone receptors (HR)-positive, and, 18% (95) Her2-positive/endocrine receptors (ER)-negative BC. Advanced tumor stage was associated with older age but no other prognostic factors (tumor subtype, tumor grade, LVI). Adjuvant chemotherapy delivery was inversely proportional to age. With 49 months median follow-up, all patient outcomes (overall survival (OS), disease-free survival (DFS), breast cancer-specific survival (BCSS), and recurrence-free survival (RFS)) significantly decreased as age increased. In multivariate analysis, age >80, pT2-3 sizes, axillary macrometastases, lymphovascular involvement, and HR-negativity tumor negatively affected DFS and OS. Comparison between age >80 and <=80 years old showed worse RFS in patients aged > 80 (HR=1.771, p=0.031). Conclusion: TN and Her2-positive subtypes occur at similar frequency in elderly patients. Older age is associated with more advanced tumor stage presentation. Chemotherapy use decreases with older age without worse other pejorative prognostic factors. Age >80, but not ≤80, independently affected DFS and OS.

Mastectomy and Immediate Breast Reconstruction with Pre-Pectoral or Sub-Pectoral Implant: Assessing Clinical Practice, Post-Surgical Outcomes, Patient's Satisfaction and Cost.

Immediate breast reconstruction (IBR) rates increase during last years and implant-based reconstruction was the most commonly performed procedure. We examined data collected over 25 months to assess complication rate, duration of surgery, patient's satisfaction and cost, according to pre-pectoral or sub-pectoral implant-IBR. All patients who received an implant-IBR, from January 2020 to January 2022, were included. Results were compared between pre-pectoral and sub-pectoral implant-IBR in univariate and multivariate analysis. We performed 316 implant-IBR, 218 sub-pectoral and 98 (31%) pre-pectoral. Pre-pectoral implant-IBR was significantly associated with the year (2021: OR=12.08 and 2022: OR=76.6), the surgeons and type of mastectomy (SSM vs NSM: OR=0.377). Complications and complications Grade 2-3 rates were 12.9% and 10.1% for sub-pectoral implant-IBR respectively, without significant difference with pre-pectoral implant-IBR: 17.3% and 13.2%. Complications Grade 2-3 were significantly associated with age <50-years (OR=2.27), ASA-2 status (OR=3.63) and cup-size >C (OR=3.08), without difference between pre and sub-pectoral implant-IBR. Durations of surgery were significantly associated with cup-size C and >C (OR=1.72 and 2.80), with sentinel lymph-node biopsy and axillary dissection (OR=3.66 and 9.59) and with sub-pectoral implant-IBR (OR=2.088). Median hospitalization stay was 1 day, without difference between pre and sub-pectoral implant-IBR. Cost of surgery was significantly associated with cup-size > C (OR=2.216) and pre-pectoral implant-IBR (OR=8.02). Bad-medium satisfaction and IBR-failure were significantly associated with local recurrence (OR=8.820), post-mastectomy radiotherapy (OR=1.904) and sub-pectoral implant-IBR (OR=2.098). Conclusion: Complications were not different between pre and sub-pectoral implant-IBR. Pre-pectoral implant-IBR seems a reliable and faster technique with better patient satisfaction but with higher cost.

Contribution of endocrine therapy in oestrogen receptor-positive pT1a-b breast cancer: Results of a retrospective study.

INTRODUCTION: Few data have been reported regarding endocrine therapy (ET) in patients with small pT1a-b ER-postive breast cancer (BC). Thus, we conducted a study to detect possible survival improvements due to ET in such patients. METHODS: Our retrospective observational study included 5545 patients with pT1a-b ER-positive BC treated in 15 French centres, excluding patients with HER2-positive status, neoadjuvant chemotherapy, ER-negative status, unknown pN status or in situ BC. We estimated disease-free survival (DFS), recurrence-free survival (RFS) and overall survival (OS) via univariate analysis and multivariate Cox regression. RESULTS: Most patients (80.3%: 4453) received ET and-when compared to those without ET-experienced increases of 2.5% and 3.3% in DFS and 1.9% and 4.3% in RFS after 5 and 7 years of follow-up, respectively, with little difference in OS. In Cox regression analysis, no ET was significantly associated with decreased DFS (hazard ratio, HR = 1.275, p = 0.047, 95% CI[1.003-1.620]) but not OS or RFS in all patients, while in 2363 patients with pT1a-b ER-positive grade 2-3 BC, no ET was significantly associated with decreased DFS (HR = 1.502, p = 0.049, 95% CI[1.001-2.252]), but not OS (HR = 1.361, p = 0.272). ET omission was not significantly associated with decreased survival in 3047 patients with pT1a-b ER-positive grade 1 BC. CONCLUSION: Our results indicate that while ET provided a beneficial impact on survival to patients with pT1a-bN0 ER-positive BC-and especially in those with grade 2-3 tumours-no such impact was observed in grade 1 tumours. Consequently, ET should be discussed with these patients, particularly in those with pT1a grade 1 tumours.

Pathological complete response rate and disease-free survival after neoadjuvant chemotherapy in patients with HER2-low and HER2-0 breast cancers.

BACKGROUND: Half of HER2-negative breast cancers (BC) show HER2-low expression. The strong efficacy of recent anti-HER2 antibody-drug conjugates (ADC) in HER2-low tumours has risen the interest of HER2-low as a proper BC subtype. Chemosensitivity and prognosis of this subtype are not clear when compared to HER2-0 tumours. We investigated the pathological complete response (pCR) and disease-free survival (DFS) rates in BC patients receiving neoadjuvant chemotherapy for HER2-low or HER2-0 tumours. METHODS: Data were collected from the Institut Paoli-Calmettes database. HER2-low tumours were defined by HER2 IHC score of 1+ or 2+ with negative FISH, and HER2-0 by IHC score of 0. Clinicopathological characteristics, pCR (defined as [ypT0/ypTis] and [pN0sn or ypN0]) and DFS rates were compared between the two cohorts. RESULTS: From Jan/2005 to Jun/2021, 1111 patients receiving neoadjuvant chemotherapy were evaluable. The incidence of HER2-low was 41%, including 63% of hormone receptor (HR)-positive and 37% of HR-negative tumours (p < 0.001). In the whole population, the pCR rate was lower in HER2-low (23%) versus HER2-0 (30%) tumours (p = 0.013), but this association was lost in multivariate analysis. In HR-positive patients, HER2-low negatively impacted pCR rates when compared to HER2-0 (10% vs. 16%, p = 0.046), but not in HR-negatives (46% vs. 42%), and this result was maintained in multivariate analysis. No correlation existed between DFS and HER2-status. CONCLUSION: HER2-low is associated with HR positivity. HER2 status did not impact pCR in HR-negative patients, whereas HER2-low was associated with lower pCR rate in HR-positive patients.

Superior Hemimastectomy with Inferior Pedicle Nipple-Bearing Flap: A Five-Step Surgical Technique.

SUMMARY: Oncoplastic breast surgery is an evolving field combining both breast aesthetic surgery and oncologic breast surgery. It aims to optimize cosmetic outcomes without interfering with oncologic safety. The superior hemimastectomy is a technique that can be considered for large upper-quadrant breast tumors or multifocal and multicentric breast tumors localized in the upper quadrants. As with mastectomy, axillary procedures can be performed through the same incision. The nipple-areola complex can be preserved and reimplanted. Superior hemimastectomy allows wide excision of the breast tissue, but its main disadvantage is the increased risk of necrosis of the free grafted nipple-areola complex. In this article, the authors present the surgical technique of superior hemimastectomy with an inferior pedicle nipple-bearing flap. This technique is presented as a simple five-step algorithm. A modified superior hemimastectomy with nipple-areola complex preservation using an inferior pedicle nipple-bearing flap is an alternative to the classic superior hemimastectomy technique. This modified technique decreases the risk of nipple-areola complex necrosis and preserves better nipple-areola complex sensitivity.

Neoadjuvant Chemotherapy for Breast Cancer: Evolution of Clinical Practice in a French Cancer Center Over 16 Years and Pathologic Response Rates According to Tumor Subtypes and Clinical Tumor Size: Retrospective Cohort Study.

We examined characteristics trends in early breast cancer patients receiving neoadjuvant chemotherapy (NAC) over a 16-year period. Our primary objective was to analyze variations in tumor stage and subtype over time. Secondary objectives included analyses of type of surgery and pathological response, from January 2005 to May 2021, 1623 patients receiving NAC were identified. Three periods were determined: 2005-2009 (P1), 2010-2014 (P2), 2015-2021 (P3). Correlations between periods and patient features with cT stage, pathological breast and axillary node response, pathological complete response (pCR), and type of surgery were assessed in univariate and multivariate analyses. We observed a significant increase in cT0-1 and N0 stages with periods (from 6.8% at P1 to 21.2% at P3, and from 43.2% at P1 to 55.9% at P3, respectively) and in the proportion of HER2+ and triple negative (TN) subtypes. In a multivariate analysis, a decrease of cT2-3-4 tumors during P3 was observed for HER2+ (OR:0.174; p=0.004) and TN tumors (OR:0.287; p=0.042). In-breast pCR and pCR were observed in 40.8% and 34.4% of all patients, respectively, with strong association with tumor subtypes, but not with tumor size in multivariate analysis (37.0% pCR for cT0-1 tumors, 36.4% for cT2 tumors, 29.1% for cT3 tumors (cT0-1 versus cT≥2; p=0.222)). pCR was negatively associated with cN1 stage (OR:1.499; p<0.001 for cN1 patients compared to cN0). We observed an increase in the proportion of small cT0-1 and N0 stages treated with NAC, especially in HER2+ and TN subtypes. No significant impact of tumor size on pCR rates was found.

Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial.

Based on results of clinical trials, completion ALND (cALND) is frequently not performed for patients with breast conservation therapy and one or two involved sentinel nodes (SN) by micro- or macro-metastases. However, there were limitations despite a conclusion of non-inferiority for cALND omission. No trial had included patients with SN macro-metastases and total mastectomy or with >2 SN macro-metastases. The aim of the study was too analyze treatment delivered and pathologic results of patients included in SERC trial. SERC trial is a multicenter randomized non-inferiority phase-3 trial comparing no cALND with cALND in cT0-1-2, cN0 patients with SN ITC (isolated tumor cells) or micro-metastases or macro-metastases, mastectomy or breast conservative surgery. We randomized 1855 patients, 929 to receive cALND and 926 SLNB alone. No significant differences in patient's and tumor characteristics, type of surgery, and adjuvant chemotherapy (AC) were observed between the two arms. Rates of involved SN nodes by ITC, micro-metastases, and macro-metastases were 5.91%, 28.12%, and 65.97%, respectively, without significant difference between two arms for all criteria. In multivariate analysis, two factors were associated with higher positive non-SN rate: no AC versus AC administered after ALND (OR = 3.32, p < 0.0001) and >2 involved SN versus ≤2 (OR = 3.45, p = 0.0258). Crude rates of positive NSN were 17.62% (74/420) and 26.45% (73/276) for patient's eligible and non-eligible to ACOSOG-Z0011 trial. No significant differences in patient's and tumor characteristics and treatment delivered were observed between the two arms. Higher positive-NSN rate was observed for patients with AC performed after ALND (17.65% for SN micro-metastases, 35.22% for SN macro-metastases) in comparison with AC administered before ALND.

Robotic Versus Conventional Nipple-Sparing Mastectomy With Immediate Breast Reconstruction.

BACKGROUND: Several studies reported the feasibility and safety of robotic-NSM (R-NSM). The aim of our prospective study was to compare R-NSM and conventional-NSM (C-NSM). METHODS: We analyzed patients who were operated on with and without robotic assistance (R-NSM or C-NSM) and who received immediate breast reconstruction (IBR) with implant or latissimus dorsi-flap (LDF). The main objective was complication rate and secondary aims were post-operative length of hospitalization (POLH), duration of surgery, and cost. RESULTS: We analyzed 87 R-NSM and 142 C-NSM with implant-IBR in 50 and 135 patients, with LDF-IBR in 37 and 7 patients, respectively. Higher durations of surgery and costs were observed for R-NSM, without a difference in POLH and interval time to adjuvant therapy between R-NSM and C-NSM. In the multivariate analysis, R-NSM was not associated with a higher breast complication rate (OR=0.608) and significant factors were breast cup-size, LDF combined with implant-IBR, tobacco and inversed-T incision. Grade 2-3 breast complications rate were 13% for R-NSM and 17.3% for C-NSM, significantly higher for LDF combined with implant-IBR, areolar/radial incisions and BMI>=30. A predictive score was calculated (AUC=0.754). In logistic regression, patient's satisfaction between C-NSM and R-NSM were not significantly different, with unfavorable results for BMI >=25 (OR=2.139), NSM for recurrence (OR=5.371) and primary breast cancer with radiotherapy (OR=4.533). A predictive score was calculated. In conclusion, our study confirms the comparable clinical outcome between C- NSM and R-NSM, in the price of longer surgery and higher cost for R-NSM. Predictive scores of breast complications and satisfaction were significantly associated with factors known in the pre-operative period.

Mastectomy with immediate breast reconstruction: Results of a mono-centric 4-years cohort.

INTRODUCTION: Oncological safety, quality of life and cosmetic outcomes seems to be similar between breast conserving surgery (BCS) and mastectomy with immediate breast reconstruction (IBR). We report our experience of IBR for consecutive mastectomies realized in a recent period of four years in order to determined immediate surgical results according to type of mastectomy and type of reconstruction, as mains objectives. METHODS: All mastectomies with IBR during years 2016-2019 were included. A retrospective analysis with prospective data collection was performed. RESULTS: We analyzed 748 IBR: 353 nipple-sparing mastectomies (NSM), 391 skin-sparing mastectomies (SSM) and 4 standard mastectomies, 551 with definitive implant or expanders and 196 with latissimus dorsi-flap (LDF). More NSM were performed during the 2 last years and more LDF were performed for high BMI, high breast cup-size, neo-adjuvant chemotherapy and radiotherapy and local recurrence. We realized 111 robotic NSM and 125 robotic LDF. Longer duration of surgery was significantly associated with the robotic procedures.The overall complications crude rate was 31.4% with 9.9% of re-operations and 5.8% of implant loss. Grade 2-3 complications were significantly associated with smoking. Breast complications occurred in 32.9% of mastectomies with principally skin or nipple-areola-complex suffering or necrosis, hematomas and infections. A predictive score was determined to evaluate risk of complications before surgery. CONCLUSION: Mastectomy with IBR seems to be a safe technique with an acceptable complication rate which is increased by tobacco use, high breast cup-size and IBR-type.

Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions.

BACKGROUND: Diagnosis of atypical breast lesions (ABLs) leads to unnecessary surgery in 75-90% of women. We have previously developed a model including age, complete radiological target excision after biopsy, and focus size that predicts the probability of cancer at surgery. The present study aimed to validate this model in a prospective multicenter setting. - METHODS: Women with a recently diagnosed ABL on image-guided biopsy were recruited in 18 centers, before wire-guided localized excisional lumpectomy. Primary outcome was the negative predictive value (NPV) of the model. RESULTS: The NOMAT model could be used in 287 of the 300 patients included (195 with ADH). At surgery, 12 invasive (all grade 1), and 43 in situ carcinomas were identified (all ABL: 55/287, 19%; ADH only: 49/195, 25%). The area under the receiving operating characteristics curve of the model was 0.64 (95% CI 0.58-0.69) for all ABL, and 0.63 for ADH only (95% CI 0.56-0.70). For the pre-specified threshold of 20% predicted probability of cancer, NPV was 82% (77-87%) for all ABL, and 77% (95% CI 71-83%) for patients with ADH. At a 10% threshold, NPV was 89% (84-94%) for all ABL, and 85% (95% CI 78--92%) for the ADH. At this threshold, 58% of the whole ABL population (and 54% of ADH patients) could have avoided surgery with only 2 missed invasive cancers. CONCLUSION: The NOMAT model could be useful to avoid unnecessary surgery among women with ABL, including for patients with ADH. CLINICAL TRIAL REGISTRATION: NCT02523612.

Types of Mastectomies and Immediate Reconstructions for Ipsilateral Breast Local Recurrences.

Purpose: Ipsilateral-breast-local-recurrence (ILBLR) is a rare event with little data on immediate-breast-reconstruction (IBR). We report post-operative results of different types of mastectomy for ILBLR with or without IBR performed during a period of 40 months in order to analyze post-operative complications as main objective. Methods: We analyzed mastectomies performed for ILBLR after initial breast conservative treatment from January 2016 to April 2019. The characteristics of patients, surgery, complication rate, postoperative hospitalization have been determined. Results: Of the 207 mastectomies, 32.8% had an IBR: 31 nipple-sparing-mastectomy (NSM) and 37 skin-sparing-mastectomy (SSM) with 37 latissimus-dorsi-flap (LDF) IBR and 31 implant-IBR. Few reconstruction was performed for patients with body-mass-index ≥30 (OR = 0.214), infiltrating ductal carcinomas (OR = 0.272) and ASA-3 patients (OR = 0.254). In multivariate analysis, LDF-IBR was more often realized for NSM and for patients with BMI ≥25. The overall complication rate was 37.4%: 45.6 and 33.1% with and without IBR, respectively (p = 0.056). In multivariate analysis, BMI ≥25 (OR 2.02, p = 0.023), IBR (OR 1.9, p = 0.046) and tobacco (OR 2.17, p = 0.055) were correlated with higher risk of complications. There was no difference for Grade 2-3 complications rates for IBR and no IBR, respectively (14.7%: 10/68 and 9.3%: 13/139). In multivariate analysis, overall survival from date of mastectomy for local recurrence was significantly associated with interval time to local recurrence (OR 6.981). Conclusion: Salvage mastectomy and IBR is a good choice for ILBLR, particularly using flap reconstruction. NSM can be considered as a good option in selected patients for ILBLR for NSM and/or LDFR.

Robotic-assisted skin sparing mastectomy and immediate reconstruction using latissimus dorsi flap a new effective and safe technique: A comparative study.

INTRODUCTION: Breast reconstruction is an essential part of breast cancer treatment. After skin sparing mastectomy, Immediate Breast Reconstruction (IBR) can be achieved using breast implants, autologous flaps (i.e. latissimus dorsi-myo-cutaneous flap (LDF)) or an association of both. Robotic assistance has gained popularity in many surgical fields including breast surgery. This study aims to compare the post-operative results of Robotic Assisted Latissimus Dorsi Flap (RALDF) to Traditional Latissimus Dorsi Flap (TLDF) for IBR after Skin Sparing Mastectomy (SSM) without nipple conservation. MATERIALS AND METHODS: Between March 2016 and June 2019, all patients who underwent a SSM and a concurrent IBR with a TLDF were retrospectively compared to patients who underwent SSM and a concurrent IBR with a RALDF. Outcomes compared included operative time, length of hospital stay and complications rate. RESULTS: 105 cases of SSM with a LDF based IBR were included in the study. 46 patients underwent RALDF and 59 patients underwent TLDF. Mean operative time was longer in the RALDF group (290.5min versus 259.7min). In binary regression, the concomitant placement of breast implant was the only factor associated with an operative time exceeding 290 min (p = 0.032). Univariate analysis showed no significant difference concerning the rate of complications (p = 0.061). After logistic regression, RALDF was associated with a decreased rate of complications (p = 0.042; OR 0.37; IC 95% (0.142-0.966)). DISCUSSION: SSM with IBR using RALDF is an effective and safe technique. This technique is actually associated with a lower complication rate at the expense of a longer operative time.

External Validation of the SERC Trial Population: Comparison with the Multicenter French Cohort, the Swedish and SENOMIC Trial Populations for Breast Cancer Patients with Sentinel Node Micro-Metastasis.

Many trials confirmed the safety of omitting axillary dissection in the selected patients treated for early breast cancer. The external validity of these trials is questionable. Our study aimed to evaluate the accuracy of the French population representativity in the SERC trial and the differences between these two populations as well as comparing the French and the Swedish populations (the SENOMIC trial population and the Swedish National Breast Cancer Registry (NKBC) cohort) of patients with sentinel node (SN) micro-metastasis. A higher rate of smaller tumors and grade 1 tumors was observed in the French cohort when compared to the SERC population. Our findings conclude that both French populations show similar characteristics. Positive non-sentinel node (NSN) rates at completion axillary lymph node dissection (ALND) were 10.28 % and 11.3 % in the SERC trial and French cohort, respectively (p = 0.5). The rate of grade 1 tumors was lower in the SENOMIC trial (16.2%) and in the NKBC cohort (17.4%) compared to the SERC trial population (27.3%) and the French cohort (34.4%). Our findings in addition to the previously demonstrated concordance between the SENOMIC trial and the NKBC populations imply that the results of both the SERC and the SENOMIC trials can be applied to both French and Swedish real populations.

When to do surgical resection for atypical breast lesions: Results of a prospective cohort of 518 lesions.

AIM: There is no consensual indication for surgical resection after diagnosis on per-cutaneous biopsy of borderline breast lesions (B3). We evaluate under-evaluation rate of per-cutaneous biopsy and predictive factors of under-evaluation. We analyze accuracy of reported decision-making tools. METHODS: We conduct a prospective multicentric study including, atypic-ductal hyperplasia (ADH), atypic-lobular hyperplasia (ALH), atypic-cylindro-cubic metaplasia (FEA), papilloma, radial scars (RS) and phyllod tumors. When several B3 lesions were associated, the more severe lesion was used to classify the lesion. We determined breast cancers (BC) rate and histologic type. Among 478 patients, 518 B3 lesions were studied: 15.1% (78) FEA, 48.6% (252) ADH, 16.8% (n = 87) ALH, 5.4% (n = 28) RS, 12% (n = 62) papilloma, 0.8% (n = 4) phyllod tumors and 0,8% (n = 4) with a suspicious low grade DCIS. More than 1 lesion was identified in 31.9% (165) of cases. A surgical resection was performed for 86.3% (447/518) lesions. Significant factors of surgical resection were: residual micro-calcification after biopsy (OR: 2.7) and type of B3 lesion. RESULTS: Overall BC rate was 15.3% (68/445) with 79.4% (54) in-situ carcinomas. According to B3 lesions, BC rates were 12.9% for FEA, 20% for ADH, 11.6% for ALH, 3.7% for RS, 8.8% for papilloma and 25% for suspicious in-situ carcinoma. A score has been calculated and patients were distributed in 3 groups. Patient's rates without BC were respectively: 100%, 80.4% and 80.6% (p = 0.029). CONCLUSION: In conclusion, it could be suggested to avoided complementary surgical resection in case of good radio-pathologic concordance and low probability of BC.