Palpable Nodules After Autologous Fat Grafting in Breast Cancer Patients: Incidence and Impact on Follow-up.

INTRODUCTION: Autologous fat grafting (AFG) is a promising breast reconstruction technique, following surgery. However, fat necrosis after AFG can cause palpable nodules, inducing anxiety and prompting additional investigations. We aimed to determine the occurrence rate and to identify the risk factors of palpable nodules in breast cancer patients prompting complementary explorations. MATERIALS AND METHODS: We retrospectively reviewed the computerized files of consecutive breast cancer patients who underwent AFG after mastectomy or breast conservative treatment (BCT) at our center from January 2013 to December 2016. We collected data regarding palpable nodule incidences and suspicious breast imaging findings that led to additional explorations. RESULTS: Of the 252 patients reviewed, 222 (88%) underwent AFG for breast reconstruction, while 30 (12%) underwent AFG for correction of defects after BCT. The follow-up period ranged from 0 to 74 months (median: 27 months), and 201 patients had follow-ups beyond 1 year. Of the 252 patients, 66 (26.2%) underwent at least one control imaging and 24 (10%) underwent a biopsy, including 6 (2.4%) locoregional recurrence. Sixty patients (24%) were diagnosed with nodules during follow-ups. Among them, 52 (87%) patients had additional imaging, and 17 patients (28%) had a biopsy, including 82% benign histology. Patients with BCT had significantly more palpable nodules at 1 year than patients who underwent total mastectomy (odds ratio = 2.50, 95% confidence interval: 1.04. 6.03, p = 0.04). CONCLUSION: This study underlines the importance of preoperative patient information. This intervention and its follow-up should be reserved for experienced teams to limit unnecessary additional explorations. 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 .

Functional Cerebral MRI Evaluation of Integration of Breast Reconstruction into the Body Schema.

BACKGROUND: The objective of breast reconstruction (BR) is to erase the after-effects of total mastectomy by allowing patients to restore their breast shape. The aim of our study was to investigate the body map integration of different types of BR using functional magnetic resonance (fMRI). PATIENTS AND METHODS: We prospectively enrolled all women undergoing BR for breast cancer to the Remasco study (NCT02553967). Participants were categorized into four groups according to the standard of care they required: immediate BR (IBR), delayed BR (DBR), flap (autologous), or implant BR. Each patient performed sensorimotor tasks during the fMRI acquisition. RESULTS: Data of 38 patients were analyzed. We identified the cingulate region as the area of interest in the brain. In the case of DBR, the brain area activated during palpation of the total mastectomy scar (before BR) was different from the brain area activated during palpation of the reconstructed breast (Brodmann areas 31 versus 32). Palpation of the native breast and reconstructed breast activated the same Brodmann area 32. Comparing the brain activation signal during palpation of the native breast and the reconstructed breast did not reveal any significant difference in the overall population (P = 0.41) or in the groups: autologous (P = 0.32), implant (P = 0.10), IBR (P = 0.72), or DBR (P = 0.10). CONCLUSIONS: This experimental study allowed us to describe and understand the brain plasticity processes that accompany BR. The results suggest that the reconstructed breast is integrated into the body schema, regardless of the type of BR or the timing.

Decision-making determinants for breast reconstruction in women over 65 years old.

Despite the positive effects that breast reconstruction (BR) has on quality of life, access to it remains limited for older women. The aim of this study was to identify decision-making determinants for BR in women over 65 years old, using a specifically designed questionnaire. We included in a case-control study 134 patients treated by mastectomy for breast cancer with or without BR in a cancer center performing BR. We showed higher motivation scores and quality of delivered information in the BR group. Surgeons are a key in convincing elderly patients that their age should no longer be an obstacle to BR.

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node.

BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.

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.

Reducing the seroma volume by quilting suture after breast reconstruction with a latissimus dorsi flap: Single institutional experience.

INTRODUCTION: After breast reconstruction (BR) with latissimus dorsi flap (LDF) postoperative seroma is a frequent source of functional discomfort. The aim of this study was to evaluate the quilting suture on reducing the seroma volume by reducing the dead space created by LDF harvest for BR. MATERIAL AND METHODS: This retrospective monocenter study was designed to compare patients who underwent BR using LDF with or without quilting suture. The primary endpoint was the seroma volume drained during hospitalization and percutaneous puncture. Complications and painful or functional sequelae were also evaluated in both groups. RESULTS: One hundred eight patients were included in the study. The mean (standard deviation, SD) age of our population was 49.7 years (9.3) and the mean body mass index (BMI) 26.9kg/m2 (4.1). Sixty-nine patients (63%) underwent quilting suturing in the latissimus dorsi compartment, 41% with overedge and 59% with simple stitches. The mean total volume of fluid drainage was 1238mL (1111). In multivariate analysis, the use of quilting suture was associated with a significant reduction in the total volume of drainage (-502mL, P=0.03); reduction was greater using overedge stitches than simple stitches (P=0.02). The beneficial effect of quilting suture appears to be more important in patients with a BMI greater than 30kg/m2 (interaction test, P=0.01). CONCLUSION: This study shows the efficacy of quilting suture in reducing postoperative seroma formation in BR using LDF. Efficacy was greater when overedge stitches were used. Obese patients benefited more from quilting suture than patients with BMI<25.

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.

Variations in the breast reconstruction rate in France: A nationwide study of 19,466 patients based on the French medico-administrative database.

BACKGROUND: Access to breast reconstruction (BR) surgery after a mastectomy remains limited, with a large degree of national and international variation despite its known psychological benefits and impact on quality of life. The aim of this study was to investigate the factors influencing breast reconstruction in France where cancer-related healthcare costs are fully reimbursed. METHODS: All primary mastectomies for breast carcinoma performed in 2012 and linked BR surgeries from 2012 to December 2015 were extracted from the French medico-administrative database. A three-level logistic regression analysis was performed to model the probability of breast reconstruction according to patient, hospital and administrative region characteristics. RESULTS: Among the 19,466 women who had a mastectomy in 2012, 5328 (27.4%) had breast reconstruction. Multivariate analysis showed that the BR rate was lower in patients living in an area with an unfavourable socioeconomic level (p < .001), in low volume hospitals (p < .001), and in public hospitals (18.6%) compared to private hospitals (25.9%), university hospitals (29.8%), and cancer centres (35.0%) (p < .001). BR rate was significantly lower in patients older than 65 compared to those younger (7.5% versus 42.1%, p < .001). The impact of age was even greater in public hospitals than in other centres (interaction test, p = .001). We also observed significant heterogeneity in the BR rate across regions, which could be partially explained by differences in the plastic surgeon density. CONCLUSIONS: Breast reconstruction rate heterogeneity could be attributed to women choice. However, our study suggests that unequal access to high-quality procedures also plays a role, particularly for older breast cancer women.

Fluorescence diagnosis of cervical squamous intraepithelial lesions: A clinical feasability study.

UNLABELLED: The potential of fluorescence diagnosis (FD) is still undeveloped in gynaecology. In order to diagnose and localize squamous intraepithelial lesion (SIL) of the cervix, a new method improving the low specificity of colposcopy, would be useful. OBJECTIVE: The goal of this study was to assess the feasability and safety of colposcopic FD of SIL after topicaly application of methyl aminolevulinate (MAL). MATERIALS AND METHODS: Patients with histologic proved cervical intraepithelial neoplasia (CIN) and planned for loop electrosurgical excision procedure (LEEP) under general anesthesia, were included in a prospective study. Before general anesthesia, a thick layer of MAL (Metvix(®)-160mg/mL cream) was applied on the cervix for 35-150min. Fluorescent colposcopic inspection of the cervix was performed using a rigid 10-mm laparoscope inserted in the vaginal cavity and connected to D-light AF system (Karl Storz Endoskope, Tuttlingen Germany). In order to confirm neoplasic status, fluorescent foci underwent directed punch biopsy(ies). RESULTS: Fourteen patients were included in the study. Colposcopic fluorescence imaging revealed red fluorescent foci in 71.4% of cases (10/14) (neoplasic status of fluorescent foci was confirmed in 80%). Concerning ME-ALA, the mean of application time was 73min (35-150). Two cases presented a false-positive fluorescence and four cases of false-negative fluorescence. For all cases of false-negative fluorescence, application time of MAL was less than 60min. We observed no systemic or local toxicity of MAL application in any of the groups. CONCLUSION: Using topical application of MAL to the cervix, we demonstrated that FD of SIL is feasible. This study justifies the further development of fluorescence imaging that combines classical white light colposcopy with the use of a photosensitizer.

Comparison of aminolevulinic acid- and hexylester aminolevulinate-induced protoporphyrin IX fluorescence for the detection of ovarian cancer in a rat model.

OBJECTIVES: This study set out to compare the photodetection of peritoneal micrometastases in an ovarian cancer model following administration of two precursors of protoporphyrin IX (PpIX): 5-aminolevulinic acid (ALA) and hexylester aminolevulinate (He-ALA). METHODS: ALA or He-ALA (100 mg/kg) was injected into the peritoneal cavity of 16 rats with induced peritoneal metastases of ovarian cancer. Two hours later, the tumors were visualized laparoscopically using both white light for standard exploration and blue light for fluorescence. Peritoneal micrometastases were counted. Fluorescence intensities of tumoral and normal surrounding tissues were compared. The distribution of PpIX throughout the peritoneum was studied on frozen biopsies using fluorescence microscopy and correlated with pathological findings. RESULTS: The number of micrometastases detected by the fluorescence blue mode was significantly higher (p < 0.05) than with standard white light for both ALA (235 versus 198) and He-ALA application (248 versus 199). The mean fluorescence intensity ratio between tumor and normal surrounding tissue was significantly (p < 0.05) higher for He-ALA (1.55 +/- 0.1) compared to ALA (1.45 +/- 0.1). Fluorescence microscopy confirmed that the PpIX fluorescence remained limited to cancer cells. Macroscopically fluorescing nodules were histopathologically confirmed as malignant. CONCLUSION: He-ALA is an excellent precursor for PpIX synthesis, giving the highest PpIX fluorescence contrast between normal and tumoral peritoneal tissues. Imaging with He-ALA improves the detection of peritoneal metastases compared to ALA.