Impact of Ovarian Cancer Surgery Volume on Overall and Progression-Free Survival: A Population-Based Retrospective National French Study.

BACKGROUND: Data are limited on the relationship between ovarian cancer surgery volume and outcomes in France. METHODS: For this retrospective, population-based study, patients with ovarian cancer that was diagnosed between January 1, 2012 and December 31, 2016 were identified from the French National Health Data System (SNDS). Hospitals were classified in function of their ovarian cancer surgery volume. Patient, tumor, hospital, and hospital stay characteristics also were evaluated. The hospital procedure volume effect on 5-year overall survival (OS) and recurrence-free survival (RFS) was determined with Cox-proportional hazards models. RESULTS: This study included 8429 patients and 53.4% underwent cytoreductive surgery in hospitals with procedure volume < 20 cases/year. The 5-year OS rates were 63% and 60% in hospitals with procedure volume ≥ 20 and < 20 cases/year (p = 0.02). In multivariate analysis, OS and RFS were significantly increased when surgery was performed in hospitals doing ≥ 20 surgeries/year (vs. < 20) (hazard ratio HR = 1.18, 95% CI = 1.08-1.29 and HR = 1.10, 95% CI = 1.03-1.17). In the volume subgroup analysis, a difference was observed mainly between hospitals with < 10 surgeries/year and the other hospitals (HR = 1.27, 95% CI = 1.14-1.41 and HR = 1.14, 95% CI = 1.05-1.23). The patients' age and comorbidities, tumor stage, and hospital stay (duration, first cytoreduction surgery) were associated with OS. CONCLUSIONS: Ovarian cancer surgery volume ≥ 20 cases/year was significantly associated with improved OS and RFS but only with a limited clinical benefit. The biggest differences in OS and RFS were observed between hospitals with procedure volume < 10 cases/year and all the other hospitals.

Evaluation of breast skin and tissue stiffness using a non-invasive aspiration device and impact of clinical predictors.

A personalized 3D breast model could present a real benefit for preoperative discussion with patients, surgical planning, and guidance. Breast tissue biomechanical properties have been poorly studied in vivo, although they are important for breast deformation simulation. The main objective of our study was to determine breast skin thickness and breast skin and adipose/fibroglandular tissue stiffness. The secondary objective was to assess clinical predictors of elasticity and thickness: age, smoking status, body mass index, contraception, pregnancies, breastfeeding, menopausal status, history of radiotherapy or breast surgery. Participants were included at the Montpellier University Breast Surgery Department from March to May 2022. Breast skin thickness was measured by ultrasonography, breast skin and adipose/fibroglandular tissue stiffnesses were determined with a VLASTIC non-invasive aspiration device at three different sites (breast segments I-III). Multivariable linear models were used to assess clinical predictors of elasticity and thickness. In this cohort of 196 women, the mean breast skin and adipose/fibroglandular tissue stiffness values were 39 and 3 kPa, respectively. The mean breast skin thickness was 1.83 mm. Only menopausal status was significantly correlated with breast skin thickness and adipose/fibroglandular tissue stiffness. The next step will be to implement these stiffness and thickness values in a biomechanical breast model and to evaluate its capacity to predict breast tissue deformations.

Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial.

INTRODUCTION: Hormone therapy (HT) is a major adjuvant treatment for breast cancer. Despite their effectiveness, aromatase inhibitors can cause several side effects, including arthralgia in 35%-50% of patients. These side effects frequently lead to the premature discontinuation of HT. Whole-body cryotherapy (WBC) can be used for managing arthritic pain. The primary objective of this study will be to evaluate the effect of WBC on aromatase-induced joint pain, compared with placebo cryotherapy, in patients with hormone-dependent breast cancer receiving adjuvant aromatase inhibitors. The secondary objectives will be to evaluate WBC safety and its effect on analgesic consumption, HT adherence and quality of life. METHODS AND ANALYSIS: In this randomised, placebo-controlled, double-blinded clinical trial, 56 patients with aromatase inhibitor-induced joint pain and a Brief Pain Inventory-Short Form (BPI-SF) score ≥3 for the worst pain experienced in the previous week will be randomised into the WBC or placebo cryotherapy arm (10 sessions in each group). The primary outcome will be the BPI-SF score at week 6 post-treatment. The secondary outcomes will include the BPI-SF scores at months 3 and 6 post-treatment, the BPI-SF pain severity index and pain interference index, the Health Assessment Questionnaire score, the number of days of aromatase inhibitor treatment and analgesic consumption in the 15 days before the visits at week 6 and months 3 and 6 after cryotherapy. The incidence of adverse events will also be investigated. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee Est IV of Hospital Civil, Strasbourg, France. Protocol V.5 was approved in December 2022. The results will be disseminated in a peer-reviewed journal and presented at international congresses. TRIAL REGISTRATION NUMBER: NCT05315011.

Anatomical knowledge retention in Obstetrics and Gynaecology residents and impact of an e-learning tool.

PURPOSE: Anatomical knowledge of medical students and residents is insufficient and further anatomical sciences throughout medical curriculum may be necessary. The first aim of this study was to assess pelvic and perineal anatomical knowledge retention of Obstetrics and Gynaecology (Ob/Gyn) residents. The second was to assess the impact of an e-learning tool on anatomical knowledge. METHODS: A survey was sent by mail to medical students and Ob/Gyn residents. After completion, Ob/Gyn residents were randomised to "e-learning" group or to "Control" group. "E-learning" group had an unlimited access to a tool about female pelvic and perineum anatomy, implemented by iMAIOS society in their online platform. A second assessment of residents' anatomical knowledge was done 2 months after randomisation. RESULTS: Ob/Gyn residents (N = 23) had a significant lower global score than third-year medical students (N = 103) (22.1% (± 10.2) vs 43.8% (± 12.1), p < 0.0001). Two months after randomisation, residents of "control" group demonstrated no significant difference between the two questionnaires (3.6%, p = 0.31), whilst the "e-learning" group demonstrated a significant increase overall (10.6%, p = 0.09). There was no significant difference on the post-intervention questionnaire between control and "e-learning" group (25.4% vs 33% respectively, p = 0.34). CONCLUSION: Knowledge of pelvic and perineal anatomy is poor. This e-learning tool aimed at improving anatomical knowledge retention but is not sufficient. A combination of traditional approaches and innovative solutions should be proposed throughout medical school and residency to maintain anatomical knowledge.

Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study.

The recurrence of non-metastatic endometrial carcinoma (EC) (6 to 21%) might be due to disseminated tumor cells. This feasibility study investigated whether circulating tumor cells (CTCs) were detectable in blood samples from the peripheral and ovarian veins of 10 patients undergoing laparoscopic resection of stage I-II EC between July 2019 and September 2021. CTCs were detected using the CellSearch® system (i) preoperatively (T0) in peripheral blood, (ii) after ovary suspensory ligament pediculation in ovarian vein blood (T1), and (iii) before colpotomy in peripheral blood (T2). CTCs were detected only in ovarian vein samples in 8/10 patients. The CTC median number did not differ with patient age (37 (min-max: 0-91) in <70-year-old vs. 11 (0-65) in ≥70 year-old women, p = 0.59), tumor grade (15 (0-72) for grade 1 vs. 15 (0-91) for grade 2, p = 0.97), FIGO stage (72 (27-91) vs. 2 (0-65) vs. 3 (0-6]) for stage IA, B, and II, respectively; p = 0.08), and tumor size (40 (2-72) for size < 30 mm vs. 4 (0-91) for size ≥ 30 mm, p = 0.39). Estrogen receptor-positive CTCs and CTC clusters were identified. The prognostic and therapeutic values of CTCs released during EC surgery need to be determined.

Long-term quality of life after surgical Essure removal for device-attributed symptoms.

OBJECTIVE: To analyze quality of life(QoL) and symptom resolution after surgical removal of Essure devices. METHODS: Single-center cohort study which included patients with Essure removal between February 2017 and March 2018. Surgery was performed in 65 patients by laparoscopy (Salpingectomy only or Hysterectomy). Questionnaires were used to assess QoL(SF-36), emotional disorders(HAD) and symptoms preoperatively, at 3 months and 4 years postoperatively. RESULTS: 4(6,1%) and 16(24,6%) patients were lost of follow-up at three months and 4 years postoperatively respectively. Four(6,1%) intraoperative surgical complications occurred. During the three-months postoperative period, 3(4,6%) complications occurred: five Clavien Dindo Grade 1 complications (umbilical hematoma) and one Grade 2 complication (hyperthermia and digestive disorder requiring antibiotic therapy). Preoperative QoL scores were lower than those of general population. Scores were significantly improved at 3 months and 4 years postoperatively. At 4 years postoperatively, 17/49(34,7%) had a complete regression of symptoms, 21/49(42,8%) partial resolution and 11/49(22,4%) no improvement. 27/49(55,1%) patients made the connection between symptoms and ESSURE device after media coverage. 22/49(44,89 %) were influenced by media coverage in their decision of surgery. There was a higher percentage of patients with anxiety disorder before Essure removal than 4 years after [22/44 (50 %) versus 11/44 (25 %); p = 0.0045]. CONCLUSION: Essure removal has a restorative role in terms of QoL in short and long-term. Patients should be informed about possibility of no improvement after surgery and surgical morbidity. Larger prospective cohort is needed to make a well-considered decision about risks of surgery compared with expected benefits.

Fertility preservation in patients of childbearing age treated for breast cancer: A nationwide cohort study.

BACKGROUND: Approximately 7% of breast cancers are diagnosed in women under 40. Question of subsequent fertility has become fundamental. We aimed to evaluate the rate of fertility preservation (FP) by oocyte retrieval (OR) after ovarian stimulation in patients of childbearing age, managed for breast cancer with adjuvant chemotherapy in France, reuse rate of frozen gametes and live births rate (LBR) after treatment. METHODS: We included 15,774 women between 18 and 40 years old, managed by surgery and adjuvant chemotherapy for breast cancer, between January 2011 and December 2020 from a French health registry. Patients with OR after breast surgery and before chemotherapy were considered as FP group; those with no OR as no FP group. To compare LBR with French population independently of age, we calculated Standardized Incidence Rates (SIR) of live births using indirect standardization method. RESULTS: FP rate increased gradually since 2011, reaching 17% in 2019. A decrease in use was observed in 2020 (13,9%). Among patients with at least 2 years of follow-up, gamete reuse rate was 5,6%. Births after cancer were mostly from spontaneous pregnancies. Among patients with at least 3 years of follow-up, LBR was 19,6% in FP group, 3,9% in second group. SIR of live births was of 1,05 (95% CI = 0.91-1.19) and 0.33 (95% CI = 0.30-0.36) in FP and no FP group respectively. CONCLUSION: Oncofertility activity increased until 2019 in France, reaching 17%. Gamete reuse rate was low. Births resulted mainly from spontaneous pregnancies. SIR of live births was lower in no FP group.

Interest of para-aortic lymphadenectomy for locally advanced cervical cancer in the era of PET scanning.

BACKGROUND AND OBJECTIVES: Treatment of locally advanced cervical cancer (LACC) involves pelvic chemoradiotherapy, using an extended field in the case of para-aortic involvement. 18-Fluoro-D-glucose positron emission tomography combined with computer tomography (PET-CT) is an accurate method for the detection of metastatic nodes. The objective of this study was to evaluate the performance of PET-CT for lymph node staging of LACC. METHODS: This bicentric retrospective study included patients with LACC who had a PET-CT scan followed by para-aortic lymphadenectomy between January 2015 and December 2019. Based on pathological findings, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) and false-negative (FN) rates of PET-CT for para-aortic node involvement were evaluated. RESULTS: Seventy-one patients who had undergone laparoscopic lymphadenectomy were included in this study. The intraoperative complication rate was 2.8%. Sensitivity, specificity, NPV and PPV for PET-CT were 55% [95% confidence interval (CI) 44.6-67.1], 84% (95% CI 75-92), 93% (95% CI 87-99) and 33% (95% CI 22-44), respectively. FN rates in the case of negative or positive pelvic PET-CT were 5.7% and 9.5%, respectively. CONCLUSIONS: Para-aortic lymphadenectomy is recommended for lymph node staging in the case of negative para-aortic PET-CT. In view of the low FN rate of PET-CT, surgical staging should be discussed regardless of pelvic status if the patient presents high surgical risk, or if this delays the commencement of chemoradiotherapy.

Fertility-sparing management of a suspicion of leiomyosarcoma: avoiding hysterectomy by performing transcervical myoma biopsy.

OBJECTIVE: To describe the fertility-sparing management of an atypical uterine myoma. DESIGN: Step-by-step video explanation of transcervical biopsy using transabdominal ultrasound guidance, highlighting tips and tricks. Patient consent was obtained before the publication of the case. SETTING: University hospital. PATIENT(S): A 32-year-old nulliparous woman with a history of dysmenorrhea was found to have an atypical myoma FIGO 6, with suspicion of leiomyosarcoma on magnetic resonance imaging. INTERVENTION(S): A transcervical biopsy of an atypical myoma was done under transabdominal ultrasound guidance. A myomectomy by a minimally invasive approach was performed without morcellation. MAIN OUTCOME MEASURE(S): Feasibility of transcervical biopsy and correlation with definitive anatomopathological diagnosis. RESULT(S): The patient was under general anesthesia. A hysteroscopy confirmed the normal appearance of the uterine cavity with no direct access to the myoma. Four core biopsies were performed with a 16-gauge needle transcervically under ultrasound guidance. The preliminary diagnosis of cellular leiomyoma allowed a fertility-sparing surgery. Myomectomy and surgical treatment of endometriosis were performed secondarily. This patient had a successful recovery, and the diagnosis of benign cellular leiomyoma was confirmed on the surgical specimen. CONCLUSION(S): The current video highlights the safety and feasibility of transcervical ultrasound-guided core biopsy in patients with atypical uterine fibroids.

Higher Anti-Tumor Efficacy of the Dual HER3-EGFR Antibody MEHD7945a Combined with Ionizing Irradiation in Cervical Cancer Cells.

PURPOSE: The outcome of locally advanced cervical cancer (LACC) is dismal. Biomarkers are needed to individualize treatments and to improve patient outcomes. Here, we investigated whether coexpression of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) could be an outcome prognostic biomarker, and whether targeting both EGFR and HER3 with a dual antibody (MEHD7945A) enhanced ionizing radiation (IR) efficacy. METHODS AND MATERIALS: Expression of EGFR and HER3 was evaluated by immunohistochemistry in cancer biopsies (n = 72 patients with LACC). The antitumor effects of the MEHD7945A and IR combotherapy were assessed in 2 EGFR- and HER3-positive cervical cancer cell lines (A431 and CaSki) and in A431 cell xenografts. The mechanisms involved in tumor cell radiosensitization were also studied. The interaction of MEHD7945A, IR, and cisplatin was evaluated using dose-response matrix data. RESULTS: EGFR and HER3 were coexpressed in only in 7 of the 22 biopsies of FIGO IVB cervix cancer. The median overall survival was 14.6 months and 23.1 months in patients with FIGO IVB tumors that coexpressed or did not coexpress EGFR and HER3, respectively. In mice xenografted with A431 (squamous cell carcinoma) cells, MEHD7945A significantly increased IR response by reducing tumor growth and increasing cleaved caspase-3 expression. In A431 and CaSki cells, the combotherapy increased DNA damage and cell death, particularly immunogenic cell death, and decreased survival by inhibiting the MAPK and AKT pathways. An additive effect was observed when IR, MEHD7945A, and cisplatin were combined. CONCLUSIONS: Targeting EGFR and HER3 with a specific dual antibody enhanced IR efficacy. These preliminary results and the prognostic value of EGFR and HER3 coexpression should be confirmed in a larger sample.

Endoscopic Nipple-Sparing Mastectomy with Immediate Prepectoral Implant-Based Reconstruction: A Case Report.

BACKGROUND Technical innovations allow endoscopic nipple-sparing mastectomy (NSM), which is well tolerated and associated with greater patient satisfaction. Endoscopic technique did not have wide diffusion; many centers have abandoned this technique because of technical challenges. Implant-based reconstruction (IBR) remains the most common form of breast reconstruction. Current techniques involve partial or total coverage of the implant with pectoralis major muscle to prevent exposure or infection. Muscle dissection has functional and cosmetic consequences. CASE REPORT We present a case of 45-year-old patient presenting with personal history of right breast cancer. The patient requested left prophylactic mastectomy. We used a 4 cm-long single hidden scar on axillary line. Endoscopic nipple-sparing mastectomy was done using a single port with 3 sleeves. Immediate breast reconstruction was performed by inserting a silicon implant in prepectoral plane without Acellular Dermal Matrix (ADM). At 6 months postoperatively, no complication had been reported. The patient was satisfied with the result and no further correction was necessary. CONCLUSIONS Endoscopic surgery is a valuable option for nipple-sparing mastectomy. This method is a less expensive alternative technique to robotic approach. It could enable safe prepectoral IBR without placement of ADM and with lower risk of complications.

Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization.

INTRODUCTION: Preoperative localization procedures of occult breast cancer (radioisotopic and wire localization) are invasive and uncomfortable. We have evaluated a novel technique which allows a virtual localization. MATERIAL AND METHODS: Our retrospective study focused on patients treated for occult and unifocal breast cancer from September 2016 to June 2017. All patients had radioisotopic preoperative localization. We included patients who had a preoperative prone Magnetic Resonance Imaging (MRI) and an intraoperative 3D optical scan. During surgery, the surgeon localized the tumor thanks to a gamma detection probe and marked the localization on the skin with a black marker. The breast was then optically scanned. MRI was adjusted to the optical surface to match the exact breast position in the Operating Room. The virtual localization provided by the 3D breast modeling tool was retrospectively compared with the radioisotopic localization, defined as the pen mark visible in the optical scan. RESULTS: Nine patients were included in this feasibility study. Tumors were successfully localized in the respective breast quadrant. The mean cutaneous distance between virtual and radioisotopic localization was 1.4 cm in patients with low breast volume (5/9) and 2.8 cm in those with large breast volume (4/9). CONCLUSION: We developed a research prototype which enables virtual preoperative localization of nonpalpable breast lesions using MRI images and intraoperative optical scanning. Parameter optimization is required and will lead to a precise and noninvasive tool. By adding augmented reality, it will be possible to initiate a prospective study to compare this tool with the traditional localizations.

Ovarian Clear Cell Carcinoma in Cowden Syndrome.

Cowden syndrome (CS) is an autosomal dominant mendelian disease related to germline pathogenic variants affecting the PTEN-gene. CS is characterized by macrocephaly, mucocutaneous lesions, and an increased risk of breast and thyroid cancers. Rare ovarian cancer cases (mostly embryonic tumors) associated with PTEN have been described in the literature, but no current CS guidelines are available for ovarian cancer risk management. We report on a woman diagnosed with ovarian clear cell carcinoma (OCCC) at 28 years of age. The patient displayed macrocephaly, trichilemmomas, oral papillomatosis, and acral keratosis. A family history of multiple cancer cases within the PTEN-related tumor spectrum was identified. In addition, PET scan and fine-needle biopsy results led to a diagnosis of thyroid follicular neoplasia. PTEN sequencing revealed that she carried a germline inherited pathogenic variant in exon 5 c.388C>T, p.(Arg130*) (NM_000314). Somatic mismatch repair immunohistochemistry analysis showed normal expression, and germline BRCA1/2 sequencing did not reveal pathogenic or likely pathogenic variants. An ovarian cell immunohistochemistry analysis reported total loss of PTEN expression, which strongly suggested the role of PTEN in the oncogenesis of this cancer. Hence, a total thyroid resection was performed instead of thyroid lobectomy and a risk-reducing bilateral mastectomy was discussed. Co-occurrence of this pathogenic germline mutation in PTEN in this patient, early development of OCCC at age 28 years, and total loss of PTEN expression in the tumor might support the involvement of PTEN in the carcinogenesis of her ovarian cancer. We describe a new ovarian cancer case with an atypical histologic type-clear cell carcinoma-in CS. This observation might be the first indication of the need to expand the PTEN-related tumor spectrum to incorporate OCCC. The CS diagnosis significantly changed the therapeutic outcome of this patient.

Diagnostic performance of CT signs for predicting adnexal torsion in women presenting with an adnexal mass and abdominal pain: A case-control study.

PURPOSE: To determine which CT findings or combinations of CT findings could accurately identify adnexal torsion in a cohort of women admitted for abdominal pain and presenting with an adnexal mass. MATERIALS AND METHODS: The local institutional review board approved this retrospective case-control study involving adults-the informed consent requirement was waived. Enhanced computed tomography (CT) findings of 32 consecutive adnexal torsion and 32 control patients admitted for abdominal pain and presenting with an adnexal mass were independently reviewed by two radiologists, with consensus by a third one, for all CT findings commonly assessed in adnexal torsion. All twisted and untwisted adnexa were confirmed by surgery. Univariate and multivariate analyses were performed for adnexal torsion prediction. RESULTS: The median patient age was 41 years (interquartile range, 30.5-62 years). Only benign masses were encountered in the torsion group. Five CT features were significantly associated with adnexal torsion: a large ovary with a threshold at 80mm (p=0.005), median or contralateral displacement of the adnexa (p=0.00014), asymmetric wall thickening of the mass (p<0.0001), inter-utero-ovarian mass (p<0.0001) and whirlpool sign (p=0.0006). In the multivariate analysis, only the inter-utero-ovarian mass was independently associated with adnexal torsion (odds ratio=130 (CI95%: 15-infinite), p<0.0001) with an excellent overall diagnostic performance (AUC=0.89; CI95%: 0.81-0.97). It was a sensitive (Se=97%, CI95%: 84-100) and specific feature (Sp=81%, CI95%: 64-93). CONCLUSION: An inter-utero-ovarian mass is an accurate and reliable CT finding for diagnosing adnexal torsion in patients with acute abdominal pain and an adnexal mass.

Recto-vaginal septum cystadenocarcinoma: a case report and review of the literature.

BACKGROUND: Carcinoma of the recto-vaginal septum is a quite rare location and related to peritoneal and primary ovarian carcinomas. There are only few reports in the literature with a very poor prognosis. CASE PRESENTATION: Here we report the case of a 63 years old woman with past medical history of left oophorectomy presenting with a pelvic pain. The magnetic resonance imaging (MRI) demonstrated a 10 cm mass located in the recto-vaginal septum. A block resection was performed allowing the retrieval of a 10 cm solid tumor of the recto-vaginal septum. Peritoneal biopsies and the right ovary were normal the final diagnosis was cystadenocarcinoma of the recto-vaginal septum. The patient received adjuvant chemotherapy and displays no sign of recurrence 36 months after diagnosis. CONCLUSION: The management of recto-vaginal septum carcinoma with en bloc resection should be performed to avoid peritoneal spread and improve prognosis.

Synechia after uterine compression sutures.

We present a study of 37 women who underwent uterine compression suture for postpartum hemorrhage, with 13 postoperative assessments by hysteroscopy. Synechia occurred in seven patients, of whom three had Asherman syndrome (23% of women who desired pregnancy and had hysteroscopic evaluation) that could not be corrected.

New concept for immediate breast reconstruction for invasive cancers: feasibility, oncological safety and esthetic outcome of post-neoadjuvant therapy immediate breast reconstruction versus delayed breast reconstruction: a prospective pilot study.

Feasibility and oncological safety of post-adjuvant skin-sparing mastectomy (SSM) plus immediate breast reconstruction (IBR) cannot be evaluated by randomized trials. However, comparative study could modify guidelines for the oncosurgical treatment of invasive breast cancer. Our study compared the feasibility, oncological safety and esthetic outcome of SSM plus latissimus dorsi (LD) flap IBR after chemotherapy (CT) and radiotherapy (RT) with the standard management for invasive breast cancer: mastectomy as primary treatment, adjuvant CT and RT, and LD flap delayed breast reconstruction (DBR). Twenty-six selected patients with stages IIA-IIIA breast cancer were offered post-neoadjuvant SSM plus IBR with LD flap plus implant (IBR group). Seventy-eight other patients had primary mastectomy, adjuvant CT and RT, and LD-assisted DBR (DBR group). After 4.1 years (range 1-8) of follow-up, feasibility, oncological safety, and esthetic outcome were compared. Sixteen (61%) early complications were reported for the IBR group versus 44 (56%) for the DBR group (P = 0.645). Early implant loss was 0% in IBR versus 12% in DBR. IBR had 8 (30%) late complications versus 17 (21%) for DBR (P = 0.362). Capsular contracture and reconstruction failure rates were similar. Local recurrence was 7.7% (2/26) in IBR and 6.4% (5/78) in DBR (P = 0.823). Cosmetic evaluation by independent physicians and by the patients themselves was identical in the two groups. Our concept provides a basis for offering more women the opportunity to elect for immediate reconstruction, even in the setting of radiation therapy.