Acute and Long-Term Toxicity after Planned Intraoperative Boost and Whole Breast Irradiation in High-Risk Patients with Breast Cancer-Results from the Targeted Intraoperative Radiotherapy Boost Quality Registry (TARGIT BQR).

In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1-120, 20.4% dropped out), with a median age of 61 years (range 30-90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation.

Major complications after intraoperative radiotherapy with low-energy x-rays in early breast cancer.

PURPOSE: To describe and analyze major local complications after intraoperative radiotherapy (IORT) with low-energy x­rays during breast-conserving surgery (BCS) in early breast cancer. METHODS: Ten women out of 408 who were treated with IORT between 2002 and 2017 and subsequently developed a severe local complication requiring surgical intervention were retrospectively identified and analyzed. Demographic, clinical, and surgical parameters as well as complication characteristics and treatment methods were evaluated. RESULTS: At initial presentation, eight patients (80%) showed redness, six (60%) seroma, six (60%) wound infection, six (60%) suture dehiscence, and four (40%) induration of the former surgical area. Hematoma and necrosis were observed in one case (10%) each. Time interval until appearance of the first symptoms ranged from directly postoperative until 15 years postoperatively (median 3.1 months). Initial treatment modalities comprised antibiotic therapy (n = 8/80%) and transcutaneous aspiration of seroma (n = 3/30%). In the majority of patients, smaller surgical interventions (excision of a necrotic area/fistula [n = 6/60%] or secondary suture [n = 5/50%]) were sufficient to overcome the complication, yet larger interventions such as complex flap surgery and mastectomy were necessary in one patient each. CONCLUSION: IORT is an efficient and safe treatment method as < 2.5% of all IORT patients experienced major local complications. However, it seems to pose the risk of causing severe local complications that may require lengthy and burdensome treatment. Thorough preoperative counseling, implementation of recommended intraoperative precautions, and high vigilance for first symptoms of complications during follow-up appointments are necessary measures.

Intraoperative radiotherapy (IORT) of early breast cancer with low-energy x-rays in breast-conserving surgery : Prospective identification of pre- and intraoperative factors influencing the feasibility of IORT.

PURPOSE: The aim of this study is to identify pre- and intraoperative factors indicating the feasibility of intraoperative radiotherapy (IORT) during breast-conserving surgery (BCS). MATERIALS AND METHODS: From January 2018 to December 2019, a total of 128 women undergoing BCS due to early breast cancer were included in this prospective observational study, independent of whether IORT was planned or not. Patient and tumor characteristics as well as surgical parameters that could potentially influence the feasibility of IORT were recorded for the entire collective. In addition, a preoperative senological assessment was performed and analyzed to assess the feasibility of IORT. Logistic regression was then used to identify relevant preoperative parameters and to generate a formula predicting the feasibility of IORT. RESULTS: Of the 128 included women undergoing BCS, 46 were preoperatively rated to be feasible, 20 to be questionably feasible for IORT. Ultimately, IORT was realized in 30 patients. The most frequent reasons for omission of IORT were insufficient tumor-to-skin distance and/or an excessively large tumor cavity. Small clinical tumor size and large tumor-to-skin distance according to preoperative ultrasound were significantly related to accomplishment of IORT. CONCLUSION: We observed that preoperative ultrasound-based tumor-skin distance is a significant factor in addition to already known parameters to predict feasibility of IORT. Based on our findings we developed a formula to optimize IORT planning which might serve as an additional tool to improve patient selection for IORT in early breast cancer.

Laparoscopic Fertility-Sparing Surgery for Early Ovarian Malignancies.

The demand for fertility-sparing surgery (FSS) has increased in the last decade due to increased maternal age, increased incidence of ovarian malignancies in younger patients, and technical advances in surgery. Data on oncological safety and fertility outcomes of patients with ovarian cancer after laparoscopic FSS are sparse, but some retrospective studies have shown that open FSS may be offered to selected patients. We assessed the role of minimally invasive FSS in comparison with radical surgery (RS) in terms of oncological safety and reproductive outcomes after FSS in this multicenter study. Eighty patients with FIGO stage I/II ovarian cancer treated with laparoscopic FSS or RS between 01/2000 and 10/2018 at the participating centers (comprehensive gynecological cancer centers with minimally invasive surgical expertise) were included in this retrospective analysis of prospectively kept data. Case-control (n = 40 each) matching according to the FIGO stage was performed. Progression-free survival [150 (3-150) and 150 (5-150) months; p = 0.61] and overall survival [36 (3-150) and 50 (1-275) months; p = 0.65] did not differ between the FSS and RS groups. Eight (25.8%) women became pregnant after FSS, resulting in seven (22.5%) deliveries; three (37.5%) patients conceived after in vitro fertilization, and five (62.5%) conceived spontaneously. Laparoscopic FSS seems to be applicable and oncologically safe for patients with early-stage ovarian cancer, with adequate fertility outcomes.

Longitudinal cosmetic outcome after planned IORT boost with low kV X-rays-monocentric results from the TARGIT BQR registry.

Background: Intraoperative radiotherapy can serve as an anticipated boost (IORT boost) in combination with a subsequent external whole breast irradiation in high-risk breast cancer patients and is part of many guidelines. Nevertheless, there are only few prospective data available regarding cosmetic outcome after IORT boost using kV X-rays. The aim of this study was to evaluate the cosmetic outcome of patients treated within the prospective phase IV TARGeted Intraoperative radioTherapy (TARGIT) Boost Quality Registry (BQR) study (NCT01440010) in one center. Methods: In the context of the TARGIT BQR study standardized photos in three positions (arms down, arms up, from the side) were available for different time points. For this analysis a layperson, a radiation oncologist and a gynecologist evaluated available photos at different time points during follow-up with up to 4 years using the Harvard scale (comparison of treated and the untreated breast; rating: excellent, good, fair, poor). Longitudinal results were compared to preoperative results (baseline). Results: Seventy-three patients were available for the analysis. Baseline cosmetic assessment was excellent/good in 98.8% (mean value for all three positions). Postoperative cosmetic outcome (median) was good for all positions and remained constant for 4 years. Around 30% of the patients showed a constant or even improved cosmetic outcome compared to baseline. Only few patients showed a poor result at 4 years. The majority of patients showed an excellent or good cosmetic outcome at all time points. Conclusions: Patients from the prospective TARGIT BQR study treated with IORT boost and additional whole breast irradiation showed good or excellent cosmetic outcomes in most cases during 4 years of follow-up. These results add important information for shared decision making in breast cancer patients.

Therapy Guidance by Vaginal Smears of Pregnant Women With Preterm Complications in Correlation With Maternal and Neonatal Outcome: A Retrospective Analysis.

BACKGROUND/AIM: This retrospective cohort study enrolled hospitalized women with 24+0 to 33+6 gestational weeks with conditions associated with preterm birth. We evaluated the ability of vaginal swab isolates to guide antibiotic management decisions in the setting of threatened preterm towards a clinical advantage, i.e., longer delay between diagnosis and birth, better neonatal outcomes. PATIENTS AND METHODS: Vaginal swabs were obtained from all patients and antibiotic resistance profiles determined in case of growth. The cohort was divided into two groups: the antibiogram-noncongruently managed Group 1 and the antibiogram-congruently managed Group 2. These groups were compared in regard to multiple maternal and neonatal endpoints. RESULTS: In total, 698 cases were analyzed - 224 in Group 1 and 474 in Group 2. Antibiotics were ordered/continued by the treating physician in 138 cases (138/698; 19.8%) upon review of vaginal swab cultures results. Forty-five among them (32.6%) received antibiotics inactive against the isolated bacteria. 335 (25.4%) patients had only normal vaginal flora, and 95.6% of them had not received antibiotics. Facultatively pathogenic microorganisms were isolated in 52% patients. Only 5% of the neonates had bacterial isolates identical to those of their mothers. There were no significant differences in outcomes between Group 1 and Group 2. CONCLUSION: No association was found between a swab-result-guided antibiotic management protocol and maternal or fetal outcome in the setting of preterm birth risk between 24 and 34 gestational weeks. These findings underline the importance of critical rethinking the frequency of vaginal smears and fine-tuning the indications for antibiotic treatment.

Prevalence of higher-grade dysplasia in persistently high-risk human papillomavirus positive, cytology negative women after introduction of the new cervical cancer screening in Germany.

PURPOSE: According to the recently implemented organized cervical cancer screening program in Germany, women older than 35 years with negative cytology but persistent high-risk human papilloma virus (hrHPV) infection > 12 months should be referred to colposcopy for further evaluation. This study aimed to present and dissect colposcopic and histopathological findings with particular focus on associated hrHPV genotypes. METHODS: This study is a retrospective analysis of clinical data from 89 hrHPV positive patients with normal cytology who underwent colposcopic examination at a certified dysplasia outpatient clinic in Germany in 2021. RESULTS: While 38 (43%) women had a normal colposcopic finding, 45 (51%) had minor and 6 (7%) major changes. Thirty-one (35%) of the women were HPV 16 and/or HPV 18 positive and 58 (65%) women were positive for other hrHPV only. Among patients who underwent colposcopy with biopsies (in case of an abnormal finding or type 3 transformation zone, n = 68), eight (12%) had cervical intraepithelial neoplasia (CIN) 3 and six (9%) had CIN 2. The proportion of women diagnosed with CIN 3 varied among different hrHPV genotypes (HPV 16: 11%, HPV 18: 33%, HPV 31: 27%, HPV 33: 33%, HPV 52: 33%). CONCLUSION: Persistently hrHPV positive women with negative cytology are at increased risk of being diagnosed with CIN 3. As CIN 3 prevalence seems to differ with regard to hrHPV strain, immediate HPV genotyping for risk stratification and subsequent early referral for colposcopy might constitute a feasible strategy.

Forensic Medical Examination After Sexual Violence: Implications Based on Victims' Perceptions.

BACKGROUND/AIM: The objective of this study was to assess the perception of the forensic medical examination (FME) by victims of sexual violence. Based on patient-related outcomes gained in terms of personnel, chronological and spatial parameters, an additional aim was to derive improved examination procedures. PATIENTS AND METHODS: A total of 49 sexually assaulted women were enrolled in this study. After standardized FME by a forensic doctor followed by a gynecologist, women were asked to complete a questionnaire addressing general perception, preferences regarding attending staff's sex, sequence and time frame of the examinations performed. The attending gynecologist also completed a questionnaire addressing demographic and medical parameters of the patient as well as assault-related information. RESULTS: The examination setting in general was evaluated positively. Nevertheless, 52% of examined victims perceived the FME as an additional psychological burden. Overall, 85% of the affected women preferred a female forensic physician and 76% a female gynecologist to perform the examination. When women said they experienced a violation of their privacy during the gynecological examination, a male was more often present (60% vs. 35%, p=0.0866). Regarding the sequence of the examination components, 65% of the victims preferred to start with their medical history followed by the forensic and then the gynecological examination. CONCLUSION: Forensic medical and gynecological examination after sexual assault is an essential procedure, yet it is a potentially further traumatizing experience for the victim. The identified patient preferences should be taken into account in order to diminish further trauma.

Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue.

BACKGROUND/AIM: To compare the microscopic, macroscopic and thermal damage inflicted to ovarian tissue by conventional monopolar and bipolar energy, argon plasma coagulation (APC) and diode laser. MATERIALS AND METHODS: Bovine ovaries were used as a substitute for human tissue and subjected to the four aforementioned techniques and the inflicted damage was measured. Sixty fresh and morphologically similar cadaveric bovine ovaries were divided into five equal groups, each group was subjected to one of the following energy applications for both 1 and 5 s: Monopolar, bipolar electrocoagulation, diode laser, preciseAPC® and forcedAPC® Ovarian temperatures were measured at 4 and 8 s after treatment. Formalin-fixed ovarian specimens were examined by pathologists regarding macroscopic, microscopic and thermal tissue damage. RESULTS: None of the ovaries reached the temperature producing severe damage (40°C) after 1 s of energy transfer. Heating of adjacent ovarian tissue was least pronounced when preciseAPC® and monopolar electrocoagulation were applied (27.2±3.3°C and 28.2±2.9°C after 5 s of application, respectively). Conversely, 41.7% of the ovaries subjected to bipolar electrocoagulation for 5 s overheated. ForcedAPC® resulted in the most pronounced lateral tissue defects (2.8±0.3 mm after 1 s and 4.7±0.6 mm after 5 s). When the modalities were applied for 5 s, the electrosurgical instruments (mono- and bipolar) and preciseAPC® induced similar lateral tissue damage (1.3±0.6 mm, 1.1±1.6 mm and 1.2±1.3 mm, respectively). preciseAPC® created the shallowest defect of all the techniques (0.05±0.1 mm after 5 s of application). CONCLUSION: Our study hints at superior safety profiles of preciseAPC® and monopolar electrocoagulation compared to bipolar electrocoagulation, diode laser and forcedAPC® for ovarian laparoscopic surgery.

First experiences with a diode laser in major gynecological laparoscopic procedures show lack of benefit and impaired feasibility.

PURPOSE: The aim of this study is to evaluate feasibility and potential benefit of a diode laser in major laparoscopic procedures in gynecology. METHODS: Between 2018 and 2020, a total of 42 cases were enrolled in this study comparing standard electrosurgery with diode laser-supported therapy in laparoscopic supracervical hysterectomy (LASH), total laparoscopic hysterectomy (TLH), or laparoscopic myoma enucleation (LME). Dual wavelength 45 W diode laser light was used to cut and coagulate during laparoscopy in the prospective interventional arm consisting of 11 cases, while 31 matching patients who received conventional treatment with monopolar/bipolar current for the same interventions were retrospectively identified in our laparoscopy database. Recruitment in the prospective interventional laser diode arm was terminated after only 11 patients (instead of planned 50) due to intense hemorrhage and massive smoke development. RESULTS: A total of 42 cases were analyzed (11 LME, 19 LASH, and 12 TLH). Strong smoke development was evident in all 11 cases in the diode laser arm. It was necessary to convert to bipolar or monopolar current in all hysterectomies (n = 9) with initial diode laser implementation due to increased bleeding and smoke development. Conventional current sources had to be used in LMEs (n = 2) due to excessive bleeding and poor visibility during enucleation of the fibroid. A significant difference (p < 0.0001) was observed regarding smoke development when comparing the laser arm with the control arm. CONCLUSION: We found a 45-W diode laser to be inferior to electrosurgical techniques for major laparoscopic gynecologic surgeries regarding bleeding control and smoke development.

Long-term evaluation of uterine fibroid embolisation using MRI perfusion parameters and patient questionnaires: preliminary results.

BACKGROUND: Uterine fibroid embolisation (UFE) is an established treatment method for symptomatic uterine myomas. This study evaluates the efficacy of UFE using objective magnetic resonance imaging (MRI) data for size and perfusion analysis as well as patient questionnaires assessing fibroid-related symptoms. METHOD: Patients underwent MR-Angiography before UFE and 4 days, 6 and 12 months after the procedure. The images were evaluated using dedicated software. Patient questionnaires were completed before UFE and at 12 months follow-up, focussing on the embolization procedure and symptoms associated with uterine fibroids. Statistical analysis of the questionnaires was performed using paired sample t-test and Wilcoxon signed rank test, while Kruskal-Wallis test and Friedman test were applied for MRI-analysis. RESULTS: Eleven women were included. There was a significant reduction in fibroid-related symptoms. The volume reduction after 12 months was significant in both, uterus and myomas, after an initial increase in uterine volume at the first post-interventional MRI. The perfusion analysis showed that blood flow to the fibroids could be significantly reduced up to 12 months after UFE while uterine tissue was not affected. CONCLUSION: This study shows that uterine fibroid embolisation induces a significant long-term decrease in myoma size and perfusion while healthy uterine tissue remains unaffected. Fibroid-related symptoms are reduced for the sake of improved quality of life.

Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study.

The need for pelvic treatment in patients with node-positive vulvar cancer (VSCC) and the value of pelvic lymphadenectomy (LAE) as a staging procedure to plan adjuvant radiotherapy (RT) is controversial. In this retrospective, multicenter analysis, 306 patients with primary node-positive VSCC treated at 33 gynecologic oncology centers in Germany between 2017 and 2019 were analyzed. All patients received surgical staging of the groins; nodal status was as follows: 23.9% (73/306) pN1a, 23.5% (72/306) pN1b, 20.4% (62/306) pN2a/b, and 31.9% (97/306) pN2c/pN3. A total of 35.6% (109/306) received pelvic LAE; pelvic nodal involvement was observed in 18.5%. None of the patients with nodal status pN1a or pN1b and pelvic LAE showed pelvic nodal involvement. Taking only patients with nodal status ≥pN2a into account, the rate of pelvic involvement was 25%. In total, adjuvant RT was applied in 64.4% (197/306). Only half of the pelvic node-positive (N+) patients received adjuvant RT to the pelvis (50%, 10/20 patients); 41.9% (122/291 patients) experienced recurrent disease or died. In patients with histologically-confirmed pelvic metastases after LAE, distant recurrences were most frequently observed (7/20 recurrences). Conclusions: A relevant risk regarding pelvic nodal involvement was observed from nodal status pN2a and higher. Our data support the omission of pelvic treatment in patients with nodal status pN1a and pN1b.

Female genital injury-which findings have to be considered physiological using colposcopy with and without toluidine blue dye?

This study aimed to assess the validity and efficacy of blue dye in colposcopic assessment of genital injury in pre- and postmenopausal women with and without history of consensual sexual intercourse. Two hundred women were prospectively enrolled and examined colposcopically with and without toluidine blue dye in order to detect and categorize genital lesions (laceration, bruise and abrasion). Examination of genital trauma was accomplished in a standardized way and findings were photo documented. A wide range of influencing factors with a potential impact on prevalence and nature of genital injury was recorded beforehand using a questionnaire. The frequency of diagnostic injury differed substantially depending on the examination technique, ranging from 9% using colposcopic magnification only to 28% with the additional use of toluidine blue dye. A vertical laceration affecting the posterior fourchette was the most frequent lesion detected (17%, n = 32). Menopausal status seems to have significant impact on genital injury prevalence (p = 0.0165), as 42% (16/ 38) of postmenopausal compared to 24% (36/ 151) of premenopausal women had at least one genital lesion. Furthermore, vaginal medication (p = 0.0369), vaginal dryness (p = 0.0228), dyspareunia (p = 0.0234) and low frequency of sexual intercourse (p = 0.0022) were found to significantly correlate with the presence of genital lesions. According to our findings, standardized colposcopy in combination with toluidine blue dye facilitates accurate assessment of genital lesions. Genital trauma situated at another site than the posterior part of the vaginal introitus seems to be uncommon after consensual intercourse.

Wound Fluid from Breast Cancer Patients Undergoing Intraoperative Radiotherapy Exhibits an Altered Cytokine Profile and Impairs Mesenchymal Stromal Cell Function.

Intraoperative radiotherapy (IORT) displays an increasingly used treatment option for early breast cancer. It exhibits non-inferiority concerning the risk of recurrence compared to conventional external irradiation (EBRT) in suitable patients with early breast cancer. Since most relapses occur in direct proximity of the former tumor site, the reduction of the risk of local recurrence effected by radiotherapy might partially be due to an alteration of the irradiated tumor bed's micromilieu. Our aim was to investigate if IORT affects the local micromilieu, especially immune cells with concomitant cytokine profile, and if it has an impact on growth conditions for breast cancer cells as well as mammary mesenchymal stromal cells (MSC), the latter considered as a model of the tumor bed stroma.42 breast cancer patients with breast-conserving surgery were included, of whom 21 received IORT (IORT group) and 21 underwent surgery without IORT (control group). Drainage wound fluid (WF) was collected from both groups 24 h after surgery for flow cytometric analysis of immune cell subset counts and potential apoptosis and for multiplex cytokine analyses (cytokine array and ELISA). It served further as a supplement in cultures of MDA-MB 231 breast cancer cells and mammary MSC for functional analyses, including proliferation, wound healing and migration. Furthermore, the cytokine profile within conditioned media from WF-treated MSC cultures was assessed. Flow cytometric analysis showed no group-related changes of cell count, activation state and apoptosis rates of myeloid, lymphoid leucocytes and regulatory T cells in the WF. Multiplex cytokine analysis of the WF revealed group-related differences in the expression levels of several cytokines, e.g., oncostatin-M, leptin and IL-1ß. The application of WF in MDA-MB 231 cultures did not show a group-related difference in proliferation, wound healing and chemotactic migration. However, WF from IORT-treated patients significantly inhibited mammary MSC proliferation, wound healing and migration compared to WF from the control group. The conditioned media collected from WF-treated MSC-cultures also exhibited altered concentrations of VEGF, RANTES and GROα. IORT causes significant changes in the cytokine profile and MSC growth behavior. These changes in the tumor bed could potentially contribute to the beneficial oncological outcome entailed by this technique. The consideration whether this alteration also affects MSC interaction with other stroma components presents a promising gateway for future investigations.

Cardiac serum marker alterations after intraoperative radiotherapy with low-energy x-rays in early breast cancer as an indicator of possible cardiac toxicity.

PURPOSE: To assess acute cardiac toxicity caused by intraoperative radiotherapy (IORT) with low-energy x­rays for early breast cancer. METHODS: We prospectively analyzed pre- and postoperative troponin I and NT-proBNP in 94 women who underwent breast-conserving surgery between 2013 and 2017 at the Department of Gynecology and Obstetrics of the University Medical Center Mannheim, Germany. Thirty-nine women received IORT using low-energy x­rays during breast-conserving surgery while 55 patients without IORT formed the control group. Demographic and surgical parameters as well as cardiac markers were evaluated. RESULTS: There were no significant differences concerning age and side of breast cancer between the groups. Furthermore, no significant difference between the troponin I assays of the IORT and control groups could be found (preoperatively: 0.017 ± 0.006 ng/ml vs. 0.018 ± 0.008 ng/ml; p = 0.5105; postoperatively: 0.019 ± 0.012 ng/ml vs. 0.018 ± 0.010 ng/ml; p = 0.6225). N­terminal fragment of B­type natriuretic peptide (NT-proBNP) was significantly higher in the control group 24 h after surgery (preoperatively: 158.154 ± 169.427 pg/ml vs. 162.109 ± 147.343 pg/ml; p = 0.56; postoperatively: 168.846 ± 160.227 pg/ml vs. 232.527 ± 188.957 pg/ml; p = 0.0279). CONCLUSION: Troponin I levels as a marker of acute cardiac toxicity did not show any significant differences in patients who received IORT during breast-conserving surgery compared to those who did not.

Influence of Peripartum Expectations, Mode of Delivery, and Perineal Injury on Women's Postpartum Sexuality.

BACKGROUND: Sexual health has been identified as an important factor for postpartum quality of life. Although pregnancy-related changes in anatomy and metabolism return to their prepregnancy state, female sexual function may not be at the level it was before birth because of physical and psychological changes. AIM: The goal of our study was to explore the influence of the mode of delivery, perineal injury, and peripartum expectations on postpartum sexual function. METHODS: Between 2013 and 2018, 522 women were enrolled in this prospective investigation. At time of recruitment during the peripartum hospitalization, patients completed a standardized questionnaire addressing expectations concerning postpartum sexuality with focus on expected influence of the mode of delivery. Sexual function was evaluated using the Female Sexual Function Index (FSFI) and Sexual Activity Questionnaire (SAQ) at time of recruitment to evaluate baseline sexual function (4 weeks before pregnancy). Follow-up assessments were conducted at 3, 6, and 12 months postpartum. OUTCOMES: Peripartum expectations, influence of the mode of delivery, and perineal injury were analyzed for their impact on women's sexual function within 12 months postpartum by repetitive FSFI and SAQ assessments. RESULTS: A total of 522 women with 263 spontaneous vaginal deliveries, 41 operative vaginal deliveries, and 218 cesarean sections were analyzed. Although the data demonstrate a significant postpartum decline in sexual function at 3 and 6 months postpartum, sexual functioning converges to baseline prepregnancy values 12 months postpartum. This observation was independent of the mode of delivery and perineal injuries with no significant between-group differences at any of the analyzed time points. Apart from breastfeeding, for which negative anticipations resulted in impaired sexuality, women's expectations (pertaining to quantity and quality of female orgasm, partner's sexuality, fear of altered sexuality, frequency of intercourse, the mode of delivery) do not influence female sexual function at 12 months postpartum. CLINICAL IMPLICATIONS: Deciphering the potential influence of patient expectations as well as pregnancy- and childbirth-related aspects on female postpartum sexuality will help in the effort to improve women's postpartum sexual health. STRENGTHS & LIMITATIONS: As a strength of this study, postpartum sexuality was independently assessed with 2 different scoring systems (FSFI and SAQ). Limitations include that our follow-up is incomplete and amounts to about 2-thirds of patients who were initially recruited. CONCLUSION: The mode of delivery and perineal trauma do not influence women's postpartum sexual function. With the exception of breastfeeding, peripartum expectations do not result in altered sexual functioning at 12 months postpartum. Spaich S, Link G, Alvarez SO, et al. Influence of Peripartum Expectations, Mode of Delivery, and Perineal Injury on Women's Postpartum Sexuality. J Sex Med 2020;17:1312-1325.

Intraoperative radiotherapy for breast cancer treatment efficiently targets the tumor bed preventing breast adipose stromal cell outgrowth.

OBJECTIVES: Mesenchymal stromal cells (MSC) in bone marrow have been shown to be radioresistant, which is related to pronounced DNA repair mechanisms. Intraoperative radiotherapy (IORT) during breast-conserving surgery for early breast cancer is an innovative technique applying low energy x­ray to the tumor bed immediately after removal of the tumor. IORT is considered to reduce the risk of local tumor recurrence by directly targeting cells of the tumor bed and altering the local microenvironment. Aim of this study was to investigate whether IORT affects the outgrowth potential of breast adipose tissue-derived MSC (bASC) as part of the tumor bed. MATERIALS AND METHODS: After surgical tumor resection, biopsies of the tumor bed were taken before (pre IORT) and after IORT (post IORT) and processed applying well-established protocols for ASC isolation and characterization. RESULTS: In all, 95% of pre IORT tumor bed samples yielded persistently outgrowing bASC with typical ASC characteristics: fibroblastoid morphology, proliferation, adipogenic and osteogenic differentiation and ASC surface marker expression. However, none of the post IORT samples yielded persistent outgrowth of bASC. CONCLUSIONS: After breast-conserving surgery, approximately 90% of local recurrences emerge in close proximity to the initial tumor bed, potentially reflecting a significant contribution of the tumor bed to relapse. Our data show that IORT, besides the proven effect on breast cancer cells, efficiently modifies the tumor environment by having an impact on tumor bed bASC. This effect on tumor bed stromal cells might contribute to reduce the risk of tumor relapse and metastases.

Long-term outcome after intraoperative radiotherapy as a boost in breast cancer.

PURPOSE: To investigate long-term oncological outcome and incidence of chronic side effects in patients with breast cancer and intraoperative radiotherapy given as an upfront boost (IORT boost). METHODS: Retrospective analysis of 400 patients with an IORT boost with low-energy X­rays (20 Gy), subsequent whole-breast irradiation (46-50 Gy), and annual oncological follow-up. Side effects were prospectively evaluated (LENT-SOMA scales) over a period of up to 15 years. Side effects scored ≥grade 2 at least three times during follow-up were judged to be chronic. RESULTS: The median age was 63 years (30-85) and the median follow-up was 78 months (2-180) after IORT boost. In 15 patients a local recurrence occurred, resulting in a local recurrence rate at 5, 10, and 15 years of 2.0%, 6.6%, and 10.1%, respectively. The overall survival rates at 5, 10, and 15 years were 92.1%, 81.8%, and 80.7%, respectively. The most common high-grade side effects were fibrosis (21%) and pain (8.6%). The majority of side effects occurred within the first 3 years. The actuarial rates of chronic fibrosis were 19.1% and 21.1% at 5 and ≥8 years, of chronic pain 8.6% at ≥4 years, of chronic edema of the breast 2.4% at ≥2 years, of chronic lymphedema 0.0% at 5 and 10 years, and of chronic hyperpigmentation 0.5% at ≥2 years. Side effects were similar or less than expected from an external beam boost. CONCLUSION: IORT boost appears to be a highly efficient and safe method for upfront delivery of the tumor bed boost in high-risk breast cancer patients.

Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial).

OBJECTIVE: Standard transcervical fibroid treatment via hysteroscopic myomectomy can result in a significant rate of intrauterine adhesiogenesis. The primary objective of this study was to document the incidence of de novo uterine adhesions after transcervical fibroid ablation (TFA) of symptomatic uterine fibroids with the Sonata® system. STUDY DESIGN: In this European postmarket prospective, multicenter, single-arm interventional trial, patients were eligible for inclusion if they chose TFA with the Sonata System for symptomatic fibroids and had at least 1 type 1, type 2 or type 2-5 myoma. The presence or absence of intrauterine adhesions was assessed by diagnostic hysteroscopy at baseline and at 6 weeks post-ablation. The hysteroscopy videos were scored by a committee of 3 independent readers. RESULTS: A total of 6 sites enrolled 37 patients. Fifty fibroids with a mean diameter of 3.4 ±â€¯1.8 cm (range 1-8 cm) were ablated. Of the 37 enrolled subjects, 35 completed the study follow-up and 2 electively withdrew from the study prior to the completion of study follow-up. Thirty-four out of 35 pairs of baseline and 6-week hysteroscopies were evaluated by the independent readers with none having de novo adhesions at 6 weeks after treatment with Sonata, including 6 patients with apposing myomata. One patient was excluded from the analysis due to an unevaluable hysteroscopy video. CONCLUSION: Intrauterine adhesiogenesis was not seen post-TFA with the Sonata system. These results suggest the potential for adhesiogenesis after TFA, including in women with apposing submucous and/or transmural myomata, may be minimal.

Feasibility of quantitative MR-perfusion imaging to monitor treatment response after uterine artery embolization (UAE) in symptomatic uterus fibroids.

INTRODUCTION: In 25% of women, symptomatic uterus myomas are diagnosed with clinical and functional impairment ranging from abdominal and pelvic pain to dys- and hypermenorrhea, dyspareunia, pollakiuria and infertility. Women undergoing a treatment increasingly prefer nowadays minimal invasive, uterus preserving therapies like uterine artery embolization (UAE) over surgical hysterectomy, nowadays. To emphasize the efficacy of UAE as a uterus preserving treatment with targeted therapy of myomas only, analysis of tissue perfusion pre and post embolization is required. The purpose of this study was to assess treatment response in UAE in females with symptomatic uterus myomas by quantitative magnetic resonance perfusion imaging. METHODS: Seven females scheduled for uterus myoma embolization underwent three MRI examinations (pre, post, follow-up) including morphological and dynamic contrast enhanced perfusion imaging at 3 T. To measure tumor volume, regions-of-interest covering the tumor and the uterus were drawn by two readers in consensus. Blood flow, blood volume, and mean transit time were calculated by a pixel-by-pixel deconvolution approach. Kruskal-Wallis/Friedman test was employed to test whether the group medians differ significantly with correction for multiple comparisons using Bonferroni method. RESULTS: Change of volume could be observed in all patients after embolization but was significantly different only between pre/post and follow-up time point. Measured differences in all perfusion parameters were significant between pre-intervention and post-intervention/follow-up in the myomas, no significant differences could be detected for the uterus tissue. CONCLUSIONS: Our results demonstrate devascularization of symptomatic myomas which correlates with cessation of hypermenorrhea in all treated patients without affecting healthy uterus tissue. Supplementing UAE with perfusion imaging to monitor early treatment response is feasible and might provide valuable information for the follow-up of patients and contribute to providing confidence for the patients in treatment success.