Search

Funding Information: The authors thank ESGO, ESTRO, and ESP for their support. The authors also thank the 155 international reviewers (physicians and patient representatives, see Appendix 2 in Online Supplemental File 2) for their valuable comments and suggestions. The authors thank the ESGO office, especially Kamila Macku, Tereza Cicakova, and Kateřina Šibravová, provided invaluable logistical and administrative support throughout the process. The development group (including all authors) is collectively responsible for the decision to submit for publication. DC (chair), JL (chair), MRR (chair) and FP (methodologist) wrote the first draft of the manuscript. All other contributors have actively given personal input, reviewed the manuscript, and have given final approval before submission. DC is responsible for the overall content as the guarantor. Initiated through the ESGO the decision to develop multidisciplinary guidelines was made jointly by the ESGO, ESTRO, and ESP. The ESGO provided administrative support. The ESGO, ESTRO and ESP are nonprofit knowledgeable societies. *These guidelines were developed by ESGO, ESTRO and ESP and are published in the Int J Gynecol Cancer, Radiother Oncol and Virchows Archiv. CCh has reported advisory boards for GSK, MSD and EISAI; SFL has reported advisory boards for MSD, GSK, AstraZeneca and Novartis; DL has reported consultant honoria from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Amgen, Seagen and PharmaMar, advisory boards for AstraZeneca, Merck Serono, Seagen, Immunogen, Genmab, Oncoinvest, Corcept and Sutro, research institutional funding from Clovis Oncology, GSK, MSD and PharmaMar, research sponsored by AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, Incyte, MSD, Roche, Seagen and Novartis, and speakers’ bureau activities for AstraZeneca, Clovis Oncology, GSK, MSD and PharmaMar; UM has reported advisory boards for AstraZeneca (Steering committee member for CALLA Study); RN has reported research grants from Elekta, Varian, Accuray, Dutch Research Council, and Dutch Cancer Society; AO has reported personal fees for advisory board membersip from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, EMD Serono, F. Hoffmann-La Roche, Genmab/Seagen, GSK, ImmunoGen, Itheos, Merck Sharp & Dohme de Espana, SA, Mersana Thereapeutics, Novocure, PharmaMar, piIME Oncology, Roche, Sattucklabs, Sutro Biopharma and Tesaro, and personal fees for travel/accomodation from AstraZeneca, PharmaMar and Roche; DQ has reported advisory boards for Mimark inc; MPS has reported research grants and personal fees for workshops from Elekta AB; DC, MRR, FP, CC, AF, DF, DJK, FJ, CK, PM, RN, FPec, JP, SR, AS, VS, KT, IZ and JCL have reported no conflicts of interest. Not commissioned; internally peer reviewed. Not applicable. Not applicable. David Cibula, Maria Rosaria Raspollini, François Planchamp, Carlos Centeno, Cyrus Chargari, Ana Felix, Daniela Fischerova, Daniela Jahn-Kuch, Florence Joly, Christhardt Kohler, Sigurd F. Lax, Domenica Lorusso, Umesh Mahantshetty, Patrice Mathevet, Raj Naik, Remi Nout, Ana Oaknin, Fedro Peccatori, Jan Persson, Denis Querleu, Sandra Rubio, Maximilian Paul Schmid, Artem Stepanyan, Valentyn Svintsitskyi, Karl Tamussino, Ignacio Zapardiel, Jacob Christian Lindegaard. All data relevant to the study are included in the article or uploaded as supplementary information. Funding Information: CCh has reported advisory boards for GSK, MSD and EISAI; SFL has reported advisory boards for MSD, GSK, AstraZeneca and Novartis; DL has reported consultant honoria from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Amgen, Seagen and PharmaMar, advisory boards for AstraZeneca, Merck Serono, Seagen, Immunogen, Genmab, Oncoinvest, Corcept and Sutro, research institutional funding from Clovis Oncology, GSK, MSD and PharmaMar, research sponsored by AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, Incyte, MSD, Roche, Seagen and Novartis, and speakers’ bureau activities for AstraZeneca, Clovis Oncology, GSK, MSD and PharmaMar; UM has reported advisory boards for AstraZeneca (Steering committee member for CALLA Study); RN has reported research grants from Elekta, Varian, Accuray, Dutch Research Council, and Dutch Cancer Society; AO has reported personal fees for advisory board membersip from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, EMD Serono, F. Hoffmann-La Roche, Genmab/Seagen, GSK, ImmunoGen, Itheos, Merck Sharp & Dohme de Espana, SA, Mersana Thereapeutics, Novocure, PharmaMar, piIME Oncology, Roche, Sattucklabs, Sutro Biopharma and Tesaro, and personal fees for travel/accomodation from AstraZeneca, PharmaMar and Roche; DQ has reported advisory boards for Mimark inc; MPS has reported research grants and personal fees for workshops from Elekta AB; DC, MRR, FP, CC, AF, DF, DJK, FJ, CK, PM, RN, FPec, JP, SR, AS, VS, KT, IZ and JCL have reported no conflicts of interest. Publisher Copyright: © 2023 ESGO, ESTRO, ESP In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer. To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives. These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined. publishersversion published

The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Medical treatment with imiquimod is an effective alternative, but the two modalities have not been compared in a randomised trial. The aim of this study was to compare the clinical effectiveness, histological response, human papillomavirus (HPV) clearance, acceptance, and psychosexual morbidity of primary imiquimod treatment versus surgical treatment in women with vHSIL.This study was a multicentre, randomised, phase 3, non-inferiority clinical trial done by the Austrian Gynaecological Oncology group at six hospitals in Austria. We recruited female patients aged 18-90 years with histologically confirmed vHSIL with visible unifocal or multifocal lesions. Main exclusion criteria were clinical suspicion of invasion, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, and any active treatment for vHSIL within the previous 3 months. Women with known immunodeficiency, who were pregnant, or who were lactating were excluded. Patients were randomly assigned (1:1) by block randomisation to imiquimod or surgery, and stratified by unifocal or multifocal disease. Treatment with imiquimod was self-administered in a slowly escalating dosage scheme up to three times per week for a period of 4-6 months. Surgery consisted of excision or ablation. Patients were assessed with vulvoscopy, vulvar biopsy, HPV tests, and patient-reported outcomes at baseline and after 6 months and 12 months. The primary endpoint was complete clinical response (CCR) at 6 months after local imiquimod treatment or one surgical intervention. Primary analysis was per protocol with a non-inferiority margin of 20%. This trial is registered at ClinicalTrials.gov, NCT01861535.110 patients with vHSIL (78% with unifocal vHSIL and 22% with multifocal vHSIL) were randomly assigned between June 7, 2013, and Jan 8, 2020. Clinical response to treatment could be assessed in 107 patients (54 in the imiquimod group and 53 in the surgery group), and 98 patients (46 in the imiquimod group and 52 in the surgery group) completed the study per protocol. 37 (80%) of 46 patients using imiquimod had CCR, compared with 41 (79%) of 52 patients after one surgical intervention, showing non-inferiority of the new treatment (difference in proportion -0·016, 95% CI -0·15 to -0·18; p=0·0056). Invasive disease was found in five patients at primary or secondary surgery, but not in patients with per-protocol imiquimod treatment. There was no significant difference in HPV clearance, adverse events, and treatment satisfaction between study groups.Imiquimod is a safe, effective, and well accepted alternative to surgery for women with vHSIL and can be considered as first-line treatment.Austrian Science Fund and Austrian Gynaecological Oncology group.

PURPOSE The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL ( P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

There are few data on complications with gender affirming surgery. The aim of this study was to assess peri- and postoperative complications of laparoscopic hysterectomy and mastectomy performed in a single sitting in transgender men. Assessment of intra- and postoperative complications in a series of 65 transgender men (mean age 27, range 18–47) undergoing concomitant mastectomy and laparoscopic hysterectomy with salpingo-oophorectomy. Mean operating time was 292 ± 47 min. Thirty-four (52%) patients experienced complications: 28 (41%) DINDO grade I, 0 DINDO grade 2, 6 (11%) DINDO grade III. The six grade 3 complications consisted of 5 hematomas requiring evacuation after mastectomy and 2 vaginal tears requiring transvaginal repair. Three patients were readmitted within 30 days, all for postoperative bleeding/hematoma. In transgender men, performing laparoscopic hysterectomy and mastectomy at a single sitting has a modest rate of perioperative complications, and may improve resource utilization. Supplementary Information The online version contains supplementary material available at 10.1007/s43032-021-00724-x.

ZusammenfassungDurch die Einführung der sog. Krebsfährtensuche mittels Kolposkopie, Zytologie und Histopathologie durch Ernst Navratil (1902–1977) im Jahr 1946 kam es zu einem markanten Aufschwung der Gynäkopathologie an der Grazer Univ.-Frauenklinik. Dieser Aufschwung war im Wesentlichen Fritz Bajardi (1918–2006) und Erich Burghardt (1921–2006) zu verdanken. Diese haben in der Zeit ihrer klinischen Tätigkeit durch ihre Zusammenarbeit wesentliche Erkenntnisse über die Pathogenese des Zervixkarzinoms geliefert. Erich Burghardt ist es im Besonderen zu verdanken, dass die in der Literatur verstreuten diesbezüglichen Publikationen in einem synoptischen Werk zusammengefasst wurden. Es werden die richtungsweisenden Forschungsergebnisse von Bajardi und vor allem von Burghardt im Lichte des heutigen Erkenntnisstandes diskutiert.

BACKGROUND: Colpectomy is a frequent part of gender-affirming surgery in transgender men. Urologic complications with these procedures can complicate and delay further management. Aim: We reviewed the rate of postoperative voiding dysfunction after colpectomy with urethral lengthening in transgender men. METHODS: We reviewed postoperative voiding in 47 transgender men (age, 19-50 years) who underwent colpectomy with urethral lengthening. Thirty-eight patients (81%) had undergone hysterectomy (36 total, 2 subtotal/supracervical) previously and 11 (23%) underwent concomitant hysterectomy or removal of the residual cervix (4 abdominal, 6 laparoscopic, 1 transvaginal). Colpectomy was done transvaginally by opening and developing laterally the vesicovaginal and rectovaginal spaces and then transecting the lateral vaginal attachments with bipolar vessel sealing. Urethral lengthening with an anterior vaginal flap was performed in the same procedure as colpectomy. A transurethral catheter was left in situ for 14 days postoperatively. Voiding dysfunction was defined as failure of spontaneous micturition after removal of the catheter at 14 days. RESULTS: 40/47 (85%) patients were able to void after catheter removal, 7 (15%) were not. Voiding dysfunction occurred in 3/11 (27%) patients undergoing concomitant hysterectomy or removal of a residual cervix and in 4/36 patients (11%) status post total hysterectomy. Voiding dysfunction persisted for a median of 3 months (2 days − 46 months). CONCLUSIONS: In this series voiding dysfunction developed in 15% of transgender men undergoing colpectomy with urethral lengthening and appeared to be more common in patients undergoing concomitant hysterectomy or removal of a residual cervix than in those status post hysterectomy. Patients should be counseled accordingly.

Study Objective Sacrocolpopexy (SCP) has become the standard procedure to correct uterovaginal prolapse in women, but techniques and approaches are not standardized. We report the results of the Austrian Sacrocolpopexy Registry, which aimed to collect data on surgical techniques and perioperative outcomes. Design The Austrian Urogynecology Working Group initiated a registry to assess surgical variability and perioperative safety of SCP. The study was performed at 14 centers (13 in Austria,1 in Switzerland). Institutional review board approvals were obtained. Patients Consecutive patients with symptomatic pelvic organ prolapse (POP). Interventions SCP in the course of routine POP treatment. Measurements and Main results Preoperative assessment included demographic data, clinical data on bladder, and bowel functions and POP-Q status. Surgical data included surgical approach (open, laparoscopic, robotic), type of mesh, depth of dissection, nerve sparing techniques, suture materials, uterus or cervix-sparing techniques, peritoneal closure, and concomitant surgeries. A total of 401 patients were recruited into the study. The mean age was 57 years (range: 26–84) and mean body mass index was 34. A total of 137 (34%) patients had undergone previous surgery for prolapse and in 264 cases SCP was the primary procedure. A total of 170 (42%) patients had undergone previous hysterectomy; For patients with uterus, SCP was performed with subtotal (n = 148) or total (n = 3) hysterectomy. A total of 285 (71%) SCPs were done laparoscopically, 102 (25%) robotically and 10 (3%) per laparotomy. The conversion rate from laparoscopy to abdominal surgery was 4.5%. Various meshes and suture materials were used and fixation techniques also varied widely. Four patients underwent reoperation within 30 days (2 trocar herniations, and 1 bowel obstruction, 1 compartment syndrome). One patient died of aortic dissection 7 days after SCP. Conclusions Most SCPs in this registry were performed laparoscopically, but there was considerable variation in surgical techniques. Perioperative morbidity appears modest.

This is the first collaborative Enhanced Recovery After Surgery Society guideline for optimal perioperative care for vulvar and vaginal surgeries. An Embase and PubMed database search of publications was performed. Studies on each topic within the Enhanced Recovery After Surgery vulvar and vaginal outline were selected, with emphasis on meta-analyses, randomized controlled trials, and prospective cohort studies. All studies were reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation system. All recommendations on the Enhanced Recovery After Surgery topics are based on the best available evidence. The level of evidence for each item is presented.

Urogenital atrophy affects50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion.We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires.Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy.Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens.gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.

Introduction Treatment for vulvodynia is challenging and a multidisciplinary approach is recommended. Aim To examine the effectiveness, safety and treatment satisfaction of vulvovaginal microablative laser treatment for vulvodynia. Methods Case study of women who received laser treatment as part of a multidisciplinary treatment program for vulvodynia. Subjective improvement was compared to a retrospective cohort of women treated for vulvodynia without LASER therapy. LASER treatment was offered to women with vulvodynia presenting to a gynecologic pain clinic of a tertiary university hospital. LASER treatments were performed with a microablative 2,940 nm Er:YAG LASER and potentially repeated after 1 month. Main outcome measures Change in local vulvar pain was assessed with cotton-swab tests and rated on a numeric rating scale (NRS). Treatment discomfort and short-term adverse events were recorded. The Freiburg Index of Patient Satisfaction was used to assess treatment satisfaction. Subjective symptom improvement was assessed with the Patient Global Impression of Improvement questionnaire. Results 35 women received at least 1 laser treatment, with overall mild treatment adverse effects (mean pain NRS 2.4 ± 1.9) and good treatment satisfaction (mean total score of 27.6 ±5.1; potential range 8–32). One month after last LASER treatment the pain NRS on vulvar cotton swab test improved from 6.1 ± 2.6 at baseline to 3.1 ± 2.6 (P < .001), and 74% of women (n = 26) reported symptom improvement. At 9–12 months follow-up 66% reported ongoing symptom improvement, with no significant difference to the control group of 32 women. Conclusion Microablative Er:YAG vulvovaginal LASER therapy appears safe and well accepted among vulvodynia patients, but there was no significant difference in symptom improvement compared to a control group.

Introduction/Background* Primary therapy planning, meaning primary surgery vs. neoadjuvant chemotherapy (NACT), in suspected advanced ovarian cancer is a professional and logistical challenge. Prompt diagnostic laparoscopy in such patients should confirm the diagnosis by frozen section, assess operability and thus, avoid unnecessary laparotomies. Methodology Retrospective evaluation of 130 patients who presented in 2016-2020 with suspected advanced ovarian cancer (peritoneal carcinomatosis, ascites on average 1,5L). Result(s)* In 2016-20, 82/130 patients (63%) underwent diagnostic laparoscopy; the others received either primary laparotomy, NACT, palliative chemotherapy, or best supportive care. 47% of the 82 patients were triaged to NACT, and 53% to primary surgery. The median time between initial presentation and laparoscopy was almost 8 days, the time from laparoscopy to first cycle of NACT was 14 days, and the time from laparoscopy to laparotomy was 15 days. The rate of R0 resections in patients with primary surgery after laparoscopy was 84%. Conclusion* Diagnostic laparoscopy seems to be an efficient measure in the workup and treatment planning of patients with suspected advanced ovarian cancer. The times between first presentation and laparoscopy as well as between laparoscopy and NACT or primary laparotomy need improvement.

Background Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. Methods In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1–IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. Results Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. Conclusions Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment. Trial registration: ClinicalTrials.gov : NCT02494063

Introduction and hypothesis We conducted a systematic review of the effectiveness of local preemptive analgesia for postoperative pain control in women undergoing vaginal hysterectomy. Methods MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews were searched systematically to identify eligible studies published through September 25, 2019. Only randomized controlled trials and systematic reviews addressing local preemptive analgesia compared to placebo at vaginal hysterectomy were considered. Data were extracted by two independent reviewers. Results were compared, and disagreement was resolved by discussion. Forty-seven studies met inclusion criteria for full-text review. Four RCTs, including a total of 197 patients, and two SRs were included in the review. Results Preemptive local analgesia reduced postoperative pain scores up to 6 h and postoperative opioid requirements in the first 24 h after surgery. Conclusion Preemptive local analgesia at vaginal hysterectomy results in less postoperative pain and less postoperative opioid consumption.

Background: Breast cancer (BC) is with 30% among all cancers the most common cancer among women in Austria. Regarding therapy and management of BC, surgical treatments with resection and reconstruction play a crucial role. Breast-conserving therapy (BCT) represents a common procedure. However, mastectomy is still needed in about 30% of the patients with the diagnosis BC and as prophylactic surgery in indicated cases. Recently, autologous fat transfer (AFT, lipofilling) has been used to improve cosmesis in oncoplastic and reconstructive breast surgery. There is a gap of evidence for the oncological safety as well as the benefit for quality of life (QoL) in patients who had an AFT after the BC or prophylactic surgery. Material and methods: We assessed peri-and postoperative results, oncological outcomes and QoL in 55 patients undergoing AFT after BCT or mastectomy at our department between 2013 and 2018. QoL was assessed with the EORTC QLQ C30 and QLQ-BRECON23 questionnaires. Results: Overall, 55 patients (73 breasts) underwent AFT after BCT or mastectomy. 39 patients had a diagnosis of invasive BC (four bilateral) and six patients a diagnosis of DCIS. 24 mastectomies were done as prophylactic surgery. AFT was done in 22 cases with nipple sparing mastectomy (NSM), in 30 cases with skin sparing mastectomy (SSM), in 9 cases with simple mastectomy ± reconstruction and in 12 cases with BCT. The number of AFT sessions was 1-8 (mean 1.8). The injected fat volume per session was 30-390 ml. There were 10 (14%) complications: 3 hematomas (none needed reintervention), local inflammation requiring antibiotic therapy (n=3), formation of an oil cyst (n=1), and fat necrosis (n=3). In two cases of fat necrosis biopsy was performed to confirm the diagnosis. After a median follow-up of 34 months there was one recurrence (Paget´s disease after BC). QoL data will be presented at the meeting. Conclusion: Lipofilling after mastectomy for cancer appears to be oncologically safe. Our complication rate is relatively high, although additional surgical intervention (biopsy) was only necessary in two cases. Patients considering AFT should be informed about additional risk for biopsy, as well as other common complications. Citation Format: Bjelic-Radisic V, Oberfichtner K, Wurzer P, Trapp E, Rappl T, Reisniger J, Kamolz L-P, Tamussino K. Short-term outcomes and QoL following autologous fat transfer in oncoplastic and reconstructive breast surgery [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-07.

Purpose On January 1st, 2018, the ÖGZ (Austrian Society of Cytology) revised its cytological nomenclature to make it more similar to the 2015 Bethesda system. Following these changes, the Austrian Society of Gynecology and Obstetrics felt it necessary to revise the approach currently used in Austria to diagnose and treat CIN and to review the procedures to be followed when the quality of cytological specimens is unsatisfactory. It was not possible to adopt the German S3 guideline “Prevention of Cervical Cancer” in its entirety, because the Munich III gynecological cytology nomenclature used in Germany is not used in Austria. This made it necessary to compile a separate scientific opinion for Austria. Methodology The OEGGG worked together with the ÖGZ (Austrian Society for Cytology), AGO Austria (Austrian Working Group for Gynecological Oncology), the AGK (Colposcopy Working Group), and physicians representing gynecologists in private practice. The different scientific associations nominated representatives, who attended the various meetings. After an in-depth analysis of the recent literature, three meetings and numerous votes by telephone, we were able to achieve a consensus about the contents of this guideline. Recommendations The guideline provides recommendations for the diagnosis and treatment of CIN which take account of the gynecological cytology nomenclature used in Austria.

Fortschritte der chirurgischen und systemischen Therapien des Ovarialkarzinoms haben die Uberlebenszeiten von Patientinnen verlangert und den Fokus auf deren Lebensqualitat (LQ) erhoht. Die Berucksichtigung von Patient Reported Outcomes (PROs) als primare oder sekundare Endpunkte in klinischen Ovarialkarzinomstudien ist in den letzten Jahren deutlich angestiegen. Fur die Messung von PROs stehen standardisierte Instrumente zur Verfugung, die speziell fur Patientinnen mit Ovarialkarzinom entwickelt wurden. PRO-Instrumente sind mittels internetbasierter Erfassungsmethoden als ePROs verfugbar und weniger zeit- und kostenintensiv. Klinische Studienergebnisse mit PRO-Endpunkten haben in der Behandlung des Ovarialkarzinoms zur Veranderung des international anerkannten Therapiestandards gefuhrt. Auf Grundlage der Daten wurden Carboplatin plus Paclitaxel weltweit als neuer Standard der Primartherapie des fortgeschrittenen Ovarialkarzinoms festgelegt. Eine weitere Individualisierung der Therapie unter Berucksichtigung der LQ von Patientinnen konnte in der spaten Rezidivsituation des Ovarialkarzinoms ermoglicht werden. Neben klinischen Studien finden PROs zunehmend auch in der klinischen Routine Eingang. Die Mehrheit onkologischer Patienten befurwortet die routinemasige Erfassung der LQ. PRO-Daten geben wichtige Information uber die subjektive Auswirkung der Erkrankung und der Therapie auf die LQ der Patientinnen, konnen fur gemeinsame Therapieentscheidungen herangezogen werden und Behandlungsoptionen an die Bedurfnisse der Patientinnen anpassen.

Introduction/Background Usual type vulvar intraepithelial neoplasia (u-VIN) is a premalignant condition of the squamous epithelium of the vulva caused by persistent infection with high-risk human papillomavirus (HPV), and classified as high grade squamous intraepithelial lesion (HSIL). Surgery is the standard treatment, but recurrences occur in about 50% of patients. Imiquimod, a topical immune response modifier, has been shown to be effective, but has not been compared to surgery. The aim of this study was to compare the effectiveness and acceptance of primary imiquimod treatment with surgical treatment of HSIL/VIN. Methodology This was a multicentre randomised controlled trial of women with histologically confirmed HSIL/VIN II-III. Exclusion criteria were clinical suspicion of microinvasion, a history of vulvar cancer, severe dermatosis, pregnancy, and any active treatment for VIN within the previous three months. Patients were randomized to primary topical treatment or surgery at a ratio of 1:1 and stratified by unifocal or multifocal disease. Treatment with imiquimod was self-administered for a period of 4 months with possible extension. Surgical treatment was performed according to the standard procedures of the trial site. Clinical assessment, colposcopy, vulvar punch-biopsy and HPV-test (cobas®, Roche) were performed at baseline and 6 months. Clinical follow-up, including questionnaires on health-related quality-of-life, was conducted at 12 months. Results Between June 2013 and January 2020 a total of 110 patients were enrolled at six hospitals in Austria. Mean age was 51 years (SD 16, range 19 -82) with 57% being postmenopausal. 66 patients (61%) had a history of previous HPV related anogenital HSIL or genital warts, and 21 women (19%) had received previous treatment for VIN. 85 women (78%) presented with unifocal and 24 (22%) with multifocal VIN, and 56 women (51%) reported local symptoms. 40 women (37%) had a history of current or past smoking. 56 women were allocated to primary treatment with imiquimod, and 54 women to primary surgery. Surgical treatment was performed by local excision in 22 cases (14 cold-knife, 6 electrosurgical), by laser destruction (n= 27), or combined (n=3). 12-months follow-up will be completed in January 2021. Conclusion The results of this clinical trial will show whether imiquimod is a safe and effective alternative to surgery in women with HSIL/VIN2-3. Disclosures The study was funded by the Austrian Science Fund (FWF) and the Austrian Association for Gynecologic Oncology (AGO). The study medication Aldara 5% cream was provided by Meda Pharma GmbH. The authors have no conflict of interest.

The quality of pathological assessment is crucial for the safety of patients with cervical cancer if pelvic lymph node dissection is to be replaced by sentinel lymph node (SLN) biopsy. Central pathology review of SLN pathological ultrastaging was conducted in the prospective SENTIX/European Network of Gynaecological Oncological Trial (ENGOT)-CX2 study. All specimens from at least two patients per site were submitted for the central review. For cases with major or critical deviations, the sites were requested to submit all samples from all additional patients for second-round assessment. From the group of 300 patients, samples from 83 cases from 37 sites were reviewed in the first round. Minor, major, critical, and no deviations were identified in 28%, 19%, 14%, and 39% of cases, respectively. Samples from 26 patients were submitted for the second-round review, with only two major deviations found. In conclusion, a high rate of major or critical deviations was identified in the first round of the central pathology review (28% of samples). This reflects a substantial heterogeneity in current practice, despite trial protocol requirements. The importance of the central review conducted prospectively at the early phase of the trial is demonstrated by a substantial improvement of SLN ultrastaging quality in the second-round review. ispartof: CANCERS vol:12 issue:5 ispartof: location:Switzerland status: published

BackgroundOptimizing and ensuring the quality of surgical care is essential to improve the management and outcome of patients with cervical cancer.To develop a list of quality indicators for surgical treatment of cervical cancer that can be used to audit and improve clinical practice.MethodsQuality indicators were developed using a four-step evaluation process that included a systematic literature search to identify potential quality indicators, in-person meetings of an ad hoc group of international experts, an internal validation process, and external review by a large panel of European clinicians and patient representatives.ResultsFifteen structural, process, and outcome indicators were selected. Using a structured format, each quality indicator has a description specifying what the indicator is measuring. Measurability specifications are also detailed to define how the indicator will be measured in practice. Each indicator has a target which gives practitioners and health administrators a quantitative basis for improving care and organizational processes.DiscussionImplementation of institutional quality assurance programs can improve quality of care, even in high-volume centers. This set of quality indicators from the European Society of Gynaecological Cancer may be a major instrument to improve the quality of surgical treatment of cervical cancer.

Introduction/Background Introduction: GROINSS-V II investigated whether radiotherapy is a safe alternative for inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). Methodology Methods: In GROINSS-V II, a prospective multicentre phase II trial, patients were included with early-stage squamous cell carcinoma (SCC) of the vulva (diameter Results From December 2005 until October 2016, 1552 eligible patients were registered. SN-metastasis occurred in 324/1552 (21%) patients. After 54 months of inclusion the stopping-rule for SN-positive patients was activated; interim analysis showed an increased risk for groin recurrence in case of SN-metastasis >2 mm and/or extranodal extension (ENE). After amendment of the protocol only patients with SN-micrometastasis ≤2 mm received radiotherapy, while those with SN metastasis >2 mm underwent IFL (with radiotherapy if >1 metastasis or ENE). Final analysis after ≥2 years of follow-up revealed six isolated groin recurrences in 157 patients with a SN-micrometastasis (3.8%). Four could not be considered radiotherapy failures: two developed recurrence in the contralateral (SN-negative) groin, two refused radiotherapy. Twenty-eight patients did not get radiotherapy (2 recurrences;7.1%). Among 129 patients who received radiotherapy to the groin(s) only two isolated groin recurrences were diagnosed (1.6%: 95%CI:0–3.8%). The combination of radiotherapy with SN was associated with minimal toxicity: 5/118(4.2%) grade 3 toxicity, no grade 4 or 5 toxicity. In 38/1222 SN-negative patients (3.1%: 95%CI:2.1–4.1%) isolated groin recurrences were diagnosed with clear protocol violations in 6 patients: incomplete treatment of the groin (n=3); primary tumor >4cm (n=1); not all SNs visualized on the lymphoscintigram removed (n=2). After exclusion of these protocol violations an isolated groin recurrence rate of 2.6% (95%CI:1.7–3.5%) was observed. Conclusion Radiotherapy to the groins is a safe alternative for IFL in patients with SN metastasis ≤2 mm, with minimal toxicity. We further established the safety of omitting IFL in patients with SCC of the vulva 2 mm, radiotherapy with a total dose of 50Gy was no safe alternative for IFL; dose escalation and/or chemoradiation should be investigated in these patients. Disclosure Funded by Dutch Cancer Society.

Introduction: Vulvodynia and chronic pelvic pain are common but underdiagnosed chronic gynecologic pain syndromes. Insufficient knowledge regarding prevalence, typical pain patterns and ass...

Objective To assess whether there is any association between the implantation of synthetic polypropylene mesh slings for the treatment of stress urinary incontinence (SUI) and risk of cancer. Methods We performed a nationwide cohort study based on the general female population in Sweden. All women entered the observational period as unexposed on January 1, 1997, and contributed person-time as unexposed unless they underwent a midurethral sling procedure for SUI, after which they contributed person-time as exposed until first occurrence of any cancer, death, emigration, or end of the observational period (December 31, 2009). Occurrence of primary cancer was ascertained from the Cancer Register. Hazard ratios (HRs) with 95% CIs were calculated by Cox proportional hazards regression. Results The final study population included 5,385,186 women, including 20,905 exposed, encompassing a total of 44,012,936 person-years at risk. Other than an inverse association with rectal cancer (HR 0.5, 95% CI 0.3-0.8), there were no significant differences in risk between exposed and unexposed women for pelvic organ cancers including ovarian (HR 0.8, 95% CI 0.5-1.2), endometrial (HR 1.1, 95% CI 0.8-1.4), cervical (HR 0.4, 95% CI 0.2-1.0), bladder, and urethra (HR 0.7, 95% CI 0.4-1.2). No significant association was observed between exposed women and primary cancer in any organ system when compared with unexposed women. The relative risk for cancer after exposure showed little variation over time except for an inverse overall correlation within the first 4 years of surgery (HR 0.7, 95% CI 0.7-0.8). The incidence rates per 100,000 person-years (95% CIs) for exposed vs unexposed women were 20.5 (14.3-29.5) vs 21.0 (20.6-21.5) for rectal cancer, 25.5 (18.4-35.3) vs 19.8 (19.4-20.2) for ovarian cancer, 65.0 (53.0-79.8) vs 33.1 (32.6-33.7) for endometrial cancer, 5.7 (2.8-11.3) vs 11.9 (11.6-12.2) for cervical cancer, and 19.1 (13.1-27.8) vs 13.3 (13.0-13.7) for bladder and urethra cancer. Conclusion Our results suggest that midurethral polypropylene sling surgery for SUI is not associated with an increased cancer risk later in life.

Ovarian, tubal, and peritoneal carcinomas primarily affect the peritoneal cavity, and they are typically diagnosed at an advanced tumor stage (Foley, Rauh-Hain, del Carmen in Oncology (Williston Park) 27:288–294, 2013). In the course of primary surgery, postoperative tumor residuals are, apart from the tumor stage, the strongest independent factors of prognosis (du Bois, Reuss, Pujade-Lauraine, Harter, Ray-Coquard, Pfisterer in Cancer 115:1234–1244, 2009). Due to improved surgical techniques, including the use of multi-visceral procedures, macroscopic tumor clearance can be achieved in oncological centers, in most cases (Harter, Muallem, Buhrmann et al in Gynecol Oncol 121:615–619, 2011). However, to date, it has not been shown that peritoneal carcinomatosis is, per se, an independent factor of prognosis or that it excludes the achievement of tumor clearance. Several studies have shown that a preceding drug therapy in peritoneal carcinomatosis could positively influence the overall prognosis (Trimbos, Trimbos, Vergote et al in J Natl Cancer Inst 95:105–112, 2003). In relapses of ovarian carcinoma, studies have shown that peritoneal carcinomatosis is a negative predictor of complete tumor resection; however, when it is possible to resect the tumor completely, peritoneal carcinomatosis does not play a role in the prognosis (Harter, Hahmann, Lueck et al in Ann Surg Oncol 16:1324–1330, 2009). PIPAC is a highly experimental method for treating patients with ovarian, tubal, and peritoneal cancer. To date, only three studies have investigated a total of 184 patients with peritoneal carcinomatosis (Grass, Vuagniaux, Teixeira-Farinha, Lehmann, Demartines, Hubner in Br J Surg 104:669–678, 2017). Only some of those studies were phase I/II studies that included PIPAC for patients with different indications and different cancer entities. It is important to keep in mind that the PIPAC approach is associated with relatively high toxicity. To date, no systematic dose-finding studies have been reported. Moreover, no studies have reported improvements in progression-free or overall survival associated with PIPAC therapy. Randomized phase III studies are required to evaluate the effect of this therapy compared to other standard treatments (sequential or simultaneous applications with systemic chemotherapy). In cases of ovarian, tubal, and peritoneal cancer, PIPAC should not be performed outside the framework of prospective, controlled studies.

Summary Background To assess emotional distress, anxiety and stress reactions in breast cancer (BC) patients before the follow-up visits. Study design Between September 2009 and December 2011 a total of 284 patients completed the BC-psychosocial assessment screening scale (PASS) and a questionnaire about their views of follow-up after treatment for BC. Results Of the patients 64% reported low level of distress on the BC-PASS. The mean scores on the physical well-being scale was 5.3, the satisfaction/sense of coherence scale 7.4, and the emotional distress scale 8.1. Women rated mammography as the most important component (71%), followed by breast ultrasound (63%) and the consultation with the physician (60%). Of the patients 94% were satisfied with the current follow-up regimen. Conclusions In this series BC patients were satisfied with their aftercare. Mammography was thought to be the most important component of aftercare. Patient-reported outcomes should be taken into account when planning follow-up.

Introduction: Most serous ovarian cancers are now thought to originate in the fallopian tubes. This has raised the issue of performing incidental salpingectomy (also called elective, opportunistic, prophylactic or risk-reducing salpingectomy) at the time of benign gynecologic surgery or cesarean section. We conducted an online survey to ascertain the policies regarding incidental salpingectomy in Austria in late 2014. Material and Methods: All 75 departments of obstetrics and gynecology in public hospitals in Austria were surveyed for their policies regarding incidental salpingectomy at benign gynecologic surgery or cesarean section. Results: Sixty-six of 75 surveyed departments completed the questionnaire, resulting in a response rate of 88 %. Overall, 46 of 66 (70 %) units reported offering or recommending incidental salpingectomy at benign gynecologic surgery, 12 units (18 %) did not, and eight units (12 %) did not have a consistent policy. Salpingectomy was the preferred method for surgical sterilization, including sterilization at the time of cesarean section (71 % and 64 % of units, respectively). Conclusions: Incidental (elective, opportunistic, prophylactic, risk-reducing) salpingectomy is now widely offered at benign gynecologic surgery and cesarean section in Austria. Evidence for the role of the fallopian tubes in the origin of serous pelvic cancer has led to changes in clinical practice.

Objective To determine how many FIGO (International Federation of Obstetrics and Gynecology) member societies have statements regarding opportunistic (incidental, prophylactic, risk-reducing) salpingectomy at the time of benign gynecologic surgery and to categorize statements as positive, negative or ambivalent. Study design The websites of the 130 FIGO member societies were searched for statements on opportunistic salpingectomy. We looked for separate statements and statements embedded in other documents such as clinical guidelines as well as statements by national societies of gynecologic oncology. If nothing was found on the websites we contacted societies by Email or fax. Results As of early 2018, 13 FIGO member societies representing 14 countries have statements regarding opportunistic salpingectomy. Nine were separate, stand-alone statements, four were embedded in other documents. Nine of the 13 statements (from Canada, Finland, U.S.A., Great Britain, Australia and New Zealand, Denmark, Austria, Turkey, and Japan) support consideration of opportunistic salpingectomy in appropriate women and four (from Germany, Sweden, Norway, and France) are ambivalent; there are no statements recommending against opportunistic salpingectomy. Conclusion In 2018 only a small minority of FIGO members have statements on opportunistic prophylactic salpingectomy. These statements are ambivalent or supportive, none is negative.