77 results on '"Muallem MZ"'
Search Results
2. Results of a German Wide Survey by NOGGO and AGE towards Current Surgical Approach in Early Stage Cervical Cancer after the LACC Trial- NOGGO MONITOR 11
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Armbrust R, Chen F, Holthaus B, Jalid Sehouli, Rolf Richter, Muallem Mz, and Mustea A
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German ,Cervical cancer ,medicine.medical_specialty ,Surgical approach ,business.industry ,General surgery ,language ,Medicine ,General Medicine ,Stage (cooking) ,business ,medicine.disease ,language.human_language - Abstract
Purpose: Minimally Invasive Surgery (MIS) has become the standard approach in Early Stage Cervical Cancer (ECC). However, the recently published “LACC” trial and even others could show inferior PFS and OS of MIS compared to open radical hysterectomy. The results led to a widespread debate about the best surgical approach in ECC. The present survey aimed to get first insights after publication. Methods: NOGGO and AGE conducted a nationwide digital survey among 186 Gynecological Cancer Centers. Descriptive statistics and t-tests were performed using SPSS. Results: A majority of the centers were of high expertise and/or experience in treatment of ECC and were highly aware of the LACC trial results. Trial quality and scientific value were rated as very good/good. However, still 40% would not change the standard of care to open surgery. Centers with higher volume and participating in clinical trials were more likely to change. Conclusion: This survey represents some first insights after the surprising results of recently published trials towards the surgical approach of ECC. There still seems to be a high need of future trials and possible explanations for the unexpected worse outcomes in the MIS group.
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- 2021
3. 463 LVSI and Ki67 in prediction of lymph-node metastasis in primary low-grade ovarian cancer
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Grabowski, J, primary, Glajzer, J, additional, Richter, R, additional, Plett, H, additional, Muallem, MZ, additional, Braicu, EI, additional, Taube, E, additional, and Sehouli, J, additional
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- 2020
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4. Therapie des lokal-fortgeschrittenen Zervixkarzinoms. Operatives Vorgehen vs. Radiochemotherapie
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Muallem, MZ, additional
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- 2020
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5. Abschätzung des Schweregrades einer abnormal invasiven Plazenta (AIP) mit Serum-Biomarkern
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Schwickert, A, additional, Chantraine, F, additional, Nonnenmacher, A, additional, Weizsäcker, K von, additional, Muallem, MZ, additional, Henrich, W, additional, and Braun, T, additional
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- 2019
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6. EP1169 Laparoscopic pelvic lymphadenectomy in vulva cancer vs postoperative radiation in pelvic area
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Klonos, EG, primary, Muallem, MZ, additional, Muallem, J, additional, Hatoum, I, additional, Tolkos, AZ, additional, and Sehouli, J, additional
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- 2019
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7. Case report: Behandlung einer heterotopen Zwillingsschwangerschaft mit ektoper zervikaler Narbenschwangerschaft
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Seidel, V, additional, Nonnenmacher, A, additional, Schwickert, A, additional, Braun, T, additional, Muallem, MZ, additional, and Henrich, W, additional
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- 2018
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8. Patientinnen mit gynäkologischem Sarkom: Charakteristika aus der Online-Tumorkonferenz für seltene Tumoren
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Dröge, LA, additional, Alavi, S, additional, Chekerov, R, additional, Muallem, MZ, additional, Pietzner, K, additional, and Sehouli, J, additional
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- 2018
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9. Management von Patientinnen mit gynäkologischem Sarkom – Eine Umfrage zur Behandlungspraxis der betreuenden GynäkologInnen im Rahmen der REGSA-Studie (Deutsches gynäkoonkologisches Sarkomregister) – MONITOR IX
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Dröge, LA, additional, Eckes, L, additional, Osman, S, additional, Pasternak, J, additional, Jordan, J, additional, Harter, P, additional, Mustea, A, additional, Muallem, MZ, additional, Wimberger, P, additional, Mahner, S, additional, Kurzeder, C, additional, Hasenburg, A, additional, Chekerov, R, additional, Denschlag, D, additional, and Sehouli, J, additional
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- 2018
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10. Angiosarkom des weiblichen Genitaltraktes – Fallserie eines äußerst seltenen, aggressiven und vielgesichtigen Tumors mit systematischem Review
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Alavi, S, additional, Chinczewski, L, additional, Taube, ET, additional, Feldhaus, FW, additional, Dröge, LA, additional, Chekerov, R, additional, Pietzner, K, additional, Muallem, MZ, additional, and Sehouli, J, additional
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- 2018
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11. Peritoneal metastasiertes High-grade-Stromasarkom – Eine Kasuistik
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Dröge, LA, additional, Alavi, S, additional, Taube, ET, additional, Muallem, MZ, additional, Chekerov, R, additional, Pietzner, K, additional, and Sehouli, J, additional
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- 2018
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12. Patientinnen mit Keimstrang-Stroma-Tumor: Charakteristika aus der Online-Tumorkonferenz für seltene Tumoren
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Dröge, LA, additional, Alavi, S, additional, Chekerov, R, additional, Muallem, MZ, additional, Pietzner, K, additional, Seifert, G, additional, and Sehouli, J, additional
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- 2018
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13. Oberbauchchirurgie beim Ovarialkarzinom (Zwerchfellresektion im Fokus)
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Muallem, MZ, primary, Almuheimid, J, additional, Braicu, EI, additional, Plett, H, additional, Richter, R, additional, Osman, S, additional, and Sehouli, J, additional
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- 2016
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14. Oberbauchchirurgie beim Ovarialkarzinom (Splenektomie im Fokus)
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Osman, S, primary, Braicu, I, additional, Richter, R, additional, Almuheimed, J, additional, Sehouli, J, additional, and Muallem, MZ, additional
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- 2016
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15. Laparoscopic radical hysterectomy in cervical cancer as total mesometrial resection (L-TMMR): A multicentric experience
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Chiantera, V, Vizzielli, G, Lucidi, A, Gallotta, V, Petrillo, M, Legge, F, Fagotti, Anna, Sehouli, J, Scambia, Giovanni, Muallem, Mz, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Chiantera, V, Vizzielli, G, Lucidi, A, Gallotta, V, Petrillo, M, Legge, F, Fagotti, Anna, Sehouli, J, Scambia, Giovanni, Muallem, Mz, and Scambia, Giovanni (ORCID:0000-0003-2758-1063)
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OBJECTIVE: To analyze the feasibility of total mesometrial resection by laparoscopy (L-TMMR) in a multicentric series of early stage cervical cancer. METHOD: We prospectively evaluated a consecutive series of cervical cancer patients with pre-operative FIGO stages IA2-IB1 at the Catholic University in Rome and in Campobasso and the Charitè University in Berlin. All cases were assessed at pre-operative MRI scan and clinically confirmed by investigation under anesthesia, adhering strictly to the FIGO criteria. The surgical and post-surgical data were collected. RESULTS: 104 women with cervical cancer were admitted between July 2013 and August 2014 and among them 71 patients with pre-operative FIGO stages IA2-IB1 were treated with L-TMMR. One laparotomic conversion was registered. The median operative time was 260min (120-670min), estimated blood loss was 100cm(3) (25-900cm(3)), and the median length of hospital stay was 6days (2-26days). We observed 8 intra-operative complications including a vascular injury of the left internal iliac vein that caused conversion, 6 vesical injuries and 1 ureteral injury managed laparoscopically. Two vescico-vaginal fistula and one hemoperitoneum were observed as major post-operative complications (4.2%). CONCLUSION: L-TMMR can be safely performed in selected cervical cancer patients. Further larger prospective trials are needed to evaluate the oncological outcome of patients undergoing this surgical procedure.
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- 2015
16. Pilotstudie – sFLT1 and PLGF als Serummarker zur Detektion der abnorm invasiven Plazenta (AIP)
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Braun, T, primary, Weizsäcker, K, additional, Chantraine, F, additional, Muallem, MZ, additional, and Henrich, W, additional
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- 2015
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17. Seltener Fall einer schweren retroperitonealen Blutung nach Spontangeburt als lebensbedrohliche postpartale Komplikation
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Schulze, W, primary, Siedentopf, JP, additional, Muallem, MZ, additional, and Henrich, W, additional
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- 2011
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18. Ovarian cancer management in an ESGO ovarian cancer center of excellence: a systematic case study of the interprofessional and interdisciplinary interaction.
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Krankenberg DJ, Muallem MZ, Pietzner K, Chekerov R, Armbrust R, Beteta C, Schöning W, Lee M, Klews J, and Sehouli J
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- Female, Humans, Male, Middle Aged, Cytoreduction Surgical Procedures, Interdisciplinary Communication, Interprofessional Relations, Medical Oncology, Quality Indicators, Health Care, Ovarian Neoplasms therapy, Patient Care Team
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Purpose: With growing knowledge about ovarian cancer over the last decades, diagnosis, evaluation and treatment of ovarian cancer patients have become highly specialized, and an individually adapted approach should be made in each woman by interdisciplinary cooperation. The present study aims to show the variety and extent of medical specialties involved at our institution according to the European Society of Gynecologic Oncology (ESGO) Quality indicators (QI)., Methods: A woman, diagnosed with high-grade ovarian cancer, International Federation of Gynecology and Obstetrics (FIGO) class IVb was selected for a single case observational study. The observation period (total = 22d) comprised preoperative diagnostic procedures, including imaging, the in-patient stay for cytoreductive surgery, and the postoperative course and case discussion at our interdisciplinary tumor board. Data were obtained by self-reporting and by patient file review., Results: Patient tracking demonstrated an interdisciplinary cooperation of 12 medical specialties [62 physicians (63% male, 37% female)], 8 different types of nursing staff [n = 59 (22% male, 78% female)], and 9 different types of perioperative/administrative staff (n = 23; male 17,4%, female n = 19, 82,6%). Contact with the patient was direct (n = 199; 76%) or without face-to-face interaction (n = 63; 24%)., Conclusion: The present study demonstrates the high diversity of physicians and the affiliated medical staff, as well as interdisciplinary intersections within teams of a specialized hospital. Matching the ESGO QIs, this report underlines the requirement of an adequate infrastructure for the complex management of advanced ovarian cancer patients. Future prospective studies are warranted to evaluate the specific procedures and actions to optimize the interprofessional and interdisciplinary workflows., (© 2024. The Author(s).)
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- 2024
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19. Randomized phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer.
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Vergote I, Van Nieuwenhuysen E, Casado A, Laenen A, Lorusso D, Braicu EI, Guerra-Alia E, Zola P, Wimberger P, Debruyne PR, Falcó E, Ferrero A, Muallem MZ, Kerger J, García-Martinez E, Pignata S, Sehouli J, Van Gorp T, Gennigens C, and Rubio MJ
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- Female, Humans, Carboplatin, Vascular Endothelial Growth Factor A, Neoplasm Recurrence, Local pathology, Paclitaxel, Antineoplastic Combined Chemotherapy Protocols adverse effects, Double-Blind Method, Uterine Cervical Neoplasms drug therapy, Uterine Cervical Neoplasms etiology, Lung Neoplasms drug therapy
- Abstract
Objective: Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor. The aim was to establish the role of nintedanib in addition to paclitaxel and carboplatin in first-line recurrent/metastatic cervical cancer., Methods: Double-blind phase II randomized study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin-paclitaxel with oral nintedanib 200 mg BID/placebo. The primary endpoint was progression-free survival (PFS) at 1.5 years and α = 0.15, β = 80%, one sided., Results: 120 patients (62 N, 58C) were randomized. Median follow-up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favor of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However, N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Global health status during and at the end of the study was similar in both arms., Conclusion: The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed., Competing Interests: Declaration of Competing Interest Vergote I. as corresponding author declares consulting fees from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, Exelixis, F. Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Regeneron, Sanofi, Seagen, Sotio, Verastem Oncology, Zentalis; Contracted research (via KULeuven) from Oncoinvent AS; Corporate sponsored research from Amgen and Roche and accommodations and travel expenses from Karyopharm, Genmab and Novocure. Van Nieuwenhuysen E. declares consulting/advisory board fees from AstraZeneca, Regeneron; research support from Eli Lilly and travel expenses from Roche and PharmaMar. Casado A. declares consulting or advisory role from Roche Spain, PharmaMar, Eisai, Merck Sharp & Dohme, Eisai (all personal); research funding from PharmaMar (institutional); travel and accommodation support from PharmaMar, Roche, Lilly Spain (all personal); other relationship with Lilly (institutional). Laenen A. declares no conflicts. Lorusso D. declares consultant honoraria from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Seagen, Novartis and PharmaMar; invited member of advisory board from Oncoinvest, Corcept, Sutro; invited speaker and member of advisory boards from AstraZeneca, Immunogen, GSK, Seagen, Genmab; research institutional funding from Clovis Oncology, GSK, MSD and PharmaMar; grants for traveling: AstraZeneca, Clovis Oncology, GSK. Braicu E.I. received research funding from Bayer, Roche Diagnostics, Tesaro, GSK, and AstraZeneca and received personal fees from AstraZeneca, Clovis, GSK, Tesaro, EISAI, RochePharma, and Roche Diagnostics. Guerra-Alia E. has received advisory/consultancy honorarium from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; she has received speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis and she received travel/accommodation/expenses from Roche, GSK-Tesaro and Baxter. Zola P. declares consulting fees from Astrazeneca. Wimberger P. has received research funding from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, Lilly, honoraria from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead, Daichii Sankyo. He participates at advisory boards from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead and Daichii Sankyo. Debruyne P.R. received grants from Pfizer (institutional); consulting fees for Advisory Boards from BMS, Merck Pfizer, Ipsen; honoraria for lectures from Bayer; travel support from Janssen; (Substitute) Board Member, Clinical Trials College, Federal Public Service, Kingdom of Belgium; stock or stock options from Alkermes and Biocartis Group NV. Ferrero A declares honoraria from GlaxoSmithKline, Clovis, Astra Zeneca-MSD; invited member of advisory boards from Astra Zeneca-MSD. Muallem MZ received consulting fees from Styker, Intuitive and BD. Garcia-Martinez E. received accommodations and travel expenses from GSK, Roche, MSD and consulting or educational fees from GSK, AstraZeneca, Pharmamar, MSD. Pignata S. has no COI related to this paper. Sehouli J. received consulting fees from Tesaro, Merck/Pfizer, PharmaMar, Clovis Oncology, Eisai, Oncoinvent, AstraZeneca, Roche Pharma, GlaxoSmith, MSD, Novocure; honoraria for lectures from Tesaro, PharmaMar, Clovis, Roche, Vifor Pharma, Novartis Pharma, GlaxoSmith, AstraZeneca, Bayer, PharmaMar, Hexal AG; patents from Roche Pharma, Bayer, GlaxoSmith, Tesaro, AstraZeneca, Clovis and Lilly. Van Gorp T. received grants from Amgen, Roche and AstraZeneca (institutional); consulting fees from AstraZeneca, Eisai Europe, OncXerna Therapeutics, MSD/Merck, GSK, ImmunoGen and Seagen (all institutional); he received travel support from Amgen, Pfizer, Roche, Sanofi-Aventis, Novartis, Roche, Immunogen, MSD, AstraZeneca, PharmaMar and GSK. Gennigens Ch. declares no disclosures for the present manuscript; grants/contracts from AstraZeneca, consulting fees from Ipsen, GSK and MSD; honoraria for lectures etc. from MSD, BMS, Ipsen, Pfizer, Pharmamar, AstraZeneca, GSK; support for meetings and/or travel: Ipsen, Pharmamar, Pfizer, MSD, GSK; participation on data safety monitoring board or Advisory Board: MSD, BMS, Ipsen, AstraZeneca, GSK, Eisai. Rubio MJ. has served on advisory boards for MSD, AstraZeneca, Roche, GSK, Clovis, PharmaMar and received support for travel or accommodation from Roche, AstraZeneca, PharmaMar, MSD and GSK., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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20. Challenges in the Diagnosis and Individualized Treatment of Cervical Cancer.
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Schubert M, Bauerschlag DO, Muallem MZ, Maass N, and Alkatout I
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- Female, Humans, Immunization, Developed Countries, Prevalence, Early Detection of Cancer, Uterine Cervical Neoplasms therapy, Uterine Cervical Neoplasms prevention & control, Papillomavirus Infections prevention & control
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Cervical cancer is still the fourth most common cancer in women throughout the world; an estimated 604,000 new cases were observed in 2020. Better knowledge of its pathogenesis, gained in recent years, has introduced new preventive and diagnostic approaches. Knowledge of its pathogenesis has made it possible to provide individualized surgical and drug treatment. In industrialized countries, cervical cancer has become a less frequent tumor entity due to the accessibility of the human papilloma virus vaccination, systematic preventive programs/early detection programs, health care infrastructure and the availability of effective therapy options. Nevertheless, globally, neither mortality nor morbidity has been significantly reduced over the past 10 years, and therapy approaches differ widely. The aim of this review is to address recent advances in the prevention, diagnostic investigation and treatment of cervical cancer globally, focusing on advances in Germany, with a view toward providing an updated overview for clinicians. The following aspects are addressed in detail: (a) the prevalence and causes of cervical cancer, (b) diagnostic tools using imaging techniques, cytology and pathology, (c) pathomechanisms and clinical symptoms of cervical cancer and (d) different treatment approaches (pharmacological, surgical and others) and their impact on outcomes.
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- 2023
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21. Adult ovarian granulosa cell tumors: analysis of outcomes and risk factors for recurrence.
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Plett H, Ricciardi E, Vacaru V, Ramspott JP, Colombo N, Sehouli J, du Bois A, Garbi A, Richter R, Ataseven B, Aletti G, Braicu E, Heitz F, Portuesi R, Muallem MZ, Dagres T, Parma G, Roser E, Traut A, Multinu F, and Harter P
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- Female, Adult, Humans, Adolescent, Young Adult, Middle Aged, Aged, Aged, 80 and over, Prospective Studies, Neoplasm Staging, Retrospective Studies, Chemotherapy, Adjuvant, Risk Factors, Granulosa Cell Tumor pathology, Ovarian Neoplasms pathology
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Objective: Adult granulosa cell tumors represent less than 5% of all ovarian malignancies. The aim of this study was to analyze the clinicopathological parameters and their impact on progression-free and overall survival., Methods: Patients with primary adult granulosa cell tumors treated in three international referral centers between July 1999 and December 2018 were included. The following data were anonymously exported from the prospective database: age at diagnosis, International Federation of Gynecology and Obstetrics (FIGO) stage, adjuvant therapy, surgical procedures, progression-free survival, and overall survival. Descriptive statistical analysis regarding tumor and treatment characteristics was performed. Survival analyses included Kaplan-Meier functions and Cox proportional hazard ratios (HR)., Results: A total of 168 patients with primary adult granulosa cell tumors were included. Median age was 50 years (range 13-82). With regard to stage distribution, 54.2% (n=91) of patients were FIGO stage IA, 1.2% (n=2) were stage IB, 26.8% (n=45) were stage IC, and 17.9% (n=30) were FIGO stage II-IV. 66.7% (n=112) of patients underwent surgical restaging, of whom 17.9% (n=20) were moved to a higher stage. In addition, 36 (21.4%) patients underwent fertility-sparing surgery. After a median follow-up of 61 months (range 0-209), 10.7% of patients (n=18) had recurrent disease and 4.8% (n=8) died of disease. Five-year progression-free survival was 86.1% and estimated overall survival was 95.7%. Five-year progression-free survival was worse for patients with advanced stages (FIGO stage IA/B vs IC: HR 5.09 (95% CI 1.53 to 16.9); FIGO stage IA/B vs II-IV: HR 5.62 (95% CI 1.58 to 19.9)). Nineteen patients receiving adjuvant chemotherapy had lower estimated 5-year progression-free survival compared with patients not receiving chemotherapy (49.7% vs 91.1%, p<0.001; HR 9.15 (95% CI 3.62 to 23.1))., Conclusion: The prognosis of patients with primary adult granulosa cell tumors is mainly determined by FIGO stage. The outcome of patients with FIGO stage IC is comparable to those with advanced stages. Fertility-sparing surgery seems to be a safe procedure in stage IA. Our data do not support the use of adjuvant chemotherapy in early and advanced stages of adult granulosa cell tumors., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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22. PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study.
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Martinez A, Lecuru F, Bizzarri N, Chargari C, Ducassou A, Fagotti A, Fanfani F, Scambia G, Cibula D, Díaz-Feijoo B, Gil Moreno A, Angeles MA, Muallem MZ, Kohler C, Luyckx M, Kridelka F, Rychlik A, Gerestein KG, Heinzelmann V, Ramirez PT, Frumovitz M, Ferron G, Betrian S, Filleron T, Fotopoulou C, and Querleu D
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- Female, Humans, Lymphatic Metastasis pathology, Neoplasm Recurrence, Local pathology, Lymph Node Excision methods, Lymph Nodes surgery, Lymph Nodes pathology, Neoplasm Staging, Retrospective Studies, Positron Emission Tomography Computed Tomography, Uterine Cervical Neoplasms surgery, Uterine Cervical Neoplasms pathology
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Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para-aortic and distant control., Primary Objectives: To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3-year disease-free survival compared with patients staged with PET/CT staging only., Study Hypothesis: Surgical staging followed by tailored chemoradiation will improve disease-free survival while avoiding unnecessary prophylactic extended-field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer., Trial Design: This is an international multicenter, randomized, phase III study. Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment., Major Inclusion/exclusion Criteria: Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer. Main exclusion criteria include unequivocal positive common iliac or para-aortic lymph node at pre-therapeutic imaging PET/CT., Primary Endpoints: The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause., Sample Size: 510 eligible patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The estimated date for completing accrual will be Q2 2027. The estimated date for presenting results will be Q4 2030., Trial Registration Number: NCT05581121., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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23. Treatment strategies in patients with gynecological sarcoma: Results of the prospective intergroup real-world registry for gynecological sarcoma in Germany (REGSA-NOGGO RU1).
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Roser E, Harter P, Zocholl D, Denschlag D, Chekerov R, Wimberger P, Kurzeder C, Hasenburg A, Muallem MZ, Mustea A, Emons G, Zeimet AG, Beck F, Arndt T, Brucker SY, Kommoss S, Heitz F, Welz J, Egger EK, Kalder M, Buderath P, Klar M, Marth C, Ulrich UA, Weigel M, Traub L, Anthuber C, Strauss H, Hanker L, Link T, Kubiak K, Melekian B, Hornung D, Pölcher M, Lampe B, Krauß T, Keilholz U, Flörcken A, Pietzner K, and Sehouli J
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- Humans, Female, Hysterectomy, Germany epidemiology, Retrospective Studies, Sarcoma epidemiology, Sarcoma therapy, Sarcoma pathology, Gynecology, Endometrial Neoplasms pathology, Uterine Neoplasms pathology
- Abstract
Objective: Gynecological sarcomas account for 3% of all gynecological malignancies and are associated with a poor prognosis. Due to the rarity and heterogeneity of gynecological sarcomas there is still no consensus on optimal therapeutic strategies. This study's objective was to describe the treatment strategies used in patients with gynecological sarcomas in the primary course of disease., Methods: The German prospective registry for gynecological sarcoma (REGSA) is the largest registry for gynecological sarcomas in Germany, Austria and Switzerland. Primary inclusion criteria for REGSA are histological diagnosis of sarcoma of the female genital tract, sarcoma of the breast or uterine smooth muscle tumors of uncertain malignant potential (STUMP). We evaluated data of the REGSA registry on therapeutic strategies used for primary treatment from August 2015 to February 2021., Results: A total of 723 patients from 120 centers were included. Data on therapeutic strategies for primary treatment were available in 605 cases. Overall, 580 (95.9%) patients underwent primary surgery, 472 (81.4%) of whom underwent only hysterectomy. Morcellation was reported in 11.4% (n=54) of all hysterectomies. A total of 42.8% (n=202) had no further surgical interventions, whereas an additional salpingo-ophorectomy was performed in 54% (n=255) of patients. An additional lymphadenectomy was performed in 12.7% (n=60), an omentectomy in 9.5% (n=45) and intestinal resection in 6.1% (n=29) of all patients. Among 448 patients with available information, 21.4% (n=96) received chemo- or targeted therapies, more commonly as single-agent treatment than as drug combinations. Information about anti-hormonal treatment was available for 423 patients, among which 42 (9.9%) received anti-hormonal treatment, 23 (54.8%) of whom with low-grade endometrial stroma sarcomas. For radiotherapy, data of 437 patients were available, among which 29 (6.6%) patients underwent radiotherapy., Conclusion: Our study showed that treatment of patients with gynecologic sarcomas is heterogeneous. Further trials are needed along with more information on treatment modalities, therapy response and patient-reported outcomes to implement new treatment strategies., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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24. Can a morphological description of the peritoneal carcinomatosis in advanced ovarian cancer add prognostic information? Analysis of 1686 patients of the tumor bank ovarian cancer.
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Nasser S, Babayeva A, Braicu I, Richter R, Bilir E, Chekerov R, Muallem MZ, Pietzner K, Inci MG, and Sehouli J
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Background: Peritoneal carcinomatosis in ovarian cancer is frequent and generally associated with higher stage and poorer outcome. The clinical features of peritoneal carcinomatosis are diverse and their relevance for surgical and long-term outcome remains unclear. We conducted this prospective study to describe intraoperatively the different features of peritoneal carcinomatosis(PC) and correlate them with clinicopathological features, progression-free(PFS) and overall survival (OS),., Methods: We performed a systematic analysis of all patients with documented intraoperative PC and a primary diagnosis of epithelial ovarian, tubal, or peritoneal cancer from January 2001 to September 2018. All data were evaluated by using the systematic tumor bank tool. Specific PC features included texture(soft-hard), consistency(coarse-fine or both), wet vs dry(PC with ascites vs. PC without ascites), and localization(diffuse-local). PC characteristics were then evaluated for correlation with age, FIGO-stage, histology, lymph-node involvement, grade, and presence of residual tumor at primary surgery. Moreover, the influence of PC characteristics on OS and PFS was analyzed., Results: A total of 1686 patients with PC and primary epithelial ovarian cancer were included. Majority of the patients were characterized by diffuse PC(73.9%). The majority of peritoneal nodules were fine in texture (55.3%) and hard in consistency (87.4%). Moreover, 27.6% of patients had dry PC. Diffuse PC localization was significantly associated with higher FIGO-stage (p<0.001), high-grade (p=0.003) and serous tumors (p=0.006) as well as residual tumor as compared to local PC (p<0.001). Wet PC also significantly correlated with diffuse localization (p <0.001) and residual tumor as compared to dry PC (p<0.001). Coarse PC was significantly associated with residual tumor as compared to fine PC (p=0.044). All other PC features didn´t correlate with clinicopathological features. As for survival outcomes, diffuse peritoneal localization (p<0.001), wet PC (p<0.001), and additional lymph node involvement (p<0.001) were associated with lower OS and PFS rates. Other PC features did not significantly impact survival., Conclusion: Diffuse localization of peritoneal carcinomatosis was significant predictor of recurrence. Lower OS and PFS were associated with diffuse peritoneal localization, wet PC, and additional lymph node involvement. Further prospective trials are warranted with the inclusion of translational research aspects to better understand the different peritoneal carcinomatosis patterns., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Nasser, Babayeva, Braicu, Richter, Bilir, Chekerov, Muallem, Pietzner, Inci and Sehouli.)
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- 2022
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25. OVA-LEAK: Prognostic score for colo-rectal anastomotic leakage in patients undergoing ovarian cancer surgery.
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Lago V, Segarra-Vidal B, Cappucio S, Angeles MA, Fotopoulou C, Muallem MZ, Manzanedo I, Iglesias JLS, Chacón E, Padilla-Iserte P, Fagotti A, Ferron G, Kluge L, Vargiu V, Del M, Scambia G, Minig L, Tejerizo Á, Segovia MG, Cascales-Campos PA, Hervás D, and Domingo S
- Subjects
- Anastomosis, Surgical adverse effects, Cohort Studies, Female, Humans, Ileostomy adverse effects, Neoplasm Recurrence, Local etiology, Prognosis, Retrospective Studies, Anastomotic Leak diagnosis, Anastomotic Leak etiology, Ovarian Neoplasms complications
- Abstract
Objective: The objective of the present study was to define and validate an anastomotic leak prognostic score based on previously described and reported anastomotic leak risk factors (OVA-LEAK: https://n9.cl/ova-leakscore) and to establish if the use of OVA-LEAK score is better than clinical criteria (surgeon's choice) selecting anastomosis to be protected with a diverting ileostomy., Material & Methods: This is a retrospective, multicentre cohort study that included patients who underwent cytoreductive surgery for primary advanced or relapsed ovarian cancer with colorectal resection and anastomosis between January 2011 and June 2021. Data from patients already included in the previous predictive model were not considered in the present analysis. To validate the performance of our logistic regression model, we used the OVA-LEAK formula (Annex I: https://n9.cl/ova-leakscore) for estimating leakage probabilities in a new independent cohort. Then, receiver operating characteristic (ROC) analysis was performed and area under the curve (AUC) was used to measure the performance of the model. Additionally, the Brier score was also estimated. 95% confidence intervals (CI) for each of the estimated performance measures were also calculated., Results: 848 out of 1159 recruited patients were finally included in the multivariable logistic regression model validation. The AUC of the new cohort was 0.63 for predicting anastomotic leak. Considering a cut-off point of 22.1% to be 'positive' (to get a leak) this would provide a sensitivity of 0.45, specificity of 0.80, positive predictive value of 0.09 and negative predictive value of 0.97 for anastomotic leak. If we consider this cut-off point to select patients at risk of leak for bowel diversion, up to 22.5% of the sampled patients would undergo a diverting ileostomy and 47% (18/40) of the anastomotic leaks would be 'protected' with the stoma. Nevertheless, if we consider only the 'clinical criteria' for performing or not a diverting ileostomy, only 12.5% (5/40) of the leaks would be 'protected' with a stoma, with a rate of diverting ileostomy of up to 24.3%., Conclusions: Compared with subjective clinical criteria, the use of a predictive model for anastomotic leak improves the selection of patients who would benefit from a diverting ileostomy without increasing the rate of stoma use., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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26. Predictive biomarker for surgical outcome in patients with advanced primary high-grade serous ovarian cancer. Are we there yet? An analysis of the prospective biobank for ovarian cancer.
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Keunecke C, Kulbe H, Dreher F, Taube ET, Chekerov R, Horst D, Hummel M, Kessler T, Pietzner K, Kassuhn W, Heitz F, Muallem MZ, Lang SM, Vergote I, Dorigo O, Lammert H, du Bois A, Angelotti T, Fotopoulou C, Sehouli J, and Braicu EI
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- Biological Specimen Banks, Biomarkers, Carcinoma, Ovarian Epithelial, Female, Humans, Neoplasm, Residual, Prospective Studies, Treatment Outcome, Cystadenocarcinoma, Serous genetics, Cystadenocarcinoma, Serous surgery, Ovarian Neoplasms genetics, Ovarian Neoplasms pathology, Ovarian Neoplasms surgery, Peritoneal Neoplasms
- Abstract
Background: High-grade serous ovarian cancer (HGSOC) is the most common subtype of ovarian cancer and is associated with high mortality rates. Surgical outcome is one of the most important prognostic factors. There are no valid biomarkers to identify which patients may benefit from a primary debulking approach., Objective: Our study aimed to discover and validate a predictive panel for surgical outcome of residual tumor mass after first-line debulking surgery., Study Design: Firstly, "In silico" analysis of publicly available datasets identified 200 genes as predictors for surgical outcome. The top selected genes were then validated using the novel Nanostring method, which was applied for the first time for this particular research objective. 225 primary ovarian cancer patients with well annotated clinical data and a complete debulking rate of 60% were compiled for a clinical cohort. The 14 best rated genes were then validated through the cohort, using immunohistochemistry testing. Lastly, we used our biomarker expression data to predict the presence of miliary carcinomatosis patterns., Results: The Nanostring analysis identified 37 genes differentially expressed between optimal and suboptimal debulked patients (p < 0.05). The immunohistochemistry validated the top 14 genes, reaching an AUC Ø0.650. The analysis for the prediction of miliary carcinomatosis patterns reached an AUC of Ø0.797., Conclusion: The tissue-based biomarkers in our analysis could not reliably predict post-operative residual tumor. Patient and non-patient-associated co-factors, surgical skills, and center experience remain the main determining factors when considering the surgical outcome at primary debulking in high-grade serous ovarian cancer patients., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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27. Ten years of live surgical broadcast at Charité-MAYO conferences (2010-2019): a systematic evaluation of the surgical outcome.
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Altmann J, Chekerov R, Fotopoulou C, Muallem MZ, du Bois A, Cliby W, Dowdy S, Podratz K, Lichtenegger W, Camara O, Tunn R, Cibula D, Kuemmel S, Scambia G, Vergote I, Chiantera V, Pietzner K, Inci MG, Chopra S, Biebl M, Neymeyer J, Blohmer JU, and Sehouli J
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- Female, Gynecologic Surgical Procedures adverse effects, Humans, Retrospective Studies, Treatment Outcome, Genital Neoplasms, Female complications, Genital Neoplasms, Female surgery, Postoperative Complications etiology
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Objective: The international Charité-MAYO Conference aims to promote international dialog on diagnostics, management, scientific breakthroughs, and state-of-the-art surgical procedures in gynecology and gynecologic oncology and senology. Live surgeries are a fundamental tool of interdisciplinary and international exchange of experts in their respective fields. Currently, there is a controversial and emotional debate about the true value, risks, and safety of live surgical broadcasts. The aim of the current study is to analyze peri-operative risks in patients who were operated live during the Charité-MAYO Conferences., Methods: Live surgeries were performed by the core Charité team consisting of gynecologic oncologic surgeons, breast and plastic surgeons, partly in collaboration with visiting gynecologic oncologic surgeons. We performed a retrospective analysis of live surgeries performed during seven Charité-MAYO Conferences from 2010 to 2019 held in Berlin, Germany. Patients' files and tumor databases were analyzed as required and patients were contacted to update their long-term follow-up., Results: Sixty-nine patients who were operated live were included. The types of surgery were as follows: urogynecologic procedures (n=13), breast surgery (n=21), and gynecologic oncology surgery for ovarian, uterine, vulvar or cervical cancer (n=35). Peri-operative complications were assessed according to the Clavien-Dindo classification. Despite a high rate of complete resection and the high frequency of multivisceral procedures, the rate of peri-operative complications was within the range published in the literature. Time of surgery and length of intensive unit care and hospital stay did not differ from data acquired at the home institution., Conclusions: Based on our analysis, live surgeries appear to be safe when performed within a multidisciplinary setting without an increase in surgical morbidity and mortality compared with historical controls and without compromise of patients' outcome. This is the first analysis of its kind to set the basis for patient information and consent for this type of surgeries., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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28. A Promising Approach for Primary Cytoreductive Surgery for Advanced Ovarian Cancer: Survival Outcomes and Step-by-Step Description of Total Retroperitoneal en-Bloc Resection of Multivisceral-Peritoneal Packet (TROMP).
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Muallem MZ, Kluge L, Sayasneh A, Sehouli J, Zocholl D, Muallem J, and Miranda A
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(1) Background: A complete tumor resection during primary cytoreductive surgery has been reported to be the most important and perhaps the only independent prognostic factor in advanced ovarian cancers. The goal of complete cytoreduction needs to be weighed against the potential morbidities and long-term survival outcomes. (2) Methods: in this retrospective analysis of a prospectively obtained database, 208 consecutive patients with advanced ovarian cancer who underwent a conventional primary cytoreductive surgery (150 patients) or TROMP technique (58 patients) were included. Progression-free and overall survival rates were calculated using Kaplan-Meier analysis as well as the 95% confidence interval of the hazard ratio between treatment groups. (3) Results: After a median follow-up phase of more than 3 years (range 1-72 months), there are no statistically significant differences between both groups in progression-free and overall survival rates. Albeit, the TROMP group included statistically significant more advanced-stage cases compared to the conventional surgery group. (4) Conclusions: the TROMP technique is a promising tool for successful primary cytoreductive surgery in a selected group of patients with high tumor burdens in order to achieve optimal surgical results and survival outcomes without introducing any additional risks or complications.
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- 2022
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29. Reconstructive Surgery versus Primary Closure following Vulvar Cancer Excision: A Wide Single-Center Experience.
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Muallem MZ, Sehouli J, Miranda A, Plett H, Sayasneh A, Diab Y, Muallem J, and Hatoum I
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(1) Background: plastic reconstruction in vulvar surgery can lead to a better treatment outcome than primary closure. This study aims to compare the preoperative parameters (co-morbidities and tumor size) and postoperative results (tumor free margins and wound healing) between the primary closure and reconstructive surgery after vulvar cancer surgery; (2) Methods: this is a retrospective analysis of prospectively collected data from 2009 to 2021 at a tertiary cancer institution; (3) Results: 177 patients were included in the final analysis (51 patients had primary closure PC and 126 had reconstructive surgery RS). About half (49%) of the PC patients had no co-morbidities ( p = 0.043). The RS group had a 45 mm median maximal tumor diameter compared to the PC group's 23 mm ( p = 0.013). More than 90% of RS and 80% of PC had tumor-free margins ( p = 0.1). Both groups had anterior vulvar excision as the most common surgery (52.4% RS vs. 23.5% PC; p = 0.001). Both groups had identical rates of wound healing disorders. In a median follow-up of 39 months; recurrent disease was found in 23.5% of PC vs. 10.3% in RS ( p = 0.012). In terms of overall survival there was no significant difference between the both groups; (4) Conclusions: reconstructive vulvar surgery enables enhanced complete resection rates of larger vulvar tumors with better anatomical restoration and a comparable wound recovery in comparison to primary closure. This results in a lower recurrence rate despite the increased tumor volume.
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- 2022
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30. Survival outcomes of women with grade 3 endometrioid endometrial cancer: the impact of adjuvant treatment strategies.
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Gungorduk K, Muallem J, Aşıcıoğlu O, Gülseren V, Güleç ÜK, Meydanlı MM, Sehouli J, Özdemir A, Şahin H, Khatib G, Miranda A, Boran N, Şenol T, Yıldırım N, Turan T, Oge T, Taşkın S, Vardar MA, Ayhan A, and Muallem MZ
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- Disease-Free Survival, Female, Humans, Lymph Node Excision, Neoplasm Staging, Prognosis, Retrospective Studies, Carcinoma, Endometrioid surgery, Endometrial Neoplasms surgery
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Aim: This multicenter investigation was performed to evaluate the adjuvant treatment options, prognostic factors, and patterns of recurrence in patients with grade 3 endometrioid endometrial cancer (G3-EEC)., Materials and Methods: The medical reports of patients undergoing at least total hysterectomy and salpingo-oophorectomy for G3-EEC between 1996 and 2018 at 11 gynecological oncology centers were analyzed. Optimal surgery was defined as removal of all disease except for residual nodules with a maximum diameter ≤ 1 cm, as determined at completion of the primary operation. Adequate systematic lymphadenectomy was defined as the removal of at least 15 pelvic and at least 5 paraaortic LNs., Results: The study population consists of 465 women with G3-EEC. The 5-year disease-free survival (DFS) and overall survival (OS) rates of the entire cohort are 50.3% and 57.6%, respectively. Adequate systematic lymphadenectomy was achieved in 429 (92.2%) patients. Optimal surgery was achieved in 135 (75.0%) patients in advanced stage. Inadequate lymphadenectomy (DFS; HR 3.4, 95% CI 3.0-5.6; P = 0.016-OS; HR 3.2, 95% CI 1.6-6.5; P = 0.019) was independent prognostic factors for 5-year DFS and OS., Conclusion: Inadequate lymphadenectomy and LVSI were independent prognostic factors for worse DFS and OS in women with stage I-II G3-EEC. Adequate lymphadenectomy and optimal surgery were independent prognostic factors for better DFS and OS in women with stage III-IV G3-EEC., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2022
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31. Nerve sparing systematic lymph node dissection (para-aortic region): a technique for enhanced functional outcomes after gynecological cancer surgeries.
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Muallem MZ, Nasser S, and Miranda A
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- Female, Genital Neoplasms, Female surgery, Humans, Lymph Nodes innervation, Lymph Nodes pathology, Lymph Node Excision methods
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Competing Interests: Competing interests: None declared.
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- 2022
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32. Reply to: "Hysterectomy versus continuing conservative management: which is better for disseminated intravascular coagulation?"; Shinya Matsuzaki, MD, PhD, Yoshikazu Nagase, MD, Masayuki Endo, MD, PhD, Tadashi Kimura, MD, PhD.
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Biele C, Kaufner L, Nonnenmacher A, von Weizsäcker K, Muallem MZ, Henrich W, and Braun T
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- Female, Humans, Hysterectomy, Schools, Medical, Acetylglucosaminidase, Disseminated Intravascular Coagulation therapy
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- 2022
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33. Sentinel Lymph Node Staging with Indocyanine Green for Patients with Cervical Cancer: The Safety and Feasibility of Open Approach Using SPY-PHI Technique.
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Muallem MZ, Sayasneh A, Armbrust R, Sehouli J, and Miranda A
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(1) Background: Sentinel lymph node staging (SLN) with indocyanine green (ICG) in cervical cancer is the standard of care in most national and international guidelines. However, the vast majority of relevant studies about the safety and feasibility of this method are conducted on minimally invasive surgery; (2) Methods: This study is a retrospective analysis of a retrospective collected database of 76 consecutive patients with cervical cancers, who were operated laparoscopically (50%), or laparotomy (50%). Sentinel nodes were defined as the ICG-positive pelvic nodes in the first and second echelons. False negative cases were defined as positive non-sentinel lymph nodes despite successful sentinel mapping or failed mapping bilaterally by per-patient assessment or unilaterally by pelvic sidewall assessment; (3) Results: Regardless of the approach (open or laparoscopic), the SLN technique achieved a total sensitivity, specificity, and negative predictive value (NPV) of 94.7%, 98.6%, and 94.7%, respectively in the entire sample. The bilateral detection rate was as high as 93.4% with identical results in both approaches. The sensitivity and NPV for SNL in open surgery was found to be similar to minimal access surgery; (4) Conclusions: ICG and SPY-PHI technique is a reliable tool to detect sentinel lymph nodes in cervical cancer during laparotomy.
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- 2021
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34. A New Anatomic and Staging-Oriented Classification of Radical Hysterectomy.
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Muallem MZ
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The current understanding of radical hysterectomy more is centered on the uterus and little is being discussed about the resection of the vaginal cuff and the paracolpium as an essential part of this procedure. This is because that the current classifications of radical hysterectomy are based only on the lateral extent of resection. This way is easier to be understood but does not reflect the anatomical and surgical conception of radical hysterectomy and the three-dimensional ways of tumour spreading, neither meet the need of adjusting the radicality according to the different stages of FIGO classification, which depends-at least in the early stages-on the tumour volume and the infiltration in the vagina (but not on the directly spread in the parametrium). The new classification presented in this paper does not base anymore on the lateral extent of resection only but too on the depth of resection in the small pelvic and the extent of the resected vaginal vault without or with its three-dimensional paracolpium. This classification takes into account the tumour size, stage, localization and infiltration in the vaginal vault and may offer the optimal tool to adjust and tailor the surgery according to these important variables.
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- 2021
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35. Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6).
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Emons G, Kim JW, Weide K, de Gregorio N, Wimberger P, Trillsch F, Gabriel B, Denschlag D, Kommoss S, Aydogdu M, Papathemelis T, Gropp-Meier M, Muallem MZ, Kühn C, Müller A, Frank M, Weigel M, Bronger H, Lampe B, Rau J, Schade-Brittinger C, and Harter P
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- Female, Humans, Neoplasm Recurrence, Local, Neoplasm Staging, Risk Factors, Treatment Outcome, Endometrial Neoplasms surgery, Lymph Node Excision methods
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Background: The impact of comprehensive pelvic and para-aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident., Primary Objective: Evaluation of the effect of comprehensive pelvic and para-aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence., Study Hypothesis: Comprehensive pelvic and para-aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65., Trial Design: Open label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo-oophorectomy is performed. In arm B, in addition, a systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended., Major Inclusion Criteria: Patients with histologically confirmed endometrial cancer stages pT1b-pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible., Exclusion Criteria: Patients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease., Primary Endpoint: Overall survival calculated from the date of randomization until death., Sample Size: 640 patients will be enrolled in the study., Estimated Dates for Completing Accrual and Presenting Results: At present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031., Trial Registration: NCT03438474., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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36. Results of a German wide survey towards current surgical approach in early stage cervical cancer NOGGO MONITOR 11.
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Armbrust R, Chen F, Richter R, Muallem MZ, Mustea A, Holthaus B, and Sehouli J
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- Adult, Aged, Female, Germany epidemiology, Humans, Middle Aged, Minimally Invasive Surgical Procedures, Neoplasm Staging, Uterine Cervical Neoplasms epidemiology, Surveys and Questionnaires, Uterine Cervical Neoplasms pathology, Uterine Cervical Neoplasms surgery
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Minimally invasive surgery (MIS) has become the standard approach in early stage cervical cancer (ECC). However, the recently published "LACC" trial and even others could show inferior PFS and OS of MIS compared to open radical hysterectomy. The results led to a widespread debate about the best surgical approach in ECC. The present survey aimed to get first insights after publication. NOGGO and AGE conducted a nationwide digital survey among 186 Gynecological Cancer Centers. Descriptive statistics and t-tests were performed using SPSS. A majority of the centers were of high expertise and/or experience in treatment of ECC and were highly aware of the LACC trial results. Trial quality and scientific value were rated as very good/good. However, still 40% would not change the standard of care to open surgery. Centers with higher volume and participating in clinical trials were more likely to change. This survey represents insights after the surprising results of recently published trials towards the surgical approach of ECC. There still seems to be a high need of future trials and possible explanations for the unexpected worse outcomes in the MIS group.
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- 2021
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37. Nerve-sparing radical hysterectomy-Muallem technique with explanation of parametrium and paracolpium anatomy.
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Muallem MZ, Miranda A, and Muallem J
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- Female, Humans, Hysterectomy adverse effects, Urinary Bladder innervation, Hysterectomy methods, Peritoneum anatomy & histology, Splanchnic Nerves anatomy & histology, Uterine Cervical Neoplasms surgery
- Abstract
Competing Interests: Competing interests: None declared.
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- 2021
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38. Age, treatment and prognosis of patients with squamous cell vulvar cancer (VSCC) - analysis of the AGO-CaRE-1 study.
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Prieske K, Woelber L, Muallem MZ, Eulenburg C, Jueckstock JK, Hilpert F, de Gregorio N, Iborra S, Ignatov A, Hillemanns P, Fuerst S, Strauss HG, Baumann K, Beckmann M, Mustea A, Meier W, Harter P, Wimberger P, Sehouli J, and Mahner S
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- Adult, Age Factors, Aged, Aged, 80 and over, Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell pathology, Combined Modality Therapy, Databases, Factual, Female, Follow-Up Studies, Germany, Humans, Middle Aged, Multivariate Analysis, Neoplasm Grading, Neoplasm Recurrence, Local epidemiology, Neoplasm Recurrence, Local etiology, Neoplasm Staging, Prognosis, Retrospective Studies, Survival Analysis, Vulvar Neoplasms mortality, Vulvar Neoplasms pathology, Carcinoma, Squamous Cell diagnosis, Carcinoma, Squamous Cell therapy, Practice Patterns, Physicians' statistics & numerical data, Vulvar Neoplasms diagnosis, Vulvar Neoplasms therapy
- Abstract
Background: Despite an increasing incidence with simultaneous decreasing age of onset, vulvar squamous cell carcinoma (VSCC) is still a disease that mainly effects the elderly population. Data on the association of age with prognosis and treatment patterns in VSCC are sparse., Methods: This is an analysis of the AGO-CaRE-1 cohort. Patients with VSCC (FIGO stage ≥1B), treated at 29 cancer centers in Germany from 1998 to 2008, were included in a centralized database (n = 1618). In this subgroup analysis patients were analyzed according to age [<50 yrs. (n = 220), 50-69 yrs. (n = 506), ≥70 yrs. (n = 521)] with regard to treatment patterns and prognosis. Only patients with documented age, surgical groin staging and known nodal status were included (n = 1247). Median follow-up was 27.5 months., Results: At first diagnosis, women ≥70 yrs. presented with more advanced tumor stages (<0.001), larger tumor diameter (<0.001), poorer ECOG status (<0.001), more frequent HPV negative tumors (p = 0.03) as well as a higher rate of nodal involvement (<0.001). Disease recurrence occurred significantly more often in elderly patients (p = 0.001) and age as well as ECOG status, microscopic residual resection, tumor stage, grading, and (chemo)radiation were independent prognostic factors for death or recurrence in multivariate analysis. 2-year disease-free survival rates were 59.3% (≥70 yrs), 65.8% (50-69 yrs) and 81.1% (<50 yrs), respectively (p < 0.001)., Conclusions: Older women with VSCC present with advanced tumor stages at first diagnosis and have an increased risk of recurrence as well as a decreased 2-year DFS in comparison to younger patients. Potential reasons could be self-awareness and/or more aggressive tumor biology due to HPV independent disease., Competing Interests: Declaration of Competing Interest Dr. Prieske reports personal fees from AstraZeneca, Molecular Health,Gsk, Roche, Clovis Oncology outside the submitted work. Prof. Woelber reports grants from medac oncology, during the conduct of the study; personal fees from med update GmbH, grants, personal fees and non-financial support from medac oncology, personal fees from promedics GmbH, grants, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from Tesaro, personal fees from Teva, personal fees from OmniaMed, personal fees from Pfizer, personal fees from Greiner, outside the submitted work; Prof. Hilpert discloses personal fees and other from AstraZeneca, Tesaro/ Gsk, PharmaMar, Roche, Clovis and MSD outside the submitted work. Dr. DeGregorio reports personal fees non-financial support from AstraZeneca, Roche, Gsk and MSD as well as personal fees from Clovis and Amgen outside the submitted work. Dr. Harter reports grants and personal fees from Astra Zeneca, grants and personal fees from Roche, personal fees from Sotio, grants and personal fees from Tesaro, personal fees from Stryker, personal fees from Zai Lab, personal fees from MSD, grants and personal fees from Public funding (ASCO, DKH, DFG), personal fees from Clovis, personal fees from Immunogen, grants and personal fees from GSK, grants from Boehringer Ingelheim, grants from Medac, grants from Genmab, outside the submitted work. Prof. Mahner reports grants and personal fees from MEDAC, during the conduct of the study; grants and personal fees from AstraZeneca, personal fees from Clovis, grants and personal fees from Medac, grants and personal fees from MSD, personal fees from Novartis, personal fees from Olympus Europa, grants and personal fees from PharmaMar, grants and personal fees from Roche, personal fees from Sensor Kinesis, grants and personal fees from TESARO, grants and personal fees from Teva, personal fees from AbbVie, personal fees from GSK, personal fees from Pfizer, outside the submitted work; All other authors report no conflict of interest., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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39. Maternal Serum VEGF Predicts Abnormally Invasive Placenta Better than NT-proBNP: a Multicenter Case-Control Study.
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Schwickert A, Chantraine F, Ehrlich L, Henrich W, Muallem MZ, Nonnenmacher A, Petit P, Weizsäcker K, and Braun T
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- Adult, Belgium, Biomarkers blood, Female, Germany, Humans, Placenta diagnostic imaging, Placenta Accreta blood, Placenta Accreta etiology, Placentation, Predictive Value of Tests, Pregnancy, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Natriuretic Peptide, Brain blood, Peptide Fragments blood, Placenta metabolism, Placenta Accreta diagnosis, Vascular Endothelial Growth Factor A blood
- Abstract
The aim of this study was to test if maternal serum vascular endothelial growth factor (VEGF) or N-terminal pro B-type natriuretic peptide (NT-proBNP) predicts abnormally invasive placenta (AIP) better. Secondary objective was to test whether the serum levels of VEGF and NT-proBNP can predict the degree of invasion. In a multicenter case-control study design, gestational age-matched serum samples from pregnant women with AIP (n = 44) and uncomplicated pregnancies (n = 55) who had been enrolled at Charité - Universitätsmedizin Berlin, Germany and Centre Hospitalier Régional de la Citadelle in Liège, Belgium were analyzed. Maternal blood serum VEGF and NT-proBNP levels were immunoassayed from samples taken immediately before delivery (GA median: 35 weeks). Biomarker levels were compared between AIP and control group. The correlation of biomarker levels with the clinical AIP degree was assessed. The predictive biomarker ability was characterized through a multivariate regression model and receiver operating characteristic curves. Women with AIP had significantly lower maternal serum VEGF levels (AIP mean 285 pg/ml, 95% CI 248-322, vs. control: 391 pg/ml, 95% CI 356-426, p < 0.01) and higher NT-proBNP levels (AIP median 329 pg/ml, IQR 287-385, vs. control 295 pg/ml, IQR 273-356, p = 0.03). Maternal serum VEGF levels were able to predict AIP better (AUC = 0.729, 0.622-0.836, p < 0.001; VEGF + number of previous cesarean deliveries: AUC = 0.915, 0.853-0.977, p < 0.001). Maternal serum VEGF levels correlated inversely with the clinical AIP degree (r = - 0.32, p < 0.01). In short, maternal serum VEGF, more than NT-proBNP, can help in predicting AIP and hints at the degree of invasion.
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- 2021
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40. Lymphovascular space invasion and Ki67 as predictors of lymph node metastasis in primary low grade serous ovarian cancer.
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Grabowski JP, Glajzer J, Richter R, Plett H, Muallem MZ, Braicu EI, Taube E, and Sehouli J
- Subjects
- Adult, Aged, Cystadenocarcinoma, Serous mortality, Female, Humans, Middle Aged, Ovarian Neoplasms mortality, Prospective Studies, Risk Factors, Cystadenocarcinoma, Serous pathology, Ki-67 Antigen metabolism, Lymphatic Metastasis pathology, Neoplasm Invasiveness pathology, Ovarian Neoplasms pathology
- Abstract
Objective: Low grade serous ovarian cancers characterize a unique clinical pattern and likely less frequent incidence of lymphatic metastasis. The expression level of Ki67 is associated with differences in prognosis and therapy outcome. However, its expression in combination with lymphovascular space invasion has not been evaluated in the prediction of lymphatic metastasis., Methods: Patients with low grade serous ovarian cancer were identified in an institutional database. Patients with primary low grade serous ovarian cancer diagnosed and/or treated at our center between September 2000 and December 2018 were identified. Receiver operator characteristics curve analysis was performed to find the cut-off values of per cent Ki67 to discriminate patients with lymph node metastasis. The association between the presence of lymphovascular space invasion and lymph node involvement was analyzed., Results: A total of 109 patients with primary low grade serous ovarian cancer were identified in our institution's database. Of these, 72 (66.1%) patients underwent primary surgery with pelvic and para-aortic lymph node dissection. Complete data for Ki67 expression and lymphovascular space invasion were obtained for 61 (84.7%) of these patients. Among them, 37 (60.7%) patients had lymph node metastasis. The presence of lymphovascular space invasion was associated with an increased risk of lymph node metastases (odds ratio (OR)=12.78, 95% confidence interval (CI) 3.15 to 51.81; p<0.001). In multivariate analysis including age >65 years, peritoneal carcinomatosis, and ascites>500 mL, lymphovascular space invasion remained a significant risk factor for lymphatic metastases (OR=35.11, 95% CI 2.38 to 517.69; p=0.010). Ki67 ≥6% was associated with a higher risk of lymphovascular space invasion (OR=3.67, 95% CI 1.26 to 10.64; p=0.017). No significant correlation between Ki67 expression level and nodal metastases was found (OR=2.19, 95% CI 0.76 to 6.26; p=0.14). Neither presence of lymphovascular space invasion or nodal metastases was associated with a statistically poorer prognosis., Conclusions: We showed an association between lymphovascular space invasion, Ki67 expression, and risk of lymph node metastasis in primary low grade ovarian cancer. Further prospective trials evaluating lymphovascular space invasion and Ki-67 as predictors of lymph node metastasis are needed., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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41. Conservative management of abnormally invasive placenta complicated by local hyperfibrinolysis and beginning disseminated intravascular coagulation.
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Biele C, Kaufner L, Schwickert A, Nonnenmacher A, von Weizsäcker K, Muallem MZ, Henrich W, and Braun T
- Subjects
- Adult, Female, Fibrinogen metabolism, Humans, Hysterectomy adverse effects, Placenta Diseases surgery, Postpartum Hemorrhage etiology, Pregnancy, Pregnancy Outcome, Cesarean Section, Conservative Treatment methods, Disseminated Intravascular Coagulation complications, Placenta physiopathology, Placenta Accreta surgery
- Abstract
Introduction: Abnormally invasive placenta (AIP) is often associated with high maternal morbidity. In surgical treatment, caesarean hysterectomy or partial uterine resection may lead to high perioperative maternal blood loss. A conservative treatment by leaving the placenta in utero after caesarean delivery of the baby is an option to preserve fertility and to reduce peripartum hysterectomy-related morbidity. Nevertheless, due to increased placental coagulation activity as well as consumption of clotting factors, a disseminated intravascular coagulation (DIC)-like state with secondary late postpartum bleeding can occur., Purpose: Systematic review after the presentation of a case of conservative management of placenta percreta with secondary partial uterine wall resection due to vaginal bleeding, complicated by local hyperfibrinolysis and consecutive systemic decrease in fibrinogen levels., Methods: Systematic PubMed database search was done until August 2019 without any restriction of publication date or journal RESULTS: Among 58 publications, a total of 11 reported on DIC-like symptoms in the conservative management of AIP, in the median on day 59 postpartum. In most cases, emergency hysterectomy was performed, which led to an almost immediate normalization of coagulation status but was accompanied with high maternal blood loss. In two cases, fertility-preserving conservative management could be continued after successful medical therapy., Conclusion: Based on these results, we suggest routinely monitoring of the coagulation parameters next to signs of infection in the postpartum check-ups during conservative management of AIP. Postpartum tranexamic acid oral dosage should be discussed when fibrinogen levels are decreasing and D-Dimers are increasing.
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- 2021
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42. Nerve-Sparing Systematic Lymph Node Dissection in Gynaecological Oncology: An Innovative Neuro-Anatomical and Surgical Protocol for Enhanced Functional Outcomes.
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Muallem MZ, Diab Y, Jöns T, Sehouli J, and Muallem J
- Abstract
Whilst systematic lymph node dissection has been less prevalent in gynaecological cancer cases in the last few years, there is still a good number of cases that mandate a systematic lymph node dissection for diagnostic and therapeutic purposes. In all of these cases, it is crucial to perform the procedure as a nerve-sparing technique with utmost exactitude, which can be achieved optimally only by isolating and sparing all components of the aortic plexus and superior hypogastric plexus. To meet this purpose, it is essential to provide a comprehensive characterization of the specific anatomy of the human female aortic plexus and its variations. The anatomic dissections of two fresh and 17 formalin-fixed female cadavers were utilized to study, understand, and decipher the hitherto ambiguously annotated anatomy of the autonomic nervous system in the retroperitoneal para-aortic region. This study describes the precise anatomy of aortic and superior hypogastric plexus and provides the surgical maneuvers to dissect, highlight, and spare them during systematic lymph node dissection for gynaecological malignancies. The study also confirms the utility and feasibility of this surgery in gynaecological oncology.
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- 2020
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43. Role of delayed interval debulking for persistent residual disease after more than 5 cycles of chemotherapy for primary advanced ovarian cancer. An international multicenter study.
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Plett H, Filippova OT, Garbi A, Kommoss S, Rosendahl M, Langstraat C, Phadnis S, Muallem MZ, Baert T, Chi DS, Aletti GD, Taran FA, Ramspott JP, Zivanovic O, du Bois A, Sonoda Y, Gardner G, Traut A, Roche KL, and Harter P
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Ovarian Epithelial mortality, Cystadenocarcinoma, Serous mortality, Cytoreduction Surgical Procedures statistics & numerical data, Female, Humans, Middle Aged, Neoplasm, Residual, Ovarian Neoplasms mortality, Postoperative Complications epidemiology, Retrospective Studies, Carcinoma, Ovarian Epithelial therapy, Cystadenocarcinoma, Serous therapy, Cytoreduction Surgical Procedures methods, Ovarian Neoplasms therapy
- Abstract
Background: Standard of care in patients with advanced ovarian cancer (AOC) is upfront surgery followed by chemotherapy. Neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS) is an alternative in selected patients. Most data exist with IDS following 3-4 cycles chemotherapy, however, some patients experience a delay of IDS. So far, the impact of a "delayed" interval debulking surgery (DID) is poorly defined., Methods: We analyzed data from eight international gynecology-oncology referral centers. Patients were included if they had newly diagnosed AOC and were prone to DID (minimum 5 cycles of NACT) between 2011 and 2017., Results: 308 patients underwent DID. 89.6% had a high-grade serous ovarian cancer. The median number of pre-op NACT was 6 cycles (range 5-9) and 6.1% of patients received additionally bevacizumab. The majority of patients had stage-IV disease (51.3%). Median duration of surgery was 210 min (range 34-561), the median surgical complexity score was 4 (range 1-16). Complete resection was achieved in 60.1%. The median number of post-op chemotherapy cycles was 2 (range 0-5). The rate of severe complications (Clavien-Dindo£3°) was 9.7% and 30 days post-op mortality was 0.3%. The median PFS and OS in patients with complete resection was 19.5 and 49.2 months compared to 14.8 and 33.0 months in patients with incomplete resection (p = 0.001), respectively. We did not observe any survival benefit for patients with cytoreduction to small residuals (1-10 mm) compared to residual disease >1 cm., Conclusion: Our data may suggest that offering surgery to patients with persistent disease after 5+ cycles could be associated with favorable outcome if a complete resection is achieved. Patients who had residual disease postoperatively may experience rather peri-operative treatment burden than any benefit from DID., Competing Interests: Declaration of Competing Interest H. Plett, O.T. Filippova, J.P. Ramspott, A. Garbi, G.D. Aletti, MZ Muallem, C. Langstraat, S. Phadnis, O. Zivanovic, Y. Sonoda, G. Gardner, A. Traut, F.A. Taran, S. Kommoss, M. Rosendahl, and K. Long Roche have nothing to disclose. P. Harter: Honoraria: Astra Zeneca, Roche, Sotio, Tesaro, Stryker, ASCO, Zai Lab,MSD; Advisory Board: Astra Zeneca, Roche, Tesaro, Lilly, Clovis, Immunogen, MSD/Merck; Research funding (Inst): Astra Zeneca, Roche, GSK, Boehringer Ingelheim,Medac, DFG, European Union, DKH, Tesaro, Genmab. A. du Bois: personal fees fromRoche, personal fees fromAstra Zeneca, personal fees fromTesaro, personal fees from Clovis, personal fees from Pfizer, personal fees from Genmab, personal fees from Pharmar, personal fees from Biocad, outside the submitted work. Dr. Chi reports personal fees from Bovie Medical Co., Verthermia Inc. (now Apyx Medical Corp.), and C Surgeries; is a former stock owner of Intuitive Surgical, Inc. (sold 12/18) and TransEnterix, Inc. (sold 12/18); and served on the Medical Advisory Board of Biom ‘Up (4/19/19). Dr. Chi is funded in part through the NIH/NCI Cancer Center Support GrantP30 CA008748. T. Baert has been an advisor for Tesaro and received research grant from Amgen, non-financial support from Amgen, MSD, Roche and Tesaro, outside the submitted work., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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44. Angiosarcomas of Primary Gynecologic Origin - A Case Series and Review of the Literature.
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Chinczewski L, Taube ET, Feldhaus FW, DrÖge LA, Chekerov R, Muallem MZ, Pietzner K, Sehouli J, and Alavi S
- Subjects
- Adult, Aged, Combined Modality Therapy, Female, Genital Neoplasms, Female diagnostic imaging, Genital Neoplasms, Female pathology, Genital Neoplasms, Female surgery, Hemangiosarcoma diagnostic imaging, Hemangiosarcoma pathology, Hemangiosarcoma surgery, Humans, Laparotomy, Middle Aged, Neoplasm Metastasis, Paclitaxel adverse effects, Drug Therapy, Genital Neoplasms, Female drug therapy, Hemangiosarcoma drug therapy, Paclitaxel administration & dosage
- Abstract
Background/aim: Angiosarcoma of primary gynecologic origin is an extremely rare and highly malignant tumor of endothelial origin with a 5-year survival rate of less than 35%. To date, only 61 cases have been described in the literature. The aim of this study was to present more cases and discuss potential therapy options., Case Report: The following case series presents three cases of gynecologic angiosarcomas that were under therapy at the Charité - University medicine of Berlin from June 2014 to February 2018., Results: Two of the cases deal with primary angiosarcomas of the uterus whereas the third case was diagnosed after the suspicion of a recurrence of a poorly differentiated squamous cell carcinoma of the cervix uteri. In case one a 75-year old patient with initial postmenopausal bleeding and a tumor mass of the uterus is described. After surgery a hemangiosarcoma of the uterus was confirmed. After two months the patient presented with a presacral peritoneal sarcomatosis. Chemotherapy of weekly paclitaxel was administered. Case two deals with a patient presenting with abdominal pain. A uterine sarcoma with infiltration of the parametry and angiosarcomatosis peritonei was diagnosed during an emergency laparotomy because of spontaneous peritoneal bleeding. Moreover, osseous metastasis was found. The patient underwent weekly paclitaxel. Due to tumor progression, chemotherapy was changed to doxorubicin and olaratumab and radiotherapy was induced. The patient died 33 months after initial diagnosis. Case three describes a 34-year old patient with suspected local recurrence of cervical cancer with infiltration of the bladder. During TURB an angiosarcoma was found. Following laparoscopy revealed peritoneal metastasis. The patient underwent weekly paclitaxel followed by a paclitaxel and pazopanib maintainance therapy which showed a regression. Due to progression afterwards, chemotherapy was changed to gemcitabine and docetaxel and gemcitabine monotherapy. The patient died 33 months after initial diagnosis., Conclusion: Even though there is no evidence on standard treatment of this extremely rare and aggressive tumor entity of the female genital tract the patients showed the longest stability of disease during chemotherapy with weekly paclitaxel., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)
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- 2020
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45. A Concise Paradigm on Radical Hysterectomy: The Comprehensive Anatomy of Parametrium, Paracolpium and the Pelvic Autonomic Nerve System and Its Surgical Implication.
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Muallem MZ, Jöns T, Seidel N, Sehouli J, Diab Y, and Querleu D
- Abstract
The current understanding of radical hysterectomy is more centered on the uterus and little is discussed regarding the resection of the vaginal cuff and the paracolpium as an essential part of this procedure. The anatomic dissections of two fresh and 17 formalin-fixed female pelvis cadavers were utilized to understand and decipher the anatomy of the pelvic autonomic nerve system (PANS) and its connections to the surrounding anatomical structures, especially the paracolpium. The study mandates the recognition of the three-dimensional (3D) anatomic template of the parametrium and paracolpium and provides herewith an enhanced scope during a nerve-sparing radical hysterectomy procedure by precise description of the paracolpium and its close anatomical relationships to the components of the PANS. This enables the medical fraternity to distinguish between direct infiltration of the paracolpium, where the nerve sparing technique is no longer possible, and the affected lymph node in the paracolpium, where nerve sparing is still an option. This study gives rise to a tailored surgical option that allows for abandoning the resection of the paracolpium by FIGO stage IB1, where less than 2 cm vaginal vault resection is demanded.
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- 2020
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46. IGCS Intraoperative Technology Taskforce. Update on near infrared imaging technology: beyond white light and the naked eye, indocyanine green and near infrared technology in the treatment of gynecologic cancers.
- Author
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Abu-Rustum NR, Angioli R, Bailey AE, Broach V, Buda A, Coriddi MR, Dayan JH, Frumovitz M, Kim YM, Kimmig R, Leitao MM Jr, Muallem MZ, McKittrick M, Mehrara B, Montera R, Moukarzel LA, Naik R, Pedra Nobre S, Plante M, Plotti F, and Zivanovic O
- Subjects
- Coloring Agents, Female, Genital Neoplasms, Female pathology, Humans, Lymph Nodes diagnostic imaging, Lymph Nodes pathology, Lymph Nodes surgery, Monitoring, Intraoperative methods, Optical Imaging methods, Randomized Controlled Trials as Topic, Sentinel Lymph Node Biopsy methods, Spectroscopy, Near-Infrared methods, Genital Neoplasms, Female diagnostic imaging, Genital Neoplasms, Female surgery, Indocyanine Green
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2020
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47. Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation): a novel surgical technique for advanced ovarian cancer.
- Author
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Muallem MZ, Sehouli J, Miranda A, Richter R, and Muallem J
- Subjects
- Adult, Aged, Aged, 80 and over, Carcinoma, Ovarian Epithelial mortality, Carcinoma, Ovarian Epithelial pathology, Cytoreduction Surgical Procedures adverse effects, Cytoreduction Surgical Procedures methods, Cytoreduction Surgical Procedures mortality, Female, Germany epidemiology, Humans, Middle Aged, Morbidity, Neoplasm Staging, Ovarian Neoplasms mortality, Ovarian Neoplasms pathology, Peritoneum surgery, Retroperitoneal Space surgery, Retrospective Studies, Viscera surgery, Young Adult, Carcinoma, Ovarian Epithelial surgery, Ovarian Neoplasms surgery
- Abstract
Background: A Total Retroperitoneal en bloc resection Of Multivisceral-Peritoneal packet (TROMP operation) is a no-touch isolation technique in a retroperitoneal space to resect the parietal peritoneum and the affected organs in advanced ovarian cancer. The study prescribed and analysed the results of this novel technique for primary cytoreductive surgery., Methods: The study included 208 patients operated between January 2015 and December 2017 in Charité, Berlin. The TROMP operation was performed in 58 patients, whereas the other 150 patients were operated with the conventional cytoreductive method., Results: The complete tumor resection rate accounts for 87.9% in TROMP group and 61.3% in the conventional surgery group. (p=0.001). This difference was even stronger in the sub-group of very advanced stages (T3c+T4) (85.1% of TROMP group and in only 53.1% in the conventional surgery group, p=0.001). The duration of the primary cytoreductive surgery was about 33 minutes shorter in TROMP group (median: 335 minutes vs 368 minutes; TROMP vs conventional, respectively) in spite of the fact that the most advanced cytoreductive procedures were performed statically significant more in TROMP operation arm in comparison with the conventional surgery arm. There was no statistically significant difference between the groups regarding the postoperative complication, blood loss or the length of stay in intensive care unit., Conclusion: Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation) is a feasible and very effective technique of surgical therapy in advanced ovarian cancer. This technique increased the complete tumor resection rate to 87.9% without increasing the blood loss, postoperative complications or the duration of surgery. A prospective randomized study is advised to validate these results., Competing Interests: Competing interests: M-ZM is an adviser for Stryker. In the last 2 years he has received honoraria from Olympus, Ethicon (Johnson & Johnson), Roche and AstraZeneca. JS has received honoraria from AstraZeneca, Eisai, Clovis, Olympus, Johnson & Johnson, PharmaMar, Pfizer, TEVA, TESARO, and MSD, and performs advisory roles for AstraZeneca, Clovis, Lilly, PharmaMar, Pfizer, Roche, TESARO, and MSD. He has received research funding (not for this study) from AstraZeneca, Clovis, Merck, Bayer, PharmaMar, Pfizer, TESARO, and MSD. He has disclosed travel, accommodation, and other expenses paid or reimbursed by AstraZeneca, Clovis, PharmaMar, Roche, Pfizer, TESARO, and MSD, and were part of his scientific activities in the last 2 years. AM, RR and JM have no conflicts of interest., (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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48. Nerve Sparing Radical Hysterectomy: Short-Term Oncologic, Surgical, and Functional Outcomes.
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Muallem MZ, Armbrust R, Neymeyer J, Miranda A, and Muallem J
- Abstract
There is an obvious prevalence of disparity in opinions concerning the technique of nerve-sparing radical hysterectomy and its application, despite agreement on the need to spare the pelvic autonomic nerve system during such a radical operation. Understanding the precise three-dimensional anatomy of paracolpium and its close anatomical relationship to the components of the pelvic autonomic nervous system is the key in performing the nerve-sparing radical hysterectomy. A total of 42 consecutive patients with primary cervical cancers, who were operated upon in our institution between January 2017 and June 2019, were analyzed, concerning surgical, urinary functional, and short-term oncologic outcomes. Two thirds of the patients had locally advanced tumors (T > 40 mm or pT ≥ IIA2) with a median tumor size of 44.1 mm. The nerve-sparing radical hysterectomy was combined with the complete recovery of bladder function in 90% of patients directly after surgery and in 97% of patients in the first 2 weeks. The recurrence rate in a median follow-up time of 18 months was 9.5%. The nerve-sparing radical hysterectomy approach, which depends on the comprehensive understanding of the precise entire anatomy of paracolpium, was found to be feasible and applicable, even in locally advanced tumors, with good functional results and convincing short-term oncologic outcomes., Competing Interests: The first author, M.Z.M., is an adviser for Stryker. He received honoraria from Olympus, Ethicon (Johnson and Johnson), Roche, and Astrazeneca in the last 2 years. The second author, R.A., has no conflict of interest. The third author, J.N., received honoraria from Johnson and Johnson. The fourth author, A.M., has no conflict of interest. The fifth author, J.M., has no conflict of interest. Inomed Medizintechnik paid the fee for online access of this paper.
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- 2020
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49. Pre-operative serum CA125, peritoneal cancer index and intra-operative mapping score as predictors of surgical results in primary epithelial ovarian cancer.
- Author
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Muallem MZ, Sehouli J, Richter R, Babayeva A, Gasimli K, and Parashkevova A
- Subjects
- Adult, Aged, Aged, 80 and over, Biomarkers, Tumor blood, Carcinoma, Ovarian Epithelial pathology, Cytoreduction Surgical Procedures methods, Female, Humans, Intraoperative Care, Middle Aged, Neoplasm, Residual blood, Neoplasm, Residual pathology, Peritoneal Neoplasms blood, Peritoneal Neoplasms pathology, Peritoneal Neoplasms surgery, Predictive Value of Tests, Preoperative Care methods, ROC Curve, Retrospective Studies, CA-125 Antigen blood, Carcinoma, Ovarian Epithelial blood, Carcinoma, Ovarian Epithelial surgery, Membrane Proteins blood
- Abstract
Objective: Prediction of post-operative residual disease after ovarian cancer cytoreductive surgery remains a topic of interest to gynecologic oncologists. The aim of this study was to explore the correlation between serum CA125, peritoneal cancer index, and intra-operative mapping of ovarian cancer and their predictive value for post-operative outcome., Methods: A total of 70 patients with primary epithelial ovarian cancer, who underwent primary cytoreductive surgery at Charité, Berlin between January 2013 and February 2014 were included. In all patients, pre-operative CA125 values, intra-operative peritoneal cancer index, and intra-operative mapping of ovarian cancer were determined., Results: Using a receiver operating characteristic analysis, cut-off values for CA125, peritoneal cancer index, and intra-operative mapping of ovarian cancer score could be defined. Patients with pre-operative serum CA125 >600 U/mL had a three times higher risk for residual tumor after primary cytoreductive surgery (p=0.037). A peritoneal cancer index score >20 indicated a nine times increased risk for residual tumor (p=0.003). More than six affected abdominopelvic fields on the intra-operative mapping of ovarian cancer was associated with a 25 times higher risk of residual tumor after primary cytoreductive surgery (p≤0.05). The combination of all three values predicted residual tumor in up to 90% of patients., Conclusion: We found that pre-operative CA125 >600 U/mL, peritoneal cancer index >20, and intra-operative mapping of ovarian cancer score >6 could be used as predictors of complete tumor resection. The combination of all these three values predicted the incomplete resection of disease in up to 90% of patients even in experienced centers., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2020
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50. Incidence and Pattern of Spread of Lymph Node Metastasis in Patients With Low-grade Serous Ovarian Cancer.
- Author
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Wafa M, Braicu EI, Muallem MZ, Richter R, Taube E, Sehouli J, and Grabowski JP
- Subjects
- Adult, Aged, Female, Humans, Incidence, Lymph Node Excision methods, Middle Aged, Neoplasm Staging methods, Pelvis pathology, Retrospective Studies, Cystadenocarcinoma, Serous epidemiology, Cystadenocarcinoma, Serous pathology, Lymph Nodes pathology, Lymphatic Metastasis pathology, Ovarian Neoplasms epidemiology, Ovarian Neoplasms pathology
- Abstract
Background/aim: Involvement of lymph nodes (LNs) and their surgical resection in low-grade ovarian cancer remains a field of discussion. The aim of this study was to determine the incidence and pattern of distribution of lymph node metastases in patients with low-grade serous ovarian cancer., Patients and Methods: A retrospective analysis was carried out in patients with primary low-grade serous ovarian cancer who underwent primary surgery including systematic lymphadenectomy. Analysis of the affected LNs along with pattern of lymphatic spread was performed., Results: Thirty-seven patients who underwent systematic pelvic and para-aortal LN dissection were identified. The median age was 48 years (range=26-76 years). The majority of patients had International Federation of Gynecology and Obstetrics stage III (89.2%). A median of 41 (range=10-97) LNs were resected. LN metastases were found in 27 (72.9%) patients. In 15 (55.5%) patients, both pelvic and para-aortic LNs were affected concomitantly, in isolated para-aortal and pelvic lymph nodes in three (11.1%) and eight (29.6%) patients, respectively. The most frequently affected region was the right obturator fossa, found in 14 (51.8%) patients, followed by the left obturator fossa in 11 (40.7%) patients., Conclusion: Low-grade serous ovarian cancer exhibits a high percentage of lymphatic spread, with more confinement to the pelvic compared to the para-aortic region., (Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)
- Published
- 2019
- Full Text
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