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1. SUCCOR Nodes: May Sentinel Node Biopsy Determine the Need for Adjuvant Treatment?

Author

Arantxa Berasaluce Gómez MD, Nerea Martín-Calvo MD, Félix Boria MD, Nabil Manzour MD, Enrique Chacón MD, Nicolò Bizzarri MD, Luis Chiva MD, Alejandra, Martinez, Alfonso, Quesada, Ali, Kucukmetin, Alicia, Vázquez, Aljosa, Mandic, Andrea, Casajuana, Andreas, Kavallaris, Anna, Fagotti, Anna, Perrone, Annamaria, Ferrero, Arantxa, Lekuona, Arno, Uppin, Artem, Stepanyan, Benito, Chiofalo, Bibiana, Morillas, Carmen, Tauste, Claudia, Andrade, Constantijne, Mom, Cosima, Brucker, Cosmin-Paul, Sarac, Daniel, Vázquez-Vicente, David, Cibula, Denis, Querleu, Diego, Erasun, Dilyara, Kaidarova, Dimitrios, Tsolakidis, Dimitros, Haidopoulos, Dmytro, Golub, Eduard-Aexandru, Bonci, Elif, Aksahin, Elisabete, Gonçalves, Enrique, Moratalla, Erbil, Karaman, Eva, Myriokefalitaki, Fabio, Ghezzi, Fabrice, Narducci, Fernando, Roldan, Francesco, Raspagliesi, Frédéric, Goffin, Frederic, Grandjean, Frédéric, Guyon, Fuat, Demirkiran, Gabriel, Fiol, Galina, Chakalova, Gemma, Mancebo, George, Vorgias, Gerhard, Gebauer, Gesine, Meili, Gines, Hernandez-Cortes, Giorgio, Bogani, Gloria, Cordeiro, Goran, Vujić, Gustavo, Mendinhos, Hans, Trum, Hélène, Bonsang-Kitzis, Herman, Haller, Ignace, Vergote, Ignacio, Zapardiel, Igor, Aluloski, Igor, Berlev, Imre, Pete, Ioannis, Kalogiannidis, Ioannis, Kotsopoulos, Iryna, Yezhova, Javier, Díez, Feron, Jean G., Jens-Peter, Scharf, Jogchum, Beltman, Jolien, Haesen, Jordi, Ponce, Jorge, Cea, Jose Ángel Mínguez, José, García, Juan, Arévalo-Serrano, Juan, Gilabert, Juan Luis Alcazar, Kersti, Kukk, Khadra, Galaal, Laura, Cárdenas, Laurentiu, Pirtea, Mereu, Liliana, Luigi Pedone Anchora, Lukas, Dostalek, Lukasz, Klasa, Maja, Pakižimre, Manuela, Undurraga, Marcin, Jedryka, Margarida, Bernardino, Maria, Alonso-Espias, María Belén Martín-Salamanca, Maria, Cuadra, Mariana, Tavares, Mario, Malzoni, Mathias, Fehr, Mathieu, Luyckx, Maximilian, Lanner, Meelis, Leht, Mehmet, Meydanli, Michael, Mallmann, Mihai, Căpîlna, Mikulás, Redecha, Milena, Mitrovic, Maenpaa, Minna M., Miriam, Guijarro, Nabil, Abdalla, Nana, Gomes, Natalia, Povolotskaya, Nikola, Badzakov, Octavio, Arencibia, Özgür, Akbayir, Pere, Cavalle, Petra, Zusterzeel, Philip, Rolland, Pluvio, Coronado, Rasiah, Bharathan, Reeli, Saaron, Rita, Sousa, Robert, Fruscio, Robert, Jach, Robert, Poka, Rosa, Barrachina, Santiago, Domingo, Sara, Morales, Sedat, Akgöl, Sergi, Fernandez-Gonzalez, Shamistan, Aliyev, Sofía, Herrero, Soledad, Fidalgo, Sonia, Prader, Špela, Smrkolj, Stamatios, Petousis, Stefan, Kovachev, Taner, Turan, Tayfun, Toptas, Teresa, Castellanos, Teresa Diniz da Costa, Tiermes, Marina, Vanna, Zanagnolo, Victor, Martin, Virginia, Gonzalez, Vladimír Študent &amp, and Vladyslav, Sukhin

Published
2023

2. Die Versorgung gynäkologischer und geburtsmedizinischer Patientinnen in der COVID-19-Pandemie

Author

Mandy Mangler, Michael Untch, Malgorzata Lanowska, B. Ramsauer, Robert Armbrust, Jana Barinoff, Wolfgang Henrich, Jalid Sehouli, W. Hartmann, J-U Blohmer, Jens-Peter Scharf, J. Rohne, L Hellmeyer, M. Dombrowski, and B Müller

Subjects
Gynecology, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Obstetrics and Gynecology, Alliance, Maternity and Midwifery, Female patient, Pandemic, medicine, business, Interim report
Abstract

Die COVID-19-Pandemie halt weiter an und stellt alle Beteiligten im Gesundheitssystem vor neue und bisher so nie dagewesene Herausforderungen, die sowohl die Strukturen innerhalb von Kliniken sowie des Gesundheitssystems als auch die Kommunikation inter-sowie intradisziplinar betreffen. Die Pandemie macht deutlich, wie wichtig die intersektorale (also zwischen der ambulanten und der stationaren Versorgung), -professionelle und -interdisziplinare Abstimmung ist, um die Versorgung der Patientinnen aufrechtzuerhalten. Dabei gilt es, wiederholt Bestandsaufnahmen vorzunehmen, um zum einen notwendige Anpassungen, zum anderen aber auch Konsequenzen fur zukunftige Entwicklungen zu diskutieren.

Published
2021
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3. Cervical ripening after cesarean section: a prospective dual center study comparing a mechanical osmotic dilator vs. prostaglandin E2

Author

L Hellmeyer, E Schalinski, Jens-Peter Scharf, Ute Jarchau, Josefine Theresia Koenigbauer, Werner Rath, Sandra C. Klaucke, Ulrich Gauger, and Katrin Brandt

Subjects
Adult, medicine.medical_specialty, Adolescent, Polymers, Pilot Projects, Uterine hyperstimulation, Dinoprostone, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, Oxytocics, Humans, Medicine, Labor, Induced, Prospective Studies, 030212 general & internal medicine, Cervix, Retrospective Studies, Fetus, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, Balloon catheter, Obstetrics and Gynecology, Ripening, medicine.disease, Dilatation, Vaginal Birth after Cesarean, Trial of Labor, Uterine rupture, Treatment Outcome, medicine.anatomical_structure, Dilator, Pediatrics, Perinatology and Child Health, Female, business, Cervical Ripening
Abstract

Objectives Worldwide, the overall cesarean section is rising. Trial of labor after cesarean (TOLAC) is an overall safe option with an immediate impact on neonatal and maternal short- and long-term health. Since the use of prostaglandins in cervical ripening is associated with an increased risk of uterine rupture, mechanical methods as balloon catheters or osmotic dilators have been suggested for cervical ripening prior to induction of labour. Here we are analyzing and comparing the VBAC rate, as well as maternal and fetal outcome in cervical ripening prior to TOLAC. Methods This prospective dual center study analyses maternal and neonatal outcomes of TOLAC in women with an unfavorable cervix requiring cervical ripening agent. The prospective application of an osmotic dilator (Dilapan-S, n=104) was analysed in comparison to the retrospective application of off-label dinoprostone (n=102). Results The overall fetal and neonatal outcome revealed no significant differences in both groups. Patients receiving cervical ripening with the osmotic dilator delivered vaginally/by ventouse in 52% of cases, compared to 53% when using dinoprostone (p=0.603). The interval between application to onset of labor was significantly higher in the osmotic dilator group (37.9 vs.20.7 h, p= Conclusions Our data shows that the application of the osmotic dilator leads to similar outcomes in VBAC rate and time from onset of labor to delivery as well as safety in both groups compared to off-label use dinoprostone. Cervical ripening using the mechanical dilator is a viable and effective option, without the risk of uterine hyperstimulation.

Published
2021
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4. SUCCOR Risk: Design and Validation of a Recurrence Prediction Index for Early-Stage Cervical Cancer

Author

Manzour, Nabil, Chiva, Luis, Chacón, Enrique, Martin-Calvo, Nerea, Boria, Felix, Minguez, José A, Alcazar, Juan, L, Vanna, Zanagnolo, Denis, Querleu, Mihai, Căpîlna, Anna, Fagotti, Ali, Kucukmetin, Constantijne, Mom, Galina, Chakalova, Shamistan, Aliyev, Mario, Malzoni, Fabrice, Narducci, Octavio, Arencibia, Francesci, Raspagliesi, Tayfun, Toptas, David, Cibula, Dilyara, Kaidarova, Mehmet, Meydanli, Mariana, Tavares, Dmytro, Golub, Anna, Perrone, Robert, Poka, Dimitrios, Tsolakidis, Goran, Vujić, Marcin, Jedryka, Petra, Zusterzeel, Jogchum, Beltman, Frédéric, Goffin, Dimitros, Haidopoulos, Herman, Haller, Robert, Jach, Iryna, Yezhova, Igor, Berlev, Margarida, Bernardino, Rasiah, Bharathan, Maximilian, Lanner, Vladyslav, Sukhin, Jean, G Feron, Robert, Fruscio, Kersti, Kukk, Jordi, Ponce, Nabil, Abdalla, Özgür, Akbayir, Sedat, Akgöl, Elif, Aksahin, Maria, Alonso-Espias, Igor, Aluloski, Claudia, Andrade, Nikola, Badzakov, Rosa, Barrachina, Giorgio, Bogani, Eduard-Aexandru, Bonci, Hélène, Bonsang-Kitzis, Cosima, Brucker, Laura, Cárdenas, Andrea, Casajuana, Pere, Cavalle, Jorge, Cea, Benito, Chiofalo, Gloria, Cordeiro, Pluvio, Coronado, Maria, Cuadra, Javier, Díez, Teresa Diniz da Costa, Santiago, Domingo, Lukas, Dostalek, Fuat, Demirkiran, Diego, Erasun, Mathias, Fehr, Sergi, Fernandez-Gonzalez, Soledad, Fidalgo, Gabriel, Fiol, Khadra, Galaal, José, García, Gerhard, Gebauer, Fabio, Ghezzi, Juan, Gilabert, Nana, Gomes, Elisabete, Gonçalves, Virginia, Gonzalez, Frederic, Grandjean, Miriam, Guijarro, Frédéric, Guyon, Jolien, Haesen, Gines, Hernandez-Cortes, Sofía, Herrero, Imre, Pete, Ioannis, Kalogiannidis, Erbil, Karaman, Andreas, Kavallaris, Lukasz, Klasa, Ioannis, Kotsopoulos, Stefan, Kovachev, Meelis, Leht, Arantxa, Lekuona, Mathieu, Luyckx, Michael, Mallmann, Gemma, Mancebo, Aljosa, Mandic, Tiermes, Marina, Victor, Martin, María Belén Martín-Salamanca, Alejandra, Martinez, Gesine, Meili, Gustavo, Mendinhos, Mereu, Liliana, Milena, Mitrovic, Sara, Morales, Enrique, Moratalla, Bibiana, Morillas, Eva, Myriokefalitaki, Maja, Pakižimre, Stamatios, Petousis, Laurentiu, Pirtea, Natalia, Povolotskaya, Sonia, Prader, Alfonso, Quesada, Mikuláš, Redecha, Fernando, Roldan, Philip, Rolland, Reeli, Saaron, Cosmin-Paul, Sarac, Jens-Peter, Scharf, Špela, Smrkolj, Rita, Sousa, Artem, Stepanyan, Vladimír, Študent, Carmen, Tauste, Hans, Trum, Taner, Turan, Manuela, Undurraga, Arno, Uppin, Alicia, Vázquez, Ignace, Vergote, George, Vorgias, Ignacio, Zapardiel, Amsterdam Reproduction & Development (AR&D), Obstetrics and gynaecology, CCA - Imaging and biomarkers, Manzour, N, Chiva, L, Chacon, E, Martin-Calvo, N, Boria, F, Minguez, J, Alcazar, J, Zanagnolo, V, Querleu, D, Capilna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Aliyev, S, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujic, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Sukhin, V, Feron, J, Fruscio, R, Kukk, K, Ponce, J, Abdalla, N, Akbayir, O, Akgol, S, Aksahin, E, Alonso-Espias, M, Aluloski, I, Andrade, C, Badzakov, N, Barrachina, R, Bogani, G, Bonci, E, Bonsang-Kitzis, H, Brucker, C, Cardenas, L, Casajuana, A, Cavalle, P, Cea, J, Chiofalo, B, Cordeiro, G, Coronado, P, Cuadra, M, Diez, J, da Costa, T, Domingo, S, Dostalek, L, Demirkiran, F, Erasun, D, Fehr, M, Fernandez-Gonzalez, S, Fidalgo, S, Fiol, G, Galaal, K, Garcia, J, Gebauer, G, Ghezzi, F, Gilabert, J, Gomes, N, Goncalves, E, Gonzalez, V, Grandjean, F, Guijarro, M, Guyon, F, Haesen, J, Hernandez-Cortes, G, Herrero, S, Pete, I, Kalogiannidis, I, Karaman, E, Kavallaris, A, Klasa, L, Kotsopoulos, I, Kovachev, S, Leht, M, Lekuona, A, Luyckx, M, Mallmann, M, Mancebo, G, Mandic, A, Marina, T, Martin, V, Martin-Salamanca, M, Martinez, A, Meili, G, Mendinhos, G, Mereu, L, Mitrovic, M, Morales, S, Moratalla, E, Morillas, B, Myriokefalitaki, E, Pakizimre, M, Petousis, S, Pirtea, L, Povolotskaya, N, Prader, S, Quesada, A, Redecha, M, Roldan, F, Rolland, P, Saaron, R, Sarac, C, Scharf, J, Smrkolj, S, Sousa, R, Stepanyan, A, Student, V, Tauste, C, Trum, H, Turan, T, Undurraga, M, Uppin, A, Vazquez, A, Vergote, I, Vorgias, G, and Zapardiel, I

Subjects
cervical cancer, Cevical cancer, Uterine Cervical Neoplasms, Hysterectomy, Prognosis, Risk Assessment, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], conization, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, Recurrence, radical hysterectomy, Humans, Female, Surgery, Neoplasm Recurrence, Local, Neoplasm Staging, Retrospective Studies
Abstract

Objective Based on the SUCCOR study database, our primary objective was to identify the independent clinical pathological variables associated with the risk of relapse in patients with stage IB1 cervical cancer who underwent a radical hysterectomy. Our secondary goal was to design and validate a risk predictive index (RPI) for classifying patients depending on the risk of recurrence. Methods Overall, 1116 women were included from January 2013 to December 2014. We randomly divided our sample into two cohorts: discovery and validation cohorts. The test group was used to identify the independent variables associated with relapse, and with these variables, we designed our RPI. The index was applied to calculate a relapse risk score for each participant in the validation group. Results A previous cone biopsy was the most significant independent variable that lowered the rate of relapse (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.17–0.60). Additionally, patients with a tumor diameter >2 cm on preoperative imaging assessment (OR 2.15, 95% CI 1.33–3.5) and operated by the minimally invasive approach (OR 1.61, 95% CI 1.00–2.57) were more likely to have a recurrence. Based on these findings, patients in the validation cohort were classified according to the RPI of low, medium, or high risk of relapse, with rates of 3.4%, 9.8%, and 21.3% observed in each group, respectively. With a median follow-up of 58 months, the 5-year disease-free survival rates were 97.2% for the low-risk group, 88.0% for the medium-risk group, and 80.5% for the high-risk group (p < 0.001). Conclusion Previous conization to radical hysterectomy was the most powerful protective variable of relapse. Our risk predictor index was validated to identify patients at risk of recurrence.

Published
2022
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6. Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB-IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study

Author

Hermann Hertel, Andreas D. Ebert, Audrey Tieko Tsunoda, Peter Martus, Christhardt Köhler, Marcelo Vieira, Simone Marnitz, Renato Jose Affonso Junior, Jens-Peter Scharf, Iris Piwonski, Volker Budach, Jalid Sehouli, A Mustea, Joao Soares Nunes, and U. Ulrich

Subjects
operative, Adult, medicine.medical_specialty, Existentialism, cervical cancer, Uterine Cervical Neoplasms, Disease-Free Survival, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Adaptation, Psychological, medicine, Clinical endpoint, Humans, Prospective Studies, Stage (cooking), Laparoscopy, Prospective cohort study, Lymph node, Original Research, Aged, Neoplasm Staging, Cervical cancer, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, business.industry, Obstetrics and Gynecology, Cancer, radiation oncology, Chemoradiotherapy, Middle Aged, medicine.disease, surgical procedures, Survival Rate, laparoscopes, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Adenocarcinoma, Female, Radiology, business
Abstract

ObjectiveRevised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer.MethodsUterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB–IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013.ResultsA total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1–123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020).ConclusionOur study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

Published
2020

7. SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer

Author

Chiva, Luis, Zanagnolo, Vanna, Querleu, Denis, Martin-Calvo, Nerea, Arévalo-Serrano, Juan, Căpîlna, Mihai Emil, Fagotti, Anna, Kucukmetin, Ali, Mom, Constantijne, Chakalova, Galina, Aliyev, Shamistan, Malzoni, Mario, Narducci, Fabrice, Arencibia, Octavio, Raspagliesi, Francesco, Toptas, Tayfun, Cibula, David, Kaidarova, Dilyara, Meydanli, Mehmet Mutlu, Tavares, Mariana, Golub, Dmytro, Perrone, Anna Myriam, Poka, Robert, Tsolakidis, Dimitrios, Vujić, Goran, Jedryka, Marcin A, Zusterzeel, Petra L M, Beltman, Jogchum Jan, Goffin, Frederic, Haidopoulos, Dimitrios, Haller, Herman, Jach, Robert, Yezhova, Iryna, Berlev, Igor, Bernardino, Margarida, Bharathan, Rasiah, Lanner, Maximilian, Maenpaa, Minna M, Sukhin, Vladyslav, Feron, Jean-Guillaume, Fruscio, Robert, Kukk, Kersti, Ponce, Jordi, Minguez, Jose Angel, Vázquez-Vicente, Daniel, Castellanos, Teresa, Chacon, Enrique, Alcazar, Juan, Luis, Nabil, Abdalla, Özgür, Akbayir, Sedat, Akgöl, Elif, Aksahin, Shamistan, Aliyev, Maria, Alonso-Espias, Igor, Aluloski, Claudia, Andrade, Nikola, Badzakov, Rosa, Barrachina, Giorgio, Bogani, Eduard-Aexandru, Bonci, Hélène, Bonsang-Kitzis, Felix, Boria, Cosima, Brucker, Laura, Cárdenas, Andrea, Casajuana, Pere, Cavalle, Jorge, Cea, Benito, Chiofalo, Gloria, Cordeiro, Pluvio, Coronado, Maria, Cuadra, Javier, Díez, Teresa Diniz da Costa, Santiago, Domingo, Lukas, Dostalek, Fuat, Demirkiran, Diego, Erasun, Mathias, Fehr, Sergi, Fernandez-Gonzalez, Annamaria, Ferrero, Soledad, Fidalgo, Gabriel, Fiol, Khadra, Galaal, José, García, Gerhard, Gebauer, Fabio, Ghezzi, Juan, Gilabert, Nana, Gomes, Elisabete, Gonçalves, Virginia, Gonzalez, Frederic, Grandjean, Miriam, Guijarro, Frédéric, Guyon, Jolien, Haesen, Gines, Hernandez-Cortes, Sofía, Herrero, Imre, Pete, Ioannis, Kalogiannidis, Erbil, Karaman, Andreas, Kavallaris, Lukasz, Klasa, Ioannis, Kotsopoulos, Stefan, Kovachev, Meelis, Leht, Arantxa, Lekuona, Mathieu, Luyckx, Michael, Mallmann, Gemma, Mancebo, Aljosa, Mandic, Nabil, Manzour, Tiermes, Marina, Victor, Martin, María Belén Martín-Salamanca, Alejandra, Martinez, Gesine, Meili, Gustavo, Mendinhos, Mereu, Liliana, Milena, Mitrovic, Sara, Morales, Enrique, Moratalla, Bibiana, Morillas, Eva, Myriokefalitaki, Maja, Pakižimre, Stamatios, Petousis, Laurentiu, Pirtea, Natalia, Povolotskaya, Sonia, Prader, Alfonso, Quesada, Mikuláš, Redecha, Fernando, Roldan, Philip, Rolland, Reeli, Saaron, Cosmin-Paul, Sarac, Jens-Peter, Scharf, Špela, Smrkolj, Rita, Sousa, Artem, Stepanyan, Vladimír, Študent, Carmen, Tauste, Hans, Trum, Taner, Turan, Manuela, Undurraga, Arno, Uppin, Alicia, Vázquez, Ignace, Vergote, George, Vorgias, Ignacio, Zapardiel, Obstetrics and gynaecology, CCA - Cancer biology and immunology, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), Ethics, Law & Medical humanities, Chiva L., Zanagnolo V., Querleu D., Martin-Calvo N., Arevalo-Serrano J., Capilna M.E., Fagotti A., Kucukmetin A., Mom C., Chakalova G., Aliyev S., Malzoni M., Narducci F., Arencibia O., Raspagliesi F., Toptas T., Cibula D., Kaidarova D., Meydanli M.M., Tavares M., Golub D., Perrone A.M., Poka R., Tsolakidis D., Vujic G., Jedryka M.A., Zusterzeel P.L.M., Beltman J.J., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Berlev I., Bernardino M., Bharathan R., Lanner M., Maenpaa M.M., Sukhin V., Feron J.-G., Fruscio R., Kukk K., Ponce J., Minguez J.A., Vazquez-Vicente D., Castellanos T., Chacon E., Alcazar J.L., Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, Arévalo-Serrano, J, Căpîlna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Aliyev, S, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujić, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, M, Sukhin, V, Feron, J, Fruscio, R, Kukk, K, Ponce, J, Minguez, J, Vázquez-Vicente, D, Castellanos, T, Chacon, E, Alcazar, J, INSERM, Université de Lille, Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192, Clínica Universidad de Navarra [Pamplona], Istituto Europeo di Oncologia [Milano] [IEO], Institut Bergonié [Bordeaux], Universidad de Navarra [Pamplona] [UNAV], Istituto Europeo di Oncologia [Milano] (IEO), UNICANCER, Universidad de Navarra [Pamplona] (UNAV), Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U 1192 (PRISM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)

Subjects
Adult, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences, medicine.medical_specialty, Uterine Cervical Neoplasm, cervical cancer, [SDV]Life Sciences [q-bio], 03 medical and health sciences, Young Adult, surgical oncology, 0302 clinical medicine, hysterectomy, laparoscope, cervix uteri, laparotomy, Surgical oncology, local, medicine, Radical Hysterectomy, Prospective cohort study, Cancer staging, Aged, Neoplasm Staging, Cervical cancer, Aged, 80 and over, 030219 obstetrics & reproductive medicine, neoplasm recurrence, local, business.industry, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti, Obstetrics and Gynecology, Retrospective cohort study, Minimally Invasive Surgical Procedure, Middle Aged, medicine.disease, neoplasm recurrence, Surgery, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], Europe, Settore MED/40 - GINECOLOGIA E OSTETRICIA, laparoscopes, Oncology, 030220 oncology & carcinogenesis, Cohort, Female, Cohort Studie, business, Cohort study, Human
Abstract

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer FREE http://orcid.org/0000-0002-1908-3251Luis Chiva1, Vanna Zanagnolo2, Denis Querleu3, Nerea Martin- Calvo4, Juan Arévalo-Serrano5, Mihai Emil Căpîlna6, Anna Fagotti7, Ali Kucukmetin8, Constantijne Mom9, Galina Chakalova10, Shamistan Aliyev11, Mario Malzoni12, http://orcid.org/0000- 0001-5809-3535Fabrice Narducci13, Octavio Arencibia14, Francesco Raspagliesi15, Tayfun Toptas16, David Cibula17, Dilyara Kaidarova18, http://orcid.org/0000-0001-6763-9720Mehmet Mutlu Meydanli19, Mariana Tavares20, Dmytro Golub21, http://orcid.org/0000-0003-3140-4772Anna Myriam Perrone22, Robert Poka23, Dimitrios Tsolakidis24, Goran Vujić25, http://orcid.org/0000-0001-8935- 0311Marcin A Jedryka26, Petra L M Zusterzeel27, Jogchum Jan Beltman28, Frederic Goffin29, Dimitrios Haidopoulos30, Herman Haller31, Robert Jach32, Iryna Yezhova33, Igor Berlev34, Margarida Bernardino35, Rasiah Bharathan36, Maximilian Lanner37, Minna M Maenpaa38, http://orcid.org/0000-0002-4403-3707Vladyslav Sukhin39, Jean-Guillaume Feron40, Robert Fruscio41, 42, Kersti Kukk43, Jordi Ponce44, Jose Angel Minguez45, http://orcid.org/0000-0002-9618- 5606Daniel Vázquez-Vicente45, Teresa Castellanos45, Enrique Chacon46 and http://orcid.org/0000-0002-9700-0853Juan Luis Alcazar47 On behalf of the SUCCOR study Group Author affiliations Abstract Background Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. Methods We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Results Mean age was 48.3 years (range ; 23–83) while the mean BMI was 25.7 kg/m2 (range ; 15–49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07 ; 95% CI, 1.35 to 3.15 ; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45 ; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76 ; 95% CI, 1.75 to 4.33 ; P

Published
2020
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8. Perioperative morbidity and rate of upstaging after laparoscopic staging for patients with locally advanced cervical cancer: results of a prospective randomized trial

Author

Simone Marnitz, Audrey Tieko Tsunoda, Christhardt Köhler, Uwe Ulrich, Vito Chiantera, Jens-Peter Scharf, Marcelo de Andrade Vieira, Alexander Mustea, Peter Martus, Achim Schneider, Köhler, C., Mustea, A., Marnitz, S., Schneider, A., Chiantera, V., Ulrich, U., Scharf, J., Martus, P., Vieira, M., and Tsunoda, A.

Subjects
Uterine Cervical Neoplasm, medicine.medical_treatment, Brachytherapy, Uterine Cervical Neoplasms, Carcinoma, Adenosquamou, Antineoplastic Agent, Postoperative Complications, Laparotomy, randomized trial, locally advanced cervical cancer, Laparoscopy, Cervical cancer, medicine.diagnostic_test, Medicine (all), Lymph Node, Obstetrics and Gynecology, Chemoradiotherapy, Middle Aged, laparoscopic staging, Treatment Outcome, Carcinoma, Squamous Cell, Female, operative morbidity, Human, Adult, medicine.medical_specialty, Pelvi, Antineoplastic Agents, Gynecologic oncology, Adenocarcinoma, Pelvis, Carcinoma, Adenosquamous, Young Adult, medicine, Humans, External beam radiotherapy, Aged, Neoplasm Staging, Radiotherapy, business.industry, Postoperative complication, Perioperative, medicine.disease, Surgery, Feasibility Studie, Feasibility Studies, Lymph Node Excision, Postoperative Complication, Lymph Nodes, Cisplatin, business
Abstract

Objective The International Federation of Gynecology and Obstetrics (FIGO) staging for cervical cancer is based on clinical examination. Previous studies have demonstrated significant upstaging with surgical staging. However, no randomized trial has ever shown a survival benefit when radiation combined with chemoradiation (RCTX) is modified according to surgical staging. The objective of the study was to evaluate the feasibility and outcomes of surgical staging prior to radical RCTX treatment among patients with locally advanced cervical cancer in the setting of a larger, prospective, randomized study (the Uterus-11 study of the German Gynecologic Oncology Group). Study Design Between 2009 and 2013, 255 patients with advanced cervical cancer (FIGO IIB-IVA) were randomized to surgical staging and RCTX (arm A) or RCTX (arm B). RCTX in both arms included pelvic external beam radiotherapy with weekly cisplatin at 40 mg/m 2 and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases. Results One hundred thirty patients were randomized to surgical staging; 121 were eligible for this analysis. The mean patient age was 47.2 years, and the mean body mass index was 26.2 kg/m 2 ; the FIGO stages were IIB, IIIA, IIIB, and IVA in 85 (70.2%), 4 (3.3%), 29 (24%), and 3 (2.5%) patients, respectively. Arm A and arm B were similar with respect to Karnofsky performance status, histology, comorbidities, and lymphovascular space involvement. The surgical approach was transperitoneal laparoscopy in nearly all patients (93.4%), with no operative mortality. One patient (0.8%) had a conversion to laparotomy; 2 patients had more than 500 mL blood loss; the early postoperative complication rate was 7.3%. A mean of 19 pelvic and 17 paraaortic nodes were removed, with means of 2.4 and 1.3 positive nodes, respectively. RCTX began between 7 and 21 days after surgery. Operative staging led to upstaging in 40 of 121 (33%). Conclusion Surgical staging in patients with locally advanced cervical cancer is safe and does not delay primary RCTX in a randomized study.

Published
2015

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