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6. SUCCOR cone study: conization before radical hysterectomy

Author

Chacon, E, Manzour, N, Zanagnolo, V, Querleu, D, Núñez-Córdoba, J, Martin-Calvo, N, Căpîlna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, A, Gil Moreno, A, 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, Boria, F, Alcazar, J, Chiva, L, Chacon, Enrique, Manzour, Nabil, Zanagnolo, Vanna, Querleu, Denis, Núñez-Córdoba, Jorge M, Martin-Calvo, Nerea, Căpîlna, Mihai Emil, Fagotti, Anna, Kucukmetin, Ali, Mom, Constantijne, Chakalova, Galina, Shamistan, Aliyev, Gil Moreno, Antonio, 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, Boria, Felix, Alcazar, Juan Luis, Chiva, Luis, Chacon, E, Manzour, N, Zanagnolo, V, Querleu, D, Núñez-Córdoba, J, Martin-Calvo, N, Căpîlna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, A, Gil Moreno, A, 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, Boria, F, Alcazar, J, Chiva, L, Chacon, Enrique, Manzour, Nabil, Zanagnolo, Vanna, Querleu, Denis, Núñez-Córdoba, Jorge M, Martin-Calvo, Nerea, Căpîlna, Mihai Emil, Fagotti, Anna, Kucukmetin, Ali, Mom, Constantijne, Chakalova, Galina, Shamistan, Aliyev, Gil Moreno, Antonio, 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, Boria, Felix, Alcazar, Juan Luis, and Chiva, Luis

Abstract

OBJECTIVE: To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). METHODS: A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width ≤0.2 standard deviations of the logit odds of the estimated propensity score. RESULTS: We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). CONCLUSIONS: In this retrospective study, patients undergoing cervical conizatio

Published
2022

7. SUCCOR cone study: conization before radical hysterectomy

Author

Chacon, Enrique Manzour, Nabil Zanagnolo, Vanna Querleu, Denis Nunez-Cordoba, Jorge M. Martin-Calvo, Nerea Capilna, Mihai Emil Fagotti, Anna Kucukmetin, Ali Mom, Constantijne and Chakalova, Galina Shamistan, Aliyev Gil Moreno, Antonio and Malzoni, Mario Narducci, Fabrice Arencibia, Octavio and Raspagliesi, Francesco Toptas, Tayfun Cibula, David and Kaidarova, Dilyara Meydanli, Mehmet Mutlu Tavares, Mariana and Golub, Dmytro Perrone, Anna Myriam Poka, Robert Tsolakidis, Dimitrios Vujic, Goran Jedryka, Marcin A. Zusterzeel, Petra L. M. Beltman, Jogchum Jan Goffin, Frederic Haidopoulos, Dimitrios Haller, Herman Jach, Robert Yezhova, Iryna and Berlev, Igor Bernardino, Margarida Bharathan, Rasiah Lanner, Maximilian Maenpaa, Minna M. Sukhin, Vladyslav Feron, Jean-Guillaume Fruscio, Robert Kukk, Kersti Ponce, Jordi and Angel Minguez, Jose Vazquez-Vicente, Daniel Castellanos, Teresa and Boria, Felix Luis Alcazar, Juan Chiva, Luis SUCCOR Study Grp

Abstract

Objective To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). Methods A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width

Published
2022

9. Modern strategies to improve diagnosis and treatment of rare gynecologic tumors—current challenges and future directions

Author

Di Fiore, Riccardo, Suleiman, Sherif, Ellul, Bridget, O’toole, Sharon A., Savona-Ventura, Charles, Felix, Ana, Napolioni, Valerio, Conlon, Neil T., Erson-Bensan, Ayse Elif, Kahramanoglu, Ilker, Azzopardi, Miriam J., Dalmas, Miriam, Calleja, Neville, Brincat, Mark R., Muscat-Baron, Yves, Sabol, Maja, Dimitrievska, Vera, Yordanov, Angel, Vasileva-Slaveva, Mariela, von Brockdorff, Kristelle, Micallef, Rachel A., Kubelac, Paul, Achimas-Cadariu, Patriciu, Vlad, Catalin, Tzortzatou, Olga, Poka, Robert, Giordano, Antonio, Felice, Alex, Reed, Nicholas, Herrington, C. Simon, Faraggi, David, Calleja-Agius, Jean, and NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)

Subjects
Biobanking, Rare gynecologic tumors, Cancer Research, Oncology, SDG 3 - Good Health and Well-being, Cancer stem cells, Circulating tumor-specific markers, Theranostics, Personalized medicine
Abstract

More than 50% of all gynecologic tumors can be classified as rare (defined as an incidence of ≤6 per 100,000 women) and usually have a poor prognosis owing to delayed diagnosis and treatment. In contrast to almost all other common solid tumors, the treatment of rare gynecologic tumors (RGT) is often based on retrospective studies, expert opinion, or extrapolation from other tumor sites with similar histology, leading to difficulty in developing guidelines for clinical practice. Currently, gynecologic cancer research, due to distinct scientific and technological challenges, is lagging behind. Moreover, the overall efforts for addressing these challenges are fragmented across different European countries and indeed, worldwide. The GYNOCARE, COST Action CA18117 (European Network for Gynecological Rare Cancer Research) programme aims to address these challenges by creating a unique network between key stakeholders covering distinct domains from concept to cure: basic research on RGT, biobanking, bridging with industry, and setting up the legal and regulatory requirements for international innovative clinical trials. On this basis, members of this COST Action, (Working Group 1, “Basic and Translational Research on Rare Gynecological Cancer”) have decided to focus their future efforts on the development of new approaches to improve the diagnosis and treatment of RGT. Here, we provide a brief overview of the current state-of-the-art and describe the goals of this COST Action and its future challenges with the aim to stimulate discussion and promote synergy across scientists engaged in the fight against this rare cancer worldwide. publishersversion published

Published
2021

10. Radical hysterectomy in early cervical cancer in Europe: characteristics, outcomes and evaluation of ESGO quality indicators

Author

Boria, Felix Chiva, Luis Zanagnolo, Vanna Querleu, Denis and Martin-Calvo, Nerea Capilna, Mihai Emil Fagotti, Anna and Kucukmetin, Ali Mom, Constantijne Chakalova, Galina and Shamistan, Aliyev Malzoni, Mario Narducci, Fabrice and Arencibia, Octavio Raspagliesi, Francesco Toptas, Tayfun and Cibula, David Kaidarova, Dilyara Meydanli, Mehmet Mutlu and Tavares, Mariana Golub, Dmytro Perrone, Anna Myriam Poka, Robert Tsolakidis, Dimitrios Vujic, Goran Jedryka, Marcin A. and Zusterzeel, Petra L. M. Beltman, Jogchum Jan Goffin, Frederic Haidopoulos, Dimitrios Haller, Herman Jach, Robert and Yezhova, Iryna Berlev, Igor Bernardino, Margarida and Bharathan, Rasiah Lanner, Maximilian Maenpaa, Minna M. and Sukhin, Vladyslav Feron, Jean-Guillaume Fruscio, Robert and Kukk, Kersti Ponce, Jordi Alonso-Espias, Maria Angel Minguez, Jose Vazquez-Vicente, Daniel Manzour, Nabil Jurado, Matias Castellanos, Teresa Chacon, Enrique Luis Alcazar, Juan

Abstract

Introduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. Methods The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. Results The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m(2) (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination)

Published
2021

11. Voiding recovery after radical parametrectomy in cervical cancer patients: An international prospective multicentre trial – SENTIX

Author

UCL - SSS/IREC/GYNE - Pôle de Gynécologie, UCL - (SLuc) Service de gynécologie et d'andrologie, Zapardiel, Ignacio, Kocian, Roman, Köhler, Cristhardt, Klat, Jaroslav, Germanova, Anna, Jacob, Anna, Bajsova, Sylva, Böhmer, Gerd, Lay, Laura, Gil-Ibañez, Blanca, Havelka, Pavel, Kipp, Barbara, Szewczyk, Grzegorz, Toth, Robert, Staringer, Juan Carlos, De Santiago, Javier, Coronado, Pluvio J., Poka, Robert, Laky, Rene, Luyckx, Mathieu, Fastrez, Maxime, Dusek, Ladislav, Hernandez, Alicia, Cibula, David, UCL - SSS/IREC/GYNE - Pôle de Gynécologie, UCL - (SLuc) Service de gynécologie et d'andrologie, Zapardiel, Ignacio, Kocian, Roman, Köhler, Cristhardt, Klat, Jaroslav, Germanova, Anna, Jacob, Anna, Bajsova, Sylva, Böhmer, Gerd, Lay, Laura, Gil-Ibañez, Blanca, Havelka, Pavel, Kipp, Barbara, Szewczyk, Grzegorz, Toth, Robert, Staringer, Juan Carlos, De Santiago, Javier, Coronado, Pluvio J., Poka, Robert, Laky, Rene, Luyckx, Mathieu, Fastrez, Maxime, Dusek, Ladislav, Hernandez, Alicia, and Cibula, David

Abstract

OBJECTIVE: Voiding dysfunctions represent a leading morbidity after radical hysterectomy performed in patients with early-stage cervical cancer. The aim of this study was to perform ad hoc analysis of factors influencing voiding recovery in SENTIX (SENTinel lymph node biopsy in cervIX cancer) trial. METHODS: The SENTIX trial (47 sites, 18 countries) is a prospective study on sentinel lymph node biopsy without pelvic lymphadenectomy in patients with early-stage cervical cancer. Overall, the data of 300 patients were analysed. Voiding recovery was defined as the number of days from surgery to bladder catheter/epicystostomy removal or to post-voiding urine residuum ≤50 mL. RESULTS: The median voiding recovery time was three days (5th-95th percentile: 0-21): 235 (78.3%) patients recovered in <7 days and 293 (97.7%) in <30 days. Only seven (2.3%) patients recovered after >30 days. In the multivariate analysis, only previous pregnancy (p = 0.033) and type of parametrectomy (p < 0.001) significantly influenced voiding recovery >7 days post-surgery. Type-B parametrectomy was associated with a higher risk of delayed voiding recovery than type-C1 (OR = 4.69; p = 0.023 vs. OR = 3.62; p = 0.052, respectively), followed by type-C2 (OR = 5.84; p = 0.011). Both previous pregnancy and type C2 parametrectomy independently prolonged time to voiding recovery by two days. CONCLUSIONS: Time to voiding recovery is significantly related to previous pregnancy and type of parametrectomy but it is not influenced by surgical approach (open vs minimally invasive), age, or BMI. Type B parametrectomy, without direct visualisation of nerves, was associated with longer recovery than nerve-sparing type C1. Importantly, voiding dysfunctions after radical surgery are temporary, and the majority of the patients recover in less than 30 days, including patients after C2 parametrectomy.

Published
2021

12. GYNOCARE Update: Modern Strategies to Improve Diagnosis and Treatment of Rare Gynecologic Tumors—Current Challenges and Future Directions

Author

Di Fiore, Riccardo, primary, Suleiman, Sherif, additional, Ellul, Bridget, additional, O’Toole, Sharon A., additional, Savona-Ventura, Charles, additional, Felix, Ana, additional, Napolioni, Valerio, additional, Conlon, Neil T., additional, Kahramanoglu, Ilker, additional, Azzopardi, Miriam J., additional, Dalmas, Miriam, additional, Calleja, Neville, additional, Brincat, Mark R., additional, Muscat-Baron, Yves, additional, Sabol, Maja, additional, Dimitrievska, Vera, additional, Yordanov, Angel, additional, Vasileva-Slaveva, Mariela, additional, von Brockdorff, Kristelle, additional, Micallef, Rachel A., additional, Kubelac, Paul, additional, Achimaș-Cadariu, Patriciu, additional, Vlad, Catalin, additional, Tzortzatou, Olga, additional, Poka, Robert, additional, Giordano, Antonio, additional, Felice, Alex, additional, Reed, Nicholas, additional, Herrington, C. Simon, additional, Faraggi, David, additional, and Calleja-Agius, Jean, additional

Published
2021
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14. Central Pathology Review in SENTIX, a Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

Author

Nemejcova, Kristyna, primary, Kocian, Roman, additional, Kohler, Christhardt, additional, Jarkovsky, Jiri, additional, Klat, Jaroslav, additional, Berjon, Alberto, additional, Pilka, Radovan, additional, Sehnal, Borek, additional, Gil-Ibanez, Blanca, additional, Lupo, Ezequiel, additional, Petiz, Almerinda, additional, Arencibia Sanchez, Octavio, additional, Kascak, Peter, additional, Martinelli, Fabio, additional, Buda, Alessandro, additional, Presl, Jiri, additional, Barahona, Marc, additional, van Lonkhuijzen, Luc, additional, Szatkowski, Wiktor, additional, Minar, Lubos, additional, Pakiz, Maja, additional, Havelka, Pavel, additional, Zorrero, Cristina, additional, Misiek, Marcin, additional, Snyman, Leon Cornelius, additional, Wydra, Dariusz, additional, Vergote, Ignace, additional, Vinnytska, Alla, additional, Redecha, Mikulas, additional, Michal, Martin, additional, Tingulstad, Solveig, additional, Kipp, Barbara, additional, Szewczyk, Grzegorz, additional, Toth, Robert, additional, de Santiago Garcia, Francisco Javier, additional, Coronado Martin, Pluvio Jesus, additional, Poka, Robert, additional, Tamussino, Karl, additional, Luyckx, Mathieu, additional, Fastrez, Maxime, additional, Staringer, Juan Carlos, additional, Germanova, Anna, additional, Plaikner, Andrea, additional, Bajsova, Sylva, additional, Dundr, Pavel, additional, Mallmann-Gottschalk, Nina, additional, and Cibula, David, additional

Published
2020
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15. 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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16. Central Pathology Review in SENTIX, a Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

Author

Nemejcova, Kristyna, Kocian, Roman, Kohler, Christhardt, Jarkovsky, Jiri, Klat, Jaroslav, Berjon, Alberto, Pilka, Radovan, Sehnal, Borek, Gil-Ibanez, Blanca, Lupo, Ezequiel, Petiz, Almerinda, Arencibia Sanchez, Octavio, Kascak, Peter, Martinelli, Fabio, Buda, Alessandro, Presl, Jiri, Barahona, Marc, van Lonkhuijzen, Luc, Szatkowski, Wiktor, Minar, Lubos, Pakiz, Maja, Havelka, Pavel, Zorrero, Cristina, Misiek, Marcin, Snyman, Leon Cornelius, Wydra, Dariusz, Vergote, Ignace, Vinnytska, Alla, Redecha, Mikulas, Michal, Martin, Tingulstad, Solveig, Kipp, Barbara, Szewczyk, Grzegorz, Toth, Robert, de Santiago Garcia, Francisco Javier, Coronado Martin, Pluvio Jesus, Poka, Robert, Tamussino, Karl, Luyckx, Mathieu, Fastrez, Maxime, Carlos Staringer, Juan, Germanova, Anna, Plaikner, Andrea, Bajsova, Sylva, Dundr, Pavel, Mallmann-Gottschalk, Nina, Cibula, David, Nemejcova, Kristyna, Kocian, Roman, Kohler, Christhardt, Jarkovsky, Jiri, Klat, Jaroslav, Berjon, Alberto, Pilka, Radovan, Sehnal, Borek, Gil-Ibanez, Blanca, Lupo, Ezequiel, Petiz, Almerinda, Arencibia Sanchez, Octavio, Kascak, Peter, Martinelli, Fabio, Buda, Alessandro, Presl, Jiri, Barahona, Marc, van Lonkhuijzen, Luc, Szatkowski, Wiktor, Minar, Lubos, Pakiz, Maja, Havelka, Pavel, Zorrero, Cristina, Misiek, Marcin, Snyman, Leon Cornelius, Wydra, Dariusz, Vergote, Ignace, Vinnytska, Alla, Redecha, Mikulas, Michal, Martin, Tingulstad, Solveig, Kipp, Barbara, Szewczyk, Grzegorz, Toth, Robert, de Santiago Garcia, Francisco Javier, Coronado Martin, Pluvio Jesus, Poka, Robert, Tamussino, Karl, Luyckx, Mathieu, Fastrez, Maxime, Carlos Staringer, Juan, Germanova, Anna, Plaikner, Andrea, Bajsova, Sylva, Dundr, Pavel, Mallmann-Gottschalk, Nina, and Cibula, David

Abstract

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

Published
2020

17. 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, 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, 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, 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, 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, and Alcazar, Juan Luis

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<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective va

Published
2020

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