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1. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative)

Author

Faiza Gaba, Karen Ash, Oleg Blyuss, Nicolò Bizzarri, Paul Kamfwa, Pedro T Ramirez, Ioannis C Kotsopoulos, Dhivya Chandrasekaran, Nana Gomes, John Butler, Marielle Nobbenhuis, Thomas Ind, Owen Heath, Desmond Barton, Arjun Jeyarajah, Elly Brockbank, Alexandra Lawrence, James Dilley, Ranjit Manchanda, Saurabh Phadnis, and GO SOAR

Subjects
Oncology, Obstetrics and Gynecology
Abstract

BackgroundThe Global Gynecological Oncology Surgical Outcomes Collaborative (GO SOAR) has developed a network of gynecological oncology surgeons, surgical departments, and other interested parties that have the long-term ability to collaborate on outcome studies. Presented is the protocol for the GO SOAR2 study.Primary ObjectivesTo compare survival following interval and delayed cytoreductive surgery, between delayed cytoreductive surgery and no surgery (chemotherapy alone); and international variations in access to cytoreductive surgery for women with stage III–IV epithelial ovarian cancer.Study HypothesesThere is no difference in survival following interval and delayed cytoreductive surgery; there is poorer survival with no surgery compared with delayed cytoreductive surgery; and there are international disparities in prevalent practice and access to cytoreductive surgery in women with stage III–IV epithelial ovarian cancer.Trial DesignInternational, multicenter, mixed-methods cohort study. Participating centers, will review medical charts/electronic records of patients who had been consecutively diagnosed with stage III–IV ovarian cancer between January 1, 2006 and December 31, 2021. Qualitative interviews will be conducted to identify factors determining international variations in prevalent practice and access to cytoreductive surgery.Major Inclusion/Exclusion CriteriaInclusion criteria include women with stage III–IV epithelial ovarian cancer, undergoing interval (after 3–4 cycles of chemotherapy) or delayed (≥5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (≥5 cycles of chemotherapy alone).Primary EndpointsOverall survival (defined from date of diagnosis to date of death); progression-free survival (defined from date of diagnosis to date of first recurrence); facilitator/barriers to prevalent practice and access to cytoreductive surgery.Sample SizeIn order to determine whether there is a difference in survival following interval and delayed cytoreductive surgery and no surgery, data will be abstracted from 1000 patients.Estimated Dates for Completing Accrual and Presenting ResultsIt is estimated that recruitment will be completed by 2023, and results published by 2024.Trial RegistrationNCT05523804

Published
2022
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2. 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

6. 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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