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11 results on '"Goffin, F"'

1. SUCCOR cone study

Author

Chacon, E, Manzour, N, Zanagnolo, V, Querleu, D, Núñez-Córdoba, Jm, Martin-Calvo, N, Căpîlna, Me, 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, Mm, Tavares, M, Golub, D, Perrone, Am, Poka, R, Tsolakidis, D, Vujić, G, Jedryka, Ma, Zusterzeel, Plm, Beltman, Jj, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, Mm, Sukhin, V, Feron, Jg, Fruscio, R, Kukk, K, Ponce, J, Minguez, Ja, Vázquez-Vicente, D, Castellanos, T, Boria, F, Alcazar, Jl, Chiva, L, SUCCOR study group, SUCCOR study Group: Abdalla, N, Akgöl, S, Aksahin, D, Aliyev, S, Alonso-Espias, M, Aluloski, I, Andrade, C, Badzakov, N, Barrachina, R, Bogani, G, Bonci, E-A, Bonsang-Kitzis, H, Brucker, C, Cárdenas, L, Casajuana, A, Cavalle, P, Cea, J, Chiofalo, B, Cordeiro, G, Coronado, P, Cuadra, M, Díez, J, Diniz da Costa, T, Domingo, S, Dostalek, L, Elif, F, Erasun, D, Fehr, M, Fernandez-Gonzalez, S, Ferrero, A, Fidalgo, S, Fiol, G, Galaal, K, García, J, Gebauer, G, Ghezzi, F, Gilabert, J, Gomes, N, Gonçalves, 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, Stefan Kovachev, S, U A, Leht, Lekuona, A, Luyckx, M, Mallmann, M, Mancebo, G, Mandic, A, Marina, T, Martin, V, M B, Martín-Salamanca, Lago, V, Martinez, A, Meili, G, Mendinhos, G, Mereu, L, Mitrovic, M, Morales, S, Moratalla, E, N R, Gómez-Hidalgo, Morillas, B, Myriokefalitaki, E, Pakižimre, M, Petousis, S, Pirtea, L, Povolotskaya, N, Prader, S, Quesada, A, Redecha, M, Roldan, F, Rolland, P, Saaron, R, Sarac, C-P, Scharf, J-P, Smrkolj, S, Sousa, R, Stepanyan, A, Študent, V, Tauste, C, Trum, H, Turan, T, Undurraga, M, Vázquez, A, Vergote, I, Vorgias, G, and Zapardiel, I, Obstetrics and gynaecology, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), 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, and Chiva, L

Subjects
Adult, Databases, Factual, cervical cancer, Conization, Obstetrics and Gynecology, Uterine Cervical Neoplasms, Middle Aged, Disease-Free Survival, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], surgery, Settore MED/40 - GINECOLOGIA E OSTETRICIA, laparoscopes, laparoscope, Oncology, laparotomy, Humans, Minimally Invasive Surgical Procedures, Female, Neoplasm Recurrence, Local, hysterectomy, Propensity Score, Retrospective Studies
Abstract

ObjectiveTo 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).MethodsA 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.ResultsWe 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).ConclusionsIn this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.

Published
2022
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2. Robot-assisted surgery for women with endometrial cancer: Surgical and oncologic outcomes within a Belgium gynaecological oncology group cohort.

Author

Kakkos, A., Ver Eecke, C., Ongaro, S., Traen, K., Peeters, F., Van Trappen, Ph, Laenen, A., Despierre, E., Van Nieuwenhuysen, E., Vergote, I., and Goffin, F.

Subjects
SURGICAL robots, ENDOMETRIAL surgery, ENDOMETRIAL cancer, SURGICAL complications, OLDER women, ONCOLOGY
Abstract

To evaluate surgical and oncologic outcomes of patients treated by robot-assisted surgery for endometrial cancer within the Belgium Gynaecological Oncology Group (BGOG). We performed a retrospective analysis of women with clinically Stage I endometrial cancer who underwent surgical treatment from 2007 to 2018 in five institutions of the BGOG group. A total of 598 consecutive women were identified. The rate of conversion to laparotomy was low (0.8%). The mean postoperative Complication Common Comprehensive Index (CCI) score was 3.4. The rate of perioperative complications did not differ between age groups, however the disease-free survival was significantly lower in patients over 75 years compared to patients under 65 years of age (p=0.008). Per-operative complications, conversion to laparotomy rate, post-operative hospital stay, CCI score and disease-free survival were not impacted by increasing BMI. Robot-assisted surgery for the surgical treatment of patients suffering from early-stage endometrial cancer is associated with favourable surgical and oncologic outcomes, particularly for unfavourable groups such as elderly and obese women, thus permitting a low morbidity minimally-invasive surgical approach for the majority of patients in expert centres. [ABSTRACT FROM AUTHOR]

Published
2021
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3. Epidermal Growth Factor Receptor (EGFR) Pathway Biomarkers in the Randomized Phase III Trial of Erlotinib Versus Observation in Ovarian Cancer Patients with No Evidence of Disease Progression after First-Line Platinum-Based Chemotherapy

Author

Despierre, Evelyn, Vergote, Ignace, Anderson, Ryan, Coens, Corneel, Katsaros, Dionyssios, Hirsch, Fred R., Boeckx, Bram, Varella Garcia, Marileila, Ferrero, Annamaria, Ray Coquard, Isabelle, Berns, Els M. J. J., Casado, Antonio, Lambrechts, Diether, Jimeno, Antonio, Abraham, C, Chesnay, L, Amant, F, Anderson, R, Azzedine, A, Benedetto, Chiara, Bertelli, G, Berteloot, P, Berton Rigaud, D, Biglia, N, Bonichon Lamichhane, N, Bougnoux, P, Bourbouloux, E, Bourcier, C, Buck, M, Campone, M, Canuto, Em, Casado Herraez, A, Cauvin, I, Chauvenet, L, Chevalier Place, A, Cottu, P., Cretin, J, Cumin, I, Curé, H, Dalenc, F, Danese, S, Davis, A, Debruyne, P, Delplanque, G, Delva, R, D'Hondt, V, Dramais, D, Durando, X, El Kouri, C, Esteban, C, Fabbro, M, Falandry, C, Filleul, B, Floquet, A, Fumoleau, P, Garcia Varella, M, Garnier, C, Gilby, E, Gladieff, L, Goffin, F, Gouttebel, M., Green, Ja, Guastalla, J., Hardy Bessard, A., Hirsch, F, Hughes, A, Jaubert, D, Kaminsky, M., Katsaros, D, Largillier, R, Lebrun Jezekova, D, Leduc, B, Leheurteur, M, Lesoin, A, Leunen, K, Levasseur, N, Leyronnas, C, Llory, J., Lortholary, A, Mayer, F, Mayeur, D, Mendiola, C, Mignot, L, Morgan, J, Mouret Reynier, M., Neven, P, Petit, T, Picardo, E, Plaza, J, Pluvio Coronado, M, Priou, F, Pujade Lauraine, E, Coquard, I, Reed, N, Rigault de la Longrais, I, Scholl, S, Sillet Bach, I, Steer, C, Summers, J, Trillet Lenoir, V, Van Dam, P, Van Der Burg ME, Vanlerenberghe, E, Vannetzel, J., Vergote, I, Aragon, Ja, Waters, J, Weber, B, Yazbek, G, Zola, P., Medical Oncology, and Other departments

Subjects
Neuroblastoma RAS viral oncogene homolog, Oncology, Adult, Cancer Research, medicine.medical_specialty, Organoplatinum Compounds, medicine.disease_cause, Article, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Disease Progression, Disease-Free Survival, Erlotinib Hydrochloride, Female, Humans, Middle Aged, Mutation, Ovarian Neoplasms, Protein Kinase Inhibitors, Protein Kinases, Receptor, Epidermal Growth Factor, Pharmacology (medical), SDG 3 - Good Health and Well-being, Internal medicine, 80 and over, Medicine, EGFR Gene Amplification, Epidermal growth factor receptor, neoplasms, Tumor, Epidermal Growth Factor, biology, business.industry, Cancer, medicine.disease, ErbB Receptors, biology.protein, Biomarker (medicine), Erlotinib, KRAS, business, Ovarian cancer, Biomarkers, Receptor, medicine.drug
Abstract

In this work, we aimed to identify molecular epidermal growth factor receptor (EGFR) tissue biomarkers in patients with ovarian cancer who were treated within the phase III randomized European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) 55041 study comparing erlotinib with observation in patients with no evidence of disease progression after first-line platinum-based chemotherapy. Somatic mutations in KRAS, BRAF, NRAS, PIK3CA, EGFR, and PTEN were determined in 318 (38 %) and expression of EGFR, pAkt, pMAPK, E-cadherin and Vimentin, and EGFR and HER2 gene copy numbers in 218 (26 %) of a total of 835 randomized patients. Biomarker data were correlated with progression-free survival (PFS) and overall survival (OS). Only 28 mutations were observed among KRAS, BRAF, NRAS, PIK3CA, EGFR, and PTEN (in 7.5 % of patients), of which the most frequent were in KRAS and PIK3CA. EGFR mutations occurred in only three patients. When all mutations were pooled, patients with at least one mutation in KRAS, NRAS, BRAF, PIK3CA, or EGFR had longer PFS (33.1 versus 12.3 months; HR 0.57; 95 % CI 0.33 to 0.99; P = 0.042) compared to those with wild-type tumors. EGFR overexpression was detected in 93 of 218 patients (42.7 %), and 66 of 180 patients (36.7 %) had EGFR gene amplification or high levels of copy number gain. Fifty-eight of 128 patients had positive pMAPK expression (45.3 %), which was associated with inferior OS (38.9 versus 67.0 months; HR 1.81; 95 % CI 1.11 to 2.97; P = 0.016). Patients with positive EGFR fluorescence in situ hybridization (FISH) status had worse OS (46.1 months) than those with negative status (67.0 months; HR 1.56; 95 % CI 1.01 to 2.40; P = 0.044) and shorter PFS (9.6 versus 16.1 months; HR 1.57; 95 % CI 1.11 to 2.22; P = 0.010). None of the investigated biomarkers correlated with responsiveness to erlotinib. In this phase III study, increased EGFR gene copy number was associated with worse OS and PFS in patients with ovarian cancer. It remains to be determined whether this association is purely prognostic or is also predictive.

Published
2015
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4. European Society of Gynecological Oncology Statement on Fibroid and Uterine Morcellation

Author

Halaska, M. J., Haidopoulos, D., Guyon, F., Morice, P., Zapardiel, I., Kesic, V., Cibula, D., Querleu, D., Gultekin, M., Creutzberg, C., Avall-Lundqvist, E., Goffin, F., Concin, N., Ferrero, A, Kurdiani, D., Ledermann, J., Ponce, J., Sessa, C., Wimberger, P., Marth, C., and Laky, R.

Subjects
Leiomyosarcoma, medicine.medical_specialty, medicine.medical_treatment, 03 medical and health sciences, 0302 clinical medicine, Uterine Myomectomy, Medicine, Humans, Stage (cooking), Pregnancy, 030219 obstetrics & reproductive medicine, Hysterectomy, Uterine sarcoma, medicine.diagnostic_test, Leiomyoma, business.industry, Obstetrics and Gynecology, Sarcoma, Middle Aged, medicine.disease, Surgery, Oncology, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, Uterine Neoplasms, Female, business, Tamoxifen, medicine.drug, Endometrial biopsy
Abstract

Recently, there has been an intense discussion about the issue of fibroid and uterine morcellation in relation to the risk of unrecognized uterine sarcoma spread. Morcellation can negatively influence the prognosis of patients, and transecting the specimen into pieces prevents the pathologist from performing proper disease staging. Many societies have published their statements regarding this issue. The European Society for Gynecological Oncology has established a working group of clinicians involved in diagnostics and treatment of oncogynecological patients to provide a statement from the oncological point of view. Leiomyosarcomas and undifferentiated endometrial sarcomas have generally dismal prognosis, whereas low-grade endometrial stromal sarcomas and adenosarcomas have variable prognosis based on their stage. A focus on the detection of patients at risk of having a sarcoma should be mandatory before every surgery where morcellation is planned by evaluation of risk factors (African American descent, previous pelvic irradiation, use of tamoxifen, rapid lesion growth particularly in postmenopausal patients) and exclusion of patients with any suspicious ultrasonographic signs. Preoperative endometrial biopsy should be mandatory, although the sensitivity to detect sarcomas is low. An indication for myomectomy should be used only in patients with pregnancy plans; otherwise en bloc hysterectomy is preferred in both symptomatic and postmenopausal patients. Eliminating the technique of morcellation could lead to an increased morbidity in low-risk patients; therefore, after thorough preoperative evaluation and discussion with patients, morcellation still has its place in the armamentarium of gynecologic surgery.

Published
2016

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

Author

Aliyev Shamistan, Jogchum Jan Beltman, Fabrice Narducci, Juan Luis Alcázar, Iryna Yezhova, Mehmet Mutlu Meydanli, Frédéric Goffin, José Ángel Mínguez, Robert Fruscio, Dmytro Golub, Nerea Martín-Calvo, Mariana Tavares, Anna Fagotti, Robert Jach, Dimitrios Haidopoulos, N Manzour, Margarida Bernardino, E Chacon, Marcin Jędryka, Kersti Kukk, Dimitrios Tsolakidis, Ali Kucukmetin, Denis Querleu, Mihai Emil Căpîlna, Herman Haller, Jordi Ponce, Mario Malzoni, Constantijne H. Mom, Teresa Castellanos, Goran Vujić, Dilyara Kaidarova, Tayfun Toptas, Daniel Vázquez-Vicente, María Alonso-Espías, Luis Chiva, David Cibula, Jean Guillaume Feron, Galina Chakalova, Vladyslav Sukhin, Matías Jurado, Rasiah Bharathan, Vanna Zanagnolo, Igor Berlev, Minna M. Mäenpää, F Boria, Maximilian Lanner, Francesco Raspagliesi, Anna Myriam Perrone, Octavio Arencibia, Petra L.M. Zusterzeel, Róbert Póka, Boria, F, Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, CA Pilna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, 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, 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, Maenpaa, M, Sukhin, V, Feron J.,, Fruscio, R, Kukk, K, Ponce, J, Alonso-Espias, M, Minguez, J, Vazquez-Vicente, D, Manzour, N, Jurado, M, Castellanos, T, Chacon, E, Alcazar, J, Boria F., Chiva L., Zanagnolo V., Querleu D., Martin-Calvo N., CA Pilna M.E., Fagotti A., Kucukmetin A., Mom C., Chakalova, G., Shamistan A., 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., Alonso-Espias M., Minguez J.A., Vazquez-Vicente D., Manzour N., Jurado M., Castellanos T., Chacon E., Alcazar J.L., Obstetrics and gynaecology, CCA - Cancer Treatment and quality of life, and Amsterdam Reproduction & Development (AR&D)

Subjects
0301 basic medicine, medicine.medical_specialty, SLN and lympadenectomy, cervical cancer, hysterectomy, postoperative complications, radiation, medicine.medical_treatment, Population, Uterine Cervical Neoplasms, Physical examination, 03 medical and health sciences, 0302 clinical medicine, Adjuvant therapy, medicine, Humans, postoperative complication, Stage (cooking), Radical Hysterectomy, education, Quality Indicators, Health Care, Cervical cancer, education.field_of_study, Hysterectomy, medicine.diagnostic_test, business.industry, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Ginekologija i opstetricija, General surgery, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Gynecology and Obstetrics, Obstetrics and Gynecology, Middle Aged, medicine.disease, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], Europe, 030104 developmental biology, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Cohort, Female, business, Human
Abstract

IntroductionComprehensive updated information on cervical cancer surgical treatment in Europe is scarce.ObjectiveTo 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.MethodsThe 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.ResultsThe mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) ConclusionsIn this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

Published
2021
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6. 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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7. SUCCOR quality: validation of ESGO quality indicators for surgical treatment of cervical cancer

Author

Felix Boria, Luis Chiva, Enrique Chacon, Vanna Zanagnolo, Anna Fagotti, Ali Kucukmetin, Constantijne Mom, Galina Chakalova, Aliyev Shamistan, Mario Malzoni, Fabrice Narducci, Octavio Arencibia, Francesco Raspagliesi, Tayfun Toptas, David Cibula, Dilyara Kaidarova, Mehmet Mutlu Meydanli, Mariana Tavares, Dmytro Golub, Anna Myriam Perrone, Robert Poka, Petra L M Zusterzeel, Igor Aluloski, Frederic Goffin, Dimitrios Haidopoulos, Herman Haller, Robert Jach, Iryna Yezhova, Margarida Bernardino, Rasiah Bharathan, Minna M Maenpaa, Vladyslav Sukhin, Jean-Guillaume Feron, Robert Fruscio, Kersti Kukk, Jordi Ponce, Fuat Demirkiran, George Vorgias, Natalia Povolotskaya, Pluvio J Coronado Martín, Tiermes Marina, Ignacio Zapardiel, Nicolò Bizzarri, Mikel Gorostidi, Monica Gutierrez, Nabil Manzour, Arantxa Berasaluce, Nerea Martin-Calvo, Boria, F, Chiva, L, Chacon, E, Zanagnolo, V, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, 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, Zusterzeel, P, Aluloski, I, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Bernardino, M, Bharathan, R, Maenpaa, M, Sukhin, V, Feron, J, Fruscio, R, Kukk, K, Ponce, J, Demirkiran, F, Vorgias, G, Povolotskaya, N, Coronado Martin, P, Marina, T, Zapardiel, I, Bizzarri, N, Gorostidi, M, Gutierrez, M, Manzour, N, Berasaluce, A, Obstetrics and gynaecology, CCA - Cancer Treatment and quality of life, and Amsterdam Reproduction & Development (AR&D)

Subjects
Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, cervical cancer, gynecologic surgical procedure, Obstetrics and Gynecology, hysterectomy, gynecologic surgical procedures, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Abstract

ObjectiveTo evaluate whether compliance with European Society of Gynaecological Oncology (ESGO) surgery quality indicators impacts disease-free survival in patients undergoing radical hysterectomy for cervical cancer.MethodsIn this retrospective cohort study, 15 ESGO quality indicators were assessed in the SUCCOR database (patients who underwent radical hysterectomy for International Federation of Gynecology and Obstetrics (FIGO) stage 2009 IB1, FIGO 2018 IB1, and IB2 cervical cancer between January 2013 and December 2014), and the final score ranged between 0 and 16 points. Centers with more than 13 points were classified as high-quality indicator compliance centers. We constructed a weighted cohort using inverse probability weighting to adjust for the variables. We compared disease-free survival and overall survival using Cox proportional hazards regression analysis in the weighted cohort.ResultsA total of 838 patients were included in the study. The mean number of quality indicators compliance in this cohort was 13.6 (SD 1.45). A total of 479 (57.2%) patients were operated on at high compliance centers and 359 (42.8%) patients at low compliance centers. High compliance centers performed more open surgeries (58.4% vs 36.7%, pConclusionsPatients with early cervical cancer who underwent radical hysterectomy in centers with high compliance with ESGO quality indicators had a lower risk of recurrence and death.

Published
2022
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8. 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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9. Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

Author

Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klaus, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Tomas, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, Bois, Du, Andreas, Ferrandina, Ferrandina, Maria Gabriella, AGO Study Group-led GCIG/ENGOT Intergroup Consortium, Ray-Coquard, I, Cibula, D, Mirza, M, Reuss, A, Ricci, C, Colombo, N, Koch, H, Goffin, F, González-Martin, A, Ottevanger, P, Baumann, K, Bjørge, L, Lesoin, A, Burges, A, Rosenberg, P, Gropp-Meier, M, Harrela, M, Harter, P, Frenel, J, Minarik, T, Pisano, C, Hasenburg, A, Merger, M, and du Bois, A

Subjects
Cancer Research, Indoles, medicine.medical_treatment, Gastroenterology, Carboplatin, Placebos, chemistry.chemical_compound, tyrosine kinase inhibitor, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, nintedanib, Clinical endpoint, anti-angiogenic, Aged, 80 and over, Ovarian Neoplasms, Hazard ratio, Area under the curve, Cytoreduction Surgical Procedures, Middle Aged, Progression-Free Survival, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], ovarian cancer, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Nintedanib, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Placebo, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Chemotherapy, business.industry, Ovary, antiangiogenic, medicine.disease, Settore MED/40 - GINECOLOGIA E OSTETRICIA, chemistry, Ovarian cancer, business, Follow-Up Studies
Abstract

Contains fulltext : 218867.pdf (Publisher’s version ) (Closed access) AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB-IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m(2) ) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2-21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83-1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

Published
2020

10. Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy

Author

Fedro A. Peccatori, Anna Babkova, Monica Fumagalli, Amarendra Gandhi, Michael J. Halaska, Charlotte Maggen, Ingrid A. Boere, Sofia Passera, Christianne A. R. Lok, Giovanna Scarfone, Magali Verheecke, Laurence Claes, Vít Drochýtek, Mathilde van Gerwen, Vincent Rigo, Martine van Grotel, Jorine de Haan, Martina Delle Marchette, Marry M. van den Heuvel-Eibrink, Gunnar Naulaers, Robert Fruscio, Tineke Vandenbroucke, Maria Lucia Boffi, Lieven Lagae, Mina Mhallem Gziri, Fabio Mosca, Margreet A. Veening, Jens-Uwe Voigt, Jana Dekrem, Luc Mertens, Kristel Van Calsteren, Christianne J.M. de Groot, Frédéric Amant, Vera E. R. A. Wolters, Els Witteveen, Odoardo Picciolini, Camilla Fontana, Jeroen Blommaert, Petronella B. Ottevanger, Renata Nacinovich, Frédéric Goffin, Carolina P. Schröder, Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, ARD - Amsterdam Reproduction and Development, Obstetrics, Vandenbroucke, T, Verheecke, M, van Gerwen, M, Van Calsteren, K, Halaska, M, Fumagalli, M, Fruscio, R, Gandhi, A, Veening, M, Lagae, L, Ottevanger, P, Voigt, J, de Haan, J, Gziri, M, Maggen, C, Mertens, L, Naulaers, G, Claes, L, Amant, F, Blommaert, J, Dekrem, J, Goffin, F, Rigo, V, Fontana, C, Mosca, F, Passera, S, Picciolini, O, Scarfone, G, Peccatori, F, Boffi, M, Delle Marchette, M, Nacinovich, R, Lok, C, Wolters, V, Boere, I, Witteveen, E, Schroder, C, de Groot, C, van Grotel, M, van den Heuvel-Eibrink, M, Babkova, A, Drochytek, V, Obstetrics and gynaecology, Pediatric surgery, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), Erasmus MC other, Medical Oncology, and Pathology

Subjects
0301 basic medicine, Male, Pediatrics, Cancer Research, Memory/drug effects, Intelligence, Pregnancy Complications, Neoplastic/drug therapy, 0302 clinical medicine, Diastole, Pregnancy, Antineoplastic agents, Medicine, Childbirth, Fertility preservation, Prospective Studies, Child, Child development, Original Research, media_common, Cervical cancer, 0303 health sciences, Prenatal exposure delayed effect, Intelligence quotient, Obstetrics, High risk, Hematology, Prenatal exposure delayed effects, Chemotherapy regimen, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], 3. Good health, Antineoplastic agent, Oncology, 030220 oncology & carcinogenesis, Female, Pregnancy Complications, Neoplastic, Cohort study, Adult, medicine.medical_specialty, Child, preschool, media_common.quotation_subject, Fertility, Follow-up studies, 03 medical and health sciences, Intelligence/drug effects, Breast cancer, SDG 3 - Good Health and Well-being, Memory, media_common.cataloged_instance, Humans, European union, Child Development/drug effects, 030304 developmental biology, Diastole/drug effects, Follow-up studie, business.industry, Cancer, Infant, Antineoplastic Agents/adverse effects, medicine.disease, Clinical trial, 030104 developmental biology, business
Abstract

Background Data on the long-term effects of prenatal exposure to maternal cancer and its treatment on child development are scarce. Methods In a multicenter cohort study, the neurologic and cardiac outcomes of 6-year-old children born to women diagnosed with cancer during pregnancy were compared with the outcome of children born after an uncomplicated pregnancy. Assessment included clinical evaluation, comprehensive neuropsychological testing, electrocardiography and echocardiography. Results In total, 132 study children and 132 controls were included. In the study group, 97 children (73.5%) were prenatally exposed to chemotherapy (alone or in combination with other treatments), 14 (10.6%) to radiotherapy (alone or in combination), 1 (0.8%) to trastuzumab, 12 (9.1%) to surgery alone and 16 (12.1%) to no treatment. Although within normal ranges, statistically significant differences were found in mean verbal IQ and visuospatial long-term memory, with lower scores in the study versus control group (98.1, 95% confidence interval [CI]: 94.5–101.8, versus 104.4, 95% CI: 100.4–108.4, P = 0.001, Q, Highlights • Cancer treatment including chemotherapy is possible during pregnancy. • Children are at risk for lower verbal IQ and visuospatial long-term memory scores. • Other cognitive functions and cardiac outcomes were normal at the age of 6 years. • We documented ototoxicity in three children exposed to cisplatin. • Follow-up until adulthood is recommended.

Published
2020
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11. Evaluation of the quality of the management of cancer of the corpus uteri — Selection of relevant quality indicators and implementation in Belgium.

Author

Werbrouck, J., Bouche, G., de Jonge, E., Jacomen, G., D'Hondt, V., Denys, H., Van Limbergen, E., Vandermeersch, B., De Schutter, H., Van Eycken, E., Goffin, F., and Amant, F.

Subjects
*UTERINE cancer, *TREATMENT of endometrial cancer, *MEDICAL quality control, *TREATMENT effectiveness, *ONCOLOGY, *CANCER treatment
Abstract

Abstract: Objective: Describe the methodology and selection of quality indicators (QI) to be implemented in the EFFECT (EFFectiveness of Endometrial Cancer Treatment) project. EFFECT aims to monitor the variability in Quality of Care (QoC) of uterine cancer in Belgium, to compare the effectiveness of different treatment strategies to improve the QoC and to check the internal validity of the QI to validate the impact of process indicators on outcome. Methods: A QI list was retrieved from literature, recent guidelines and QI databases. The Belgian Healthcare Knowledge Center methodology was used for the selection process and involved an expert's panel rating the QI on 4 criteria. The resulting scores and further discussion resulted in a final QI list. An online EFFECT module was developed by the Belgian Cancer Registry including the list of variables required for measuring the QI. Three test phases were performed to evaluate the relevance, feasibility and understanding of the variables and to test the compatibility of the dataset. Results: 138 QI were considered for further discussion and 82 QI were eligible for rating. Based on the rating scores and consensus among the expert's panel, 41 QI were considered measurable and relevant. Testing of the data collection enabled optimization of the content and the user-friendliness of the dataset and online module. Conclusions: This first Belgian initiative for monitoring the QoC of uterine cancer indicates that the previously used QI selection methodology is reproducible for uterine cancer. The QI list could be applied by other research groups for comparison. [Copyright &y& Elsevier]

Published
2013
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