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1. ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer

Author

Van Gorp, T., Cibula, D., Lv, W., Backes, F., Ortaç, F., Hasegawa, K., Lindemann, K., Savarese, A., Laenen, A., Kim, Y.M., Bodnar, L., Barretina-Ginesta, M.-P., Gilbert, L., Pothuri, B., Chen, X., Flores, M.B., Levy, T., Colombo, N., Papadimitriou, C., Buchanan, T., Hanker, L.C., Eminowicz, G., Rob, L., Black, D., Lichfield, J., Lin, G., Orlowski, R., Keefe, S., Lortholary, A., and Slomovitz, B.

Published
2024
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2. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J.A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, D., Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A.G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., McCluggage, W.G., McNeish, I.A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J.A., Pignata, S., Ramirez, P.T., Ray-Coquard, I., Romero, I., Scambia, G., Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D.S.P., Taskiran, C., van Driel, W.J., Vergote, I., Planchamp, F., Sessa, C., and Fagotti, A.

Published
2024
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3. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., Fagotti A., Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., and Fagotti A.

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

4. Sonographic, Demographic, and Clinical Characteristics of Pre- and Postmenopausal Women with Endometrial Cancer; Results from a Post Hoc Analysis of the IETA4 (International Endometrial Tumor Analysis) Multicenter Cohort

Author

Green, R, Fischerova, D, Testa, A, Franchi, D, Fruhauf, F, Lindqvist, P, di Legge, A, Cibula, D, Fruscio, R, Haak, L, Opolskiene, G, Vidal Urbinati, A, Timmerman, D, Bourne, T, van den Bosch, T, Epstein, E, Green R. W., Fischerova D., Testa A. C., Franchi D., Fruhauf F., Lindqvist P. G., di Legge A., Cibula D., Fruscio R., Haak L. A., Opolskiene G., Vidal Urbinati A. M., Timmerman D., Bourne T., van den Bosch T., Epstein E., Green, R, Fischerova, D, Testa, A, Franchi, D, Fruhauf, F, Lindqvist, P, di Legge, A, Cibula, D, Fruscio, R, Haak, L, Opolskiene, G, Vidal Urbinati, A, Timmerman, D, Bourne, T, van den Bosch, T, Epstein, E, Green R. W., Fischerova D., Testa A. C., Franchi D., Fruhauf F., Lindqvist P. G., di Legge A., Cibula D., Fruscio R., Haak L. A., Opolskiene G., Vidal Urbinati A. M., Timmerman D., Bourne T., van den Bosch T., and Epstein E.

Abstract

In this study, we conducted a comparative analysis of demographic, histopathological, and sonographic characteristics between pre- and postmenopausal women diagnosed with endometrial cancer, while also examining sonographic and anthropometric features in ‘low’ and ‘intermediate/high-risk’ cases, stratified by menopausal status. Our analysis, based on data from the International Endometrial Tumor Analysis (IETA) 4 cohort comprising 1538 women (161 premenopausal, 1377 postmenopausal) with biopsy-confirmed endometrial cancer, revealed that premenopausal women, compared to their postmenopausal counterparts, exhibited lower parity (median 1, IQR 0–2 vs. 1, IQR 1–2, p = 0.001), a higher family history of colon cancer (16% vs. 7%, p = 0.001), and smaller waist circumferences (median 92 cm, IQR 82–108 cm vs. 98 cm, IQR 87–112 cm, p = 0.002). Premenopausal women more often had a regular endometrial–myometrial border (39% vs. 23%, p < 0.001), a visible endometrial midline (23% vs. 11%, p < 0.001), and undefined tumor (73% vs. 84%, p = 0.001). Notably, despite experiencing a longer duration of abnormal uterine bleeding (median 5 months, IQR 3–12 vs. 3 months, 2–6, p < 0.001), premenopausal women more often had ‘low’ risk disease (78% vs. 46%, p < 0.001). Among sonographic and anthropometric features, only an irregular endometrial–myometrial border was associated with ‘intermediate/high’ risk in premenopausal women. Conversely, in postmenopausal women, multiple features correlated with ‘intermediate/high’ risk disease. Our findings emphasize the importance of considering menopausal status when evaluating sonographic features in women with endometrial cancer.

Published
2024

5. Doporučené postupy klinické péče o nosiče zárodečných mutací v genech BRCA1, BRCA2, PALB2, ATM a CHEK2 predisponujících ke vzniku dědičného karcinomu prsu, vaječníků, prostaty a pankreatu (4...

Author

Kleiblová, P., Novotný, J., Cibula, D., Curtisová, V., Dubová, O., Foretová, L., Germanová, A., Janatová, M., Havránek, O., Hojsáková, M., Hudcová, M., Koudová, M., Krutílková, V., Palacova, M., Paulich, S., Petrakova, K., Presl, J., Puchmajerová, A., Soukupová, J., and Šenkeříková, M.

Published
2024

6. Consensus on surgical technique for sentinel lymph node dissection in cervical cancer

Author

Bizzarri, Nicolo', Obermair, A., Hsu, H. -C., Chacon, E., Collins, A., Tsibulak, I., Mutombo, A., Abu-Rustum, N. R., Balaya, V., Buda, A., Cibula, D., Covens, A., Fanfani, Francesco, Ferron, G., Frumovitz, M., Guani, B., Kocian, R., Kohler, C., Leblanc, E., Lecuru, F., Leitao, M. M., Mathevet, P., Mueller, M. D., Papadia, A., Pareja, R., Plante, M., Querleu, D., Scambia, Giovanni, Tanner, E., Zapardiel, I., Garcia, J. R., Ramirez, P. T., Bizzarri N., Fanfani F. (ORCID:0000-0003-1991-7284), Scambia G. (ORCID:0000-0003-2758-1063), Bizzarri, Nicolo', Obermair, A., Hsu, H. -C., Chacon, E., Collins, A., Tsibulak, I., Mutombo, A., Abu-Rustum, N. R., Balaya, V., Buda, A., Cibula, D., Covens, A., Fanfani, Francesco, Ferron, G., Frumovitz, M., Guani, B., Kocian, R., Kohler, C., Leblanc, E., Lecuru, F., Leitao, M. M., Mathevet, P., Mueller, M. D., Papadia, A., Pareja, R., Plante, M., Querleu, D., Scambia, Giovanni, Tanner, E., Zapardiel, I., Garcia, J. R., Ramirez, P. T., Bizzarri N., Fanfani F. (ORCID:0000-0003-1991-7284), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Objective: The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. Methods: A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. Results: Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. Conclusion: Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been

Published
2024

7. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), Fagotti, A. (ORCID:0000-0001-5579-335X), Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), and Fagotti, A. (ORCID:0000-0001-5579-335X)

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

8. Doporučené postupy klinické péče o nosiče zárodečných mutací v genech MLH1, MSH2, MSH6, PMS2 a velkých delecí EPCAM predisponujících ke vzniku Lynchova syndromu (4.2024).

Author

Novotný, J., Cibula, D., Curtisová, V., Dubová, O., Foretová, L., Germanová, A., Janatová, M., Havránek, O., Hojsáková, M., Hudcová, M., Koudová, M., Krutílková, V., Palacova, M., Paulich, S., Petrakova, K., Presl, J., Puchmajerová, A., Soukupová, J., Šenkeříková, M., and Šimková, Z.

Published
2024

9. Survival associated with extent of radical hysterectomy in early-stage cervical cancer: a subanalysis of the Surveillance in Cervical CANcer (SCCAN) collaborative study

Author

Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., Cibula D., Bizzarri, N, Querleu, D, Dostalek, L, van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Salehi, S, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Pareja, R, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Falconer, H, Cibula, D, Bizzarri N., Querleu D., Dostalek L., van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Salehi S., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Pareja R., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Falconer H., and Cibula D.

Abstract

Background: International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer. Objective: This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence. Study Design: This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy. Results: A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non–nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non–nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non–nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non–nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9–92.2) vs 93.8% (95% confidence in

Published
2023

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

Author

Berasaluce Gomez, A, Martin-Calvo, N, Boria, F, Manzour, N, Chacon, E, Bizzarri, N, Chiva, L, Martinez, A, Quesada, A, Kucukmetin, A, Vazquez, A, Mandic, A, Casajuana, A, Kavallaris, A, Fagotti, A, Perrone, A, Ferrero, A, Lekuona, A, Uppin, A, Stepanyan, A, Chiofalo, B, Morillas, B, Tauste, C, Andrade, C, Mom, C, Brucker, C, Sarac, C, Vazquez-Vicente, D, Cibula, D, Querleu, D, Erasun, D, Kaidarova, D, Tsolakidis, D, Haidopoulos, D, Golub, D, Bonci, E, Aksahin, E, Goncalves, E, Moratalla, E, Karaman, E, Myriokefalitaki, E, Ghezzi, F, Narducci, F, Roldan, F, Raspagliesi, F, Goffin, F, Grandjean, F, Guyon, F, Demirkiran, F, Fiol, G, Chakalova, G, Mancebo, G, Vorgias, G, Gebauer, G, Meili, G, Hernandez-Cortes, G, Bogani, G, Cordeiro, G, Vujic, G, Mendinhos, G, Trum, H, Bonsang-Kitzis, H, Haller, H, Vergote, I, Zapardiel, I, Aluloski, I, Berlev, I, Pete, I, Kalogiannidis, I, Kotsopoulos, I, Yezhova, I, Diez, J, Feron, J, Scharf, J, Beltman, J, Haesen, J, Ponce, J, Cea, J, Minguez, J, Garcia, J, Arevalo-Serrano, J, Gilabert, J, Alcazar, J, Kukk, K, Galaal, K, Cardenas, L, Pirtea, L, Mereu, L, Anchora, L, Dostalek, L, Klasa, L, Pakizimre, M, Undurraga, M, Jedryka, M, Bernardino, M, Alonso-Espias, M, Martin-Salamanca, M, Cuadra, M, Tavares, M, Malzoni, M, Fehr, M, Luyckx, M, Lanner, M, Leht, M, Meydanli, M, Mallmann, M, Capilna, M, Redecha, M, Mitrovic, M, Maenpaa, M, Guijarro, M, Abdalla, N, Gomes, N, Povolotskaya, N, Badzakov, N, Arencibia, O, Akbayir, O, Cavalle, P, Zusterzeel, P, Rolland, P, Coronado, P, Bharathan, R, Saaron, R, Sousa, R, Fruscio, R, Jach, R, Poka, R, Barrachina, R, Domingo, S, Morales, S, Akgol, S, Fernandez-Gonzalez, S, Aliyev, S, Herrero, S, Fidalgo, S, Prader, S, Smrkolj, S, Petousis, S, Kovachev, S, Turan, T, Toptas, T, Castellanos, T, da Costa, T, Marina, T, Zanagnolo, V, Martin, V, Gonzalez, V, Student, V, Sukhin, V, Berasaluce Gomez A., Martin-Calvo N., Boria F., Manzour N., Chacon E., Bizzarri N., Chiva L., Martinez A., Quesada A., Kucukmetin A., Vazquez A., Mandic A., Casajuana A., Kavallaris A., Fagotti A., Perrone A., Ferrero A., Lekuona A., Uppin A., Stepanyan A., Chiofalo B., Morillas B., Tauste C., Andrade C., Mom C., Brucker C., Sarac C. -P., Vazquez-Vicente D., Cibula D., Querleu D., Erasun D., Kaidarova D., Tsolakidis D., Haidopoulos D., Golub D., Bonci E. -A., Aksahin E., Goncalves E., Moratalla E., Karaman E., Myriokefalitaki E., Ghezzi F., Narducci F., Roldan F., Raspagliesi F., Goffin F., Grandjean F., Guyon F., Demirkiran F., Fiol G., Chakalova G., Mancebo G., Vorgias G., Gebauer G., Meili G., Hernandez-Cortes G., Bogani G., Cordeiro G., Vujic G., Mendinhos G., Trum H., Bonsang-Kitzis H., Haller H., Vergote I., Zapardiel I., Aluloski I., Berlev I., Pete I., Kalogiannidis I., Kotsopoulos I., Yezhova I., Diez J., Feron J. G., Scharf J. -P., Beltman J., Haesen J., Ponce J., Cea J., Minguez J. A., Garcia J., Arevalo-Serrano J., Gilabert J., Alcazar J. L., Kukk K., Galaal K., Cardenas L., Pirtea L., Mereu L., Anchora L. P., Dostalek L., Klasa L., PakizImre M., Undurraga M., Jedryka M., Bernardino M., Alonso-Espias M., Martin-Salamanca M. B., Cuadra M., Tavares M., Malzoni M., Fehr M., Luyckx M., Lanner M., Leht M., Meydanli M., Mallmann M., Capilna M., Redecha M., Mitrovic M., Maenpaa M. M., Guijarro M., Abdalla N., Gomes N., Povolotskaya N., Badzakov N., Arencibia O., Akbayir O., Cavalle P., Zusterzeel P., Rolland P., Coronado P., Bharathan R., Saaron R., Sousa R., Fruscio R., Jach R., Poka R., Barrachina R., Domingo S., Morales S., Akgol S., Fernandez-Gonzalez S., Aliyev S., Herrero S., Fidalgo S., Prader S., Smrkolj S., Petousis S., Kovachev S., Turan T., Toptas T., Castellanos T., da Costa T. D., Marina T., Zanagnolo V., Martin V., Gonzalez V., Student V., Sukhin V., Berasaluce Gomez, A, Martin-Calvo, N, Boria, F, Manzour, N, Chacon, E, Bizzarri, N, Chiva, L, Martinez, A, Quesada, A, Kucukmetin, A, Vazquez, A, Mandic, A, Casajuana, A, Kavallaris, A, Fagotti, A, Perrone, A, Ferrero, A, Lekuona, A, Uppin, A, Stepanyan, A, Chiofalo, B, Morillas, B, Tauste, C, Andrade, C, Mom, C, Brucker, C, Sarac, C, Vazquez-Vicente, D, Cibula, D, Querleu, D, Erasun, D, Kaidarova, D, Tsolakidis, D, Haidopoulos, D, Golub, D, Bonci, E, Aksahin, E, Goncalves, E, Moratalla, E, Karaman, E, Myriokefalitaki, E, Ghezzi, F, Narducci, F, Roldan, F, Raspagliesi, F, Goffin, F, Grandjean, F, Guyon, F, Demirkiran, F, Fiol, G, Chakalova, G, Mancebo, G, Vorgias, G, Gebauer, G, Meili, G, Hernandez-Cortes, G, Bogani, G, Cordeiro, G, Vujic, G, Mendinhos, G, Trum, H, Bonsang-Kitzis, H, Haller, H, Vergote, I, Zapardiel, I, Aluloski, I, Berlev, I, Pete, I, Kalogiannidis, I, Kotsopoulos, I, Yezhova, I, Diez, J, Feron, J, Scharf, J, Beltman, J, Haesen, J, Ponce, J, Cea, J, Minguez, J, Garcia, J, Arevalo-Serrano, J, Gilabert, J, Alcazar, J, Kukk, K, Galaal, K, Cardenas, L, Pirtea, L, Mereu, L, Anchora, L, Dostalek, L, Klasa, L, Pakizimre, M, Undurraga, M, Jedryka, M, Bernardino, M, Alonso-Espias, M, Martin-Salamanca, M, Cuadra, M, Tavares, M, Malzoni, M, Fehr, M, Luyckx, M, Lanner, M, Leht, M, Meydanli, M, Mallmann, M, Capilna, M, Redecha, M, Mitrovic, M, Maenpaa, M, Guijarro, M, Abdalla, N, Gomes, N, Povolotskaya, N, Badzakov, N, Arencibia, O, Akbayir, O, Cavalle, P, Zusterzeel, P, Rolland, P, Coronado, P, Bharathan, R, Saaron, R, Sousa, R, Fruscio, R, Jach, R, Poka, R, Barrachina, R, Domingo, S, Morales, S, Akgol, S, Fernandez-Gonzalez, S, Aliyev, S, Herrero, S, Fidalgo, S, Prader, S, Smrkolj, S, Petousis, S, Kovachev, S, Turan, T, Toptas, T, Castellanos, T, da Costa, T, Marina, T, Zanagnolo, V, Martin, V, Gonzalez, V, Student, V, Sukhin, V, Berasaluce Gomez A., Martin-Calvo N., Boria F., Manzour N., Chacon E., Bizzarri N., Chiva L., Martinez A., Quesada A., Kucukmetin A., Vazquez A., Mandic A., Casajuana A., Kavallaris A., Fagotti A., Perrone A., Ferrero A., Lekuona A., Uppin A., Stepanyan A., Chiofalo B., Morillas B., Tauste C., Andrade C., Mom C., Brucker C., Sarac C. -P., Vazquez-Vicente D., Cibula D., Querleu D., Erasun D., Kaidarova D., Tsolakidis D., Haidopoulos D., Golub D., Bonci E. -A., Aksahin E., Goncalves E., Moratalla E., Karaman E., Myriokefalitaki E., Ghezzi F., Narducci F., Roldan F., Raspagliesi F., Goffin F., Grandjean F., Guyon F., Demirkiran F., Fiol G., Chakalova G., Mancebo G., Vorgias G., Gebauer G., Meili G., Hernandez-Cortes G., Bogani G., Cordeiro G., Vujic G., Mendinhos G., Trum H., Bonsang-Kitzis H., Haller H., Vergote I., Zapardiel I., Aluloski I., Berlev I., Pete I., Kalogiannidis I., Kotsopoulos I., Yezhova I., Diez J., Feron J. G., Scharf J. -P., Beltman J., Haesen J., Ponce J., Cea J., Minguez J. A., Garcia J., Arevalo-Serrano J., Gilabert J., Alcazar J. L., Kukk K., Galaal K., Cardenas L., Pirtea L., Mereu L., Anchora L. P., Dostalek L., Klasa L., PakizImre M., Undurraga M., Jedryka M., Bernardino M., Alonso-Espias M., Martin-Salamanca M. B., Cuadra M., Tavares M., Malzoni M., Fehr M., Luyckx M., Lanner M., Leht M., Meydanli M., Mallmann M., Capilna M., Redecha M., Mitrovic M., Maenpaa M. M., Guijarro M., Abdalla N., Gomes N., Povolotskaya N., Badzakov N., Arencibia O., Akbayir O., Cavalle P., Zusterzeel P., Rolland P., Coronado P., Bharathan R., Saaron R., Sousa R., Fruscio R., Jach R., Poka R., Barrachina R., Domingo S., Morales S., Akgol S., Fernandez-Gonzalez S., Aliyev S., Herrero S., Fidalgo S., Prader S., Smrkolj S., Petousis S., Kovachev S., Turan T., Toptas T., Castellanos T., da Costa T. D., Marina T., Zanagnolo V., Martin V., Gonzalez V., Student V., and Sukhin V.

Abstract

Background: The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 years in women with FIGO 2009 stage IB1 cervical cancer. The aim of this study was to compare the use of adjuvant therapy in these women, depending on the method used to diagnose lymphatic node metastasis. Patients and Methods: We used data from the SUCCOR cohort, which collected information from 1049 women with FIGO 2009 stage IB1 cervical cancer who were operated on between January 2013 and December 2014 in Europe. We calculated the adjusted proportion of women who received adjuvant therapy depending on the lymph node diagnosis method and compared disease free and overall survival using Cox proportional-hazards regression models. Inverse probability weighting was used to adjust for baseline potential confounders. Results: The adjusted proportion of women who received adjuvant therapy was 33.8% in the sentinel node biopsy + lymphadenectomy (SNB+LA) group and 44.7% in the LA group (p = 0.02), although the proportion of positive nodal status was similar (p = 0.30). That difference was greater in women with negative nodal status and positive Sedlis criteria (difference 31.2%, p = 0.01). Here, those who underwent a SNB+LA had an increased risk of relapse [hazard ratio (HR) 2.49, 95% confidence interval (CI) 0.98–6.33, p = 0.056] and risk of death (HR 3.49, 95% CI 1.04–11.7, p = 0.042) compared with those who underwent LA. Conclusions: Women in this study were less likely to receive adjuvant therapy if their nodal invasion was determined using SNB+LA compared with LA. These results suggest a lack of therapeutic measures available when a negative result is obtained by SNB+LA, which may have an impact on the risk of recurrence and survival.

Published
2023

11. Stratification of lymph node metastases as macrometastases, micrometastases, or isolated tumor cells has no clinical implication in patients with cervical cancer: Subgroup analysis of the SCCAN project

Author

Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., Cibula D., Dostalek, L, Benesova, K, Klat, J, Kim, S, Falconer, H, Kostun, J, dos Reis, R, Zapardiel, I, Landoni, F, Ortiz, D, van Lonkhuijzen, L, Lopez, A, Odetto, D, Borcinova, M, Jarkovsky, J, Salehi, S, Nemejcova, K, Bajsova, S, Park, K, Javurkova, V, Abu-Rustum, N, Dundr, P, Cibula, D, Dostalek L., Benesova K., Klat J., Kim S. H., Falconer H., Kostun J., dos Reis R., Zapardiel I., Landoni F., Ortiz D. I., van Lonkhuijzen L. R. C. W., Lopez A., Odetto D., Borcinova M., Jarkovsky J., Salehi S., Nemejcova K., Bajsova S., Park K. J., Javurkova V., Abu-Rustum N. R., Dundr P., and Cibula D.

Abstract

Background: In cervical cancer, presence of lymph-node macrometastases (MAC) is a major prognostic factor and an indication for adjuvant treatment. However, since clinical impact of micrometastases (MIC) and isolated tumor-cells (ITC) remains controversial, we sought to identify a cut-off value for the metastasis size not associated with negative prognosis. Methods: We analyzed data from 967 cervical cancer patients (T1a1L1-T2b) registered in the SCCAN (Surveillance in Cervical CANcer) database, who underwent primary surgical treatment, including sentinel lymph-node (SLN) biopsy with pathological ultrastaging. The size of SLN metastasis was considered a continuous variable and multiple testing was performed for cut-off values of 0.01-1.0 mm. Disease-free survival (DFS) was compared between N0 and subgroups of N1 patients defined by cut-off ranges. Results: LN metastases were found in 172 (18%) patients, classified as MAC, MIC, and ITC in 79, 54, and 39 patients, respectively. DFS was shorter in patients with MAC (HR 2.20, P = 0.003) and MIC (HR 2.87, P < 0.001), while not differing between MAC/MIC (P = 0.484). DFS in the ITC subgroup was neither different from N0 (P = 0.127) nor from MIC/MAC subgroups (P = 0.449). Cut-off analysis revealed significantly shorter DFS compared to N0 in all subgroups with metastases ≥0.4 mm (HR 2.311, P = 0.04). The significance of metastases <0.4 mm could not be assessed due to limited statistical power (<80%). We did not identify any cut-off for the size of metastasis with significantly better prognosis than the rest of N1 group. Conclusions: In cervical cancer patients, the presence of LN metastases ≥0.4 mm was associated with a significant negative impact on DFS and no cut-off value for the size of metastasis with better prognosis than N1 was found. Traditional metastasis stratification based on size has no clinical implication.

Published
2023

12. The WID-EC test for the detection and risk prediction of endometrial cancer

Author

Barrett, J, Jones, A, Evans, I, Herzog, C, Reisel, D, Olaitan, A, Mould, T, Macdonald, N, Doufekas, K, Newton, C, Crosbie, E, Bjorge, L, Colombo, N, Dostalek, L, Costas, L, Peremiquel-Trillas, P, Ponce, J, Matias-Guiu, X, Zikan, M, Cibula, D, Wang, J, Sundstrom, K, Dillner, J, Widschwendter, M, Barrett J. E., Jones A., Evans I., Herzog C., Reisel D., Olaitan A., Mould T., MacDonald N., Doufekas K., Newton C., Crosbie E. J., Bjorge L., Colombo N., Dostalek L., Costas L., Peremiquel-Trillas P., Ponce J., Matias-Guiu X., Zikan M., Cibula D., Wang J., Sundstrom K., Dillner J., Widschwendter M., Barrett, J, Jones, A, Evans, I, Herzog, C, Reisel, D, Olaitan, A, Mould, T, Macdonald, N, Doufekas, K, Newton, C, Crosbie, E, Bjorge, L, Colombo, N, Dostalek, L, Costas, L, Peremiquel-Trillas, P, Ponce, J, Matias-Guiu, X, Zikan, M, Cibula, D, Wang, J, Sundstrom, K, Dillner, J, Widschwendter, M, Barrett J. E., Jones A., Evans I., Herzog C., Reisel D., Olaitan A., Mould T., MacDonald N., Doufekas K., Newton C., Crosbie E. J., Bjorge L., Colombo N., Dostalek L., Costas L., Peremiquel-Trillas P., Ponce J., Matias-Guiu X., Zikan M., Cibula D., Wang J., Sundstrom K., Dillner J., and Widschwendter M.

Abstract

The incidence of endometrial cancer is rising. Measures to identify women at risk and to detect endometrial cancer earlier are required to reduce the morbidity triggered by the aggressive treatment required for advanced endometrial cancer. We developed the WID-EC (Women's cancer risk IDentification-Endometrial Cancer) test, which is based on DNA methylation at 500 CpG sites, in a discovery set of cervical liquid-based cytology samples from 1086 women with and without an endometrial cancer (217 cancer cases and 869 healthy controls) with a worse prognosis (grade 3 or ≥stage IB). We validated the WID-EC test in an independent external validation set of 64 endometrial cancer cases and 225 controls. We further validated the test in 150 healthy women (prospective set) who provided a cervical sample as part of the routine Swedish cervical screening programme, 54 of whom developed endometrial cancer within 3 years of sample collection. The WID-EC test identified women with endometrial cancer with a receiver operator characteristic area under the curve (AUC) of 0.92 (95% CI: 0.88-0.97) in the external set and of 0.82 (95% CI: 0.74-0.89) in the prospective validation set. Using an optimal cutoff, cancer cases were detected with a sensitivity of 86% and a specificity of 90% in the external validation set, and a sensitivity and specificity of 52% and 98% respectively in the prospective validation set. The WID-EC test can identify women with or at risk of endometrial cancer.

Published
2023

13. Association of Hospital Surgical Volume With Survival in Early-Stage Cervical Cancer Treated With Radical Hysterectomy

Author

Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., Cibula D., Bizzarri, N, Dostalek, L, Van Lonkhuijzen, L, Giannarelli, D, Lopez, A, Falconer, H, Querleu, D, Ayhan, A, Kim, S, Ortiz, D, Klat, J, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, Ramirez, P, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Dos Reis, R, Pedone Anchora, L, Amaro, K, Salehi, S, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Mom, C, Scambia, G, Cibula, D, Bizzarri N., Dostalek L., Van Lonkhuijzen L. R. C. W., Giannarelli D., Lopez A., Falconer H., Querleu D., Ayhan A., Kim S. H., Ortiz D. I., Klat J., Landoni F., Rodriguez J., Manchanda R., Kostun J., Ramirez P. T., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Dos Reis R., Pedone Anchora L., Amaro K., Salehi S., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Mom C. H., Scambia G., and Cibula D.

Abstract

OBJECTIVE: To evaluate the association of number of radical hysterectomies performed per year in each center with disease-free survival and overall survival. METHODS: We conducted an international, multicenter, retrospective study of patients previously included in the Surveillance in Cervical Cancer collaborative studies. Individuals with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB1-IIA1 cervical cancer who underwent radical hysterectomy and had negative lymph nodes at final histology were included. Patients were treated at referral centers for gynecologic oncology according to updated national and international guidelines. Optimal cutoffs for surgical volume were identified using an unadjusted Cox proportional hazard model, with disease-free survival as the outcome and defined as the value that minimizes the P-value of the split in groups in terms of disease-free survival. Propensity score matching was used to create statistically similar cohorts at baseline. RESULTS: A total of 2,157 patients were initially included. The two most significant cutoffs for surgical volume were identified at seven and 17 surgical procedures, dividing the entire cohort into low-volume, middle-volume, and high-volume centers. After propensity score matching, 1,238 patients were analyzed - 619 (50.0%) in the high-volume group, 523 (42.2%) in the middle-volume group, and 96 (7.8%) in the low-volume group. Patients who underwent surgery in higher-volume institutions had progressively better 5-year disease-free survival than those who underwent surgery in lower-volume centers (92.3% vs 88.9% vs 83.8%, P=.029). No difference was noted in 5-year overall survival (95.9% vs 97.2% vs 95.2%, P=.70). Cox multivariable regression analysis showed that FIGO stage greater than IB1, presence of lymphovascular space invasion, grade greater than 1, tumor diameter greater than 20 mm, minimally invasive surgical approach, nonsquamous cell carcinoma histology, and lower-volum

Published
2023

14. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Cerana, S, Dictar, MO, Bonvehi, P, Tregnaghi, JP, Fein, L, Ashley, D, Singh, M, Hayes, T, Playford, G, Morrissey, O, Thaler, J, Kuehr, T, Greil, R, Pecherstorfer, M, Duck, L, Van Eygen, K, Aoun, M, De Prijck, B, Franke, FA, Barrios, CHE, Mendes, AVA, Serrano, SV, Garcia, RF, Moore, F, Camargo, JFC, Pires, LA, Alves, RS, Radinov, A, Oreshkov, K, Minchev, V, Hubenova, AI, Koynova, T, Ivanov, I, Rabotilova, B, Petrov, PA, Chilingirov, P, Karanikolov, S, Raynov, J, Grimard, D, McNeil, S, Kumar, D, Larratt, LM, Weiss, K, Delage, R, Diaz-Mitoma, FJ, Cano, PO, Couture, F, Carvajal, P, Yepes, A, Torres Ulloa, R, Fardella, P, Caglevic, C, Rojas, C, Orellana, E, Gonzalez, P, Acevedo, A, Galvez, KM, Gonzalez, ME, Franco, S, Restrepo, JG, Rojas, CA, Bonilla, C, Florez, LE, Ospina, AV, Manneh, R, Zorica, R, Vrdoljak, DV, Samarzija, M, Petruzelka, L, Vydra, J, Mayer, J, Cibula, D, Prausova, J, Paulson, G, Ontaneda, M, Palk, K, Vahlberg, A, Rooneem, R, Galtier, F, Postil, D, Lucht, F, Laine, F, Launay, O, Laurichesse, H, Duval, X, Cornely, OA, Camerer, B, Panse, J, Zaiss, M, Derigs, H-G, Menzel, H, Verbeek, M, Georgoulias, V, Mavroudis, D, Anagnostopoulos, A, Terpos, E, Cortes, D, Umanzor, J, Bejarano, S, Galeano, RW, Wong, RSM, Hui, P, Pedrazzoli, P, Ruggeri, L, Aversa, F, Bosi, A, Gentile, G, Rambaldi, A, Contu, A, Marei, L, Abbadi, A, Hayajneh, W, Kattan, J, Farhat, F, Chahine, G, Rutkauskiene, J, Marfil Rivera, LJ, Lopez Chuken, YA, Franco Villarreal, H, Lopez Hernandez, J, Blacklock, H, Lopez, RI, Alvarez, R, Gomez, AM, Quintana, TS, Moreno Larrea, MDC, Zorrilla, SJ, Alarcon, E, Samanez, FCA, Caguioa, PB, Tiangco, BJ, Mora, EM, Betancourt-Garcia, RD, Hallman-Navarro, D, Feliciano-Lopez, LJ, Velez-Cortes, HA, Cabanillas, F, Ganea, DE, Ciuleanu, TE, Ghizdavescu, DG, Miron, L, Cebotaru, CL, Cainap, CI, Anghel, R, Dvorkin, MV, Gladkov, OA, Fadeeva, NV, Kuzmin, AA, Lipatov, ON, Zbarskaya, II, Akhmetzyanov, FS, Litvinov, IV, Afanasyev, BV, Cherenkova, M, Lioznov, D, Lisukov, IA, Smirnova, YA, Kolomietz, S, Halawani, H, Goh, YT, Drgona, L, Chudej, J, Matejkova, M, Reckova, M, Rapoport, BL, Szpak, WM, Malan, DR, Jonas, N, Jung, CW, Lee, DG, Yoon, SS, Lopez Jimenez, J, Duran Martinez, I, Rodriguez Moreno, JF, Solano Vercet, C, de la Camara, R, Batlle Massana, M, Yeh, S-P, Chen, C-Y, Chou, H-H, Tsai, C-M, Chiu, C-H, Siritanaratkul, N, Norasetthada, L, Sriuranpong, V, Seetalarom, K, Akan, H, Dane, F, Ozcan, MA, Ozsan, GH, Kalayoglu Besisik, SF, Cagatay, A, Yalcin, S, Peniket, A, Mullan, SR, Dakhil, KM, Sivarajan, K, Suh, JJ-G, Sehgal, A, Marquez, F, Gomez, EG, Mullane, MR, Skinner, WL, Behrens, RJ, Trevarthe, DR, Mazurczak, MA, Lambiase, EA, Vidal, CA, Anac, SY, Rodrigues, GA, Baltz, B, Boccia, R, Wertheim, MS, Holladay, CS, Zenk, D, Fusselman, W, Wade III, JL, Jaslowsk, AJ, Keegan, J, Robinson, MO, Go, RS, Farnen, J, Amin, B, Jurgens, D, Risi, GF, Jr, Beatty, PG, Naqvi, T, Parshad, S, Hansen, VL, Ahmed, M, Steen, PD, Badarinath, S, Dekker, A, Scouros, MA, Young, DE, Graydon Harker, W, Kendall, SD, Citron, ML, Chedid, S, Posada, JG, Jr, Gupta, MK, Rafiyath, S, Buechler-Price, J, Sreenivasappa, S, Chay, CH, Burke, JM, Young, SE, Mahmood, A, Kugler, JW, Gerstner, G, Fuloria, J, Belman, ND, Geller, R, Nieva, J, Whittenberger, BP, Wong, BMY, Cescon, TP, Abesada-Terk, G, Jr, Guarino, MJ, Zweibach, A, Ibrahim, EN, Takahashi, G, Garrison, MA, Mowat, RB, Choi, BS, Oliff, IA, Singh, J, Guter, KA, Ayrons, K, Rowland, KM, Noga, SJ, Rao, SB, Columbie, A, Nualart, MT, Cecchi, GR, Campos, LT, Mohebtash, M, Flores, MR, Rothstein-Rubin, R, O'Connor, BM, Soori, G, Knapp, M, Miranda, FG, Goodgame, BW, Kassem, M, Belani, R, Sharma, S, Ortiz, T, Sonneborn, HL, Markowitz, AB, Wilbur, D, Meiri, E, Koo, VS, Jhangiani, HS, Wong, L, Sanani, S, Lawrence, SJ, Jones, CM, Murray, C, Papageorgiou, C, Gurtler, JS, Ascensao, JL, Venigalla, ML, D'Andrea, M, De Las Casas, C, Haile, DJ, Qazi, FU, Santander, JL, Thomas, MR, Rao, VP, Craig, M, Garg, RJ, Robles, R, Lyons, RM, Stegemoller, RK, Goel, S, Garg, S, Lowry, P, Lynch, C, Lash, B, Repka, T, Baker, J, Goueli, BS, Campbell, TC, Van Echo, DA, Lee, YJ, Reyes, EA, Senecal, FM, Donnelly, G, Byeff, P, Weiss, R, Reid, T, Roeland, E, Goel, A, Prow, DM, Brandt, DS, Kaplan, HG, Payne, JE, Boeckh, MG, Rosen, PJ, Mena, RR, Khan, R, Betts, RF, Sharp, SA, Morrison, VA, Fitz-Patrick, D, Congdon, J, Erickson, N, Abbasi, R, Henderson, S, Mehdi, A, Wos, EJ, Rehmus, E, Beltzer, L, Tamayo, RA, Mahmood, T, Reboli, AC, Moore, A, Brown, JM, Cruz, J, Quick, DP, Potz, JL, Kotz, KW, Hutchins, M, Chowhan, NM, Devabhaktuni, YD, Braly, P, Berenguer, RA, Shambaugh, SC, O'Rourke, TJ, Conkright, WA, Winkler, CF, Addo, FEK, Duic, JP, High, KP, Kutner, ME, Collins, R, Carrizosa, DR, Perry, DJ, Kailath, E, Rosen, N, Sotolongo, R, Shoham, S, Chen, T, Mullane, Kathleen M, Morrison, Vicki A, Camacho, Luis H, Arvin, Ann, McNeil, Shelly A, Durrand, Jessie, Campbell, Bernadette, Su, Shu-Chih, Chan, Ivan S F, Parrino, Janie, Kaplan, Susan S, Popmihajlov, Zoran, and Annunziato, Paula W

Published
2019
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15. ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Author

Baert, T., Banerjee, S., Belaroussi, I., Blecharz, P., Bruchim, I., Cibula, D., Colombo, N., Concin, N., Davidson, B., Dashora, A., Devouassoux-Shisheboran, M., du Bois, A., Ferrero, A., Glasspool, R., González-Martin, A., Heinzelmann-Schwarz, V., Joly, F., Kim, J.W., Kridelka, F., Ledermann, J., Lorusso, D., Mahner, S., McCluggage, W.G., McNeish, I., Mikami, M., Mirza, M.R., Morice, P., Nicum, S., Olbrecht, S., O’Donnell, D.M., Pautier, P., Planchamp, F., Pignata, S., Querleu, D., Ray-Coquard, I., Rodolakis, A., Sehouli, J., Selcukbiricik, F., Sessa, C., Singh, N., Tan, D.S.P., Timmerman, D., Tognon, G., van der Velden, J., Vergote, I., Witteveen, P.O., and Zeimet, A.G.

Published
2019
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16. OC19.01: Prediction of outcome in endometrial cancer improved by combining traditional with sonographic and demographic parameters: IETA4 cohort follow‐up

Author

Green, R. W., primary, Heremans, R., additional, Fischerová, D., additional, Yan, J., additional, Eriksson, L., additional, Mascilini, F., additional, Testa, A. C., additional, Franchi, D., additional, Sladkevicius, P., additional, Valentin, L., additional, Opolskiene, G., additional, Haak, L. A., additional, Fruscio, R., additional, Chiappa, V., additional, Van Holsbeke, C., additional, Alcazar, J., additional, Cibula, D., additional, Guerriero, S., additional, Frühauf, F., additional, Carlson, J., additional, Mestdagh, W., additional, Bourne, T., additional, Timmerman, D., additional, Van den Bosch, T., additional, and Epstein, E., additional

Published
2023
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18. OC12.08: Observer‐reality agreement for tumour spread and prediction non‐resectability in ovarian cancer (ISAAC study, imaging study on advanced ovarian cancer)

Author

Fischerová, D., primary, Pesta, M., additional, Blazko, M., additional, Moruzzi, M., additional, Hundarova, K., additional, Scovazzi, U., additional, de Sousa, N., additional, Ambrosio, M., additional, Testa, A. C., additional, Franchi, D., additional, Chiappa, V., additional, Alcazar, J., additional, Pinto, P., additional, and Cibula, D., additional

Published
2023
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19. OP12.05: Patient satisfaction with ultrasound, CT and WB‐DWI/MRI for preoperative ovarian cancer staging: a multicentre prospective survey

Author

Pinto, P., primary, Borcinova, M., additional, Wiesnerova, M., additional, Frühauf, F., additional, Burgetova, A., additional, Mašek, M., additional, Lambert, L., additional, Chiappa, V., additional, Franchi, D., additional, Testa, A. C., additional, Moro, F., additional, Avesani, G., additional, Panico, C., additional, Alessi, S., additional, Pricolo, P., additional, Vigorito, R., additional, Calareso, G., additional, Kocian, R., additional, Slama, J., additional, Fagotti, A., additional, Urbinati, A. M. Vidal, additional, Signorelli, M., additional, Valentin, L., additional, Cibula, D., additional, and Fischerová, D., additional

Published
2023
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22. SUCCOR Nodes: May Sentinel Node Biopsy Determine the Need for Adjuvant Treatment?

Author

Berasaluce Gómez A., Martín-Calvo N., Boria F., Manzour N., Chacón E., Bizzarri N., Chiva L., Martinez A., Quesada A., Kucukmetin A., Vázquez A., Mandic A., Casajuana A., Kavallaris A., Fagotti A., Perrone A., Ferrero A., Lekuona A., Uppin A., Stepanyan A., Chiofalo B., Morillas B., Tauste C., Andrade C., Mom C., Brucker C., Sarac C. P., Vázquez-Vicente D., Cibula D., Querleu D., Erasun D., Kaidarova D., Tsolakidis D., Haidopoulos D., Golub D., Bonci E. A., Aksahin E., Gonçalves E., Moratalla E., Karaman E., Myriokefalitaki E., Ghezzi F., Narducci F., Roldan F., Raspagliesi F., Goffin F., Grandjean F., Guyon F., Demirkiran F., Fiol G., Chakalova G., Mancebo G., Vorgias G., Gebauer G., Meili G., Hernandez-Cortes G., Bogani G., Cordeiro G., Vujić G., Mendinhos G., Trum H., Bonsang-Kitzis H., Haller H., Vergote I., Zapardiel I., Aluloski I., Berlev I., Pete I., Kalogiannidis I., Kotsopoulos I., Yezhova I., Díez J., Feron J. G., Scharf J. P., Beltman J., Haesen J., Ponce J., Cea J., Mínguez J. Á., García J., Arévalo-Serrano J., Gilabert J., Alcazar J. L., Kukk K., Galaal K., Cárdenas L., Pirtea L., Mereu L., Anchora L. P., Dostalek L., Klasa L., PakižImre M., Undurraga M., Jedryka M., Bernardino M., Alonso-Espias M., Martín-Salamanca M. B., Cuadra M., Tavares M., Malzoni M., Fruscio R., Berasaluce Gómez, A, Martín-Calvo, N, Boria, F, Manzour, N, Chacón, E, Bizzarri, N, Chiva, L, Martinez, A, Quesada, A, Kucukmetin, A, Vázquez, A, Mandic, A, Casajuana, A, Kavallaris, A, Fagotti, A, Perrone, A, Ferrero, A, Lekuona, A, Uppin, A, Stepanyan, A, Chiofalo, B, Morillas, B, Tauste, C, Andrade, C, Mom, C, Brucker, C, Sarac, C, Vázquez-Vicente, D, Cibula, D, Querleu, D, Erasun, D, Kaidarova, D, Tsolakidis, D, Haidopoulos, D, Golub, D, Bonci, E, Aksahin, E, Gonçalves, E, Moratalla, E, Karaman, E, Myriokefalitaki, E, Ghezzi, F, Narducci, F, Roldan, F, Raspagliesi, F, Goffin, F, Grandjean, F, Guyon, F, Demirkiran, F, Fiol, G, Chakalova, G, Mancebo, G, Vorgias, G, Gebauer, G, Meili, G, Hernandez-Cortes, G, Bogani, G, Cordeiro, G, Vujić, G, Mendinhos, G, Trum, H, Bonsang-Kitzis, H, Haller, H, Vergote, I, Zapardiel, I, Aluloski, I, Berlev, I, Pete, I, Kalogiannidis, I, Kotsopoulos, I, Yezhova, I, Díez, J, Feron, J, Scharf, J, Beltman, J, Haesen, J, Ponce, J, Cea, J, Mínguez, J, García, J, Arévalo-Serrano, J, Gilabert, J, Alcazar, J, Kukk, K, Galaal, K, Cárdenas, L, Pirtea, L, Mereu, L, Anchora, L, Dostalek, L, Klasa, L, Pakižimre, M, Undurraga, M, Jedryka, M, Bernardino, M, Alonso-Espias, M, Martín-Salamanca, M, Cuadra, M, Tavares, M, Malzoni, M, and Fruscio, R

Subjects
cervical cancer
Abstract

Background: The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 years in women with FIGO 2009 stage IB1 cervical cancer. The aim of this study was to compare the use of adjuvant therapy in these women, depending on the method used to diagnose lymphatic node metastasis. Patients and Methods: We used data from the SUCCOR cohort, which collected information from 1049 women with FIGO 2009 stage IB1 cervical cancer who were operated on between January 2013 and December 2014 in Europe. We calculated the adjusted proportion of women who received adjuvant therapy depending on the lymph node diagnosis method and compared disease free and overall survival using Cox proportional-hazards regression models. Inverse probability weighting was used to adjust for baseline potential confounders. Results: The adjusted proportion of women who received adjuvant therapy was 33.8% in the sentinel node biopsy + lymphadenectomy (SNB+LA) group and 44.7% in the LA group (p = 0.02), although the proportion of positive nodal status was similar (p = 0.30). That difference was greater in women with negative nodal status and positive Sedlis criteria (difference 31.2%, p = 0.01). Here, those who underwent a SNB+LA had an increased risk of relapse [hazard ratio (HR) 2.49, 95% confidence interval (CI) 0.98–6.33, p = 0.056] and risk of death (HR 3.49, 95% CI 1.04–11.7, p = 0.042) compared with those who underwent LA. Conclusions: Women in this study were less likely to receive adjuvant therapy if their nodal invasion was determined using SNB+LA compared with LA. These results suggest a lack of therapeutic measures available when a negative result is obtained by SNB+LA, which may have an impact on the risk of recurrence and survival.

Published
2023

23. Susceptibility to hormone-mediated cancer is reflected by different tick rates of the epithelial and general epigenetic clock

Author

Barrett, J, Herzog, C, Kim, Y, Bartlett, T, Jones, A, Evans, I, Cibula, D, Zikan, M, Bjorge, L, Harbeck, N, Colombo, N, Howell, S, Radestad, A, Gemzell-Danielsson, K, Widschwendter, M, Barrett J. E., Herzog C., Kim Y. -N., Bartlett T. E., Jones A., Evans I., Cibula D., Zikan M., Bjorge L., Harbeck N., Colombo N., Howell S. J., Radestad A. F., Gemzell-Danielsson K., Widschwendter M., Barrett, J, Herzog, C, Kim, Y, Bartlett, T, Jones, A, Evans, I, Cibula, D, Zikan, M, Bjorge, L, Harbeck, N, Colombo, N, Howell, S, Radestad, A, Gemzell-Danielsson, K, Widschwendter, M, Barrett J. E., Herzog C., Kim Y. -N., Bartlett T. E., Jones A., Evans I., Cibula D., Zikan M., Bjorge L., Harbeck N., Colombo N., Howell S. J., Radestad A. F., Gemzell-Danielsson K., and Widschwendter M.

Abstract

Background: A variety of epigenetic clocks utilizing DNA methylation changes have been developed; these clocks are either tissue-independent or designed to predict chronological age based on blood or saliva samples. Whether discordant tick rates between tissue-specific and general epigenetic clocks play a role in health and disease has not yet been explored. Results: Here we analyze 1941 cervical cytology samples, which contain a mixture of hormone-sensitive cervical epithelial cells and immune cells, and develop the WID general clock (Women’s IDentification of risk), an epigenetic clock that is shared by epithelial and immune cells and optimized for cervical samples. We then develop the WID epithelial clock and WID immune clock, which define epithelial- and immune-specific clocks, respectively. We find that the WID-relative-epithelial-age (WID-REA), defined as the difference between the epithelial and general clocks, is significantly reduced in cervical samples from pre-menopausal women with breast cancer (OR 2.7, 95% CI 1.28-5.72). We find the same effect in normal breast tissue samples from pre-menopausal women at high risk of breast cancer and show that potential risk reducing anti-progesterone drugs can reverse this. In post-menopausal women, this directionality is reversed. Hormone replacement therapy consistently leads to a significantly lower WID-REA in cancer-free women, but not in post-menopausal women with breast or ovarian cancer. Conclusions: Our findings imply that there are multiple epigenetic clocks, many of which are tissue-specific, and that the differential tick rate between these clocks may be an informative surrogate measure of disease risk.

Published
2022

24. SUCCOR quality: validation of ESGO quality indicators for surgical treatment of cervical cancer

Author

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, 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. M., Tavares M., Golub D., Perrone A. M., Poka R., Zusterzeel P. L. M., Aluloski I., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Bernardino M., Bharathan R., Maenpaa M. M., Sukhin V., Feron J. -G., Fruscio R., Kukk K., Ponce J., Demirkiran F., Vorgias G., Povolotskaya N., Coronado Martin P. J., Marina T., Zapardiel I., Bizzarri N., Gorostidi M., Gutierrez M., Manzour N., Berasaluce A., 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, 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. M., Tavares M., Golub D., Perrone A. M., Poka R., Zusterzeel P. L. M., Aluloski I., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Bernardino M., Bharathan R., Maenpaa M. M., Sukhin V., Feron J. -G., Fruscio R., Kukk K., Ponce J., Demirkiran F., Vorgias G., Povolotskaya N., Coronado Martin P. J., Marina T., Zapardiel I., Bizzarri N., Gorostidi M., Gutierrez M., Manzour N., and Berasaluce A.

Abstract

Objective To 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. Methods In 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. Results A 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%, p<0.01). Women who were operated on at centers with high compliance with quality indicators had a significantly lower risk of relapse (HR=0.39; 95% CI 0.25 to 0.61; p<0.001). The association was reduced, but remained significant, after further adjustment for conization, surgical approach, and use of manipulator surgery (HR=0.48; 95% CI 0.30 to 0.75; p=0.001) and adjustment for adjuvant therapy (HR=0.47; 95% CI 0.30 to 0.74; p=0.001). Risk of death from disease was significantly lower in women operated on at centers with high adherence to quality indicators (HR=0.43; 95% CI 0.19 to 0.97; p=0.041). However, the association was not significant after adjustment for conization, surgical approach, use of manipulator surgery, and adjuvant t

Published
2022

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

Author

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, Zapardiel, I, Manzour N., Chiva L., Chacon E., Martin-Calvo N., Boria F., Minguez J. A., Alcazar J. L., 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. G., 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. -A., 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. D., 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. B., 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. -P., Scharf J. -P., Smrkolj S., Sousa R., Stepanyan A., Student V., Tauste C., Trum H., Turan T., Undurraga M., Uppin A., Vazquez A., Vergote I., Vorgias G., Zapardiel I., 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, Zapardiel, I, Manzour N., Chiva L., Chacon E., Martin-Calvo N., Boria F., Minguez J. A., Alcazar J. L., 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. G., 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. -A., 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. D., 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. B., 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. -P., Scharf J. -P., 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.

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

26. MO-0050 Feasibility of the determination of the molecular-integrated risk profile in the PORTEC-4a trial

Author

van den Heerik, A., primary, Horeweg, N., additional, Lutgens, L., additional, Haverkort, D., additional, Kommoss, S., additional, Staebler, A., additional, Koppe, F., additional, Nowee, M., additional, Westerveld, H., additional, de Jong, M., additional, Cibula, D., additional, Dundr, P., additional, Cnossen, J., additional, Mens, J.W., additional, Chargari, C., additional, Genestie, C., additional, Bijmolt, S., additional, Gillham, C., additional, O'Riain, C., additional, Stam, T., additional, Jurgenliemk-Schulz, I., additional, Hamann, M., additional, Smit, V., additional, Bosse, T., additional, and Creutzberg, C., additional

Published
2023
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27. OC-0601 Early toxicity and quality of life after molecular-based adjuvant treatment in the PORTEC-4a trial

Author

van den Heerik, A., primary, Post, C., additional, Lutgens, L., additional, Haverkort, D., additional, Kommoss, S., additional, Koppe, F., additional, Nowee, M., additional, Westerveld, H., additional, de Jong, M., additional, Cibula, D., additional, Cnossen, J., additional, Mens, J.W., additional, Chargari, C., additional, Bijmolt, S., additional, Gillham, C., additional, Stam, T., additional, Jurgenliemk-Schulz, I., additional, Vandecasteele, K., additional, Verhoeven-Adema, K., additional, Nout, R., additional, Putter, H., additional, Smit, V., additional, Horeweg, N., additional, Bosse, T., additional, and Creutzberg, C., additional

Published
2023
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30. Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status in the ORZORA trial

Author

Pignata, S, Oza, A, Hall, G, Pardo, B, Madry, R, Cibula, D, Klat, J, Montes, A, Glasspool, R, Colombo, N, Pete, I, Herrero Ibáñez, A, Marín, M, Ilieva, R, Timcheva, C, Di Maio, M, Blakeley, C, Taylor, R, Barnicle, A, Clamp, A, Pignata, S, Oza, A, Hall, G, Pardo, B, Madry, R, Cibula, D, Klat, J, Montes, A, Glasspool, R, Colombo, N, Pete, I, Herrero Ibáñez, A, Marín, M, Ilieva, R, Timcheva, C, Di Maio, M, Blakeley, C, Taylor, R, Barnicle, A, and Clamp, A

Abstract

Background: The open-label, single-arm, multicenter ORZORA trial (NCT02476968) evaluated the efficacy and safety of maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) who had tumor BRCA mutations (BRCAm) of germline (g) or somatic (s) origin or non-BRCA homologous recombination repair mutations (HRRm) and were in response to their most recent platinum-based chemotherapy after ≥2 lines of treatment. Methods: Patients received maintenance olaparib capsules (400 mg twice daily) until disease progression. Prospective central testing at screening determined tumor BRCAm status and subsequent testing determined gBRCAm or sBRCAm status. Patients with predefined non-BRCA HRRm were assigned to an exploratory cohort. The co-primary endpoints were investigator-assessed progression-free survival (PFS; modified Response Evaluation Criteria in Solid Tumors v1.1) in BRCAm and sBRCAm cohorts. Secondary endpoints included health-related quality of life (HRQoL) and tolerability. Results: 177 patients received olaparib. At the primary data cut-off (17 April 2020), the median follow-up for PFS in the BRCAm cohort was 22.3 months. The median PFS (95% CI) in BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts was 18.0 (14.3-22.1), 16.6 (12.4-22.2), 19.3 (14.3-27.6) and 16.4 (10.9-19.3) months, respectively. Most patients with BRCAm reported improvements (21.8%) or no change (68.7%) in HRQoL and the safety profile was as expected. Conclusions: Maintenance olaparib had similar clinical activity in PSR OC patients with sBRCAm and those with any BRCAm. Activity was also observed in patients with a non-BRCA HRRm. ORZORA further supports use of maintenance olaparib in all patients with BRCA-mutated, including sBRCA-mutated, PSR OC.

Published
2023

32. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: diagnosis, treatment and follow-up

Author

Colombo, N., Creutzberg, C., Amant, F., Bosse, T., González-Martín, A., Ledermann, J., Marth, C., Nout, R., Querleu, D., Mirza, M.R., Sessa, C., Abal, M., Altundag, O., van Leeuwenhoek, Antoni, Banerjee, S., Casado, A., de Agustín, L.C., Cibula, D., del Campo, J.-M., Emons, G., Goffin, F., Greggi, S., Haie-Meder, C., Katsaros, D., Kesic, V., Kurzeder, C., Lax, S., Lécuru, F., Levy, T., Lorusso, D., Mäenpää, J., Matias-Guiu, X., Morice, P., Nijman, H.W., Powell, M., Reed, N., Rodolakis, A., Salvesen, H., Sehouli, J., Taylor, A., Westermann, A., and Zeimet, A.G.

Published
2016
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35. SENTIX - SENTINEL LYMPH NODES IN PATIENTS WITH CERVICAL CANCER: SLN DETECTION AND THE FALSE NEGATIVE RATE OF SLN FROZEN SECTION (CEEGOG-CX01; ENGOT-CX2; NCT02494063): EP334

Author

Kocian, R, Köhler, C, Klat, J, Germanova, A, Plaikner, A, Bajsova, S, Marnitz, S, Ostojich, M, Zapardiel, I, Gil-Ibańez, B, Sehnal, B, Petiz, A, Pilka, R, Martin-Martinez, A, Presl, J, Buda, A, van Lonkhuijzen, L, Minar, L, Barahona, M, Wydra, D, Blecharz, P, Dundr, P, Dusek, L, and Cibula, D

Published
2019
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40. SUCCOR study. An international european cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 (FIGO 2009, <4 cm) cervical cancer operated in 2013-2014

Author

Chiva, L, Zanagnolo, V, Kucukmetin, A, Chakalova, G, Raspagliesi, F, Narducci, F, Toptas, T, Meydanli, M, Fagotti, A, Cibula, D, Wydra, D, Póka, R, Jach, R, Tavares, M, Tamussino, K, Haidopoulos, D, Ponce, J, Berlev, I, Roldán, F, Domingo, S, Zapardiel, I, Goncalves, E, Malzoni, M, Arencibia, O, Kukk, K, Haller, H, Vorgias, G, Ghezzi, F, Guyon, F, Herrero, S, Haesen, J, Feron, J G, Minguez, J, Chacon, E, Vazquez, D, Castellanos, T, Arevalo, J, Calvo, Martin N, and Alcazar, J L

Published
2019
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42. 22 Open vs. minimally invasive radical trachelectomy in early stage cervical cancer: international multicenter irta study results

Author

Salvo, G, Ramirez, PT, Wu, X, Leitao, M, Mosgaard, BJ, Falconer, H, Perrotta, M, Rendón, G, Kucukmetin, A, Berlev, I, Persson, J, Vieira, M, Cibula, D, Fotopoulou, C, Liu, K, Ribeiro, R, Capilna, ME, Kaidarova, D, Baiocchi, G, Li, X, Li, J, Pedra-Nobre, S, Pálsdóttir, K, Noll, F, Rundle, S, Ulrikh, E, Kocian, R, Saso, S, Hu, Z, Tsunoda, A, Gheorghe, M, Bolatbekova, R, Pitcher, B, and Pareja, R

Published
2019
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43. Imaging in gynecological disease (26): clinical and ultrasound characteristics of benign retroperitoneal pelvic peripheral‐nerve‐sheath tumors.

Author

Fischerova, D., Santos, G., Wong, L., Yulzari, V., Bennett, R. J., Dundr, P., Burgetova, A., Barsa, P., Szabó, G., Sousa, N., Scovazzi, U., and Cibula, D.

Subjects
PELVIC tumors, NEUROFIBROMA, FEMALE reproductive organ diseases, SCHWANNOMAS, DIAGNOSTIC ultrasonic imaging, CORE needle biopsy, ULTRASONIC imaging
Abstract

Objective: To describe the clinical and sonographic characteristics of benign, retroperitoneal, pelvic peripheral‐nerve‐sheath tumors (PNSTs). Methods: This was a retrospective study of patients with a benign, retroperitoneal, pelvic PNST who had undergone preoperative ultrasound examination at a single gynecologic oncology center between 1 January 2018 and 31 August 2022. All ultrasound images, videoclips and final histological specimens of benign PNSTs were reviewed side‐by‐side in order to: describe the ultrasound appearance of the tumors, using the terminology of the International Ovarian Tumor Analysis (IOTA), Morphological Uterus Sonographic Assessment (MUSA) and Vulvar International Tumor Analysis (VITA) groups, following a predefined ultrasound assessment form; describe their origin in relation to nerves and pelvic anatomy; and assess the association between their ultrasound features and histotopography. A review of the literature reporting benign, retroperitoneal, pelvic PNSTs with preoperative ultrasound examination was performed. Results: Five women (mean age, 53 years) with a benign, retroperitoneal, pelvic PNST were identified, four with a schwannoma and one with a neurofibroma, of which all were sporadic and solitary. All patients had good‐quality ultrasound images and videoclips and final biopsy of surgically excised tumors, except one patient managed conservatively who had only a core needle biopsy. In all cases, the findings were incidental. The five PNSTs ranged in maximum diameter from 31 to 50 mm. All five PNSTs were solid, moderately vascular tumors, with non‐uniform echogenicity, well‐circumscribed by hyperechogenic epineurium and with no acoustic shadowing. Most of the masses were round (n = 4 (80%)), and contained small, irregular, anechoic, cystic areas (n = 3 (60%)) and hyperechogenic foci (n = 5 (100%)). In the woman with a schwannoma in whom surgery was not performed, follow‐up over a 3‐year period showed minimal growth (1.5 mm/year) of the mass. We also summarize the findings of 47 cases of benign retroperitoneal schwannoma and neurofibroma identified in a literature search. Conclusions: On ultrasound examination, no imaging characteristics differentiate reliably between benign schwannomas and neurofibromas. Moreover, benign PNSTs show some similar features to malignant retroperitoneal tumors. They are solid lesions with intralesional blood vessels and show degenerative changes such as cystic areas and hyperechogenic foci. Therefore, ultrasound‐guided biopsy may play a pivotal role in their diagnosis. If confirmed to be benign PNSTs, these tumors can be managed conservatively, with ultrasound surveillance. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Published
2023
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44. 21TiP Molecular alterations predictive of outcome in early staged cervical cancer: A translational investigation in the international validation study of sentinel node biopsy in early cervical cancer SENTICOL III

Author

El Gani, M., primary, Ibadioune, S., additional, El Beaino, Z., additional, Vacher, S., additional, Degnieau, A., additional, Jeannot, E., additional, Masliah-Planchon, J., additional, Vincent-Salomon, A., additional, Caly, M., additional, Baiocchi, G., additional, Guitmann, G., additional, Plante, M., additional, Cibula, D., additional, Zanagnolo, V., additional, Eriksson, A.G.Z., additional, Mathevet, P., additional, Kamal, M., additional, Lecuru, F., additional, and Bieche, I., additional

Published
2023
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45. Unilateral inguinofemoral lymphadenectomy in patients with early-stage vulvar squamous cell carcinoma and a unilateral metastatic sentinel lymph node is safe

Author

Kolk, W.L. van der, Zee, A.G.J. van der, Slomovitz, B.M., Baldwin, P.J.W., Doorn, H.C. van, Hullu, J.A. de, Velden, J. van der, Gaarenstroom, K.N., Slangen, B.F.M., Kjolhede, P., Brannstrom, M., Vergote, I., Holland, C.M., Coleman, R., Dorst, E.B.L. van, Driel, W.J. van, Nunns, D., Widschwendter, M., Nugent, D., DiSilvestro, P.A., Mannel, R.S., Tjiong, M.Y., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I.B., Monk, B.J., Zanagnolo, V., Tamussino, K., Oonk, M.H.M., Levenback, C.F., Hermans, R.H., Bouda, J., Sharma, A., Luesley, D., Ellis, P., Cruickshank, D.J., Duncan, T.J., Kieser, K., Palle, C., Spirtos, N.M., O'Malley, D.M., Leitao, M.M., Geller, M., Dhar, K., Asher, V., Tobias, D.H., Borgfeldt, C., Lea, J.S., Lood, M., Bailey, J., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K.S., Persson, P., Manchanda, R., Jensen, P., L. van le, GROINSS-V I II Participants, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R2 - Basic and Translational Cancer Biology, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), Targeted Gynaecologic Oncology (TARGON), Cancer Center Amsterdam, Obstetrics and Gynaecology, CCA - Cancer Treatment and Quality of Life, and Gynecological Oncology

Subjects
Lymphadenopathy, CANCER-PATIENTS, Groin, Humans, Science & Technology, Vulvar Neoplasms, Vulvar cancer, Radiotherapy, Sentinel Lymph Node Biopsy, Kirurgi, Obstetrics and Gynecology, Obstetrics & Gynecology, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], Oncology, Sentinel lymph node, Inguinofemoral lymphadenectomy, Lymph node metastases, Lymphatic Metastasis, Carcinoma, Squamous Cell, Lymph Node Excision, Surgery, Female, Lymph Nodes, Neoplasm Recurrence, Local, Life Sciences & Biomedicine
Abstract

Objective. Optimal management of the contralateral groin in patients with early-stage vulvar squamous cell carcinoma (VSCC) and a metastatic unilateral inguinal sentinel lymph node (SN) is unclear. We analyzed patients who participated in GROINSS-V I or II to determine whether treatment of the contralateral groin can safely be omitted in patients with a unilateral metastatic SN.Methods. We selected the patients with a unilateral metastatic SN from the GROINSS-V I and II databases. We determined the incidence of contralateral additional non-SN metastases in patients with unilateral SN-metastasis who underwent bilateral inguinofemoral lymphadenectomy (IFL). In those who underwent only ipsilateral groin treatment or no further treatment, we determined the incidence of contralateral groin recurrences during follow-up.Results. Of 1912 patients with early-stage VSCC, 366 had a unilateral metastatic SN. Subsequently, 244 had an IFL or no treatment of the contralateral groin. In seven patients (7/244; 2.9% [95% CI: 1.4%-5.8%]) disease was di-agnosed in the contralateral groin: five had contralateral non-SN metastasis at IFL and two developed an isolated contralateral groin recurrence after no further treatment. Five of them had a primary tumor >= 30 mm. Bilateral ra-diotherapy was administered in 122 patients, of whom one (1/122; 0.8% [95% CI: 0.1%-4.5%]) had a contralateral groin recurrence.Conclusion. The risk of contralateral lymph node metastases in patients with early-stage VSCC and a unilateral metastatic SN is low. It appears safe to limit groin treatment to unilateral IFL or inguinofemoral radiotherapy in these cases.(c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). On behalf of all GROINSS-V I and II participants: C.F. Levenback, R.H. Hermans, J. Bouda, A. Sharma, D. Luesley, P. Ellis, D.J. Cruickshank, T.J. Duncan, K. Kieser,C. Palle, N.M. Spirtos, D.M. O'Malley, M.M. Leitao, M. Geller, K. Dhar, V. Asher, D.H. Tobias, C. Borgfeldt, J.S. Lea,M. Lood, J. Bailey, B. Eyjolfsdottir, S. Attard-Montalto, K.S. Tewari, P. Persson, R. Manchanda, P. Jensen, L. Van Le

Published
2022
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46. Oncological outcomes of patients with cervical cancer after fertility-sparing treatment – fertiss retrospective multicenter trial

Author

Runnebaum, IB, additional, Cibula, D, additional, Scambia, G, additional, Fite, MA, additional, Bahrehmand, K, additional, Kommoss, S, additional, Fagotti, A, additional, Narducci, F, additional, Matylevich, O, additional, Holly, J, additional, Martinelli, F, additional, Koual, M, additional, Samokhvalova, O, additional, El-Balat, A, additional, Corrado, G, additional, Căpîlna, ME, additional, Schröder, W, additional, Novàk, Z, additional, Shushkevich, A, additional, Fricová, L, additional, and Sláma, J, additional

Published
2022
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47. Unilateral inguinofemoral lymphadenectomy in patients with early-stage vulvar squamous cell carcinoma and a unilateral metastatic sentinel lymph node is safe

Author

Van der Kolk, W.L., primary, Van der Zee, A.G.J., additional, Slomovitz, B.M., additional, Baldwin, P.J.W., additional, Van Doorn, H.C., additional, De Hullu, J.A., additional, Van der Velden, J., additional, Gaarenstroom, K.N., additional, Slangen, B.F.M., additional, Kjolhede, P., additional, Brännström, M., additional, Vergote, I., additional, Holland, C.M., additional, Coleman, R., additional, Van Dorst, E.B.L., additional, Van Driel, W.J., additional, Nunns, D., additional, Widschwendter, M., additional, Nugent, D., additional, DiSilvestro, P.A., additional, Mannel, R.S., additional, Tjiong, M.Y., additional, Boll, D., additional, Cibula, D., additional, Covens, A., additional, Provencher, D., additional, Runnebaum, I.B., additional, Monk, B.J., additional, Zanagnolo, V., additional, Tamussino, K., additional, Oonk, M.H.M., additional, Levenback, C.F., additional, Hermans, R.H., additional, Bouda, J., additional, Sharma, A., additional, Luesley, D., additional, Ellis, P., additional, Cruickshank, D.J., additional, Duncan, T.J., additional, Kieser, K., additional, Palle, C., additional, Spirtos, N.M., additional, O'Malley, D.M., additional, Leitao, M.M., additional, Geller, M., additional, Dhar, K., additional, Asher, V., additional, Tobias, D.H., additional, Borgfeldt, C., additional, Lea, J.S., additional, Lood, M., additional, Bailey, J., additional, Eyjolfsdottir, B., additional, Attard-Montalto, S., additional, Tewari, K.S., additional, Persson, P., additional, Manchanda, R., additional, Jensen, P., additional, and Van Le, L., additional

Published
2022
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48. 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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49. Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

Author

Musacchio, L, Salutari, V, Pignata, S, Braicu, E, Cibula, D, Colombo, N, Frenel, J, Zagouri, F, Carbone, V, Ghizzoni, V, Giolitto, S, Giudice, E, Perri, M, Ricci, C, Scambia, G, Lorusso, D, Musacchio L., Salutari V., Pignata S., Braicu E., Cibula D., Colombo N., Frenel J. S., Zagouri F., Carbone V., Ghizzoni V., Giolitto S., Giudice E., Perri M. T., Ricci C., Scambia G., Lorusso D., Musacchio, L, Salutari, V, Pignata, S, Braicu, E, Cibula, D, Colombo, N, Frenel, J, Zagouri, F, Carbone, V, Ghizzoni, V, Giolitto, S, Giudice, E, Perri, M, Ricci, C, Scambia, G, Lorusso, D, Musacchio L., Salutari V., Pignata S., Braicu E., Cibula D., Colombo N., Frenel J. S., Zagouri F., Carbone V., Ghizzoni V., Giolitto S., Giudice E., Perri M. T., Ricci C., Scambia G., and Lorusso D.

Abstract

Background Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. Primary Objective The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. Study Hypothesis This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. Trial Design This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. Major Inclusion/Exclusion criteria Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. Primary Endpoint The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. Sample Size 427 patients will be randomized. Estimated Dates for Completing Accrual and Presenting Results June 2024.

Published
2021

50. The annual recurrence risk model for tailored surveillance strategy in patients with cervical cancer

Author

Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., van Lonkhuijzen L. R. C. W., Cibula, D, Dostalek, L, Jarkovsky, J, Mom, C, Lopez, A, Falconer, H, Fagotti, A, Ayhan, A, Kim, S, Isla Ortiz, D, Klat, J, Obermair, A, Landoni, F, Rodriguez, J, Manchanda, R, Kostun, J, dos Reis, R, Meydanli, M, Odetto, D, Laky, R, Zapardiel, I, Weinberger, V, Benesova, K, Borcinova, M, Pari, D, Salehi, S, Bizzarri, N, Akilli, H, Abu-Rustum, N, Salcedo-Hernandez, R, Javurkova, V, Slama, J, van Lonkhuijzen, L, Cibula D., Dostalek L., Jarkovsky J., Mom C. H., Lopez A., Falconer H., Fagotti A., Ayhan A., Kim S. H., Isla Ortiz D., Klat J., Obermair A., Landoni F., Rodriguez J., Manchanda R., Kostun J., dos Reis R., Meydanli M. M., Odetto D., Laky R., Zapardiel I., Weinberger V., Benesova K., Borcinova M., Pari D., Salehi S., Bizzarri N., Akilli H., Abu-Rustum N. R., Salcedo-Hernandez R. A., Javurkova V., Slama J., and van Lonkhuijzen L. R. C. W.

Abstract

Purpose: Current guidelines for surveillance strategy in cervical cancer are rigid, recommending the same strategy for all survivors. The aim of this study was to develop a robust model allowing for individualised surveillance based on a patient's risk profile. Methods: Data of 4343 early-stage patients with cervical cancer treated between 2007 and 2016 were obtained from the international SCCAN (Surveillance in Cervical Cancer) consortium. The Cox proportional hazards model predicting disease-free survival (DFS) was developed and internally validated. The risk score, derived from regression coefficients of the model, stratified the cohort into significantly distinctive risk groups. On its basis, the annual recurrence risk model (ARRM) was calculated. Results: Five variables were included in the prognostic model: maximal pathologic tumour diameter; tumour histotype; grade; number of positive pelvic lymph nodes; and lymphovascular space invasion. Five risk groups significantly differing in prognosis were identified with a five-year DFS of 97.5%, 94.7%, 85.2% and 63.3% in increasing risk groups, whereas a two-year DFS in the highest risk group equalled 15.4%. Based on the ARRM, the annual recurrence risk in the lowest risk group was below 1% since the beginning of follow-up and declined below 1% at years three, four and >5 in the medium-risk groups. In the whole cohort, 26% of recurrences appeared at the first year of the follow-up, 48% by year two and 78% by year five. Conclusion: The ARRM represents a potent tool for tailoring the surveillance strategy in early-stage patients with cervical cancer based on the patient's risk status and respective annual recurrence risk. It can easily be used in routine clinical settings internationally.

Published
2021

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