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1. SENECA study: staging endometrial cancer based on molecular classification

Author

Chacon, E, Boria, F, Lyer, R, Fanfani, F, Malzoni, M, Bretova, P, Luzarraga Aznar, A, Fruscio, R, Jedryka, M, Toth, R, Perrone, A, Kakkos, A, Cristobal Quevedo, I, Congedo, L, Zanagnolo, V, Fernandez-Gonzalez, S, Ferro, B, Narducci, F, Hovhannisyan, T, Aksahin, E, Cardenas, L, Oliver, M, Nozaleda, G, Arnaez, M, Misiek, M, Ferrero, A, Pain, F, Zarragoitia, J, Diaz, C, Ceppi, L, Mehdiyev, S, Roldan-Rivas, F, Guijarro-Campillo, A, Amengual, J, Manzour, N, Sanchez Lorenzo, L, Nunez-Cordoba, J, Gonzalez Martin, A, Minguez, J, Chiva, L, Chacon E., Boria F., Lyer R. R., Fanfani F., Malzoni M., Bretova P., Luzarraga Aznar A., Fruscio R., Jedryka M. A., Toth R., Perrone A. M., Kakkos A., Cristobal Quevedo I., Congedo L., Zanagnolo V., Fernandez-Gonzalez S., Ferro B., Narducci F., Hovhannisyan T., Aksahin E., Cardenas L., Oliver M. R., Nozaleda G., Arnaez M., Misiek M., Ferrero A., Pain F. A., Zarragoitia J., Diaz C., Ceppi L., Mehdiyev S., Roldan-Rivas F., Guijarro-Campillo A. R., Amengual J., Manzour N., Sanchez Lorenzo L., Nunez-Cordoba J. M., Gonzalez Martin A., Minguez J. A., Chiva L., Chacon, E, Boria, F, Lyer, R, Fanfani, F, Malzoni, M, Bretova, P, Luzarraga Aznar, A, Fruscio, R, Jedryka, M, Toth, R, Perrone, A, Kakkos, A, Cristobal Quevedo, I, Congedo, L, Zanagnolo, V, Fernandez-Gonzalez, S, Ferro, B, Narducci, F, Hovhannisyan, T, Aksahin, E, Cardenas, L, Oliver, M, Nozaleda, G, Arnaez, M, Misiek, M, Ferrero, A, Pain, F, Zarragoitia, J, Diaz, C, Ceppi, L, Mehdiyev, S, Roldan-Rivas, F, Guijarro-Campillo, A, Amengual, J, Manzour, N, Sanchez Lorenzo, L, Nunez-Cordoba, J, Gonzalez Martin, A, Minguez, J, Chiva, L, Chacon E., Boria F., Lyer R. R., Fanfani F., Malzoni M., Bretova P., Luzarraga Aznar A., Fruscio R., Jedryka M. A., Toth R., Perrone A. M., Kakkos A., Cristobal Quevedo I., Congedo L., Zanagnolo V., Fernandez-Gonzalez S., Ferro B., Narducci F., Hovhannisyan T., Aksahin E., Cardenas L., Oliver M. R., Nozaleda G., Arnaez M., Misiek M., Ferrero A., Pain F. A., Zarragoitia J., Diaz C., Ceppi L., Mehdiyev S., Roldan-Rivas F., Guijarro-Campillo A. R., Amengual J., Manzour N., Sanchez Lorenzo L., Nunez-Cordoba J. M., Gonzalez Martin A., Minguez J. A., and Chiva L.

Abstract

OBJECTIVE: Management of endometrial cancer is advancing, with accurate staging crucial for guiding treatment decisions. Understanding sentinel lymph node (SLN) involvement rates across molecular subgroups is essential. To evaluate SLN involvement in early-stage (International Federation of Gynecology and Obstetrics 2009 I-II) endometrial cancer, considering molecular subtypes and new European Society of Gynaecological Oncology (ESGO) risk classification. METHODS: The SENECA study retrospectively reviewed data from 2139 women with stage I-II endometrial cancer across 66 centers in 16 countries. Patients underwent surgery with SLN assessment following ESGO guidelines between January 2021 and December 2022. Molecular analysis was performed on pre-operative biopsies or hysterectomy specimens. RESULTS: Among the 2139 patients, the molecular subgroups were as follows: 272 (12.7%) p53 abnormal (p53abn, 1191 (55.7%) non-specific molecular profile (NSMP), 581 (27.2%) mismatch repair deficient (MMRd), 95 (4.4%) POLE mutated (POLE-mut). Tracer diffusion was detected in, at least one side, in 97.2% of the cases; with a bilateral diffusion observed in 82.7% of the cases. By ultrastaging (90.7% of the cases) or one-step nucleic acid amplification (198 (9.3%) of the cases), 205 patients were identified with affected sentinel lymph nodes, representing 9.6% of the sample. Of these, 139 (67.8%) had low-volume metastases (including micrometastases, 42.9%; and isolated tumor cells, 24.9%) while 66 (32.2%) had macrometastases. Significant differences in SLN involvement were observed between molecular subtypes, with p53abn and MMRd groups having the highest rates (12.50% and 12.40%, respectively) compared with NSMP (7.80%) and POLE-mut (6.30%), (p=0.004); (p53abn, OR=1.69 (95% CI 1.11 to 2.56), p=0.014; MMRd, OR=1.67 (95% CI 1.21 to 2.31), p=0.002). Differences were also noted among ESGO risk groups (2.84% for low-risk patients, 6.62% for intermediate-risk patients, 21.63% for high-inte

Published
2024

2. SUCCOR morbidity: Complications in minimally invasive versus open radical hysterectomy in early cervical cancer

Author

Vazquez-Vicente, D, Boria, F, Castellanos, T, Gutierrez, M, Chacon, E, Manzour, N, Minguez, J, Martin-Calvo, N, Alcazar, J, Chiva, L, Fruscio, R, Vazquez-Vicente D., Boria F., Castellanos T., Gutierrez M., Chacon E., Manzour N., Minguez J. A., Martin-Calvo N., Alcazar J. L., Chiva L., Fruscio R, Vazquez-Vicente, D, Boria, F, Castellanos, T, Gutierrez, M, Chacon, E, Manzour, N, Minguez, J, Martin-Calvo, N, Alcazar, J, Chiva, L, Fruscio, R, Vazquez-Vicente D., Boria F., Castellanos T., Gutierrez M., Chacon E., Manzour N., Minguez J. A., Martin-Calvo N., Alcazar J. L., Chiva L., and Fruscio R

Abstract

Objective The aim of this study was to compare the incidence of intra-operative and post-operative complications in open and minimally invasive radical hysterectomy for patients with early-stage cervical cancer. Methods Data were collected from the SUCCOR database of 1272 patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO), 2009) who underwent radical hysterectomy in Europe between January 2013 and December 2014. We reviewed the duration of the surgeries, estimated blood loss, length of hospital stay, intra-operative and post-operative complications. The inclusion criteria were age ≥18 years and histologic type (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Pelvic MRI confirming a tumor diameter ≤4 cm with no parametrial invasion and a pre-operative CT scan, MRI, or positron emission tomography CT demonstrating no extra-cervical metastatic disease were mandatory. Outcomes of interest were any grade >3 adverse events, intra-operative adverse events, post-operative adverse events, length of hospital stay, length of operation, and blood loss. Results The study included 1156 patients, 633 (54%) in the open surgery group and 523 (46%) in the minimally invasive surgery group. Median age was 46 years (range 18-82), median body mass index 25 kg/m 2 (range 15-68), and 1022 (88.3%) patients were considered to have an optimal performance status (ECOG Performance Status 0). The most common histologic tumor type was squamous carcinoma (n=794, 68.7%) and the most frequent FIGO staging was IB1 (n=510, 44.1%). In the minimally invasive surgery group the median duration of surgery was longer (240 vs 187 min, p<0.01), median estimated blood loss was lower (100 vs 300 mL, p<0.01), and median length of hospital stay was shorter (4 vs 7 days, p<0.01) compared with the abdominal surgery group. There was no difference in the overall incidence of intra-operative and post-operative complications between th

Published
2024

3. 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

4. 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

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

Author

Boria, F, Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, CA Pilna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, A, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujic, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, M, Sukhin, V, Feron J.,, Fruscio, R, Kukk, K, Ponce, J, Alonso-Espias, M, Minguez, J, Vazquez-Vicente, D, Manzour, N, Jurado, M, Castellanos, T, Chacon, E, Alcazar, J, Boria F, Chiva L, Zanagnolo V, Querleu D, Martin-Calvo N, CA Pilna M. E, Fagotti A, Kucukmetin A, Mom C, Chakalova G., Shamistan A., Malzoni M., Narducci F., Arencibia O., Raspagliesi F., Toptas T., Cibula D., Kaidarova D., Meydanli M. M., Tavares M., Golub D., Perrone A. M., Poka R., Tsolakidis D., Vujic G., Jedryka M. A., Zusterzeel P. L. M., Beltman J. J., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Berlev I., Bernardino M., Bharathan R, Lanner M, Maenpaa M. M, Sukhin V, Feron J. -G, Fruscio R, Kukk K, Ponce J, Alonso-Espias M, Minguez J. A, Vazquez-Vicente D, Manzour N, Jurado M, Castellanos T, Chacon E, Alcazar J. L., Boria, F, Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, CA Pilna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Shamistan, A, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujic, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, M, Sukhin, V, Feron J.,, Fruscio, R, Kukk, K, Ponce, J, Alonso-Espias, M, Minguez, J, Vazquez-Vicente, D, Manzour, N, Jurado, M, Castellanos, T, Chacon, E, Alcazar, J, Boria F, Chiva L, Zanagnolo V, Querleu D, Martin-Calvo N, CA Pilna M. E, Fagotti A, Kucukmetin A, Mom C, Chakalova G., Shamistan A., Malzoni M., Narducci F., Arencibia O., Raspagliesi F., Toptas T., Cibula D., Kaidarova D., Meydanli M. M., Tavares M., Golub D., Perrone A. M., Poka R., Tsolakidis D., Vujic G., Jedryka M. A., Zusterzeel P. L. M., Beltman J. J., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Berlev I., Bernardino M., Bharathan R, Lanner M, Maenpaa M. M, Sukhin V, Feron J. -G, Fruscio R, Kukk K, Ponce J, Alonso-Espias M, Minguez J. A, Vazquez-Vicente D, Manzour N, Jurado M, Castellanos T, Chacon E, and Alcazar J. L.

Abstract

Introduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. Methods The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. Results The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m 2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0-84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation. Conc

Published
2021

6. 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. 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., Fagotti A. (ORCID:0000-0001-5579-335X), Bizzarri N., 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., Fagotti A. (ORCID:0000-0001-5579-335X), and Bizzarri N.

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

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

Author

Boria F., Chiva L., Zanagnolo V., Querleu D., Martin-Calvo N., CA Pilna M. E., Kucukmetin A., Mom C., Chakalova, G. , Shamistan, A., Malzoni M., Narducci F., Arencibia O., Raspagliesi F., Toptas T., Cibula D., Kaidarova D., Meydanli M. M., Tavares M., Golub D., Perrone A. M., Poka R., Tsolakidis D., Vujic G., Jedryka M. A., Zusterzeel P. L. M., Beltman J. J., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Berlev I., Bernardino M., Bharathan R., Lanner M., Maenpaa M. M., Sukhin V., Feron J. -G., Fruscio R., Kukk K., Ponce J., Alonso-Espias M., Minguez J. A., Vazquez-Vicente D., Manzour N., Jurado M., Castellanos T., Chacon E., Alcazar J. L., Fagotti, Anna, Fagotti A. (ORCID:0000-0001-5579-335X), Boria F., Chiva L., Zanagnolo V., Querleu D., Martin-Calvo N., CA Pilna M. E., Kucukmetin A., Mom C., Chakalova, G. , Shamistan, A., Malzoni M., Narducci F., Arencibia O., Raspagliesi F., Toptas T., Cibula D., Kaidarova D., Meydanli M. M., Tavares M., Golub D., Perrone A. M., Poka R., Tsolakidis D., Vujic G., Jedryka M. A., Zusterzeel P. L. M., Beltman J. J., Goffin F., Haidopoulos D., Haller H., Jach R., Yezhova I., Berlev I., Bernardino M., Bharathan R., Lanner M., Maenpaa M. M., Sukhin V., Feron J. -G., Fruscio R., Kukk K., Ponce J., Alonso-Espias M., Minguez J. A., Vazquez-Vicente D., Manzour N., Jurado M., Castellanos T., Chacon E., Alcazar J. L., Fagotti, Anna, and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

Introduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. Methods The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. Results The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m 2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0-84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation. Conc

Published
2021

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

Author

Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, Arévalo-Serrano, J, Căpîlna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Aliyev, S, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujić, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, M, Sukhin, V, Feron, J, Fruscio, R, Kukk, K, Ponce, J, Minguez, J, Vázquez-Vicente, D, Castellanos, T, Chacon, E, Alcazar, J, Chiva, Luis, Zanagnolo, Vanna, Querleu, Denis, Martin-Calvo, Nerea, Arévalo-Serrano, Juan, Căpîlna, Mihai Emil, Fagotti, Anna, Kucukmetin, Ali, Mom, Constantijne, Chakalova, Galina, Aliyev, Shamistan, Malzoni, Mario, Narducci, Fabrice, Arencibia, Octavio, Raspagliesi, Francesco, Toptas, Tayfun, Cibula, David, Kaidarova, Dilyara, Meydanli, Mehmet Mutlu, Tavares, Mariana, Golub, Dmytro, Perrone, Anna Myriam, Poka, Robert, Tsolakidis, Dimitrios, Vujić, Goran, Jedryka, Marcin A, Zusterzeel, Petra L M, Beltman, Jogchum Jan, Goffin, Frederic, Haidopoulos, Dimitrios, Haller, Herman, Jach, Robert, Yezhova, Iryna, Berlev, Igor, Bernardino, Margarida, Bharathan, Rasiah, Lanner, Maximilian, Maenpaa, Minna M, Sukhin, Vladyslav, Feron, Jean-Guillaume, Fruscio, Robert, Kukk, Kersti, Ponce, Jordi, Minguez, Jose Angel, Vázquez-Vicente, Daniel, Castellanos, Teresa, Chacon, Enrique, Alcazar, Juan Luis, Chiva, L, Zanagnolo, V, Querleu, D, Martin-Calvo, N, Arévalo-Serrano, J, Căpîlna, M, Fagotti, A, Kucukmetin, A, Mom, C, Chakalova, G, Aliyev, S, Malzoni, M, Narducci, F, Arencibia, O, Raspagliesi, F, Toptas, T, Cibula, D, Kaidarova, D, Meydanli, M, Tavares, M, Golub, D, Perrone, A, Poka, R, Tsolakidis, D, Vujić, G, Jedryka, M, Zusterzeel, P, Beltman, J, Goffin, F, Haidopoulos, D, Haller, H, Jach, R, Yezhova, I, Berlev, I, Bernardino, M, Bharathan, R, Lanner, M, Maenpaa, M, Sukhin, V, Feron, J, Fruscio, R, Kukk, K, Ponce, J, Minguez, J, Vázquez-Vicente, D, Castellanos, T, Chacon, E, Alcazar, J, Chiva, Luis, Zanagnolo, Vanna, Querleu, Denis, Martin-Calvo, Nerea, Arévalo-Serrano, Juan, Căpîlna, Mihai Emil, Fagotti, Anna, Kucukmetin, Ali, Mom, Constantijne, Chakalova, Galina, Aliyev, Shamistan, Malzoni, Mario, Narducci, Fabrice, Arencibia, Octavio, Raspagliesi, Francesco, Toptas, Tayfun, Cibula, David, Kaidarova, Dilyara, Meydanli, Mehmet Mutlu, Tavares, Mariana, Golub, Dmytro, Perrone, Anna Myriam, Poka, Robert, Tsolakidis, Dimitrios, Vujić, Goran, Jedryka, Marcin A, Zusterzeel, Petra L M, Beltman, Jogchum Jan, Goffin, Frederic, Haidopoulos, Dimitrios, Haller, Herman, Jach, Robert, Yezhova, Iryna, Berlev, Igor, Bernardino, Margarida, Bharathan, Rasiah, Lanner, Maximilian, Maenpaa, Minna M, Sukhin, Vladyslav, Feron, Jean-Guillaume, Fruscio, Robert, Kukk, Kersti, Ponce, Jordi, Minguez, Jose Angel, Vázquez-Vicente, Daniel, Castellanos, Teresa, Chacon, Enrique, and Alcazar, Juan Luis

Abstract

Background: Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. Methods: We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Results: Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m2 (range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective va

Published
2020

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

Author

Chiva, L., Zanagnolo, V., Querleu, D., Martin-Calvo, N., Arevalo-Serrano, J., Capilna, M. E., Fagotti, A., Kucukmetin, A., Mom, C., Chakalova, G., Aliyev, S., Malzoni, M., Narducci, F., Arencibia, O., Raspagliesi, F., Toptas, T., Cibula, D., Kaidarova, D., Meydanli, M. M., Tavares, M., Golub, D., Perrone, A. M., Poka, R., Tsolakidis, D., Vujic, G., Jedryka, M. A., Zusterzeel, P. L. M., Beltman, J. J., Goffin, F., Haidopoulos, D., Haller, H., Jach, R., Yezhova, I., Berlev, I., Bernardino, M., Bharathan, R., Lanner, M., Maenpaa, M. M., Sukhin, V., Feron, J. -G., Fruscio, R., Kukk, K., Ponce, J., Minguez, J. A., Vazquez-Vicente, D., Castellanos, T., Chacon, E., Alcazar, J. L., Fagotti A. (ORCID:0000-0001-5579-335X), Chiva, L., Zanagnolo, V., Querleu, D., Martin-Calvo, N., Arevalo-Serrano, J., Capilna, M. E., Fagotti, A., Kucukmetin, A., Mom, C., Chakalova, G., Aliyev, S., Malzoni, M., Narducci, F., Arencibia, O., Raspagliesi, F., Toptas, T., Cibula, D., Kaidarova, D., Meydanli, M. M., Tavares, M., Golub, D., Perrone, A. M., Poka, R., Tsolakidis, D., Vujic, G., Jedryka, M. A., Zusterzeel, P. L. M., Beltman, J. J., Goffin, F., Haidopoulos, D., Haller, H., Jach, R., Yezhova, I., Berlev, I., Bernardino, M., Bharathan, R., Lanner, M., Maenpaa, M. M., Sukhin, V., Feron, J. -G., Fruscio, R., Kukk, K., Ponce, J., Minguez, J. A., Vazquez-Vicente, D., Castellanos, T., Chacon, E., Alcazar, J. L., and Fagotti A. (ORCID:0000-0001-5579-335X)

Abstract

Background Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. Methods We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Results Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m 2 (range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective vagi

Published
2020

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

Author

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

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

IntroductionComprehensive updated information on cervical cancer surgical treatment in Europe is scarce.ObjectiveTo evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database.MethodsThe SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified.ResultsThe mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) ConclusionsIn this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

Published
2021
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