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

. 2020 Apr 29 ; 12 (5) : . [epub] 20200429

Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid32365651

Grantová podpora
Project RVO 64165 Ministry of Health, Czech Republic
No 16-31643A Ministerstvo Zdravotnictví Ceské Republiky
NV19-03-00023 Ministerstvo Zdravotnictví Ceské Republiky

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

Center for Gynecologic Oncology Academic Medical Centre 1100DD Amsterdam The Netherlands

Department of Gynaecology and Obstetrics University Hospital Comenius University 82101 Bratislava Slovakia

Department of Gynaecology and Obstetrics University Hospital Pilsen Charles University 30460 Prague Czech Republic

Department of Gynaecology St Olav's Hospital 7006 Trondheim Norway

Department of Gynecologic Oncology Centre of Oncology M Sklodowska Curie Memorial Institute Cracow Department 31 115 Cracow Poland

Department of Gynecologic Oncology Holycross Cancer Center 25 734 Kielce Poland

Department of Gynecology and Obstetrics Faculty of Medicine Masaryk University 60200 Brno Czech Republic

Department of Gynecology and Obstetrics Hospital Clinico San Carlos 28040 Madrid Spain

Department of Gynecology and Obstetrics Hospital Español de Buenos Aires Buenos Aires 2975 Argentina

Department of Gynecology and Obstetrics University Hospital Leuven Leuven Cancer Institute 3000 Leuven Belgium

Department of Gynecology Francisco Gentil Portuguese Oncology Institute 4200 072 Porto Portugal

Department of Gynecology Gynecologic Oncology and Gynecologic Endocrinology Medical University of 80 402 Gdansk Poland

Department of Gynecology Medical Faculty University of Cologne 50937 Cologne Germany

Department of Gynecology Universite catholique de Louvain Cliniques Universitaires St Luc 1200 Brussels Belgium

Department of Gynecology University Hospital of Bellvitge Biomedical Research Institute of Bellvitge University of Barcelona 08907 Barcelona Spain

Department of Obstetrics and Gynaecology Hospital Ceske Budejovice JSC 37001 Ceske Budejovice Czech Republic

Department of Obstetrics and Gynaecology St Pierre University Hospital Universite Libre de Bruxelles 1000 Brussels Belgium

Department of Obstetrics and Gynecology Bulovka Hospital 1st Faculty of Medicine Charles University 18081 Prague Czech Republic

Department of Obstetrics and Gynecology Cantonal Hospital of Lucerne 6000 Lucerne Switzerland

Department of Obstetrics and Gynecology Faculty Hospital Trencin 91171 Trencin Slovakia

Department of Obstetrics and Gynecology Faculty of Medicine and Dentistry Palacky University University Hospital Olomouc 77520 Olomouc Czech Republic

Department of Obstetrics and Gynecology Institute of Mother and Child 01 211 Warsaw Poland

Department of Obstetrics and Gynecology Unit of Gynecologic Oncology Surgery San Gerardo Hospital 20900 Monza Italy

Department of Obstetrics and Gynecology University Hospital Ostrava 708 52 Ostrava Poruba Czech Republic

Department of Pathology Institute of Oncology Angel H Roffo University of Buenos Aires Buenos Aires Autonomous City 1214 Argentina

Department of Pathology La Paz University Hospital 28046 Madrid Spain

Department of Special Operative and Oncologic Gynaecology Asklepios Clinic Hamburg 22763 Hamburg Germany

Departments of Gynecologic Oncology University Hospital of the Canary Islands 35016 Las Palmas de Gran Canaria Spain

Gynaecologic Oncology Unit Department of Obstetrics and Gynaecology University of Pretoria Pretoria 0001 South Africa

Gynecologic Oncology Center Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University and General University Hospital 12000 Prague Czech Republic

Gynecology Department Instituto Valenciano de Oncología 46009 Valencia Spain

Institute for Biostatistics and Analyses Faculty of Medicine Masaryk University 62500 Brno Czech Republic

Institute of Obstetrics and Gynaecology Faculty of Medicine University of Debrecen 4032 Debrecen Hungary

Institute of Pathology 1st Faculty of Medicine Charles University and General University Hospital 12000 Prague Czech Republic

IRCCS Foundation National Cancer Institute in Milan 20133 Milan Italy

KNTB a s 762 75 Zlin Czech Republic

LISOD Israeli Oncological Hospital 08720 Plyuty Ukraine

MD Anderson Cancer Center 28033 Madrid Spain

Medical University of Graz 8036 Graz Austria

Molecular Pathology and Therapeutic Targets Group IdiPAZ 28046 Madrid Spain

Oncology Institute of East Slovakia 04191 Košice Slovakia

Unit of Gynecological Oncology Institute Clinic of Gynecology Obstetrics and Neonatology Hospital Clinic of Barcelona 08036 Barcelona Spain

University Clinic for Gynaecology and Perinatology University Medical Centre Maribor 2000 Maribor Slovenia

Zobrazit více v PubMed

Cibula D., Dusek J., Jarkovsky J., Dundr P., Querleu D., van der Zee A., Kucukmetin A., Kocian R. A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX) Int. J. Gynecol. Cancer. 2019;29:212–215. doi: 10.1136/ijgc-2018-000010. PubMed DOI

Delgado G., Bundy B., Zaino R., Sevin B.U., Creasman W.T., Major F. Prospective surgical-pathological study of disease-free interval in patients with stage IB squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study. Gynecol. Oncol. 1990;38:352–357. doi: 10.1016/0090-8258(90)90072-S. PubMed DOI

Derks M., van der Velden J., de Kroon C.D., Nijman H.W., van Lonkhuijzen L., van der Zee A.G.J., Zwinderman A.H., Kenter G.G. Surgical Treatment of Early-Stage Cervical Cancer: A Multi-Institution Experience in 2124 Cases in The Netherlands Over a 30-Year Period. Int. J. Gynecol. Cancer. 2018;28:757–763. doi: 10.1097/IGC.0000000000001228. PubMed DOI

Ho C.M., Chien T.Y., Huang S.H., Wu C.J., Shih B.Y., Chang S.C. Multivariate analysis of the prognostic factors and outcomes in early cervical cancer patients undergoing radical hysterectomy. Gynecol. Oncol. 2004;93:458–464. doi: 10.1016/j.ygyno.2004.01.026. PubMed DOI

Chen Y., Zhang L., Tian J., Fu X., Ren X., Hao Q. Significance of the absolute number and ratio of metastatic lymph nodes in predicting postoperative survival for the International Federation of Gynecology and Obstetrics stage IA2 to IIA cervical cancer. Int. J. Gynecol. Cancer. 2013;23:157–163. doi: 10.1097/IGC.0b013e3182778bcf. PubMed DOI

Lee Y.J., Kim D.Y., Lee S.W., Park J.Y., Suh D.S., Kim J.H., Kim Y.M., Kim Y.T., Nam J.H. A postoperative scoring system for distant recurrence in node-positive cervical cancer patients after radical hysterectomy and pelvic lymph node dissection with para-aortic lymph node sampling or dissection. Gynecol. Oncol. 2017;144:536–540. doi: 10.1016/j.ygyno.2017.01.001. PubMed DOI

Wang C., Yang C., Wang W., Xia B., Li K., Sun F., Hou Y. A Prognostic Nomogram for Cervical Cancer after Surgery from SEER Database. J. Cancer. 2018;9:3923–3928. doi: 10.7150/jca.26220. PubMed DOI PMC

Cibula D., McCluggage W.G. Sentinel lymph node (SLN) concept in cervical cancer: Current limitations and unanswered questions. Gynecol. Oncol. 2019;152:202–207. doi: 10.1016/j.ygyno.2018.10.007. PubMed DOI

Cibula D., Potter R., Planchamp F., Avall-Lundqvist E., Fischerova D., Haie Meder C., Kohler C., Landoni F., Lax S., Lindegaard J.C., et al. The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology Guidelines for the Management of Patients With Cervical Cancer. Int. J. Gynecol. Cancer. 2018;28:641–655. doi: 10.1097/IGC.0000000000001216. PubMed DOI

Darai E., Rouzier R., Ballester M., Barranger E., Coutant C. Sentinel lymph node biopsy in gynaecological cancers: The importance of micrometastases in cervical cancer. Surg. Oncol. 2008;17:227–235. doi: 10.1016/j.suronc.2008.04.002. PubMed DOI

Ferrandina G., Pedone Anchora L., Gallotta V., Fagotti A., Vizza E., Chiantera V., De Iaco P., Ercoli A., Corrado G., Bottoni C., et al. Can We Define the Risk of Lymph Node Metastasis in Early-Stage Cervical Cancer Patients? A Large-Scale, Retrospective Study. Ann. Surg. Oncol. 2017;24:2311–2318. doi: 10.1245/s10434-017-5917-0. PubMed DOI

Cibula D., Abu-Rustum N.R., Dusek L., Slama J., Zikan M., Zaal A., Sevcik L., Kenter G., Querleu D., Jach R., et al. Bilateral ultrastaging of sentinel lymph node in cervical cancer: Lowering the false-negative rate and improving the detection of micrometastasis. Gynecol. Oncol. 2012;127:462–466. doi: 10.1016/j.ygyno.2012.08.035. PubMed DOI

Kadkhodayan S., Hasanzadeh M., Treglia G., Azad A., Yousefi Z., Zarifmahmoudi L., Sadeghi R. Sentinel node biopsy for lymph nodal staging of uterine cervix cancer: A systematic review and meta-analysis of the pertinent literature. Eur. J. Surg. Oncol. 2015;41:1–20. doi: 10.1016/j.ejso.2014.09.010. PubMed DOI

Lecuru F., Mathevet P., Querleu D., Leblanc E., Morice P., Darai E., Marret H., Magaud L., Gillaizeau F., Chatellier G., et al. Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: Results of the SENTICOL study. J. Clin. Oncol. 2011;29:1686–1691. doi: 10.1200/JCO.2010.32.0432. PubMed DOI

Tax C., Rovers M.M., de Graaf C., Zusterzeel P.L., Bekkers R.L. The sentinel node procedure in early stage cervical cancer, taking the next step; a diagnostic review. Gynecol. Oncol. 2015;139:559–567. doi: 10.1016/j.ygyno.2015.09.076. PubMed DOI

Wang X.J., Fang F., Li Y.F. Sentinel-lymph-node procedures in early stage cervical cancer: A systematic review and meta-analysis. Med. Oncol. 2015;32:385. doi: 10.1007/s12032-014-0385-x. PubMed DOI PMC

Biglia N., Librino A., Ottino M.C., Panuccio E., Daniele A., Chahin A. Lower limb lymphedema and neurological complications after lymphadenectomy for gynecological cancer. Int. J. Gynecol. Cancer. 2015;25:521–525. doi: 10.1097/IGC.0000000000000341. PubMed DOI

Hareyama H., Hada K., Goto K., Watanabe S., Hakoyama M., Oku K., Hayakashi Y., Hirayama E., Okuyama K. Prevalence, classification, and risk factors for postoperative lower extremity lymphedema in women with gynecologic malignancies: A retrospective study. Int. J. Gynecol. Cancer. 2015;25:751–757. doi: 10.1097/IGC.0000000000000405. PubMed DOI

Weinberger V., Cibula D., Zikan M. Lymphocele: Prevalence and management in gynecological malignancies. Expert Rev. Anticancer Ther. 2014;14:307–317. doi: 10.1586/14737140.2014.866043. PubMed DOI

Zikan M., Fischerova D., Pinkavova I., Slama J., Weinberger V., Dusek L., Cibula D. A prospective study examining the incidence of asymptomatic and symptomatic lymphoceles following lymphadenectomy in patients with gynecological cancer. Gynecol. Oncol. 2015;137:291–298. doi: 10.1016/j.ygyno.2015.02.016. PubMed DOI

Bats A.S., Clement D., Larousserie F., Lefrere-Belda M.A., Faraggi M., Froissart M., Lecuru F. Sentinel lymph node biopsy improves staging in early cervical cancer. Gynecol. Oncol. 2007;105:189–193. doi: 10.1016/j.ygyno.2006.11.021. PubMed DOI

Popa I., Plante M., Renaud M.C., Roy M., Tetu B. Negative sentinel lymph node accurately predicts negative status of pelvic lymph nodes in uterine cervix carcinoma. Gynecol. Oncol. 2006;103:649–653. doi: 10.1016/j.ygyno.2006.04.022. PubMed DOI

Salvo G., Ramirez P.T., Levenback C.F., Munsell M.F., Euscher E.D., Soliman P.T., Frumovitz M. Sensitivity and negative predictive value for sentinel lymph node biopsy in women with early-stage cervical cancer. Gynecol. Oncol. 2017;145:96–101. doi: 10.1016/j.ygyno.2017.02.005. PubMed DOI PMC

Cibula D., Abu-Rustum N.R., Dusek L., Zikan M., Zaal A., Sevcik L., Kenter G.G., Querleu D., Jach R., Bats A.S., et al. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol. Oncol. 2012;124:496–501. doi: 10.1016/j.ygyno.2011.11.037. PubMed DOI

Dundr P., Cibula D., Nemejcova K., Ticha I., Bartu M., Jaksa R. Pathologic Protocols for Sentinel Lymph Nodes Ultrastaging in Cervical Cancer. Arch. Pathol. Lab. Med. 2019 doi: 10.5858/arpa.2019-0249-RA. PubMed DOI

Delomenie M., Bonsang-Kitzis H., Bats A.S., Ngo C., Balaya V., Xuan H.T.N., Koual M., Mathevet P., Lecuru F. The clinical implication of lymph nodes micrometastases and isolated tumor cells in patients with cervical cancer: A systematic review. Eur. J. Obstet. Gynecol. Reprod. Biol. 2019;241:71–76. doi: 10.1016/j.ejogrb.2019.08.010. PubMed DOI

La Rosa V.L., Shah M., Kahramanoglu I., Cerentini T.M., Ciebiera M., Lin L.T., Dirnfeld M., Minona P., Tesarik J. Quality of life and fertility preservation counseling for women with gynecological cancer: An integrated psychological and clinical perspective. J. Psychosom. Obstet. Gynaecol. 2019:1–7. doi: 10.1080/0167482X.2019.1648424. PubMed DOI

Vitale S.G., La Rosa V.L., Rapisarda A.M.C., Lagana A.S. The Importance of Fertility Preservation Counseling in Patients with Gynecologic Cancer. J. Reprod. Infertil. 2017;18:261–263. PubMed PMC

Nezhat C., Roman R.A., Rambhatla A., Nezhat F. Reproductive and oncologic outcomes after fertility-sparing surgery for early stage cervical cancer: A systematic review. Fertil. Steril. 2020;113:685–703. doi: 10.1016/j.fertnstert.2020.02.003. PubMed DOI

Vergote I., Pujade-Lauraine E., Pignata S., Kristensen G.B., Ledermann J., Casado A., Sehouli J., Mirza M., Fossati R., Marth C., et al. European Network of Gynaecological Oncological Trial Groups’ requirements for trials between academic groups and pharmaceutical companies. Int. J. Gynecol. Cancer. 2010;20:476–478. doi: 10.1111/IGC.0b013e3181d3caa8. PubMed DOI

FIGO Committee on Gynecologic Oncology FIGO staging for carcinoma of the vulva, cervix, and corpus uteri. Int. J. Gynaecol. Obstet. 2014;125:97–98. doi: 10.1016/j.ijgo.2014.02.003. PubMed DOI

Buda A., Papadia A., Zapardiel I., Vizza E., Ghezzi F., De Ponti E., Lissoni A.A., Imboden S., Diestro M.D., Verri D., et al. From Conventional Radiotracer Tc-99(m) with Blue Dye to Indocyanine Green Fluorescence: A Comparison of Methods Towards Optimization of Sentinel Lymph Node Mapping in Early Stage Cervical Cancer for a Laparoscopic Approach. Ann. Surg. Oncol. 2016;23:2959–2965. doi: 10.1245/s10434-016-5227-y. PubMed DOI

Jewell E.L., Huang J.J., Abu-Rustum N.R., Gardner G.J., Brown C.L., Sonoda Y., Barakat R.R., Levine D.A., Leitao M.M., Jr. Detection of sentinel lymph nodes in minimally invasive surgery using indocyanine green and near-infrared fluorescence imaging for uterine and cervical malignancies. Gynecol. Oncol. 2014;133:274–277. doi: 10.1016/j.ygyno.2014.02.028. PubMed DOI PMC

Luhrs O., Ekdahl L., Lonnerfors C., Geppert B., Persson J. Combining Indocyanine Green and Tc(99)-nanocolloid does not increase the detection rate of sentinel lymph nodes in early stage cervical cancer compared to Indocyanine Green alone. Gynecol. Oncol. 2019 doi: 10.1016/j.ygyno.2019.11.026. PubMed DOI

Sobin L.H., Gospodarowicz M.K., Wittekind C.H. International Union against Cancer (UICC). TNM Classification of Malignant Tumours. 7th ed. Wiley; New York, NY, USA: 2009.

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