Central Pathology Review in SENTIX, A Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)
Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic
Typ dokumentu časopisecké články
Grantová podpora
Project RVO 64165
Ministry of Health, Czech Republic
No 16-31643A
Ministerstvo Zdravotnictví Ceské Republiky
NV19-03-00023
Ministerstvo Zdravotnictví Ceské Republiky
PubMed
32365651
PubMed Central
PMC7281480
DOI
10.3390/cancers12051115
PII: cancers12051115
Knihovny.cz E-zdroje
- Klíčová slova
- cervical cancer, metastases, sentinel lymph node,
- Publikační typ
- časopisecké články MeSH
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 St Olav's Hospital 7006 Trondheim Norway
Department of Gynecologic Oncology Holycross Cancer Center 25 734 Kielce Poland
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 Francisco Gentil Portuguese Oncology Institute 4200 072 Porto Portugal
Department of Gynecology Medical Faculty University of Cologne 50937 Cologne Germany
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 Institute of Mother and Child 01 211 Warsaw Poland
Department of Pathology La Paz University Hospital 28046 Madrid Spain
Gynecology Department Instituto Valenciano de Oncología 46009 Valencia Spain
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
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.