AIM: The aim of this study was to assess whether the use of sentinel lymph node (SLN) in addition to lymphadenectomy was associated with survival benefit in patients with early-stage cervical cancer. METHODS: International, multicenter, retrospective study. INCLUSION CRITERIA: cervical cancer treated between 01/2007 and 12/2016 by surgery only; squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, FIGO 2009 stage IB1-IIA2, negative surgical margins, and laparotomy approach. Patients undergoing neo-adjuvant and/or adjuvant treatment and/or with positive para-aortic lymph nodes, were excluded. Women with positive pelvic nodes who refused adjuvant treatment, were included. Lymph node assessment was performed by SLN (with ultrastaging protocol) plus pelvic lymphadenectomy ('SLN' group) or pelvic lymphadenectomy alone ('non-SLN' group). RESULTS: 1083 patients were included: 300 (27.7 %) in SLN and 783 (72.3 %) in non-SLN group. 77 (7.1 %) patients had recurrence (N = 11, 3.7 % SLN versus N = 66, 8.4 % non-SLN, p = 0.005) and 34 (3.1 %) (N = 4, 1.3 % SLN versus N = 30, 3.8 % non-SLN, p = 0.033) died. SLN group had better 5-year disease-free survival (DFS) (96.0 %,95 %CI:93.5-98.5 versus 92.0 %,95 %CI:90.0-94.0; p = 0.024). No 5-year overall survival (OS) difference was shown (98.4 %,95 %CI:96.8-99.9 versus 96.8 %,95 %CI:95.4-98.2; p = 0.160). SLN biopsy and lower stage were independent factors associated with improved DFS (HR:0.505,95 %CI:0.266-0.959, p = 0.037 and HR:2.703,95 %CI:1.389-5.261, p = 0.003, respectively). Incidence of pelvic central recurrences was higher in the non-SLN group (1.7 % versus 4.5 %, p = 0.039). CONCLUSION: Adding SLN biopsy to pelvic lymphadenectomy was associated with lower recurrence and death rate and improved 5-year DFS. This might be explained by the lower rate of missed nodal metastasis thanks to the use of SLN ultrastaging. SLN biopsy should be recommended in patients with early-stage cervical cancer.

Baskent University School of Medicine Department of Gynecology and Obstetrics Division of Gynecologic Oncology Ankara Turkey

Biostatistics Unit Scientific Directorate Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy

Center for Gynaecologic Oncology Amsterdam Amsterdam University Medical Centers Amsterdam the Netherlands

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

Department of Gynecologic Oncology Barretos Cancer Hospital Barretos Sao Paulo Brazil

Department of Gynecologic Oncology Hospital Italiano de Buenos Aires Instituto Universitario Hospital Italiano Buenos Aires Argentina

Department of Gynecologic Oncology Instituto Nacional de Cancerología Bogotá Colombia

Department of Gynecologic Oncology Zekai Tahir Burak Women's Health and Research Hospital University of Health Sciences Ankara Turkey

Department of Gynecological Surgery National Institute of Neoplastic Diseases Lima Peru

Department of Obstetrics and Gynecology Faculty of Medicine University Hospital and University of Ostrava Ostrava Czech Republic

Department of Obstetrics and Gynecology Houston Methodist Hospital Houston TX USA

Department of Pelvic Cancer Karolinska University Hospital and Department of Women's and Children's Health Karolinska Institutet Stockholm Sweden

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

Gynecologic Oncology Unit La Paz University Hospital Madrid Spain

Gynecology Medical University of Graz Graz Austria

Gynecology Oncology Center National Institute of Cancerology Mexico Mexico City Mexico

IRCCS Fondazione San Gerardo Università Milano Bicocca Monza Italy

Memorial Sloan Kettering Cancer Center New York USA

Oncology Unit of the Cayetano Heredia Hospital Lima Peru

University Hospital Brno Medical Faculty of Masaryk University Brno Czech Republic

UOC Ginecologia Oncologica Dipartimento di Scienze della Salute della Donna del Bambino e di Sanità Pubblica Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy

Wolfson Institute of Population Health Barts Cancer Centre Queen Mary University of London and Barts Health NHS Trust London UK; Department of Gynaecological Oncology Barts Health NHS Trust London UK; Department of Health Services Research | Faculty of Public Health and Policy | London School of Hygiene and Tropical Medicine London UK

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