Sentinel lymph node (SLN) biopsy with ultrastaging is standard in endometrial and vulvar cancers, whereas systematic pelvic lymphadenectomy (PLND) remains recommended in cervical cancer. The SENTIX trial prospectively evaluated the safety of SLN biopsy without PLND in early-stage cervical cancer. Female patients, International Federation of Gynaecology and Obstetrics 2018 stage IA1/LVSI+ to IB2 disease, were enrolled between 2016 and 2020 across 47 sites in 18 countries. All underwent SLN biopsy followed by hysterectomy/trachelectomy. Patients with undetected, unilateral or intraoperatively metastatic SLNs were excluded from the intention-to-treat cohort. SLNs were assessed by pathological ultrastaging. Of 731 patients enrolled, 594 formed the intention-to-treat cohort. SLN metastases were identified in 82 patients (12%), 56.1% intraoperatively and 43.9% by ultrastaging. At 2 years, the recurrence rate was 6.1% (one-sided 95% CI 7.9%), confirming noninferiority to the 7% reference rate. Two-year disease-free and overall survival rates were 93.3% (95% CI 94.9-91.6) and 97.9% (95% CI 98.9-97.0), respectively. Here we show that SLN biopsy without systematic PLND did not increase the risk of recurrence in patients with early-stage cervical cancer. Pathological ultrastaging of SLNs detected about 44% of N1 cases, which would be missed by a standard lymph node assessment. Trial registration: ClinicalTrials.gov ( NCT02494063 ).

Center for Gynecologic Oncology Amsterdam Amsterdam University Medical Centers Cancer Center Amsterdam Amsterdam The Netherlands

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

Department of Gynecology and Obstetrics University Hospital Brno and Masaryk University Brno Czech Republic

Department of Gynecology and Obstetrics University Hospital Pilsen Charles University Faculty of Medicine in Pilsen Pilsen Czech Republic

Department of Gynecology Asklepios Clinic Hamburg Altona; Department of Gynecology DRK Klinik Berlin Westend Berlin Germany

Department of Gynecology Francisco Gentil Portuguese Oncology Institute Porto Portugal

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

Department of Radiology 1st Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

Eviamed Outpatient Diagnostic and Surgery Center Berlin Charlottenburg Berlin Germany

Fondazione IRCCS Istituto Nazionale Tumori Milan Italy

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

Gynecologic Oncology Unit Institute Clinic of Gynecology Obstetrics and Neonatology Hospital Clinic de Barcelona Institut d'Investigacions Biomèdiques August Pi i Sunyer Universitat de Barcelona Barcelona Spain

Gynecologic Oncology Unit La Paz University Hospital Madrid Spain

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

Institute of Oncology Angel H Roffo Buenos Aires Argentina

Radiation Oncology Vosspalais Berlin Germany

UNIMIB IRCCS San Gerardo Monza Monza Italy

Unit Gynecology Oncology Hospital Universitario Materno Infantil de Canarias Las Palmas Spain

University Hospital Olomouc Palacky University Olomouc Olomouc Czech Republic

University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

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ClinicalTrials.gov
NCT02494063