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Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial
D. Cibula, R. Kocian, A. Plaikner, J. Jarkovsky, J. Klat, I. Zapardiel, R. Pilka, A. Torne, B. Sehnal, M. Ostojich, A. Petiz, OA. Sanchez, J. Presl, A. Buda, F. Raspagliesi, P. Kascak, L. van Lonkhuijzen, M. Barahona, L. Minar, P. Blecharz, M....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, práce podpořená grantem
- MeSH
- biopsie sentinelové lymfatické uzliny metody MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory děložního čípku patologie chirurgie MeSH
- prospektivní studie MeSH
- senioři MeSH
- sentinelová uzlina patologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
BACKGROUND: SENTIX (ENGOT-CX2/CEEGOG-CX1) is an international, multicentre, prospective observational trial evaluating sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We report the final preplanned analysis of the secondary end-points: SLN mapping and outcomes of intraoperative SLN pathology. METHODS: Forty-seven sites (18 countries) with experience of SLN biopsy participated in SENTIX. We preregistered patients with stage IA1/lymphovascular space invasion-positive to IB2 (4 cm or smaller or 2 cm or smaller for fertility-sparing treatment) cervical cancer without suspicious lymph nodes on imaging before surgery. SLN frozen section assessment and pathological ultrastaging were mandatory. Patients were registered postoperatively if SLN were bilaterally detected in the pelvis, and frozen sections were negative. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02494063). RESULTS: We analysed data for 395 preregistered patients. Bilateral detection was achieved in 91% (355/395), and it was unaffected by tumour size, tumour stage or body mass index, but it was lower in older patients, in patients who underwent open surgery, and in sites with fewer cases. No SLN were found outside the seven anatomical pelvic regions. Most SLN and positive SLN were localised below the common iliac artery bifurcation. Single positive SLN above the iliac bifurcation were found in 2% of cases. Frozen sections failed to detect 54% of positive lymph nodes (pN1), including 28% of cases with macrometastases and 90% with micrometastases. INTERPRETATION: SLN biopsy can achieve high bilateral SLN detection in patients with tumours of 4 cm or smaller. At experienced centres, all SLN were found in the pelvis, and most were located below the iliac vessel bifurcation. SLN frozen section assessment is an unreliable tool for intraoperative triage because it only detects about half of N1 cases.
Center for Gynecologic Oncology Amsterdam University Medical Center Amsterdam the Netherlands
Department of Gynaecology and Obstetrics University Hospital Comenius University Bratislava Slovakia
Department of Gynaecology St Olav's Hospital Trondheim Norway
Department of Gynecologic Oncology Holycross Cancer Center Kielce Poland
Department of Gynecology and Obstetrics Faculty of Medicine Masaryk University Brno Czech Republic
Department of Gynecology Francisco Gentil Portuguese Oncology Institute Porto Portugal
Department of Obstetrics and Gynecology Cantonal Hospital of Lucerne Lucerne Switzerland
Department of Obstetrics and Gynecology Faculty Hospital Trencin Trencin Slovakia
Department of Obstetrics and Gynecology KNTB a s Zlin Czech Republic
Department of Obstetrics and Gynecology University Hospital Ostrava Ostrava Poruba Czech Republic
Department of Special Operative and Oncologic Gynaecology Asklepios Clinic Hamburg Hamburg Germany
Fondazione IRCCS Istituto Nazionale Tumori Milan Milan Italy
Gynecologic Oncology Unit La Paz University Hospital Madrid Spain
Gynecology Department Instituto Valenciano de Oncologia Valencia Spain
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
Citace poskytuje Crossref.org
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