Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer : the SENTIX trial
Cibula, David; Kocian, Roman; Plaikner, Andrea; Jarkovsky, Jiri; Klat, Jaroslav; Zapardiel, Ignacio; Pilka, Radovan; Torne, Aureli; Sehnal, Borek; Ostojich, Marcela; Petiz, Almerinda; Sanchez, Octavio A.; Presl, Jiri; Buda, Alessandro; Raspagliesi, Francesco; Kascak, Peter; Van Lonkhuijzen, Luc; Barahona, Marc; Minar, Lubos; Blecharz, Pawel; Pakiz, Maja; Wydra, Dariusz; Snyman, Leon Cornelius; Zalewski, Kamil; Zorrero, Cristina; Havelka, Pavel; Redecha, Mikulas; Vinnytska, Alla; Vergote, Ignace; Tingulstad, Solveig; Michal, Martin; Kipp, Barbara; Slama, Jiri; Marnitz, Simone; Bajsova, Sylva; Hernandez, Alicia; Fischerova, Daniela; Nemejcova, Kristyna; Kohler, Christhardt
Date:
2020-09
Abstract:
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 ultra staging 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.
