Central Pathology Review in SENTIX, a Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

Abstract

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.

Value of sentinel node ultrastaging and pathologic techniques in tumoral detection

“…Even in the scenario of a prospective trial like the SENTIX trial, the central pathology evaluation showed substantial heterogeneity in clinical practice when following protocol requirements [48]. From a group of 300 patients, samples from 83 cases from 37 sites were reviewed in the first round of revisions.…”

Benefits of sentinel node detection in cervical cancer

“…In spite of it, the sensitivity rates of frozen section described in literature are heterogeneous due to the poor precision of frozen section in detecting low-volume metastases (micrometastases -MM -and isolated tumour cells, ITC), which limits its accuracy [31]. Moreover, there are other factors such as pathological processing protocol, team expertise, volume of the centre and nodal metastasis size that may influence the sensitivity of the technique [32][33][34]. Due to this reason, the intraoperative evaluation of SLNs remains a subject of debate, without consensus between international guidelines [1,12…”

Para-aortic lymph node involvement in cervical cancer

“…Sentinel node dissection has been used in early-stage cervical cancer. The most common locations of sentinel nodes are below common iliac bifurcation 11 12 . Hence, it is not useful for the detection of PALN metastases.…”