Preoperative tumour size assessment in patients with early-stage cervical cancer: Final results of the SENTIX study

Abstract

Background: Preoperative tumour size is a key prognostic marker in tailoring surgical treatment in early-stage cervical cancer. This post-hoc analysis assessed the accuracy of preoperative tumour size evaluation via imaging, utilizing data from the prospective, international, multicentre SENTIX study that evaluated safety of sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer.

Methods: Between 05/2016-09/2020, forty-seven sites across 18 countries enrolled cervical cancer patients (FIGO2018 stages 1A1/lymphovascular-space-invasion-positive to 1B2). Preoperative staging included pelvic MRI or ultrasound as mandatory imaging modalities. All patients underwent primary surgical treatment. Pathological assessment of surgical specimens served as reference standard for evaluating the accuracy of preoperative assessments.

Results: Among the 680 included patients, although the mean tumour size discrepancy between preoperative/pathological assessments was only 1.24 ± 8.891 mm, postoperative pT stage was upgraded in 187 (27.5 %) and downgraded in 74 (10.9 %) patients. Discrepancy of ≥10 mm was observed among 155 (22.8 %) patients across all stages, with underestimation in 105 (15.4 %), overestimation in 50 (7.4 %), and a positive correlation (P < 0.0001) between the pathological tumour size and the discrepancy in size assessment. If a maximum 2 cm tumour size threshold were applied to guide the decision between simple and radical hysterectomy, underestimation would result in inadequate surgical management for 9.0 % of patients, whereas overestimation would lead to unnecessarily radical procedures in 5.1 % of cases.

Conclusions: The study highlights, that even with the use of modern imaging in preoperative staging, inaccuracies in tumour size assessment remain a common cause of up-/down-staging after surgery resulting in potential inappropriate planning of surgery, and thus in procedure that is either excessively or insufficiently radical.

Trial registration: ClinicalTrials.gov: NCT02494063.

Keywords: Cervical cancer; Clinical staging; FIGO; Guidelines; MRI; Preoperative staging; TNM; Tumour size; Ultrasound.