The management of patients with intraoperatively detected positivity of pelvic lymph nodes (LN) remains controversial. Namely, a combination of extensive surgical dissection in the pelvis followed by pelvic radiotherapy is associated with higher morbidity. Goal of ABRAX multicentric, retrospective, cohort study was to determine whether the completion of radical hysterectomy improves oncological outcome of such patients.
A total of 515 cervical cancer patients, who intraoperatively turned to be LN positive, referred for primary surgery with a curative intent between 2005 and 2015 (stage IA-IIB, common tumour types) were retrospectively analysed in 51 institutions from 19 countries. LNs with metastasis ≥2 mm were considered positive (N1). Completion (COMPL group, n=361) or abandonment (ABAND group, n=154) of planned uterine surgery stratified the cohort in two subgroups in which oncological outcomes and major prognostic factors were evaluated. 91.4% of COMPL group underwent adjuvant chemoradiation, 100% of ABAND group were treated with primary chemoradiation.
Disease free survival reached 74% (381/515) in the whole cohort with the median follow-up of 48.9 months. Both groups (ABAND and COMPL) were balanced in main prognostic factors (tumour size, tumour type, stage of disease). No significant difference was found between the groups in the risk of recurrence (HR=1.154; p=0.446), local recurrence (HR=0.836; p=0.557), or death (HR=1.064; p=0.779). Subgroup analyses did not identify any cohort with survival benefit from radical surgery completion. Increasing FIGO stage and tumour size ≥4 cm were identified as major prognostic factors for recurrence and survival in the whole cohort.
ABRAX trial revealed that completion of radical hysterectomy in patients with intraoperative detection of positive lymph node does not improve the survival; recurrence risk is not decreased irrespective of tumour size or tumour type. Therefore, if pelvic LN involvement is diagnosed at surgery, abandonment of planned uterine procedure should be considered and the patient should be referred to definitive chemoradiation.
Clinical trial identification
NCT04037124; July 30, 2019.
Legal entity responsible for the study
Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1), and the Czech Research Council (No 16-31643A).
All authors have declared no conflicts of interest.