Quality of life outcomes after sentinel lymph node biopsy in patients with early-stage cervical cancer: Results from the prospective multicentre SENTIX study.

INTRODUCTION: The prospective SENTIX study (NCT02494063) demonstrated non-inferiority in PFS of sentinel lymph node biopsy (SLNB) without pelvic lymphadenectomy (PLND) compared with the reference rate. We report the final analysis of quality of life (QoL), lower limb lymphoedema (LLL), and postoperative complications. METHODS: Patients with early-stage cervical cancer (tumours ≤4 cm) underwent SLNB. Patients with bilateral SLN detection and negative frozen sections (SLN group; n = 594) did not undergo further lymphadenectomy. Patients with unilateral or unsuccessful SLN detection underwent unilateral or bilateral PLND (PLND group; n = 134), enabling comparison of morbidity, lymphoedema and quality-of-life outcomes. EORTC QLQ-C30 was completed at baseline, 6, 12, and 24 months. LLL was assessed subjectively as patient-reported lymphoedema (S-LLL) and objectively (O-LLL) using circumferential measurements of both limbs. RESULTS: Global Health Status and functional scales were preserved in the SLN group, whereas the PLND group showed small declines in several functional domains that did not reach the threshold for clinical relevance. Fatigue and pain were transient after surgery, resolving by 6-12 months. Severe O-LLL was rare (≤2% of patients in both groups). S-LLL occurred less frequently in the SLN group (7% vs. 16%), and cases of LLL were more often graded as mild after SLNB. Symptomatic lymphoceles were rare, with no difference between groups. Early postoperative complications occurred in 12.5% vs. 21.5% of patients in the SLN and PLND groups (P = 0.01), with most being grade I-II. CONCLUSION: SLNB was associated with preserved QoL, less frequent and milder lymphoedema, and fewer early postoperative complications than PLND.