Objectives Despite the growing evidence of sentinel lymph node mapping (SLN) in endometrial cancer, studies addressing morbidity and impact on quality of life (QoL) are still scarce. Our aim was to evaluate treatment morbidity and QoL for SLN ± systematic lymph node dissection (LND) in endometrial cancer.

Methods We performed an interim analysis of ALICE trial (NCT03366051), randomized controlled non-inferiority trial on SLN±LND. For the present analysis we included patients excluded from randomization (e.g.low-risk) that underwent only SLN (n=83). High-risk patients were randomly assigned to SLN (n=33) or SLN+LND (n=37). Complications were classified by Clavien-Dindo score and QoL by the EORTC QLQ30 and Cx24.

Results Total of 153 women were analyzed. Patients that received SLN+LND had overall more early complications (≤30days) compared to SLN (32% vs. 14.1%;p=0.011), being grade ≥3 of 5% and 0.8%, respectively. We found no difference in median score of global health status at baseline and during follow-up time at 1, 6 and 12 months. At 1 month of follow-up, the scores of physical functioning (p=0.02), social functioning (p=0.008), symptoms scales (p=0.008), constipation (p=0.001) and a sexual worry (p=0.004) were all worse for SLN+LND group. Moreover, physical functioning score maintained worse for SLN+LND group at 6 and 12months of follow-up. Regarding lower limb lymphedema, we noted a worse mean score for SLN+LND at 12 months of follow-up compared to SLN (p=0.01).

Conclusions We found that addition of LND to SLN increased the early complication rates and was related to a worse QoL scores, including for lower limb lymphedema.