Article Text
Abstract
Introduction/Background Background The sentinel lymph node (SLN) concept was developed with the purpose of alleviating postoperative morbidity, particularly lower limb lymphedema (LLL). We report the final analysis of the occurrence of LLL after SLN biopsy or systematic pelvic lymph node dissection (PLND) in the prospective SENTIX study.
Methodology SENTIX was conducted at 47 sites in 18 countries. Patients with stages 1A1/LVSI+ to 1B2 (FIGO 2018), usual histological types, and no suspicious lymph nodes on imaging were prospectively enrolled between 05/2016 and 10/2020. All patients underwent SLN biopsy and hysterectomy/trachelectomy. Patients with unilaterally detected/undetected SLNs and those in whom the SLN was intraoperatively positive, underwent systematic PLND. LLL was assessed at 6-month intervals for the period of 2 years. The assessment was based on a persistent limb volume increase [LVI] calculated using serial limb circumference measurements.
Results Among 578 evaluable patients, 486 underwent SLN biopsy only and 92 underwent PLND. The cumulative incidence of LLL at 24 months in the SLN and PLND groups was 28.0% and 29.0% (p=0.900). Persistent LVI >40% occurred at a similar frequency in both groups, with cumulative rates of 1.8% and 1.1% in the SLN and PLND groups, respectively (p=1.0) (figure 1). Although we observed a tendency towards more frequent mild LLL in the SLN group, the difference was not statistically significant (p=0.256). The median interval to LLL onset was 9 months in both groups. Transient oedema that resolved without intervention within 6 months was reported in an additional 15.2% and 13.0% of patients in the SLN and PLND groups, respectively.
Conclusion Severe persistent LLL occurred rarely after surgical pelvic LN staging in cervical cancer patients. Contrary to our expectations, de-escalation from systematic PLND to SLN biopsy was not associated with a significantly decreased risk of mild-to-moderate LLL.