Long-term lymphedema and quality of life following lymph node staging in early cervical cancer: 3 years follow-up in the prospective multicenter SENTIREC CERVIX study.

BACKGROUND Pelvic lymphadenectomy (PL) is the gold standard in nodal staging in cervical cancer but increases risk of leg lymphedema (LL). Sentinel lymph node (SLN) mapping is a less invasive technique enabling accurate detection of nodal metastases, although evidence confirming its oncological safety has yet to be established. Knowledge on chronic LL and quality of life (QOL) following PL or SLN mapping is essential for qualifying treatment and survivorship strategies in women with cervical cancer but current evidence is limited OBJECTIVES: To evaluate long-term LL after SLN mapping alone and SLN mapping + PL in women with cervical cancer. Further, to examine risk factors for LL and the condition-specific QOL among patients with LL at 12 months follow-up. STUDY DESIGN This national prospective cohort study included patients with early-stage cervical cancer who underwent radical surgery including SLN mapping (2017-2021). In case of tumors >20 mm, back-up PL was performed. Patients completed validated patient-reported outcome questionnaires before surgery and 3, 12, 24, and 36 months postoperatively. LL was assessed by the European Organization of Research and Treatment of Cancer (EORTC) cervix cancer module (QLQ-CX24), supplemented by eight single items from the EORTC item library addressing lymphedema of the legs, genitals, and groins. QOL was reported according to the Lymphedema Quality of Life (LYMQOL) tool, the EORTC QLQ-C30 and the QLQ-CX24 modules. Mean difference scores from baseline to each follow-up were estimated with 95% confidence intervals (CIs), defining a change of 8 points or more as clinically significant. Linear regression models were used to examine predictors of LL 12 months postoperatively. We evaluated QOL within LYMQOL domains in patients with lymphedema and analyzed domain trends using multiple linear regression. We compared QOL in patients with and without LL using guidelines for interpretation of clinically important differences. RESULTS Among 109 women who underwent SLN mapping alone, LL mean score differences from baseline to 3, 12, and 36 months were 6 (95% CI: 2-10), 10 (95% CI: 5-15), and 15 (95% CI: 7-22), respectively. At similar time points, 77 women reported substantial LL after SLN mapping + PL, with mean score differences of 18 (95% CI: 11-25), 29 (95% CI: 21-37), and 21 (95% CI: 11-32). Three-month LL scores were positively associated with LL scores at 12-months regardless of the extent of lymph node removal. BMI predicted LL after SLN mapping alone, whereas chemoradiotherapy was associated with lymphedema following back-up PL. Reporting lymphedema at 12-month follow-up was associated with impairment in several QOL aspects including fatigue, pain, physical, cognitive, social and sexual functioning. CONCLUSION Patients with cervical cancer reported long-term LL, most pronounced after SLN mapping + PL, and to a lesser extent after SLN mapping alone. Three months LL score predicted persistent lymphedema which was significantly associated with deterioration in several QOL symptoms and functioning. Our findings contribute with new knowledge in the field and support less invasive surgical approaches and may qualify shared decision making and survivorship intervention.