Abstract 4P
Background
Radiotherapy plays a significant role in reducing the risk of local recurrence in the affected breast and regional lymph nodes in breast cancer patients. However, this treatment approach is associated with side effects. This clinical trial aimed to explore the efficacy of melatonin administration compared to a placebo in managing fatigue induced by radiation therapy in breast cancer patients.
Methods
A retrospective multicenter cohort analysis and a meta-analysis were conducted. For the individual patient-level analysis, patients initially presenting with cN0 or cN+ breast cancer who remained or converted to ycN0 after NST between 2011 and 2022 from two hospitals were identified. Patients were divided into the SLNB-alone group and the ALND group. The primary endpoints were disease-free survival (DFS) and overall survival (OS). Inverse probability of treatment weighting (IPTW) was applied to balance baseline characteristics between groups. Additionally, a meta-analysis was conducted to verify the results.
Results
A total of 1381 patients were included in the individual patient-level analysis, among whom 461 patients received SLNB alone and 920 underwent ALND. After a median follow-up of 34.2 (range 1.2-142.6) months, no significance differences in DFS, OS, local recurrence-free survival, regional recurrence-free survival, or distant metastasis-free survival (DMFS) were observed between SLNB alone and ALND post-NST. Among patients with initially cN+ disease that converted to ycN0 after NST, no significant differences were found in long-term survival between the two treatment groups. For the meta-analysis, 20 eligible studies, covering 36973 patients, were included. Pooled analyses revealed no difference in DFS (hazard ratio [HR] 0.84, 95% CI 0.53-1.34, p=0.466), OS (HR 0.99, 95%CI 0.79-1.26, p=0.965), and DMFS (HR 0.83, 95%CI 0.55-1.26, p=0.389) between the SLND-alone and ALND groups.
Conclusions
SLNB alone were comparable to ALND in long-term outcomes for patients initially presenting with cN0 or cN+ breast cancer who remained or converted to ycN0 after NST. This suggests that SLNB alone can safely substitute ALND without compromising long-term outcomes in appropriately selected patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.