Background: In recent decades, numerous trials have shown a similar benefit between completing the axillary dissection or performing only a biopsy on patients with sentinel-note metastasis but clinically with node-negative axilla. Aiming to reinforce these results by gathering data from an extensive population, we conducted a meta-analysis of randomised controlled trials (RCTs) and a trial sequential analysis (TSA) on the theme.
Methods: We searched the PubMed, Embase and Cochrane databases through May 2024 for studies comparing omission to complete axillary dissection in patients with breast cancer with sentinel-node metastasis. We computed odds ratios (ORs) for binary endpoints and mean differences (MDs) for continuous outcomes, with 95% confidence intervals (CIs). Heterogeneity was assessed using I2 statistics.
Results: Eight trials were reported in 16 studies comprising 7788 patients, of whom 3933 (50.5%) underwent omission of axillary dissection. The intervention group had a lower number of cancer-related deaths (OR 0.69; 95% CI 0.53, 0.89; I2 = 0%; p = 0.004), confirmed by the TSA. However, there were no significant differences between the groups overall (HR 0.97; 95% CI 0.77, 1.23; I2 = 36%; p = 0.82) and disease-free survival over 10 years (HR 0.97; 95% CI 0.76, 1.24; I2 = 61%; p = 0.81). The recurrence incidence (OR 0.96; 95% CI 0.77, 1.21; I2 = 0%; p = 0.74) was also similar between the groups.s.
Conclusion: Our findings suggest that omitting axillary dissection does not compromise overall or disease-free survival at 10 years. Moreover, the intervention group showed a positive trend with fewer cancer-related deaths, and the recurrence incidence was similar between the groups The study supports omitting axillary dissection for selected patients to reduce surgical morbidity without compromising oncological outcomes. Further research and longer follow-up are needed to confirm these findings and refine patient selection criteria.