Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer.
Level 2 - randomized trial
Multicenter randomized controlled trial
PubMed 37023374 · doi:10.1200/JCO.22.01966
What was done
An open-label, multicenter randomized controlled trial evaluated whether injecting local anesthesia around the tumor before surgery improves survival in women with early breast cancer undergoing upfront surgery without neoadjuvant therapy. A total of 1,600 patients were randomized to receive peritumoral infiltration of 0.5% lidocaine 7-10 minutes prior to surgery or surgery without lidocaine. Random assignment was stratified by menopausal status, tumor size, and center. Participants received standard postoperative adjuvant treatment. Primary and secondary endpoints were disease-free survival and overall survival.
What was found
Among 1,583 evaluable patients (796 lidocaine arm, 804 no lidocaine arm) followed for a median of 68 months, there were 255 disease-free survival events (109 vs 146) and 189 deaths (79 vs 110). Five-year disease-free survival was 86.6% with lidocaine versus 82.6% without lidocaine (HR 0.74; 95% CI, 0.58 to 0.95; P = .017). Five-year overall survival was 90.1% versus 86.4% (HR 0.71; 95% CI, 0.53 to 0.94; P = .019). Five-year cumulative incidence of distant recurrence was 8.5% versus 11.6% (HR 0.73; 95% CI, 0.53 to 0.99), and locoregional recurrence was 3.4% versus 4.5% (HR 0.68; 95% CI, 0.41 to 1.11). No adverse events occurred because of lidocaine injection.
Why it matters
A simple, low-cost peritumoral injection of lidocaine minutes before surgery reduces recurrence and improves 5-year survival in early breast cancer.
Limits
The trial was open-label with no sham or saline injection control. Patients receiving neoadjuvant systemic therapy were excluded, limiting generalizability to upfront surgical cases.