Preoperative Peritumoral Infiltration of Local Anesthetic in Patients With Early Breast Cancer: Effect on Survival

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In an Indian trial reported in the Journal of Clinical Oncology, Badwe et al found that peritumoral infiltration of local anesthetic prior to surgery in patients with early breast cancer was associated with improved disease-free and overall survival.

As stated by the investigators, “Preventing metastases by using perioperative interventions has not been adequately explored. Local anesthesia blocks voltage-gated sodium channels and thereby prevents activation of prometastatic pathways.”

Study Details

In the open-label multicenter trial, 1,583 eligible patients planned for upfront surgery without neoadjuvant treatment were randomly assigned between December 2011 and October 2018 to receive a peritumoral injection of 0.5% lidocaine 7 to 10 minutes before surgery (local anesthetics [LA] group, n = 786) or surgery without lidocaine (no-LA group, n = 797). Random assignment was stratified by menopausal status, tumor size, and treatment center. All patients received standard postoperative adjuvant treatment. The primary endpoint was disease-free survival.

Key Points

At a median follow-up of 68 months (range = 0.5–72 months) in surviving patients, disease-free survival events occurred in 109 patients in the LA group vs 146 in the no-LA group. Disease-free survival at 5 years was 86.6% vs 82.6% (hazard ratio [HR] = 0.74, 95% confidence interval [CI] = 0.58–0.95, P = .017).

Death occurred in 79 patients in the LA group vs 110 in the no-LA group. Overall survival at 5 years was 90.1% and 86.4% (HR = 0.71, 95% CI = 0.53–0.94, P = .019).

The benefit of LA was similar across patient subgroups according to menopausal status, tumor size, nodal metastases, hormone receptor status, and HER2 status. Lidocaine injection was not associated with any adverse events.

On competing risk analyses, the 5-year cumulative incidence of locoregional recurrence was 3.4% in the LA group vs 4.5% in the no-LA group (HR = 0.68, 95% CI = 0.41–1.11) and 5-year distant recurrence rates were 8.5% vs 11.6% (HR = 0.73, 95% CI = 0.53–0.99).

The investigators concluded, “Peritumoral injection of lidocaine before breast cancer surgery significantly increases disease-free survival and overall survival. Altering events at the time of surgery can prevent metastases in early breast cancer.”

Rajendra A. Badwe, MS, of Tata Memorial Centre, Mumbai, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by the Department of Atomic Energy, Government of India. For full disclosures of the study authors, visit

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