Result of the feasibility study of lidocaine (LDC) for peripheral venous pain induced by oxaliplatin (L-OHP).

Abstract

e21624 Background: For the patients with colorectal cancer, CapeOx or SOX, combination of L-OHP with oral fluoropyrimidines Capecitabine or S-1, is commonly used in clinical practice. These regimens, different from FOLFOX, do not necessarily require central venous port placement and can be administered via peripheral vein. However, peripheral vascular pain induced by administration of L-OHP was discussed. Methods: LDC was concomitantly administered through the lateral duct of drip route from 30 minutes before to end of L-OHP administration, to patients with colorectal cancer who are to be administered L-OHP (100 mg/m2 or more) via the peripheral vein for the first time. LDC dose was set at two levels of 0.5 (Level 1) and 1.5 (Level 2) mg / kg / Hr. Safety, symptoms of pain and pharmacokinetics of LDC were evaluated. The DLT criteria were (1) an allergic reaction of Grade 2 or higher, (2) non-hematological toxicity of Grade 3 or more related to LDC, (3) cessation of administration of L-OHP or LDC, (4) higher than 5 mcg / mL of blood concentration of LDC. Results: A total of nine patients were enrolled (Level 1: 3, Level 2: 6). No DLTs were observed. The average Cmax of LDC was 0.4 (range: 0.3 - 0.5) mcg/ml at Level 1 and 1.3 (0.5 - 2.3) mcg / ml at Level 2. In the pain assessment (VAS score), in Level 1, 2 cases did not feel pain, 1 case was 3/10. In Level 2, there were no pain in 4 cases and 2/10 in the remaining 2 cases. Conclusions: To alleviate vascular pain caused by peripheral intravenous administration of L-OHP, concomitant administration of LDC could be safe and effective. Clinical trial information: UMIN000011393.