1638_PR - Randomized, Multicenter, Phase II Trial of Compound Chinese Herbal Extract LC07 Versus Placebo for External Treatment of Chemotherapy-Induced Periph...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Supportive Care
Presenter Liqun Jia
Authors L. Jia, Y. Lou, M. Liu, D. Wan, S. Zhu, H. Tan
  • Oncology Department Of Integrative Medicine, China Japan Friendship Hospital, 100029 - Beijing/CN

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) can impact quality of life (QoL) and may lead to dose modification or treatment interruption, even when the therapy may prove beneficial. LC07 is an external compound Chinese herbal extract including Herba Geranii. Preclinical study showed that LC07 could relieve neuropathy pain and reduce pain neurotransmitter release in rats. The mechanism may be connected with Nerve growth factor level promoting and Intraepidermal nerve fiber regeneration. The trial was designed to evaluate the efficacy and safety of LC07, versus placebo for CIPN caused by oxaliplatin. Methods: Eligible patients (pts) with CIPN grade=1 (NCI-CTCAE v3.0) after oxaliplatin therapy. Pts were randomly assigned 2:1 to receive LC07 (Arm 1) versus placebo (Arm 2). Pts soaked their hands and feet in LC07 or placebo lotion for 20 minutes, twice daily for 7 days. Physical examination, NCI grade of CIPN, NRS scale of pain and Impact of pain measurement (NCCN Guidelines for Adult Cancer Pain) were assessed at baseline, and at 1 week. Pts also completed a daily diary to document symptoms, side effects and medication compliance. Evaluation criteria, CR as symptoms disappear completely, PR as NCI Grade decreases more than 1 level, PD as symptoms or Grade increased, Total response rate as CR+PR. Results: 102 pts from 3 centers were enrolled. Arms were well balanced. Median age [range] was 58 [37-80], male/female was 62/40. NCI Grade was 1/2/3, 15/27/26 in Arm 1, 4/16/14 in Arm 2. In Arm 1/Arm 2, Total response rate was 75.36%/33.33%, CR 21.74%/3.03%, PR 53.62%/30.30%, PD 24.64%/66.67%. The mean score of Impact of pain measurement (QoL) before and after treatment were 24.22±13.36 and 11.59±13.40 in Arm 1, 25.74±15.10 and 25.44±16.79 in Arm 2 (out of a total of 70, p<0.001). The most significant complaint was pain, the mean score were 5.51±1.99 and 2.20±2.20 in Arm 1, 5.63±1.79 and 4.50 ±2.44 in Arm 2 (NRS scale of 0-10, p<0.001). The average time from therapy beginning to pain relieves in Arm 1 was 4.54±0.24 days. No side effect such as allergy or infection related to LC07 was found. Conclusions: Compound external Chinese herbal extract LC07 can treat CIPN, which is especially effective for relieving pain, can improve QoL of pts, easy use and safe. Thus may be helpful to continue beneficial anticancer therapy.