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Randomized, multicenter, phase II trial of compound Chinese herbal extract LC09 versus placebo for external treatment of hand-foot syndrome induced by anticancer therapy.

9049 Background: Hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR) induced by anticancer therapy can impact quality of life (QoL) and may lead to dose modification or treatment interruption, even when the therapy may prove beneficial. The trial was designed to evaluate the efficacy and safety of LC09, an external compound Chinese herbal extract, versus placebo for HFS/HFSR.


METHODS
Eligible patients (pts) with HFS/HFSR grade≥1 (NCI-CTCAE v3.0) after anticancer therapy. Pts were randomly assigned 2:1 to receive LC09 (Arm 1) versus placebo (Arm 2). Pts soaked their hands and feet in LC09 or placebo lotion for 20 minutes, twice daily for 7 days. NCI grade of HFS/HFSR, NRS scale of pain and DLQI (Dermatology Life Quality Index) 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 59 [47-80], male/female was 62/40. NCI Grade was 1/2/3, 4/21/43 in Arm 1, 3/13/18 in Arm 2. Anticancer therapy included Capecitabine (48%), Sorafenib /Sunitinib (34%) and others (18%). In Arm 1/Arm 2, Total response rate was 91.2%/32.3%, CR 25.0%/2.9%, PR 66.2%/29.4%, PD 1.2%/20.6%. The mean score of QoL before and after treatment were 19.90±4.85 and 7.60±5.88 in Arm 1, 17.76±4.67 and 15.41±7.34 in Arm 2 (out of a total of 30, p<0.001). The most significant complaint was pain, the mean score were 5.98±1.87 and 1.99 ±2.05 in Arm 1, 5.15±1.59 and 4.53 ±2.71 in Arm 2 (NRS scale of 0-10, p<0.001). The average time from therapy beginning to pain relieves in Arm 1 was 2.3±1.0 days. The medication compliance was 98.7% in Arm 1,93.3% in Arm 2. No side effect such as allergy or infection related to LC09 was found.


CONCLUSIONS
Compound external Chinese herbal extract LC09 can treat HFS/HFSR, which is safe and especially effective for relieving pain. Thus LC09 had trends towards a higher QoL and towards continuous beneficial anticancer therapy.