Effect of Kampo medicine Juzen-taiho-to on adverse events induced by cetuximab.

396 Background: Cetuximab is now considered a standard treatment for advanced or unresectable colorectal cancer, unfortunately patients suffer a skin reaction as the main indication of the toxicity of cetuximab. It is recently reported that Kampo medicine (Goshajinkigan) is considered to be an effective agent for the neuropathy of oxaliplatin. Kampo medicine “Juzen-taiho-to” (TJ-48, Tsumura CO. Ltd.), which consists of 10 component herbs, is known as a tonic agent which improves the general systemic condition of cancer patients by reducing the adverse effects of chemotherapy, radiation therapy, and surgical treatment and to inhibit metastases. The aim of this study was to clarify the efficacy of TJ-48 for adverse events associated with cetuximab therapy. Methods: From 2009, cetuximab was administered initially at a dose of 400 mg/m2 followed by weekly infusions at 250 mg/m2 to 20 patients with non-resectable or recurrent colorectal cancer. Eighteen patients received oral administration of 7.5 g/day of TJ-48 (TJ-48 group) every day in the first course and 7 patients did not receive TJ-48 (Control group). Adverse events were evaluated for every course according to CTCAE version 3.0. Results: There was no statistically significant difference between the two groups based on any of patient characteristics. No patients complained of persistent Grade 3 infusion reaction. The percentage of Grade 2 or more skin reactions in each course tended to be lower in the TJ-48 group compared with the Control group (TJ-48 group 34% vs control group 57%). Incidence of Grade 2 anorexia in the TJ-48 group was significantly lower than in the Control group (TJ-48 group 34% vs control group 71%, p=0.03). There were no differences regarding tumor response between the two groups. Conclusions: TJ-48 is useful to prevent anorexia in non-resectable or recurrent colorectal cancer patients treated with cetuximab regimen. [Table: see text]