The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity: A prospective randomized study

e15056 Background: Oxaliplatin is now considered a standard treatment for advanced or unresectable colorectal cancer, but sensory neurotoxicity is its dose-limiting toxicity. The OPTIMOX (stop and go) approach offers a reasonable strategy, but preventive agent is not established. It is reported that Gosha-jinki-gan (a blended herbal medicine) is recently considered as an effective agent for the neurotoxicity of taxanes and for vibration sensation in patients with diabetic neuropathy. Patients and Methods: From 2007, 32 patients treated with modified FOLFOX6 for advanced or unresectable colorectal cancer were randomized. Fifteen patients received oral administration of 7.5 g/day of Gosha-jinki-gan (G group) every days from first course and 17 patients (Control group) did not. Neurotoxicities were evaluated every course according to DEB-NTC (Neurotoxicity Criteria of DEBIOPHARM) and NCI-CTCAE Ver.3.0 using self-check sheet. Results: The median number of cycles of per patient of G group was 14 (range, 4–26), and that of C Group was 9 (range, 1–20). Cumulative dose of oxaliplatin of two groups was 1,190 mg/m2 (G group) and 765 mg/m2 (C Group). Peripheral neurotoxicity evaluated by DEB-NTC in Group G was grade 0 in 0 patients (0%), grade 1 in 11 (73%), grade 2 in 4 (27%) and grade 3 in 0 (0%) and, in C group, respectively, 1 (6%), 6 (35%), 7 (41%), 3 (18%). According to NCI-CTCAE, neurotoxicity was lower in G group than that of C group. Fifteen patients in G group were evaluated by RECIST criteria with a PR rate of 66.7%, SD rate of 20.0% and PD rate of 13.3%. Seventeen patients in C group were evaluated by RECIST criteria with a PR rate of 52.9%, SD rate of 35.3% and disease control rate of 11.8%. Conclusion: Gosha-jinki-gan is effective for preventing oxaliplatin-induced neuropathy in advanced or unresectable colorectal cancer patients. [Table: see text]