Abstract

Objective. To evaluate the efficacy of Goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients. Patients. Colorectal cancer patients (N = 29) who received ≥4 weeks of Goshajinkigan for oxaliplatin-induced peripheral neuropathy during chemotherapy at Kyoto Prefectural University of Medicine were (Goshajinkigan group) compared to 44 patients who had not received Goshajinkigan during the same period (non-Goshajinkigan group). Main Outcome Measures. The effect of Goshajinkigan was graded as curative, effective, stabilizing, or deleterious. The relationships between the grade of peripheral neuropathy and the dose of oxaliplatin in the Goshajinkigan and non-Goshajinkigan groups were evaluated. Results. The effect of Goshajinkigan on peripheral neuropathy in the Goshajinkigan group was curative, effective, stabilizing, and deleterious in 3.4, 20.7, 69.0, and 6.9% of patients, compared to the effect in the non-Goshajinkigan group (4.5, 15.9, 45.5, and 34.1%). The ratio of deleterious effects was significantly different between these two groups (P = 0.04). A Kaplan-Meier analysis in relation to the cumulative dose of oxaliplatin showed that the incidence of grade 3 peripheral neuropathy tended to be less in the Goshajinkigan group (P = 0.05). There were no significant differences in time to treatment failure and severe adverse events between these two groups. Conclusions. Goshajinkigan prevented exacerbation of oxaliplatin-induced peripheral neuropathy. This trial is registered with UMIN000009956

Highlights

  • Oxaliplatin-based chemotherapy regimens such as XELOX (CapeOX) and FOLFOX have gained acceptance worldwide as first-line therapies in advanced or recurrent colorectal cancer; subsequently, the incidence of the often intractable oxaliplatin-induced peripheral neuropathy continues to rapidly increase [1]

  • In Japan, Kampo medicines such as Goshajinkigan (GJG) that have been approved by the Ministry of Health, Labor, and Welfare as pharmaceutical drugs are used for the management of peripheral neuropathy

  • In the GJG group, the effect of GJG administration for the treatment of peripheral neuropathy was curative in 1 patient (3.4%), effective in 6 (20.7%), stabilizing in 20 (69.0%), and deleterious in 2 (6.9%) (Table 2)

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Summary

Introduction

Oxaliplatin-based chemotherapy regimens such as XELOX (CapeOX) and FOLFOX have gained acceptance worldwide as first-line therapies in advanced or recurrent colorectal cancer; subsequently, the incidence of the often intractable oxaliplatin-induced peripheral neuropathy continues to rapidly increase [1]. GJG may enhance nitric oxide production and thereby increase blood circulation while inhibiting blood coagulation. Taken together, these molecular events suggest enhanced blood supply to the nerve and the activation of an endogenous pain modulating system [10, 11]. A recent report by Ushio et al showed that GJG relieves oxaliplatin-induced cold hyperalgesia and mechanical allodynia without affecting the antitumor activity of oxaliplatin in rats [12]. A few studies indicated that GJG is effective against oxaliplatin-induced peripheral neuropathy in colorectal cancer patients [13,14,15,16]. We evaluated the efficacy of GJG for the treatment of oxaliplatin-induced peripheral neuropathy

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