Preventive effect of a traditional Japanese Kampo medicine, <i>shakuyakukanzoto</i>, against neurotoxicity of <scp>FOLFOX</scp> plus bevacizumab used for metastatic colorectal cancer management: A single‐arm phase <scp>II</scp> study

Abstract Aim 5‐Fluorouracil/folinic acid and oxaliplatin plus bevacizumab (FOLFOX + BV) is a standard chemotherapy regimen for metastatic colorectal cancer (mCRC). This study was aimed at evaluating the preventive effects of shakuyakukanzoto against oxaliplatin‐induced neurotoxicity associated with FOLFOX BV administration. Methods In this single‐arm, open‐label, phase II clinical trial, we enrolled patients previously untreated, histologically confirmed mCRC from six hospitals in Japan who were aged 20 years older had an Eastern Cooperative Oncology Group performance status 0–1. The received 2.5 g thrice daily, orally, until disease progression and/or unacceptable toxicity noted. primary endpoint incidence following administration dose 500 mg/m 2 . Neurotoxicity evaluated according to Criteria Debiopharm (DEB‐NTC). trial registered UMIN Clinical Trials Registry (UMIN000001853). Results Forty‐one non‐pretreated included between April 2009 September 2013. At , DEB‐NTC grade 1–2 developed 25.0% patients; no patient 3 neurotoxicity. most common 3/4 adverse events neutropenia (34.1%), hypertension (24.4%), fatigue (9.8%). response rate 38 measurable lesions 55.2%. median progression‐free overall survival 14.9 35.2 months respectively. Conclusion Shakuyakukanzoto substantially reduced without negatively affecting tumor or BV‐treated CRC.