Kanemitsu Y, Shimizu Y, Mizusawa J, et al. - In cases with liver-only metastasis from colorectal cancer (CRC), improvement in disease-free survival (DFS) occurs when provided adjuvant chemotherapy with mFOLFOX6 compared with hepatectomy alone but with induction of severe adverse events in nearly half of the patients. Patients treated with hepatectomy followed by chemotherapy exhibited significantly longer DFS at the interim analysis, so early termination of the trial was done. Uncertainty remains concerning the positive effect of chemotherapy on overall survival.

• Phase 2 or 3 trial (JCOG0603) involving patients (aged 20-75 years) with confirmed CRC and an unlimited number of liver metastatic lesions.

• A total of 300 participants were randomly assigned to hepatectomy alone or 12 courses of adjuvant mFOLFOX6 after hepatectomy.

• Early termination of the trial was done at the third interim analysis of phase 3 with median follow-up of 53.6 months, as patients treated with hepatectomy followed by chemotherapy showed significantly longer DFS.

• The updated 5-year DFS was 38.7% vs 49.8% but the updated 5-year overall survival (OS) was 83.1% vs 71.2% for hepatectomy alone vs hepatectomy followed by chemotherapy, respectively.

• In the chemotherapy arm, neutropenia was the most common grade 3 or higher severe adverse event (50% of patients), followed by sensory neuropathy (10%) and allergic reaction (4%).