As reported in the Journal of Clinical Oncology by Kanemitsu et al, long-term results of the Japanese phase II/III JCOG0603 trial showed that the addition of adjuvant mFOLFOX6 to hepatectomy did not improve overall survival vs hepatectomy alone in patients with liver-only metastases from colorectal cancer.
In the primary analysis from the trial, the addition of adjuvant mFOLFOX6 was associated with improved disease-free survival.
Study Details
In the multicenter trial, 300 patients with any number of liver metastases were randomly assigned between March 2007 and January 2019 to receive hepatectomy plus adjuvant chemotherapy (n = 151) or hepatectomy alone (n = 149). Overall survival was a secondary endpoint.
Median follow-up was 7.7 years for surviving patients. Death occurred in 54 patients (35.8%) in the chemotherapy group vs 51 (34.2%) in the control group (hazard ratio [HR] = 1.07, 95% CI = 0.73–1.57). Five-year overall survival was 73.4% (95% CI = 65.5%–79.7%) vs 80.1% (95% CI = 72.6%–85.7%) and 7-year overall survival was 69.4% (95% CI = 61.2%–76.2%) vs 72.4% (95% CI = 64.2%–79.1%).
Disease-free survival at 5 years was 49.7% (95% CI = 41.5%–57.3%) in the chemotherapy group vs 40.5% (95% CI = 32.5%–48.3%) in the control group (HR = 0.72, 95% CI = 0.54–0.97).
The investigators concluded: “Long-term [overall survival] did not differ with adjuvant mFOLFOX6 compared with hepatectomy alone in resectable [colorectal cancer liver metastases]. Adjuvant mFOLFOX6 may delay recurrence but did not improve long-term survival.”
Yukihide Kanemitsu, MD, of National Cancer Center Hospital, Tokyo, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by National Cancer Research and Development Funds and a Health and Labour Sciences Research Grant for Clinical Cancer Research. For full disclosures of the study authors, visit ascopubs.org.
