As reported in the Journal of Clinical Oncology by Yoshino et al, the final analysis of survival and safety of the Japanese phase III ACHIEVE trial (part of the IDEA Collaboration) has shown no difference in disease-free or overall survival with 3 vs 6 months of adjuvant mFOLFOX6 (fluorouracil, leucovorin, oxaliplatin) or CAPOX (capecitabine, oxaliplatin) in patients with curatively resected stage III colon cancer.
Study Details
In the open-label, multicenter trial, 1,291 patients (modified intent-to-treat population) were randomly assigned between August 2012 and June 2014 to receive 3 months (n = 650) or 6 months (n = 641) of investigator’s choice of mFOLFOX6 (n = 163 vs 159) or CAPOX (n = 487 vs 482).
Disease-free survival at 3 years, the primary endpoint, was previously reported, with no significant difference being observed for 3 vs 6 months of adjuvant therapy.
In Asian patients, shortening adjuvant therapy duration from 6 to 3 months did not compromise efficacy and reduced the rate of long-lasting peripheral sensory neuropathy. In this setting, 3 months of CAPOX therapy is an appropriate adjuvant treatment option.— Yoshino et al
Tweet this quote
Key Findings
Median follow-up for the analysis was 74.7 months. Overall survival at 5 years was 87.0% (95% confidence interval [CI] = 84.2%–89.4%) in the 3-month group vs 86.4% (95% CI = 83.5%–88.9%) in the 6-month group (hazard ratio [HR] = 0.91, 95% confidence interval [CI] = 0.69–1.20, P = .51). Subgroup analysis did not reveal significant interactions between baseline characteristics and treatment duration. Overall survival at 5 years was 83.2% vs 84.6% (HR = 0.99, 95% CI = 0.61–1.60, P = .95) among patients in the 3-month vs 6-month group who received mFOLFOX6 and 88.3% vs 87.0% (HR = 0.87, 95% CI = 0.62–1.22, P = .42) among those who received CAPOX.
Disease-free survival at 5 years was 75.2% (95% CI = 71.7%–78.4%) in the 3-month group vs 74.2% (95% CI = 70.6%–77.5%) in the 6-month group (HR = 0.95, 95% CI = 0.77–1.18, P = .64). Rates were 68.6% vs 69.7% (HR = 1.04, 95% CI = 0.71–1.54, P = .82) among those receiving mFOLFOX6 and 77.4% vs 75.8% (HR = 0.91, 95% CI = 0.71–1.18, P = .49) among those receiving CAPOX.
Peripheral sensory neuropathy lasting longer than 5 years was more common in the 6-month group than the 3-month group (16% vs 8%) and among those receiving mFOLFOX6 vs CAPOX (14% vs 11%).
The investigators concluded, “In Asian patients, shortening adjuvant therapy duration from 6 to 3 months did not compromise efficacy and reduced the rate of long-lasting peripheral sensory neuropathy. In this setting, 3 months of CAPOX therapy is an appropriate adjuvant treatment option.”
Takayuki Yoshino, MD, PhD, of the Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer and by Yakult Honsha Co, Ltd. For full disclosures of the study authors, visit ascopubs.org.
