Results of the IDEA project, a prospective preplanned pooled analysis of 6 concurrently conducted randomized phase III trials, were presented at ASCO 2017. ACHIEVE was one of the 6 trials which compared 3 months (3m) duration with 6 months (6m) duration of oxaliplatin-based adjuvant chemotherapy.
ACHIEVE was an open-label, multicenter trial randomizing patients with stage III colon cancer to receive 3m or 6m of mFOLFOX6/CAPOX after surgery. Choice of regimen was declared before randomization by a site investigator. Primary endpoint was disease-free survival (DFS).
Between August 2012 and June 2014, 1313 patients from Japan were randomized and, of those, 1291 patients were analyzed for analysis. Median age was 66 years; stage distribution was 15% T1-2, 57% T3, and 28% T4 and 26% N2; the highest proportion of patients with CAPOX (75%) among the 6 IDEA trials was included. The frequency of grade 2 or higher neurotoxicity was significantly lower in arm 3m than in arm 6m (14% vs 36%, p
ACHIEVE was the only investigation in Asia among 6 trials and the results were placed into the context of the IDEA collaboration. Short duration significantly decreased neurotoxicity. It is notable that the efficacy results of overall analysis as well as those of subgroup analyses by risk group and study regimen in ACHIEVE were consistent with the results of IDEA.
Clinical trial identification
Legal entity responsible for the study
Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC)
Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC) under contract with Yakult Honsha
T. Yoshino: Research funding from GlaxoSmithKline K.K. and Boehringer Ingelheim GmbH. T. Yamanaka: Honoraria from Chugai Pharmaceutical and Taiho Pharmaceutical. M. Kotaka: Honoraria from Chugai, Yakult, Merk serono, and Takeda. T. Kato: Honoraria from Chugai Pharmaceutical Co., LTD, Takeda Pharmaceutical Company Limited, Eli Lilly and Company, Bayer Yakuhin, Ltd., Sanofi S.A., and Yakult Honsha Company, Limited. A. Ohtsu: Research funding from BMS. All other authors have declared no conflicts of interest.