Abstract 323P
Background
ACHIEVE-2 was conducted as one of four phase III trials for patients with high-risk stage II colon cancer (CC) investigating the duration of adjuvant (adj) oxaliplatin-based therapy in a prospective pooled analysis, IDEA collaboration. The results of the 5-year follow-up are presented here.
Methods
From Feb 2014 to Jan 2017, 525 Asian patients with high-risk stage II CC (T4, inadequate nodal harvest, poorly differentiated, obstruction, perforation, or vascular invasion) were randomly assigned to 3- or 6-month mFOLFOX6/CAPOX treatment after curative surgery. Data analysis followed from Jan to Mar 2022.
Results
Of the 525 randomized patients, 11 were not treated. Among the 514 participants (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received CAPOX and 184 (36%) presented with T4 as a high-risk factor for recurrence. The 5-year disease-free survival (DFS) rates were 86.2% and 84.5% in the 3- and 6-month arms, respectively (hazard ratio [HR] 1.01 [95% CI, 0.64-1.61]). The 5-year overall survival (OS) rates were 93.4% and 91.8% in the 3- and 6-month arms, respectively (HR= 0.99 [95% CI, 0.53-1.85]). With CAPOX, the HR for DFS and OS of the 3-month arm compared with the 6-month arm were 0.98 (95% CI, 0.60-1.59) and 0.88 (95% CI, 0,45-1.73), respectively. Multivariate analysis of the six high-risk factors for recurrence showed that T4, inadequate nodal harvest, and perforation were independent risk factors for both DFS and OS. The rates of any grade of peripheral sensory neuropathy (PSN) lasting 5 years in the 3- vs. 6-month arms were 13.7% vs. 26.8% (P=0.0057). The incidence of PSN lasting 5 years was lower in patients treated with CAPOX than in those treated with mFOLFOX6 in the 6-month arm (25.8% vs. 31.8%; P=0.6033) but not in the 3-month arm (13.5% vs. 15.0%; P=0.7399).
Conclusions
The incidence of long-lasting PSN was significantly lower at 3 months than at 6 months of therapy. As the shortened therapy duration did not compromise the outcomes, a 3-month CAPOX therapy may be appropriate for high-risk stage II CC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Yakult Honsha Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC).
Disclosure
A. Makiyama: Financial Interests, Personal, Invited Speaker: Eli Lilly, Taiho, Ono, Daiichi Sankyo, Bristol-Myers Squibb. K. Yamazaki: Financial Interests, Personal, Invited Speaker: Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, Taiho Pharmaceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD, Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical. M. Kotaka: Financial Interests, Personal, Speaker’s Bureau: Chugai, Yakult Honsha. K. Shitara: Financial Interests, Personal, Advisory Board: Lilly, Bristol-Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Novartis, AbbVie, GlaxoSmithKline, Daiichi Sankyo, Amgen, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Takeda Pharmaceutical Company Limited, Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Astellas, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Chugai Pharmaceutical, MSD, Medi Science, Eisai, Amgen. E. Oki: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Bayer, Eli Lilly, Bristol-Myers Squibb. A. Ohtsu: Financial Interests, Personal, Advisory Board: Chugai, BMS, ONO, Taiho. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai, Merck Biopharma, Bayer, Ono, MSD; Financial Interests, Institutional, Invited Speaker: Ono, Sanofi, Daiichi Sankyo, Chugai, Pfizer; Financial Interests, Institutional, Research Grant: Taiho, MSD, Ono, Amgen, Genomedia, Sysmex, Daiichi Sankyo, Chugai, Boehringer Ingelheim. All other authors have declared no conflicts of interest.