Abstract 407P
Background
The ACHIEVE-2 trial, a part of the IDEA collaboration, was a multicenter study randomizing patients with high-risk stage II resected colon cancer to either 3 or 6 months of mFOLFOX6/CAPOX. Previous our report in the ACHIEVE trial for stage III colon cancer patients (pts) showed that the incidence of long-lasting peripheral sensory neuropathy (PSN) was significantly lower for 3 months (3m) of therapy than for 6 months (6m) of therapy. More importantly, the incidence of long-lasting PSN was significantly lower for CAPOX than for FOLFOX. The present study aimed to evaluate the incidence of long-lasting PSN in the 3m arm as compared to the 6m arm in the ACHIEVE-2 trial.
Methods
ACHIEVE-2 enrolled 514 patients. The incidence of PSN was evaluated every 3m up to three years. The grade of PSN was assessed using CTCAE ver 4.0.
Results
During the study treatment, PSN of grade 2/3 was observed more frequently in the 6m arm (36%/7%) than in the 3m arm (17%/1%). At two years from randomization, PSN of grade 1/2/3 lasted in 34%/2%/0% of pts in the 6m arm, whereas 20%/2%/0% of pts in the 3m arm. At three years, PSN of grade 1/2/3 lasted in 27%/2%/0% of pts in the 6m arm whereas 19%/1%/0% of patients in the 3m arm. Thus, PSN ≥ grade 1 was significantly less frequent in the 3m arm than in the 6m arm at two years (22% vs 36%, P=0.0049) and tended to be less frequent at three years (20% vs 29%, P=0.1630). Moreover, PSN ≥ grade 1 lasting for 3 years tended to be lower for CAPOX than for mFOLFOX6 in both the 3m (19% vs 25%, P=0.7375) and 6m arms (26% vs 47%, P=0.1252).
Conclusions
The present study for high-risk stage II colon cancer showed that the incidence of long-lasting PSN was significantly lower for 3 months of therapy than for 6 months of therapy. Further, we confirmed a similar trend that the incidence was lower for CAPOX than for mFOLFOX6, although the result was not statistically significant due, possibly, to a lack of power. The role of regimen on long-lasting PSN is still a topic of ongoing debate and our result may warrant a further analysis using the whole data of the IDEA Collaboration.
Clinical trial identification
UMIN000013036.
Editorial acknowledgement
Legal entity responsible for the study
The Japanese Foundation for Multidisciplinary Treatment of Cancer.
Funding
Yakult Honsya.
Disclosure
M. Kotaka: Honoraria (self): Yakult Honsya; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Takeda Pharmaceutical. A. Makiyama: Advisory/Consultancy: Eli lilly; Speaker Bureau/Expert testimony: Eli lilly; Speaker Bureau/Expert testimony: Chugai; Speaker Bureau/Expert testimony: Takeda. K. Shitara: Advisory/Consultancy, Research grant/Funding (self): Astellas; Advisory/Consultancy, Research grant/Funding (self): Lilly; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Ono; Advisory/Consultancy, Research grant/Funding (self): MSD; Advisory/Consultancy, Research grant/Funding (self): Taiho; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: AbbVie; Advisory/Consultancy: GlaxoSmithKline; Research grant/Funding (self): Sumoitomo Dainippon; Research grant/Funding (self): Daiichi Sankyo; Research grant/Funding (self): Chugai; Research grant/Funding (self): Medi Science; Honoraria (self): Yakult. E. Oki: Speaker Bureau/Expert testimony: Chugai Pharm; Speaker Bureau/Expert testimony: Yakult Honsha; Speaker Bureau/Expert testimony: Taiho Pharm; Speaker Bureau/Expert testimony: Eli Lilly; Speaker Bureau/Expert testimony: Bayer; Speaker Bureau/Expert testimony: Merck Biopharm; Speaker Bureau/Expert testimony: Takeda Pharm. T. Yamanaka: Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self), Research grant/Funding (self): Bayer. K. Yamazaki: Honoraria (self): Yakult Honsha; Honoraria (self): Chugai Pharma. A. Ohtsu: Honoraria (self), Research grant/Funding (self): BMS; Honoraria (self): Ono Pharma; Honoraria (self): Taiho; Honoraria (self): Chugai. T. Yoshino: Research grant/Funding (self): Novartis Pharma K.K.; Research grant/Funding (self): MSD.K.K.; Research grant/Funding (self): Sumitomo Dainippon Pharma Co., Ltd.; Research grant/Funding (self): Chugai Pharmaceutical Co., Ltd.; Research grant/Funding (self): Sanofi K.K.; Research grant/Funding (self): Daiichi Sankyo Company, Limited; Research grant/Funding (self): Parexel International Inc.; Research grant/Funding (self): Ono Pharmaceutical Co., Ltd.; Research grant/Funding (self): GlaxoSmithKline K.K. All other authors have declared no conflicts of interest.