Impact of high-risk features on disease-free survival (DFS) in patients (pts) with high-risk stage II colon cancer (CC) in ACHIEVE-2 trial as part of the IDEA collaboration.

Authors

null

Dai Manaka

Kyoto Katsura Hospital, Kyoto, Japan

Dai Manaka , Manabu Shiozawa , Masahito Kotaka , Makio Gamoh , Akio Shiomi , Akitaka Makiyama , Yoshinori Munemoto , Toshiki Rikiyama , Mutsumi Fukunaga , Takashi Ueki , Kohei Shitara , Hiroshi Shinkai , Nobuyuki Tanida , Eiji Oki , Kentaro Yamazaki , Eiji Sunami , Takeharu Yamanaka , Takayuki Yoshino , Atsushi Ohtsu , Yoshihiko Maehara

Organizations

Kyoto Katsura Hospital, Kyoto, Japan, Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan, Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan, Department of Medical Oncology, Osaki Citizen Hospital, Osaki, Japan, Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan, Department of Hematology/Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan, Fukui-ken Saiseikai Hospital, Fukui, Japan, Jichi Medical University, Saitama, Japan, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan, Department of Surgery, Hamanomachi Hospital, Japan, Fukuoka, Japan, National Cancer Center Hospital East, Kashiwa, Japan, Department of Surgery, Chigasaki Municipal Hospital, Japan, Kanagawa, Japan, Department of Surgery, Japanese Red Cross Kochi Hospital, Kochi, Japan, Kyushu University, Fukuoka, Japan, Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan, Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan, Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan, Kyushu Central Hospital, Fukuoka, Japan

Research Funding

No funding received
None

Background: The IDEA collaboration for high-risk stage 2 colorectal cancer patients (pts) demonstrated that for CAPOX, 3 months was non-inferior to 6 months treatment, while for FOLFOX, 6 months was superior to 3 months treatment. We investigated the impact of high risk features on disease-free survival (DFS). Methods: ACHIEVE-2, one of the 4 IDEA studies (SCOT, TOSCA, ACHIEVE-2, HORG), was an open-label, multicenter randomized trial for high-risk stage II colon cancer. High risk features are defined as one or more: T4, inadequate nodal harvest < 12, poorly differentiated, clinical sign of obstruction and perforation or vascular invasion. The association of high risk features with DFS were measured by Cox regression analyses. Results: Between 2014 and 2017, ACHIEVE-2 enrolled 525 pts, out of whom 514 pts were the modified ITT (mITT) population; 432 received CAPOX (84.0%) and 82 did mFOLFOX6 (16.0%). High-risk features included 35.8% of T4, 12.8% of inadequate nodal harvest, 11.5% of poorly differentiated, 19.3% of obstruction, 6.4% of perforation and 87.5% of vascular invasion; 47.3% had one features, 35.2% had two, 14.6% had three, and 2.9% had four or more. With a median follow-up of 36.1 months, 3-year DFS rates were 88% in both arms, with a hazard ratio (HR) of 1.12 (95% CI, 0.67-1.87, p=0.67). In multivariate analysis, T4 (HR 3.77 [2.18-6.53], p< 0.0001) and inadequate nodal harvest (HR 2.98 [1.59-5.59], p= 0.0006) remained independent significant negative prognostic factors. The 3-year DFS rates in T4 and Non-T4 diseases were 78% and 94% (p<0.0001), while 3-year DFS rate in pts with inadequate and adequate nodal harvest were 77% and 90% (p=0.0059). No interaction was observed between treatment duration and T4 or inadequate nodal harvest. Conclusions: Our findings indicated the relative impact of high risk features on DFS varies across factors; T4 and inadequate nodal harvest < 12 were more significant than the others. Our results must be interpreted within the combined analysis as well as within the reproducibility of results across the 4 trials. Clinical trial information: 000013036.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Discussion Session

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Other Colorectal and Anal Cancer

Clinical Trial Registration Number

000013036

Citation

J Clin Oncol 38: 2020 (suppl; abstr 4011)

DOI

10.1200/JCO.2020.38.15_suppl.4011

Abstract #

4011

Poster Bd #

3

Abstract Disclosures

Similar Abstracts

First Author: Zehua Wu

First Author: Van K. Morris II

First Author: Manish A. Shah