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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Colorectal) Cancer

Type: Oral Abstract Session

Time: Saturday June 1, 3:00 PM to 6:00 PM

Location: Hall B1

Prospective pooled analysis of four randomized trials investigating duration of adjuvant (adj) oxaliplatin-based therapy (3 vs 6 months {m}) for patients (pts) with high-risk stage II colorectal cancer (CC).


Gastrointestinal (Colorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 3501)

Author(s): Timothy Iveson, Alberto F. Sobrero, Takayuki Yoshino, Ioannis Sougklakos, Fang-Shu Ou, Jeffery P. Meyers, Qian Shi, Mark P. Saunders, Roberto Labianca, Takeharu Yamanaka, Ioannis Boukovinas, Niels Henrik Hollander, Valter Torri, Kentaro Yamazaki, Vassilis Georgoulias, Sara Lonardi, Andrea Harkin, Gerardo Rosati, James Paul, on behalf of the IDEA Collaboration; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; IRCCS Ospedale San Martino IST, Genova, Italy; National Cancer Center Hospital East, Kashiwa, Japan; University of Heraklion, Heraklion, Greece; Mayo Clinic, Rochester, MN; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Department of Health Science Research, Mayo Clinic, Rochester, MN; Christie NHS Foundation Trust, Manchester, United Kingdom; Ospedale Papa Giovanni XXIII, Bergamo, Italy; Yokohama City University School of Medicine, Yokohama, Japan; Bioclinic Thessaloniki Medical Oncology Unit, Athens, Greece; Sygehus Syd Naestved, Naestved, Denmark; IRCCS Istituto Di Ricerche Farmacologiche Mario Negri, Milan, Italy; Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Athens, AZ, Greece; Istituto Oncologico Veneto-IRCCS, Padova, Italy; CRUK, Glasgow, United Kingdom; Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy; Cancer Research UK Clinical Trials Unit, Institute of Cancer Research, University of Glasgow, Glasgow, United Kingdom

Abstract Disclosures


Background: 6m of oxaliplatin-based treatment is an option as adj chemotherapy for patients with high risk stage II CC (T4, inadequate nodal harvest, poorly differentiated, obstruction, perforation or vascular/perineural invasion). The IDEA collaboration showed shorter treatment duration to be appropriate for most pts with stage III colon cancer. The results of the 4 IDEA studies with stage II pts are presented here. Methods: A prospective, pre-planned pooled analysis of high-risk stage II patients from 4 concurrently conducted randomized phase III trials (SCOT, TOSCA, ACHIEVE-2, HORG) was performed to evaluate non-inferiority (NI) of 3m compared with 6m (ref) of adj FOLFOX/CAPOX (regimen preselected, not randomized). The primary endpoint was disease-free survival (DFS), NI was to be declared if the 2-sided 80% confidence interval (CI) for DFS hazard ratio (HR 3m v 6m) estimated by a stratified Cox model was below 1.2. 542 DFS events were required to provide 80% power to declare NI. NI was also examined within regimen, T4 (Yes v No) and inadequate nodal harvest (Yes v No) as pre-planned subgroups. Results: The primary analysis included 3273 randomised pts of which 1254 had FOLFOX and 2019 had CAPOX. There were 552 events and the median follow-up was 60.2 m. There was significantly less grade 3-5 toxicity with 3m treatment (p < .0001). The 5-year DFS rate was 80.7% and 84.0% for 3m and 6m treatment with an estimated DFS HR of 1.18 (80% CI:1.05-1.31, p for NI = 0.404). For CAPOX the estimated HR was 1.02 (80% CI: 0.88-1.17, p for NI = 0.087) and for FOLFOX the estimated HR was 1.42 (80% CI: 1.19-1.70, p for NI = 0.894). The test for interaction between duration and regimen was not statistically significant (p = .174 adjusted for multiple testing) but was stronger than that for the other subgroups examined. Conclusions: In the overall population non-inferiority for 3m adj treatment in pts with high-risk stage II CC was not shown. As with the stage III population the choice of adj regimen appears important (although this did not reach statistical significance) with a small difference in DFS between 3 and 6 m treatment if CAPOX is used. Clinical trial information: ISRCTN59757862.

Other Abstracts in this Sub-Category:


1. Three versus six months adjuvant FOLFOX or CAPOX for high risk stage II and stage III colon cancer patients: The efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant chemotherapy (IDEA) project.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3500 First Author: Ioannis Sougklakos
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional


2. Re-evaluating disease-free survival (DFS) as an endpoint versus overall survival (OS) in adjuvant colon cancer (CC) trials with chemotherapy +/- biologics: An updated surrogacy analysis based on 18,886 patients (pts) from the Accent database.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3502 First Author: Qian Shi
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional


3. FOxTROT: an international randomised controlled trial in 1052 patients (pts) evaluating neoadjuvant chemotherapy (NAC) for colon cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3504 First Author: Matthew T. Seymour
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional