Effect of age, gender, and performance status (PS) on the duration results of adjuvant chemotherapy for stage III colon cancer: The IDEA collaboration.

Authors

null

Anthony Frank Shields

Karmanos Cancer Institute, Wayne State University, Detroit, MI

Anthony Frank Shields , Fang-Shu Ou , James Paul , Alberto F. Sobrero , Takayuki Yoshino , Julien Taieb , Ioannis Souglakos , Qian Shi , Rachel Kerr , Roberto Labianca , Takeharu Yamanaka , Dewi Vernerey , Ioannis Boukovinas , Takeshi Kato , Valter Torri , Stylianos Kakolyris , Thierry Andre , Axel Grothey , Jeffrey A. Meyerhardt , Timothy Iveson

Organizations

Karmanos Cancer Institute, Wayne State University, Detroit, MI, Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, Cancer Research UK Clinical Trials Unit, Institute of Cancer Research, University of Glasgow, Glasgow, United Kingdom, IRCCS San Martino - IST, Genoa, Italy, National Cancer Center Hospital East, Chiba, Japan, Hôpital Européen Georges-Pompidou, Sorbonne Paris Cite/ Paris Descartes University, Paris, France, Department of Medical Oncology, University Hospital of Heraklion, Faculty of Medicine, University of Crete, Crete, Greece, University of Oxford, Oxford, United Kingdom, Ospedale Papa Giovanni XXIII, Bergamo, Italy, Yokohama City University School of Medicine, Yokohama, Japan, Methodology and Quality of Life Unit, INSERM UMR 1098, University Hospital of Besançon, Besançon, France, Bioclinic Thessaloniki, Thessaloniki, AZ, Greece, Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy, Department of Medical Oncology, University Hospital of Alexandroupoli, Alexandroupoli, AZ, Greece, Saint-Antoine Hospital and Sorbonne Universités, Paris, France, Division of Medical Oncology, Mayo Clinic, Rochester, MN, Dana-Farber Cancer Institute, Boston, MA, University Hospital Southampton, Southampton, United Kingdom

Research Funding

NIH

Background: The IDEA collaboration pooled data from nearly13,000 patients (pts), comparing 3 vs. 6 months (m) of adjuvant fluoropyrimidine plus oxaliplatin to test noninferiority for disease-free survival (DFS) in stage III colon cancer. We reported that duration of adjuvant therapy (Rx) should be individualized with consideration of recurrence risk, regimen, and toxicity. Here we consider the influence of age, gender, and PS. Methods: Using stratified Cox proportional hazard models we stratified the IDEA cohort by age (≤ 70 or > 70), gender, and PS (0 v 1/2), testing for interactions with subgroups and duration of Rx. Results: Overall, DFS results comparing 3 vs 6m of Rx did not significantly differ across age, gender or PS subgroups. However, significant (sig) interactions were detected within subgroups (Table). For pts ≤ 70 who received CAPOX, 3m Rx is as good as 6m (HR 0.9). 6m of Rx is required for pts ≤70 (HR 1.16) with FOLFOX and may be best for pts > 70 on either regimen (p = .068, 3 way interactions). It was found that gender influenced the impact of risk group on the duration comparison (p = .078, 3 way interaction); 3m Rx was as good as 6m for male low-risk pts (HR 0.94) but 6m is required for high risk male (HR 1.18). For females, risk group did not alter the relative merits of 3 v 6m of Rx. PS did not influence the impact of regimen/risk group on the duration comparison. Conclusions: Overall age, gender, or PS didn’t modify the comparison of 3 v 6m Rx. The biologic and clinical rationales for the differences observed within certain subgroups need to be explored before they are used to make treatment choices. Clinical trial information: NCT01150045

Events/TotalHR(3 v 6m)95% CIPi 2-way
Age < = 70FOLFOX1439/58451.161.05-1.29< 0.01
CAPOX917/37590.90.79-1.03
Age > 70FOLFOX505/18131.120.94-1.330.7
CAPOX380/12901.190.97- 1.46
MaleT1-3N1789/42200.940.82-1.080.01
T4 or N21126/29641.181.05-1.33
FemaleT1-3N1523/32471.090.91-1.290.7
T4 or N2809/22901.040.9 -1.20

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

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Local-Regional Disease

Clinical Trial Registration Number

NCT01150045

Citation

J Clin Oncol 36, 2018 (suppl; abstr 3599)

DOI

10.1200/JCO.2018.36.15_suppl.3599

Abstract #

3599

Poster Bd #

92

Abstract Disclosures

Similar Abstracts

First Author: Yoanna S Pumpalova

Abstract

2022 ASCO Gastrointestinal Cancers Symposium

Changes in prescribing patterns in stage III colon cancer (CC) since the IDEA collaboration.

First Author: Daniel Walden