Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Apr;55(4):541-548.
doi: 10.1016/j.dld.2022.08.036. Epub 2022 Sep 14.

Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon cancer from the PRODIGE 34-FFCD randomized trial

Affiliations
Free article
Randomized Controlled Trial

Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon cancer from the PRODIGE 34-FFCD randomized trial

Thomas Aparicio et al. Dig Liver Dis. 2023 Apr.
Free article

Abstract

Background: Colon adenocarcinoma mainly occurs in older patients. Oxaliplatin-based adjuvant chemotherapy improved disease-free survival after stage III colon cancer resection, but this improvement was not demonstrated in older patients.

Methods: The purpose of ADAGE-PRODIGE 34, randomized open phase III trial is to compare in patients over 70 years oxaliplatin plus fluoropyrimidine with fluoropyrimidine alone in fit patients (Group 1) and fluoropyrimidine with observation in frail patients (Group 2) after resection of stage III colon adenocarcinoma. We report a preliminary tolerance analysis on 50% of the first patients enrolled.

Results: The analysis was conducted on 491 patients (378 in Group 1 and 113 in Group 2). Patients in Group 2 were older and showed more frailty criteria than those in Group 1. Cumulative grade 3-5 toxicities were more frequent in patients treated with oxaliplatin in Group 1 or with fluoropyrimidine in Group 2 than in patients treated with fluoropyrimidine in Group 1. At least one course was deferred in more than half of the patients in all groups. Early treatment cessation was more frequent in Group 2.

Conclusion: No safety concerns were raised for the continuation of accrual. The frailty criteria distribution suggests that the investigator's evaluation for group allocation was accurate.

Keywords: Adjuvant chemotherapy; Colon cancer; Geriatric evaluation; Older.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest Thomas Aparicio declared Honoraria from Sanofi, Roche, Amgen, Servier, Pierre Fabre and Astra Zeneca; Consultancy / Advisory role for Bioven, Pierre Fabre, MSD and Sirtec; Travel accommodations from Roche. Olivier Bouché reports personal fees as a speaker and/or in an advisory role from Merck KGaA, Roche, Bayer, Astra-Zeneca, Grunenthal, MSD, Amgen, Sanofi, Servier, and Pierre Fabre, outside the submitted work. Pierre-Luc Etienne declared Travels and congress accomodations Roche, BMS, Servier, and research honoraria BMS Claire Falandry reported personal fees from Leo Pharma, Pfizer, MSD Oncology, Teva, AstraZeneca, Baxter, Eisai, Janssen Oncology, Novartis, Chugai Pharma, and Astellas Pharma outside the submitted work; grants from Chugai Pharma, Pfizer, Pierre Fabre, and Astellas Pharma outside the submitted work; and non-financial support from Janssen Oncology, Pierre Fabre, AstraZeneca, and Leo Pharma outside the submitted work. Eric Terrebone declared Honoraria from IPSEN, Servier Anthony Turpin declared Honoraria from Pierre Fabre, Servier, Viatris Marc Van den Eynde declared Honoraria from Servier, BMS, MSD, Merck and Amgen. Travel accommodations from MSD. Elisabeth Carola declared Honoraria from EISAI, Pierre Fabre, Pfizer, AMGEN, Lilly, Seagen Novartis, Sanofi. All remaining authors have declared no conflicts of interest

Publication types

MeSH terms

LinkOut - more resources