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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

Thomas Aparicio  1 , Olivier Bouché  2 , Pierre-Luc Etienne  3 , Emilie Barbier  4 , Laurent Mineur  5 , Romain Desgrippes  6 , Véronique Guérin-Meyer  7 , Fayçal Hocine  8 , Jean Martin  9 , Valérie Le Brun-Ly  10 , Jacques Cretin  11 , Jérôme Desramé  12 , Yves Rinaldi  13 , Laurent Cany  14 , Claire Falandry  15 , Leila Bengrine Lefevre  16 , Miguelle Marous  17 , Eric Terrebonne  18 , Laurent Mosser  19 , Justine Turpin  20 , Anthony Turpin  21 , Lucille Bauguion  22 , Cynthia Reichling  23 , Marc Van den Eynde  24 , Elisabeth Carola  25 , Sandrine Hiret  26
Affiliations
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.

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.

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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

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