Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon cancer from the PRODIGE 34-FFCD randomized trial - Inserm - Institut national de la santé et de la recherche médicale Accéder directement au contenu
Article Dans Une Revue Digestive and Liver Disease Année : 2023

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

1 AP-HP - Hopital Saint-Louis [AP-HP]
2 Hôpital Robert Debré
3 HPCA - Hôpital Privé des Côtes d'Armor
4 LNC - Lipides - Nutrition - Cancer (U866)
5 DIM - Service Biostatistiques et Informatique Médicale (CHU de Dijon)
6 FFCD - Fédération Francophone de Cancérologie Digestive
7 Institut Sainte Catherine [Avignon]
8 CH de Saint-Malo [Broussais]
9 CRLCC Paul Papin - CRLCC - Centre Paul Papin
10 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
11 Centre Hospitalier Simone Veil de Beauvais [Beauvais]
12 Clinique François Chénieux
13 Hôpital Dupuytren [CHU Limoges]
14 Instit Cancéro - GARD - Institut de Cancérologie du GARD ICG - CHU Nîmes
15 Hôpital privé Jean Mermoz [Lyon]
16 Hôpital Européen [Fondation Ambroise Paré - Marseille]
17 Clinique Francheville [Périgueux]
18 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
19 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
20 Service d'oncogénétique [Centre georges-François Leclerc]
21 CHU de la Martinique [Fort de France]
22 Hôpital Haut-Lévêque [CHU Bordeaux]
23 HJPB - Hôpital Jacques Puel - Bourran [Rodez]
24 Clinique Sainte Isabelle [Abbeville, France]
25 Service d'oncologie médicale (CHRU Lille)
26 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
27 CH Colmar
28 Cliniques Universitaires Saint-Luc [Bruxelles]
29 GHPSO - Groupe Hospitalier Public du Sud de l'Oise [Creil]
30 CRLCC René Gauducheau
31 Département d'oncologie médicale [Saint Herblain]
C. Reichling
  • Fonction : Auteur

Résumé

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.
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Dates et versions

inserm-03986083 , version 1 (13-02-2023)

Identifiants

Citer

T. Aparicio, O. Bouché, P. L. Etienne, E. Barbier, L. Mineur, et al.. Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon cancer from the PRODIGE 34-FFCD randomized trial. Digestive and Liver Disease, 2023, 55 (4), pp.541-548. ⟨10.1016/j.dld.2022.08.036⟩. ⟨inserm-03986083⟩
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