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ePoster Display

394P - Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon adenocarcinoma from PRODIGE 34-FFCD 1402-ADAGE randomized phase III trial

Date

16 Sep 2021

Session

ePoster Display

Presenters

Thomas Aparicio

Citation

Annals of Oncology (2021) 32 (suppl_5): S530-S582. 10.1016/annonc/annonc698

Authors

T. Aparicio1, O. Bouche2, P.L. Etienne3, E. Barbier4, L. Mineur5, R. Desgrippes6, F. Hocine7, J.J. Martin8, V. Lebrun-Ly9, J. Crétin10, J. Desrame11, Y. Rinaldi12, L. Cany13, C. Falandry14, E. Terrebonne15, L. Mosser16, M. Pauwels17, A. Turpin18, M. Van den Eynde19, S. Hiret20

Author affiliations

  • 1 Gastroenterology And Digestive Oncology Department, Hôpital Saint Louis AP-HP, 75010 - Paris/FR
  • 2 Digestive Oncology Department, CHU de Reims - Hôpital Robert Debré, 51092 - Reims/FR
  • 3 Oncology, Clinique Armoricaine de Radiologie, 22000 - St. Brieuc/FR
  • 4 Biostatistics, Fédération Francophone de Cancérologie Digestive, 21079 - Dijon/FR
  • 5 Medical Oncology, Institut Ste Catherine, 84082 - Avignon/FR
  • 6 Gastroenterology, C.H. Broussais, 35400 - Saint-Malo/FR
  • 7 Medical Oncology, Centre Hospitalier Simone Veil Beauvais, 60021 - Beauvais/FR
  • 8 Medical Oncology, Clinique Chenieux, 87039 - Limoges/FR
  • 9 Medical Oncology, Centre Hospitalier Universitaire, Limoges/FR
  • 10 Medical Oncology, Oncogard, 30103 - Alès/FR
  • 11 Oncology, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 12 Gastroenterology, Hôpital européen, 13003 - Marseille/FR
  • 13 Medical Oncology, Clinique Francheville, 24000 - Périgueux/FR
  • 14 Geriatrics Department, Lyon Sud Hospital Center, 69495 - Pierre Benite/FR
  • 15 Gastroenterology, CHU Haut Lévèque, 33600 - Pessac/FR
  • 16 Medical Oncology, Centre Hospitalier de Rodez Jacques Puel, 12027 - Rodez/FR
  • 17 Gastroenterology, Private Practice - Mathieu Pauwels, 80094 - Amiens/FR
  • 18 Medical Oncology Department, Hopital Claude Huriez, 59037 - Lille/FR
  • 19 Medical Oncology, Cliniques Universitaires Saint-Luc (UCLouvain), 1200 - Brussels/BE
  • 20 Medical Oncology, Institut de Cancérologie de l'Ouest, Site René Gauducheau, 44805 - Saint-Herblain Cedex/FR
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Abstract 394P

Background

Colon adenocarcinoma occurs mainly in older patients (pts). Oxaliplatin based adjuvant chemotherapy has demonstrated an improvement on disease-free survival (DFS) after a stage III colon cancer resection in young pts. Nevertheless, the benefit of adjuvant chemotherapy is matter of debate in old pts.

Methods

The purpose of ADAGE trial is to compare the DFS obtain with oxaliplatin combined with fluoropyrimidine (F) to F alone in fit pts over 70 years (group 1) and F to observation in frail pts (group 2) after resection of a stage III colon cancer. We here report a preliminary tolerance analysis on 50% of the first pts enrolled in the study.

Results

The analysis was performed on 491 pts (378 in group 1 and 113 in group 2). Main pts characteristics were respectively for the group 1 and 2: male in 57% and 50%, median age of 76 and 83 years, ECOG=0 in 59% and 29%, abnormal IADL in 23% and 62%, no caregiver in 26% and 28%, fall ≤6 months in 9% and 14%, depression possible 28% and 40%, fail of one-leg balance in 20% and 59%, impaired cognition in 21% and 38%, G8 score <14 75% and 94%, undernutrition 35% and 48%. The toxicity was reported in the 434 pts treated excluding the 57 pts in observation arm of group 2. One treatment related death was reported in the doublet chemotherapy arm of group 1. Table: 394P

Group 1: LV5FU2 (n=153) or capecitabine (n=31), n=189 Group 1: FOLFOX (n=166) or XELOX (n=21) n=189 Group 2: LV5FU2 (n=17) or capecitabine (n=30), n=56
Treatment started 98% 98% 84%
At least one cure delayed 56% 67% 60%
Early stop of treatment 18% 21% 38%
Cumulated grade 3-5 26% 58% 40%
Neurologic grade 1-2 / 3-4 20% / 1% 87% / 21% 19% / 4%
Diarrhoea grade 1-2 / 3-4 42% / 4% 49% / 9% 40% / 6%
Mucositis grade 1-2 / 3-4 24% / 1% 25% / 2% 19% / 0%
Vomiting grade 1-2 / 3-4 7% / 1% 13% / 2% 4% / 0%
Neutropenia grade 1-2 / 3-4 18% / 3% 36% / 22% 17% / 6%
Asthenia grade 1-2 / 3-4 59% / 4% 64% / 8% 49% / 11%

Conclusions

Toxicities of adjuvant chemotherapy are manageable in both groups. An early stop of treatment is more frequent in group 2. Severe toxicity of F are more frequent in group 2 than in group 1.

Clinical trial identification

NCT02355379.

Editorial acknowledgement

Legal entity responsible for the study

Fédération Francophone de Cancérologie Digestive.

Funding

Fédération Francophone de Cancérologie Digestive.

Disclosure

T. Aparicio: Financial Interests, Personal, Invited Speaker: Roche; Servier; Sanofi; Amgen; AstraZeneca. O. Bouche: Financial Interests, Personal, Invited Speaker: Merck; Roche; Bayer; AstraZeneca; MSD; Amgen; Servier; Pierre Fabre. F. Hocine: Financial Interests, Personal, Invited Speaker: Ipsen; Pfizer; Sanofi; Merck; Janssen; Novartis. All other authors have declared no conflicts of interest.

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