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.