576P - Adverse events in elderly patients on adjuvant therapy with UTF/LV or S-1 for stage III colon cancer: ACTS-CC trial [TRICC0706]
|Date||01 October 2012|
|Event||ESMO Congress 2012|
|Session||Poster presentation III|
|Topics|| Complications of Treatment
M. Ishiguro1, H. Uetake2, T. Ishikawa2, Y. Kusunoki3, F. Kinoshita3, N. Kashiwagi3, Y. Nagata3, Y. Matsubara3, K. Sugihara4
The ACTS-CC trial is a phase III trial designed to validate non-inferiority of S-1 to UFT/ LV, a standard adjuvant therapy for stage III colon cancer in Japan. We reported the safety profile of this trial (Brit J Cancer 2012). To clarify the characteristics of adverse events (AEs) in elderly patients, subgroup analysis was performed.Methods
20-80 aged patients with stage III colon cancer were randomly assigned to receive UFT/LV (UFT: 300 to 600 mg/day and, LV: 75 mg/day on days 1-28, followed by 7 days rest, 5 courses) or S-1 (80 to 120 mg/day on days 1-28, followed by 14 days rest, 4 courses). We compared treatment status and safety among group A (age ≤ 70), group B (age 71-75) and group C (age 76-80).Results
A total of 1,504 patients (756 in S-1 group, 748 in UFT/LV group,) were analyzed. The numbers of patients of group A, B and C were 506 (69%), 160 (20%) and 90 (11%), and the rates of patients with PS 1 in each group were 2.6%, 4.3% and 16.8%, respectively.
Pre-treatment value of Hemoglobin of group B and C was lower than that of group A, while there were no differences in that of neutrophils, platelets and creatinine.
In S-1 treatment, incidences (any grades) of anemia (group A: 29%, B: 37%, C: 47%), anorexia (30%, 34%, 46%) and fatigue (25%, 29%, 39%) were higher in group C. In ≥ grade 3 AEs, incidences of anorexia (3%, 7%, 13%), diarrhea (4%, 3%, 7%) and fatigue (2%, 3%, 7%) were higher in group C.
In UFT/LV treatment, incidence (any grades) of anorexia (22%, 33%, 30%) and anemia (24%, 32%, 35%) were higher in group B and C, while incidence of elevation of AST (23%, 15%, 12%) and ALT (25%, 15%, 12%) were higher in group A.
The completion rates of S-1 treatment was lower in group C (group A: 78%, B: 77%, C: 69%), although those of UFT/LV did not differ among the groups. There was no difference in the rate of discontinuation due to AEs listed on the discontinuation criteria among the groups, while that due to AEs not listed on the criteria (i.e. physician's judgment or patient's request) was higher in group C.Conclusions
In elderly patients, subjective AEs such as anorexia and fatigue were common, and mild anemia was observed in one-third of ≥71 aged patients.Disclosure
All authors have declared no conflicts of interest.