Elderly patients are often underrepresented in clinical trials, leading to uncertainties in the treatment of these patients in the clinical routine.
The prospective non-interventional study GIDEON allows analyzing a German real world patient collective treated with afatinib according to label. This analysis focusses on patients older than 70 years.
Patients older than 70 years account for 44% of the GIDEON study population (n = 67). Main EGFR mutation in this population was Del.19 (n = 43, 64%), followed by L858R und rare mutations (both n = 12, 18%). Brain metastases at baseline were detected in 22% of patients (n = 15). Afatinib dose was reduced in 55% (n = 37) of all patients older than 70 years and in 58% of patients younger than 70 years. The percentage of patients who received a starting dose of afatinib lower than 40mg was higher in the elderly population (n = 25, 37%) compared to patients younger than 70 years (18%). Main Afatinib related side effects of grade 3 or higher were independent of age, with diarrhea (18% in patients <70 years and 15% in patients ≥70 years) as the most frequent adverse drug reactions. Overall response rate was 78% and disease control rate was 93% in the elderly population. PFS rate at one year was 62%.
With 44% of the whole study population, elderly patients (>70 years) are well represented in GIDEON. Therefore, these data provide important information for the routine clinical use of afatinib in these patients. With an overall response rate of 78% and a PFS-rate of 62% after one year, these data support the use of afatinib in elderly patients. Adverse drug reactions of grade 3 or more were not significantly higher in the elderly group.
NCT02047903.
Boehringer Ingelheim.
Boehringer Ingelheim.
W. Brückl: Fees for consulting and/or lectures: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Chugai, Lilly, MSD, Pfizer, Roche, Stratifyer. M. Reck: Honoraria for lectures and consultancy: Hoffmann-La Roche, Lilly, Amgen, Boehringer Ingelheim, Abbot, AstraZeneca, Celgene, BMS, MSD, Merck, Novartis, Pfizer. A. Maerten, C. Hoffmann: Employee: Boehringer Ingelheim. All other authors have declared no conflicts of interest.