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Harald Schaefer



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      125P - Elderly patients treated with afatinib in clinical practice: Results from the prospective non-interventional study GIDEON (ID 294)

      12:30 - 13:00  |  Author(s): Harald Schaefer

      • Abstract

      Background

      Elderly patients are often underrepresented in clinical trials, leading to uncertainties in the treatment of these patients in the clinical routine.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      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.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      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%.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      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.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02047903.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Boehringer Ingelheim.

      213f68309caaa4ccc14d5f99789640ad Funding

      Boehringer Ingelheim.

      682889d0a1d3b50267a69346a750433d Disclosure

      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.

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