Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study.

Introduction: Lung cancer is most common in older patients; despite this, older patients are historically under-represented in clinical studies. Here we present data from GIDEON, a study undertaken in Germany in patients with epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC) receiving first-line afatinib. GIDEON enrolled a high proportion of patients aged ≥70 years, providing an opportunity to study afatinib use in older patients.
Materials and Methods: In GIDEON (NCT02047903), a prospective non-interventional study, patients with EGFRm+ NSCLC received first-line afatinib in routine clinical practice until disease progression, death or intolerable adverse events. Key objectives were twelve-month progression-free survival (PFS) rate and objective response rate (ORR). Overall survival (OS) and safety were also assessed. This post hoc analysis explores outcomes of patients grouped by age (≥70 and <70 years).
Results: In the 152 patients enrolled in GIDEON (69.7% female, 64.5%/22.4%/13.2% with Del19/L858R/other exon 18-21 mutations, 33.6% with brain metastases), the median age was 67 years (range 38-89) and 43.4% were aged ≥70 years. In the ≥70 years age group and the <70 years age group, twelve-month PFS rate was 58.9% and 43.9%, median PFS was 17.2 months and 10.6 months, ORR was 72.0% and 76.5%, twelve-month OS rate was 79.1% and 79.2%, 24-month OS rate was 52.0% and 61.7%, and median OS was 30.4 months and 27.4 months, respectively. In the ≥70 years age group and the <70 years age group, grade ≥3 adverse drug reactions (ADRs) were observed in 34.8% and 40.7% of patients, respectively; the most common were diarrhea (13.6% and 14.0%), acneiform dermatitis (7.6% and 7.0%), stomatitis (1.5% and 4.7%) and maculopapular rash (1.5% and 4.7%).
Discussion: Patients with EGFRm+ NSCLC aged ≥70 years showed clinical benefit from first-line afatinib with no unexpected safety signals, supporting the use of afatinib in this setting.
Competing Interests: Declaration of Competing Interest Wolfgang M. Brueckl reports receiving lecture and educational event (personal) fees from AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Lilly, MSD, Pfizer, Roche Pharmaceuticals, and Takeda; receiving congress (personal) fees from Boehringer Ingelheim, AstraZeneca, and Roche Pharmaceuticals; and receiving advisory board fees (personal) from AstraZeneca, Boehringer Ingelheim, Novartis, Merck Sharp & Dohme, Lilly Pharma, Bristol Myers Squibb, and Roche. Martin Reck reports serving on advisory councils or committees and receiving consulting fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Lilly, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and Sanofi; and receiving speaker honoraria from AbbVie, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Lilly, Merck, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Kai Neben reports receiving honoraria (personal fees) from Roche, Takeda, Amgen, Janssen, Pfizer, Bayer, Merck Sharp & Dohme, Bristol Myers Squibb, and Chugai. Frank Griesinger reports receiving support for scientific research from ASTRA, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen, GlaxoSmithKline, and Janssen; receiving honoraria for presentations from ASTRA, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, Abbvie, Siemens, Amgen, GlaxoSmithKline, Janssen, and Sanofi; and advisory board participation for ASTRA, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, Abbvie, Siemens, GlaxoSmithKline, Janssen, and Sanofi. Justyna Rawluk reports serving on advisory councils or committees for AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Boehringer Ingelheim, Roche, and Takeda; and receiving consulting fees from AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Boehringer Ingelheim, Roche, and Takeda. Stefan Krüger reports receiving honoraria and grants or funds from Boehringer Ingelheim. Joachim H. Ficker reports receiving speaker honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi Aventis, and Bristol Myers Squibb. Miriam Möller reports receiving consulting fees (consulting or advisory role) from Boehringer Ingelheim and Roche; and receiving payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing or educational events from Boehringer Ingelheim, Roche, AstraZeneca, and Merck Sharp & Dohme. Andrea Schueler is an employee of Boehringer Ingelheim Pharma GmbH & Co KG. Eckart Laack, Konrad Kokowski and Harald Schäfer report no potential conflict of interest.
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