1536PPatients with brain metastases treated with afatinib in clinical practice: Results from the prospective non-interventional study GIDEON

Abstract Background The presence of brain metastases is a negative prognostic factor for non-small cell lung cancer (NSCLC) patients, which are therefore frequently excluded from clinical trials. A competing risk analysis from the Lux Lung trials showed that afatinib delayed the onset/progression of brain metastases. In Lux Lung 3 patients with brain metastases revealed a median PFS of 11.1 months when treated with afatinib vs. 5.4 months with chemotherapy (HR = 0.54). Methods The prospective German non-interventional real world study GIDEON enrolled 151 advanced NSCLC adenocarcinoma patients with activating EGFR mutations treated with afatinib according to label. Here, we report results of the first interim analysis and focus on patients with brain metastases at baseline. Results Patients with brain metastases accounted for 32% of the GIDEON study population (n = 49/151). Overall response rate (ORR) and disease control rate (DCR) in patients with brain metastases were 74% and 91% (n = 35), which was similar to patients without brain metastases (ORR: 73%, DCR: 90%, n = 59). However, PFS rate at one year was 43% in patients with brain metastases and 60% in patients without brain metastases. Median PFS was 11 months in patients with brain metastases (n = 48, 95% CI 9.18- 13.88) and 16 months in patients without brain metastases (n = 94, 95% CI 10.95- 19.57). Overall survival was not mature at the time of this analysis. Conclusions Presence or absence of brain metastases had no influence on the response rate or disease control rate with afatinib. However, patients with brain metastases had shorter PFS than patients without brain metastases, confirming their negative prognostic impact. Taken together, these data underline the efficacy of afatinib and support its use in patients with brain metastases. Clinical trial identification NCT02047903. Legal entity responsible for the study Boehringer Ingelheim. Funding Boehringer Ingelheim. Disclosure C. Hoffmann: Full / Part-time employment: Boehringer Ingelheim. M. Reck: Honoraria (self), Advisory / Consultancy: Abbot; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Amgen. C. Kortsik: Travel / Accommodation / Expenses: Boehringer Ingelheim. F. Griesinger: Honoraria (self), Advisory / Consultancy: AbbVie; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Takeda; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Siemens; Honoraria (self), Advisory / Consultancy: Bayer. A. Schueler: Full / Part-time employment: Boehringer Ingelheim. W. Bruckl: Advisory / Consultancy: AbbVie; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Celgene; Advisory / Consultancy: Chugai; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Stratifyer. All other authors have declared no conflicts of interest.