Abstract 2023
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.
Editorial acknowledgement
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. Brückl: 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.
Resources from the same session
4526 - Long-term outcome of neoadjuvant tyrosine kinase inhibitors (TKI) in locally advanced dermatofibrosarcoma protuberans (DFSP)
Presenter: Jessica Beaziz
Session: Poster Display session 1
Resources:
Abstract
1214 - Neo-adjuvant (NA) Imatinib for gastrointestinal stromal tumours (GISTs): What is the optimal length of treatment?
Presenter: Tom Wilson
Session: Poster Display session 1
Resources:
Abstract
2690 - Gastrointestinal Stromal Tumours (GIST) in adolescents and young adults (AYA)
Presenter: Nikki Ijzerman
Session: Poster Display session 1
Resources:
Abstract
4558 - Radiomics improves response evaluation for desmoid tumors treated with chemotherapy
Presenter: Amandine Crombe
Session: Poster Display session 1
Resources:
Abstract
2751 - Radiomics of gastrointestinal stromal tumors; risk classification based on computed tomography images – a pilot study
Presenter: Milea Timbergen
Session: Poster Display session 1
Resources:
Abstract
2737 - Differentiating well-differentiated liposarcomas from lipomas using a radiomics approach
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
1282 - The immune landscape of chondrosarcoma reveals an anti inflammatory environment
Presenter: Iseulys Richert
Session: Poster Display session 1
Resources:
Abstract
1572 - Impact of Immunotherapy and Targeted Therapy on Tumor Growth Rate in Sarcoma
Presenter: Esmail Al-ezzi
Session: Poster Display session 1
Resources:
Abstract
3414 - DNA methylation profiles of angiosarcoma subtypes.
Presenter: Marije Weidema
Session: Poster Display session 1
Resources:
Abstract
3411 - Prognostic significance of circulating PD-1, PD-L1, pan-BTN3As and BTN3A1 in patients with metastatic gastrointestinal stromal tumors (mGISTs)
Presenter: Daniele Fanale
Session: Poster Display session 1
Resources:
Abstract