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
3157 - Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)
Presenter: Yihebali Chi
Session: Poster Display session 1
Resources:
Abstract
3710 - The effect of treatment line on the efficacy of Anlotinib hydrochloride in advanced alveolar soft part sarcoma patients
Presenter: Zhiwei Fang
Session: Poster Display session 1
Resources:
Abstract
3184 - Prior exposure to pazopanib (PAZ) did not minor efficacy of regorafenib (REG) in non-adipocytic soft tissue sarcoma patients (pts)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
798 - Pexidartinib (Pex) for locally advanced tenosynovial giant cell tumor (TGCT): characterization of hepatic adverse reactions (ARs)
Presenter: Sebastian Bauer
Session: Poster Display session 1
Resources:
Abstract
6117 - VEGFR2 and ITGA polymorphisms as novel pan-sarcoma biomarkers for sensitivity prediction as well as toxicity prevention anti-angiogenesis therapy in pediatric and young adult
Presenter: Qiyuan Bao
Session: Poster Display session 1
Resources:
Abstract
5450 - Reversion of resistance to mTOR inhibitors with the addition of exemestane in patients with malignant PEComa.
Presenter: Roberta Sanfilippo
Session: Poster Display session 1
Resources:
Abstract
4279 - Efficacy and Safety of VEGFR2 Inhibitor Apatinib combined with chemotherapy for Sarcoma in Stage IV
Presenter: Zhiwu Ren
Session: Poster Display session 1
Resources:
Abstract
5929 - Outcomes of metastatic soft tissue sarcoma treated with Pazopanib from dedicated medical oncology sarcoma clinic: A holistic care approach from a developing country
Presenter: Akhil Kapoor
Session: Poster Display session 1
Resources:
Abstract
2469 - Inhibition of mTOR signaling enhances Trabectedin activity in Soft Tissue Sarcoma
Presenter: David Moura
Session: Poster Display session 1
Resources:
Abstract
4210 - Efficacy and safety of apatinib for advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib: An open-label, multicenter, single-arm, phase II trial
Presenter: Zhaolun Cai
Session: Poster Display session 1
Resources:
Abstract