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A. Insa Molla
Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
156P - ASTRIS, a real-world study with osimertinib in patients with non-small cell lung cancer (NSCLC) EGFR T790M mutated: Characteristics and diagnostic methods used for patients included in Spain (ID 547)
12:30 - 13:00 | Author(s): A. Insa Molla
We present demographic and diagnostic data for the first planned interim analysis of ASTRIS study, currently ongoing.
ASTRIS is a single-arm, open-label, phase IIIb clinical trial to evaluate the efficacy and safety of osimertinib monotherapy in real practice. Eligible patients had stage IIIB-IV NSCLC with a T790M mutation determined by a locally validated test (not restricted by sample type), had received at least a previous EGFR-TKI, ECOG 0-2, with no history of interstitial lung disease or QTc prolongation. Asymptomatic and stable CNS metastases were allowed. Patients received osimertinib 80 mg once daily.
We included 132 patients in 18 centers, 130 began treatment. At data cut-off (3 Nov 2016), 72% continued in the study, median follow-up 5.2 (<1–12) months. Median age 66 (32–89) years, 69% women, 98% caucasian, 85% ECOG 0/1, 15% ECOG 2, 84% stage IV, 40% cerebral / leptomeningeal metastasis, 42% previous chemotherapy, 34% previous radiotherapy. EGFR-TKIs: gefinitib (43%), erlotinib (57%), afatinib (17%) and dacomitinib (2%). Only patients with a T790M positive test result were treated in the study: 73 (56%) were recruited to the study after a positive tissue test, 47 (36%) after a positive plasma test, 4 (3%) cytology and 6 (5%) after testing another specimen type. The origin of the biopsy tissue was primary tumor (60%), metastasis (40%). The local laboratory was used in 62% of the patients. Testing methods: Roche cobas (50%), Qiagen therascreen (17%), PCR-Invader (20%), TaqMan (9%), ARMS-PCR (1%), Illumina MiSeq / HiSeq (1%), AMOY (1%) and others (2%). Other EGFR mutations were EXON 19 deletions (58%), L858R (27%), S768I (5%) and G719X (3%).
The patient profile included in the study expands the patient population studied in the published studies, including excluded patients (PS-2, treated with non-marketed TKIs) or characteristics typical of the Spanish population, with a majority of Caucasians. The data from the ASTRIS study will give external validity to the results obtained in studies published with osimertinib.
Clinical trial identification:
Legal entity responsible for the study:
D. Vicente Baz: Consultant or Advisory Role: Astra Zeneca, BMS, Pfizer, Roche Research Funding: Pfizer, Boehringer. G. Marquez: AstraZeneca employee. All other authors have declared no conflicts of interest.