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A. Paredes Lario



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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      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. Paredes Lario

      • Abstract

      Background:
      We present demographic and diagnostic data for the first planned interim analysis of ASTRIS study, currently ongoing.

      Methods:
      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.

      Results:
      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%).

      Conclusions:
      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:
      NCT02474355

      Legal entity responsible for the study:
      AstraZeneca

      Funding:
      AstraZeneca

      Disclosure:
      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.