Show simple item record

dc.contributor.authorEide, Inger Johanne
dc.contributor.authorHelland, Åslaug
dc.contributor.authorEkman, Simon
dc.contributor.authorMellemgaard, Anders
dc.contributor.authorHansen, Karin Holmskov
dc.contributor.authorCicenas, Saulius
dc.contributor.authorKoivunen, Jussi
dc.contributor.authorGrønberg, Bjørn Henning
dc.contributor.authorBrustugun, Odd Terje
dc.identifier.citationLung Cancer. 2020, 143 27-35.en_US
dc.description.abstractObjectives In non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation. We assessed the efficacy of osimertinib in both T790M-positive and T790M-negative patients. Materials and methods The TREM-study is an investigator-initiated, multi-centre, single-arm, phase 2 clinical trial conducted in five Northern European countries. Patients with progression on at least one previous EGFR-TKI were assigned to treatment with 80 mg of osimertinib daily until radiological progression or death. Patients were included regardless of the presence of T790 M. The primary endpoint was objective response rate (ORR). Results Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status. 24 % had brain metastases and 15 % had an ECOG performance status of 2. Overall ORR was 48 % (95 % CI, 41 %–55 %), 60 % (51 %–69 %) for T790M-positive patients and 28 % (15 %–41 %) for T790M-negative patients, p < 0.001. ORR for patients with co-occurring del19 vs L858R was 61 % vs 32 %, p = 0.001. Duration of response was similar between the T790M-positive and –negative groups (11.8 vs 10.7 months, p = 0.229). Overall median progression-free survival (PFS) was 8.9 months (95 % CI, 7.4–10.5), and 10.8 vs 5.1 months for T790M-positive vs –negative patients (HR 0.62, p = 0.007). Median overall survival (OS) was 17.9 months (95 % CI, 14.4–21.3). For T790M-positive vs –negative median OS was 22.5 vs 13.4 months, (HR 0.55, p = 0.002). Conclusions This study confirms the efficacy of osimertinib for T790M-positive patients. There was also clinically significant activity of osimertinib in a proportion of T790M-negative patients.en_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internasjonal*
dc.titleOsimertinib in T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study)en_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.source.journalLung Canceren_US
dc.description.localcode"© 2020. This is the authors’ accepted and refereed manuscript to the article. Locked until 12.3.2022 due to copyright restrictions. This manuscript version is made available under the CC-BY-NC-ND 4.0 license "en_US

Files in this item


This item appears in the following Collection(s)

Show simple item record

Attribution-NonCommercial-NoDerivatives 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivatives 4.0 Internasjonal