Results from METIS (EF-25), an international, multicenter phase III randomized study evaluating the efficacy and safety of tumor treating fields (TTFields) therapy in NSCLC patients with brain metastases.

• DOI: 10.1200/jco.2024.42.16_suppl.2008
• Publication Date: 2024-06-04T19:02:17Z
• Authors: Minesh P. Mehta; Vinai Gondi; Manmeet Singh Ahl...; David Roberge; Rosanda Ilic; Terence Tai Weng Sio; Daniel Michael Tr...; Thierry Muanza; Ana Misir Krpan; Naren R Ramakrishna; John B. Fiveash; Philippe Metellus; Chiachien Jake Wang; Loïc Feuvret; Christian Freyschlag; Tibor Csőszi; Paul D. Brown; Zhengfei Zhu; Jinming Yu; Maciej Harat
• Keywords: Metis

2008 Background: For non-small cell lung cancer (NSCLC) with brain metastases (BM) stereotactic radiosurgery (SRS) is the current preferred therapy. Due to frequent intracranial failures, there a high unmet need for salvage therapies. Whole radiotherapy (WBRT) reduces failure but used less frequently due cognitive consequences. Tumor Treating Fields (TTFields) are electric fields that disrupt division and have shown improved survival safety in patients glioblastoma metastatic NSCLC. Phase 3 METIS trial [NCT02831959] aimed evaluate efficacy of TTFields therapy NSCLC BM treated SRS, specifically terms lengthening time progression without decline. Methods: Mutation negative (M-) 1–10 were randomized 1:1 receive followed by (TTFields; 150 kHz) best supportive care (BSC) or SRS BSC. Patients Karnofsky Performance Status (KPS) ≥70, newly diagnosed one inoperable 2–10 supra-/infratentorial suitable receiving optimal extracranial disease included. Exclusions prior WBRT single operable recurrent metastases. Primary endpoint was first (RANO-BM) based on cumulative risk. every two months until second progression. Cognition patient quality life (QoL) evaluated. Results: Between July 2016 September 2022, 298 randomized. Baseline characteristics balanced: median age 63.5 (range 37-84) years, 37.6% females, majority had KPS ≥ 80, from initial diagnosis 1.8 (range: 0.2-55.7), 77% adenocarcinoma. Median treatment duration 16 weeks, usage 67%. endpoint, significantly prolonged BSC vs. alone arm (median 21.9 11.3 months); HR=0.67 [0.48-0.93], p=0.02. TTFields-related AEs mainly dermatological, Grade ≤2. also deterioration-free global health status, physical functioning, fatigue according QoL, did not negatively impact cognition. Conclusion: study met its primary demonstrating following mutation BM, prolongs could postpone WBRT, QoL cognition Clinical information: NCT02831959 .