LTBK-06. IMPACT OF VORASIDENIB TREATMENT ON MUTANT IDH1 OR IDH2 DIFFUSE GLIOMA TUMOR GROWTH RATE: RESULTS FROM THE RANDOMIZED, DOUBLE-BLIND, PHASE 3 INDIGO STUDY

作者：Patrick Y. Wen, Ingo K. Mellinghoff, Martin J. van den Bent, Deborah T. Blumenthal, Mehdi Touat, Katherine B. Peters, Jennifer Clarke, Joe Mendez, Shlomit Yust‐Katz, Warren Mason, François Ducray, Yoshie Umemura, Burt Nabors, Matthias Holdhoff, Andreas F. Hottinger, Yoshiki Arakawa, Juan Manuel Sepúlveda-Sánchez, Wolfgang Wick, Riccardo Soffietti, James Perry, Pierre Giglio, Macarena de la Fuente, Elizabeth A. Maher, Dan Zhao, Shuchi S. Pandya, Lori Steelman, Islam Hassan, Timothy F. Cloughesy, Benjamin M. Ellingson · 发表于：Neuro-Oncology · 年份：2023 · DOI：10.1093/neuonc/noad179.1202 · 被引用次数：18 · 研究领域：Glioma Diagnosis and Treatment、Cancer, Hypoxia, and Metabolism、Radiomics and Machine Learning in Medical Imaging

Abstract INTRODUCTION The INDIGO study (NCT04164901) showed that vorasidenib, an oral, brain-penetrant, dual inhibitor of mutant isocitrate dehydrogenase (mIDH) 1/2, significantly improved imaging-based progression-free survival and time-to-next-intervention compared with placebo in patients with grade 2 mIDH1/2 glioma previously treated with surgery only. Given the limitations of traditional bi-dimensional measurements, evaluating volumetry and tumor growth rate (TGR) is an additional method of measuring treatment effect in these diffuse growing tumors. METHODS Magnetic resonance imaging (MRI) scans were performed at baseline and every 12 weeks on-treatment; up to three pre-treatment MRI scans were requested when available. Tumor volumes were derived per blinded independent review committee using a semi-automated approach. TGR was defined as percentage change in tumor volume every 6 months. Patients with evaluable baseline and ≥ 1 MRI during the corresponding period were included in the analysis. The difference in TGR in each arm was assessed by slope of tumor growth over time using a linear mixed model. RESULTS 331 patients were randomized to vorasidenib (n=168) or placebo (n=163). Median follow-up was 14.2 months. On-treatment TGR was −2.5% (95% CI, −4.7, −0.2) with vorasidenib (n=167) and 13.9% (95% CI, 11.1, 16.8) with placebo (n=161). In patients with available imaging data, TGR pre- and post-treatment with vorasidenib (n=56) was 13.2% (95% CI, 10.3, 16.3) and −3.3% (95...