石川 栄一, 村垣善浩, 田村 学, 杉井成志, 松田真秀, 大野忠夫. 自家腫瘍ワクチン療法におけるMRI画像上の造影領域全摘出の意義－進行中のCellm-001医師主導治験での適格基準に含んだ経緯を中心に－. CI研究 47 (1): 1-6, 2025.
Summary:
Background: The authors have conducted multiple clinical trials investigating the efficacy of autologous formalin-fixed tumor vaccine (AFTV) for glioblastoma (GBM). Findings suggest that AFTV combined with chemoradiotherapy (CRT) may improve prognosis in patients with newly diagnosed GBM (nGBM). However, there is a need to identify reliable predictors of treatment response. This study evaluates the significance of gross total removal (GTR) of contrast-enhanced regions on MRI as a predictor of therapeutic efficacy in AFTV therapy, based on data from previous clinical trials and real-world cases.
Methods: This study comprised three analyses. First, prognostic factors were examined using data from 277 patients with nGBM who underwent multidisciplinary treatment (Study A). Next, favorable prognostic factors associated with AFTV therapy were identified using propensity score matching between patients receiving AFTV and those undergoing standard treatment (Study B). Finally, a preplanned subgroup analysis was performed on patients with GTR in a double-blind, randomized phase IIb trial of temozolomide-based CRT plus AFTV for nGBM (UMIN000010602), initiated in 2013 (Study C).
Results: In Study A, GTR, proton therapy, and immunotherapy were associated with improved prognosis. Study B identified GTR and p53 negativity as independent predictors of better prognosis in patients receiving AFTV, based on multivariate analysis. In Study C, the GTR subgroup demonstrated a trend toward prolonged progression-free survival within the AFTV cohort.
Conclusions: Across all analyses, GTR of contrast-enhanced lesions emerged as a significant predictor of favorable outcomes in patients receiving AFTV plus CRT for nGBM. A phase III randomized controlled trial investigating AFTV in nGBM patients with GTR commenced in 2020.
Key Words: Total removal, Extent of resection, Glioma, Tumor vaccine, Immunotherapy
