Validation of diffusion MRI as a biomarker for efficacy using randomized phase III trial of bevacizumab with or without VB-111 in recurrent glioblastoma
| Autor: | Chencai Wang, Kunal S. Patel, Jian Campian, Timothy F. Cloughesy, Shan Rizvi, Patrick Y. Wen, Noa Lowenton-Spier, Leor Zach, Andrew Brenner, Tamar Rachmilewitz Minei, Yael C Cohen, Nicholas Butowski, Benjamin M. Ellingson, Catalina Raymond, John de Groot, Jacob Schlossman, Shifra Fain Shmueli |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Bevacizumab Imaging biomarker recurrent GBM Clinical Trials and Supportive Activities Clinical Investigations Urology bevacizumab law.invention diffusion MRI Rare Diseases Randomized controlled trial law Clinical Research Genetics AcademicSubjects/MED00300 Medicine imaging biomarker Cancer Univariate analysis business.industry Proportional hazards model Evaluation of treatments and therapeutic interventions Brain Disorders Clinical trial 6.1 Pharmaceuticals VB-111 Biomarker (medicine) anti-VEGF therapy Biomedical Imaging AcademicSubjects/MED00310 business medicine.drug Diffusion MRI |
| Zdroj: | Neuro-oncology advances, vol 3, iss 1 Neuro-oncology Advances |
| Popis: | Background Evidence from single and multicenter phase II trials have suggested diffusion MRI is a predictive imaging biomarker for survival benefit in recurrent glioblastoma (rGBM) treated with anti-VEGF therapy. The current study confirms these findings in a large, randomized phase III clinical trial. Methods Patients with rGBM were enrolled in a phase III randomized (1:1), controlled trial (NCT02511405) to compare the efficacy and safety of bevacizumab (BV) versus BV in combination with ofranergene obadenovec (BV+VB-111), an anti-cancer viral therapy. In 170 patients with diffusion MRI available, pretreatment enhancing tumor volume and ADC histogram analysis were used to phenotype patients as having high (>1.24 µm2/ms) or low ( Results Baseline tumor volume (P = .3460) and ADCL (P = .2143) did not differ between treatment arms. Univariate analysis showed patients with high ADCL had a significant survival advantage in all patients (P = .0006), as well as BV (P = .0159) and BV+VB-111 individually (P = .0262). Multivariable Cox regression accounting for treatment arm, age, baseline tumor volume, and ADCL identified continuous measures of tumor volume (P < .0001; HR = 1.0212) and ADCL phenotypes (P = .0012; HR = 0.5574) as independent predictors of OS. Conclusion Baseline diffusion MRI and tumor volume are independent imaging biomarkers of OS in rGBM treated with BV or BV+VB-111. |
| Databáze: | OpenAIRE |
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