Results
deaths, glioma, physician-choice, tumor
TUMOR, RECURRENCE, MAY, BRAIN TUMORS, GLIOMA
Over a period of 3 years, 123 patients affected by rGBM or grade III glioma were screened and assessed for eligibility criteria to participate in a parallel-group-randomized controlled trial at 13 clinical sites across the US. The study protocol was approved by the Western Institutional Review Board (WIRB) and the independent ethics committee of each of the participating institutions. 78 patients with rGBM (diagnosed according to the 2016 WHO classification of brain tumors) were enrolled in the study (consort diagram: CONSORT diagram of ChemoID studyA total of 123 patients were screened between May 18, 2018, and May 30, 2021; 78 of these patients were randomized to either the ChemoID or physician-choice group. After 35 deaths were reported, the first prespecified interim efficacy analysis was performed.Study schema of the registered clinical trial A multi-institutional, randomized clinical trial of patients with rGBM was initiated to assess the efficacy of chemotherapy regimens selected by the ChemoID assay vs. best physician choice. The primary efficacy endpoint of this trial was median OS. Secondary endpoints were OS at 6, 9, and 12 months, median PFS at 4, 6, 9, and 12 months, objective tumor response, time to recurrence, and health-related quality of life.A predetermined interim survival efficacy analysis was conducted when 35 deaths were reported (August 20, 2021). Patient enrollment was stopped after the interim efficacy analysis because the study’s primary endpoint (overall survival [OS]) was met during the planned interim efficacy analysis. Intention-to-treat (ITT) analysis was conducted on all 78 randomized subjects.The median time of follow-up was 10.5 months for the ChemoID assay-guided group and 6.2 months for the physician-choice group at the time of the interim efficacy analysis data cutoff. The median time of follow-up at ITT analysis was 10.5 months for the ChemoID assay-guided group and 7.5 months for the physician-choice group.A post-randomization analysis of the demographics and baseline clinical characteristics of all randomized subjects demonstrated that subjects were balanced between the two study groups (Patient demographics and baseline characteristicsGlioblastomas were diagnosed following the 2016 WHO classification.