1. In this phase 3 nonrandomized controlled trial, among 331 patients, patients with newly diagnosed glioblastoma (nGBM) receiving dendritic cell vaccination (DCVax-L) had a median overall survival of 19.3 months vs 16.5 months in the external control patients treated with standard of care.
2. Patients with recurrent glioblastoma (rGBM) had a median overall survival of 13.2 months from relapse in the DCVax-L group vs 7.8 months in the external control cohort.
Evidence Rating Level: 2 (Good)
Study Rundown: Glioblastoma is a lethal primary brain cancer with a recurrent rate of nearly 100%. The standard of care for newly diagnosed glioblastoma (nGBM) patients includes surgery, radiotherapy, and chemotherapy. The objective of this study was to investigate whether adding dendritic cell vaccination (DCVax-L) to the standard of care (SOC) extends the survival of patients with glioblastoma. The main interventions in this phase 3 prospective externally controlled nonrandomized trial included DCVax-L plus SOC temozolomide and placebo. The main outcomes included a comparison of overall survival (OS) in nGBM and rGBM, A total of 331 patients were included in this study, with 232 randomized to the DCVax-L group and 99 to the placebo group. The median OS among patients with nGBM receiving DCVax-L was 19.3 vs 16.5 in the placebo group. Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. Among 64 patients with rGBM receiving DCVax-L, the mean OS was 13.2 months from relapse vs 7.8 among the external control cohort. Meaningful increases in the long-term tails of the survival curves for both nGBM and rGBM patients were observed. A limitation to this study is that propensity score matching could not be performed due to a lack of patient-level data for the external control group. A major strength of this study, in addition to its relatively large sample size, was that it used a matching-adjusted indirect comparison (MAIC) analysis to overcome the lack of patient data and to enable the matching of specific patient characteristics between the external control and intervention group.
Click to read the study in JAMA Oncology
Relevant Reading: The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?
In-Depth [prospective cohort]: This study investigated whether autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) was associated with improved OS for patients with nGBM and rGBM vs SOC. This international multicenter trial was conducted at 94 sites across 4 countries between 2007 and 2015. A total of 331 patients were included in this study, with 232 randomized to the DCVax-L group and 99 to the placebo group. The median age was 56 (19-73) years, and 202 participants (61%) were men. The median OS among patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3 vs 16.5 (95% CI, 16.0-17.5) in the placebo group (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. Among 64 patients with rGBM receiving DCVax-L, mean OS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) among the external control group (HR, 0.58; 98% CI, 0.00-0.76; P < .001). Survival at 24 and 30 months after recurrence was 20.7% vs 9.6% and 11.1% vs 5.1%, respectively. Additionally, survival was found to improve in patients with nGBM with methylated MGMT receiving DCVax-L compared with external control patients (HR, 0.74; 98% CI, 0.55-1.00; P = .03).
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