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.
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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