1. In this non-randomised, controlled phase 3 study, among 331 patients who received dendritic cell vaccination (DCVax-L), patients with newly diagnosed glioblastoma (nGBM) had a median overall survival of 19.3 months versus 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 versus 7.8 months in the external control cohort.
Assessment Level Evidence: 2 (good)
Study overview: Glioblastoma is a deadly primary brain cancer with a recurrence rate of nearly 100%. Standard care for patients with newly diagnosed glioblastoma (nGBM) includes surgery, radiotherapy, and chemotherapy. The aim of this study was to investigate whether adding dendritic cell vaccination (DCVax-L) to standard of care (SOC) prolongs the survival of patients with glioblastoma. The main interventions in this prospective, externally controlled, non-randomized phase 3 trial were DCVax-L plus SOC temozolomide and placebo. The main outcomes were a comparison of overall survival (OS) in nGBM and rGBM. A total of 331 patients were included in this study, of which 232 were randomized to the DCVax-L group and 99 to the placebo group. The median OS in patients with nGBM receiving DCVax-L was 19.3 versus 16.5 in the placebo group. Survival at 48 months from randomization was 15.7% versus 9.9%, and at 60 months it was 13.0% versus 5.7%. Of the 64 patients with rGBM who received DCVax-L, the mean OS was 13.2 months after relapse versus 7.8 in 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 of 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 analysis (MAIC) to overcome the lack of patient data and to allow matching of specific patient characteristics between the external control groups . 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 versus SOC. This international multicenter study was conducted between 2007 and 2015 at 94 sites in 4 countries. A total of 331 patients were included in this study, of which 232 were 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 male. The median OS in patients with nGBM who received 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 = 0.002) Survival at 48 months from randomization was 15.7% versus 9.9%, and at 60 months it was 13.0% versus 5.7% Of the 64 patients with rGBM who received DCVax-L, the mean OS was 13.2 (95% CI, 9.7-16.8) months after recurrence versus 7.8 (95% CI, 7 .2-8.2) in the external control group (HR, 0.58; 98% CI, 0.00-0.76; P < 0.001) Survival at 24 and 30 months after recurrence was 20.7%, respectively, versus 9.6% and 11.1% versus 5.1% In addition, survival was shown to improve in patients with nGBM with methylated MGMT receiving DCVax-L compared to external control patients (HR, 0.74; 98% CI, 0, 55-1.00; P=.03).
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