1. In this phase 3 non-randomized 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 versus 16.5 months in outpatient control patients treated with standard of care.
2. Patients with recurrent glioblastoma (rGBM) had a median overall survival of 13.2 months after relapse in the DCVax-L group versus 7.8 months in the external control cohort.
Level of evidence assessment: 2 (good)
Summary of the study: Glioblastoma is a deadly primary brain cancer with a recurrence rate of nearly 100%. The standard of care for patients with newly diagnosed glioblastoma (nGBM) includes surgery, radiation therapy, and chemotherapy. The objective of this study was to determine whether adding dendritic cell vaccination (DCVax-L) to the standard of care (SOC) prolongs survival in patients with glioblastoma. The primary interventions in this prospective, non-randomized, externally controlled phase 3 trial included DCVax-L plus temozolomide SOC and placebo. Primary outcomes included a comparison of overall survival (OS) in nGBM and rGBM. A total of 331 patients were included in this study, including 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS among nGBM patients 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%. Among 64 rGBM patients receiving DCVax-L, mean OS was 13.2 months after relapse versus 7.8 in the outpatient control cohort. Significant 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 (MAIC) analysis to overcome the lack of patient data and to allow matching. specific characteristics of patients between the external control and intervention group.
Click to read the study in JAMA Oncology
Relevant reading: The landscape of clinical trials for glioblastoma: is it sufficient to develop new treatments?
In depth [prospective cohort]: This study investigated whether vaccination with autologous tumor lysate-loaded dendritic cells (DCVax-L) was associated with improved OS for patients with nGBM and rGBM compared to SOC. This international multicenter trial was conducted at 94 sites in 4 countries between 2007 and 2015. A total of 331 patients were included in this study, including 232 randomized to the DCVax-L group and 99 to the placebo group. The median age was 56 years (19-73) and 202 participants (61%) were male. Median OS among nGBM patients 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=0.002) Survival at 48 months after randomization was 15.7% versus 9.9%, and at 60 months, 13.0% versus 5.7% Among 64 rGBM patients receiving DCVax-L, the mean OS was 13.2 (95% CI, 9.7-16.8) months after relapse vs 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% versus 9.6% and 11.1% versus 5.1%, respectively. Additionally, survival improved in nGBM patients with methylated MGMT receiving DCVax-L compared with external control patients (HR, 0.74; 98% CI, 0.55-1.00; P=0.03).
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