Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial.

Importance: Glioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed. Objective: To investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma. Design, Setting, and Participants: This phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021. Interventions: The active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies. Main Outcomes and Measures: The primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials. Results: A total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (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%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (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. Survival was improved 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). Conclusions and Relevance: In this study, adding DCVax-L to SOC resulted in clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM compared with contemporaneous, matched external controls who received SOC alone. Trial Registration: ClinicalTrials.gov Identifier: NCT00045968.

An unusual recovery from traumatic brain injury in a young man.

CONTEXT: Traumatic brain injury (TBI), a complex neurological traumatic incident where brain function is disrupted due to physical trauma, can be categorized in multiple ways and is commonly scored using the Glasgow Coma Scale. Severe closed head injury is a form of TBI with a Glasgow Coma Scale less than 8. The outcomes and prognosis are not uniform in the population but mortality is estimated at 30-50 percent. In this case of severe closed head injury, the patient was able to make a near full recovery after several neurosurgery and medical treatments and intercessory prayer to Saint Luigi Guanella. FINDINGS: A 21-year-old male patient received a severe closed head TBI and bilateral hemotympanum while rollerblading without a helmet. After imaging, a left frontal craniotomy and evacuation of epidural and subdural hematomas and resection of a left frontal contusion were performed. Intracranial pressure increased and the patient experienced a transtentorial herniation. He underwent a right frontotemporal and subtemporal craniectomy and evacuation of a frontotemporal subdural hematoma. The patient had intraventricular hemorrhage to which a ventriculostomy was performed and later converted to a ventriculo-peritoneal shunt for recurrent hydrocephalus. The patient was not expected to regain consciousness, but made a recovery after 24 days in the hospital and 10 days in rehabilitation. The patient followed up 6 months after injury for a cranioplasty and soon after returned to near baseline. CONCLUSIONS/CLINICAL RELEVANCE: In this extraordinary case, the severe closed head injury the patient sustained required intensive neurosurgical and medical treatment and the prognosis for recovery of consciousness was very poor; however, with treatment and rehabilitation and intercessory prayer to Saint Luigi Guanella, this patient was able to recover close to baseline from a Glasgow Coma Scale of 7. LAY SUMMARY: Head injuries vary in severity and traumatic brain injuries can be extremely serious leading to bleeding, loss of consciousness, and can affect verbal responses, muscles movement in motor responses, and responses with eye movement. Traumatic brain injuries require medical care to assess the severity and treat the injury. In this case report, we discuss a patient's very severe closed head injury while rollerblading without a helmet from which he was not expected to make a full recovery, but did so following intensive medical treatment, rehabilitation, and intercessory prayer to Saint Don Guanella to combat the initial injury and subsequent issues.

The Seldinger technique for insertion of difficult to place ventricular catheters.

BACKGROUND: Multiloculated ventricular hydrocephalus is a difficult pathology for neurosurgeons to treat. Not only are the shunts for this condition prone to malfunction, but they are also difficult to place. METHODS: The Seldinger technique is used in combination with a rigid scope with a working channel. A soft filiform wire or a thick suture is inserted through the channel. The scope is withdrawn and a ventricular catheter is slid down the wire. The remainder of the shunt is inserted in the usual fashion. RESULTS: We have not encountered any neurologic compromise from this technique. No bleeding was encountered with the described technique. CONCLUSION: The Seldinger technique with appropriate types of guide wires and in combination with an endoscope is a useful technique for difficult to place shunts.