Br J Cancer: Analysis of the safety and efficacy of temozolomide and nabiximols cannabinoid spray in the treatment of recurrent glioblastoma

Glioblastoma (GBM) is the most common malignant primary brain tumor in adults.
Its incidence is about 3.
2 cases per 100,000 people, and the 5-year survival rate of patients is less than 6%.

Previous studies have shown that GBM is incurable.
The best treatment at present is to maximize tumor reduction surgery, combined with postoperative local high-dose radiotherapy and temozolomide (TMZ) chemotherapy.
The average overall survival (OS) of patients receiving this treatment strategy can reach 14.
6 months.
However, almost all patients experienced tumor recurrence 6-9 months after treatment.
The median survival time of patients after relapse has dropped to 1.
0–10.
8 months, and there is currently no effective treatment strategy for such patients.

Cannabinoids are naturally present in the cannabis plant and have been used in medical treatments centuries ago.

Test related flowchart

The first part of the clinical trial is an open, non-blind trial, and the second part is a randomized double-blind trial with a placebo as a control.
The patient was treated with nabiximols (part 1, n=6; part 2, n=12) or placebo (part 2 only, n=9); a maximum of 12 DIT sprays per day for a duration of up to 12 month.
Safety, efficacy and pharmacokinetics (PK) of temozolomide are related testing indicators.

The results showed that the most common treatment-induced adverse events (TEAEs) were vomiting, dizziness, fatigue, nausea and headache.

Kaplan-Meier survival curve

All in all, the study shows that through personalized administration, nabiximols has acceptable safety and tolerability, and no drug interactions have been found.