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Published on: October 27, 2014
Reduced-Dose Regorafenib for Recurrent Glioblastoma: A Safety and Outcome Analysis
Massimiliano Domenico Rizzaro1,2, Claudia Fanizzi2, Giorgio Fiore2
1Department of Pathophysiology and Transplantation, University of Milan, 20122 Milan, Italy.
Background/Objectives:
Recurrent glioblastoma has a poor prognosis and no universally accepted standard of care. Regorafenib has been investigated in this setting, but its use may be limited by treatment-related toxicity. This study evaluated the feasibility, safety, and clinical outcomes of reduced-dose regorafenib in patients with recurrent IDH-wildtype glioblastoma.
Methods:
We retrospectively analyzed 21 patients with recurrent IDH-wildtype glioblastoma (WHO 2021) treated at a single center after progression according to the Stupp protocol. Regorafenib was started at 80 mg/day on the standard 3-weeks-on/1-week-off schedule. We assessed overall survival from diagnosis (OS1) and from first progression (OS2), progression-free survival from diagnosis (PFS1) and from first progression (PFS2), treatment exposure, dose modifications, and treatment-related adverse events (CTCAE v5.0).
Results:
Median PFS2 was 5 months (95% CI, 3-8), median OS2 was 6 months (95% CI, 5-10), and median OS1 was 21 months (95% CI, 15-27). No grade ≥ 3 adverse events occurred, and no patient discontinued treatment permanently because of toxicity.
Conclusions:
In this retrospective single-center cohort, reduced-dose regorafenib was feasible and well tolerated in selected patients. These descriptive, hypothesis-generating findings warrant prospective studies to define the role of individualized regorafenib dosing in recurrent glioblastoma.
Insights
Reduced-dose regorafenib (80 mg/day) is a feasible and safe option for recurrent IDH-wildtype glioblastoma patients. This approach showed promising outcomes with no permanent treatment discontinuation due to toxicity.
Area of Science:
- Neuro-oncology
- Clinical pharmacology
- Cancer treatment
Background:
- Recurrent glioblastoma presents a significant challenge with no standard treatment.
- Regorafenib shows potential but is limited by toxicity.
- This study focuses on reduced-dose regorafenib for recurrent IDH-wildtype glioblastoma.
Purpose of the Study:
- To evaluate the feasibility and safety of reduced-dose regorafenib.
- To assess clinical outcomes including survival and progression-free survival.
- To explore treatment exposure and dose modifications in this patient group.
Main Methods:
- Retrospective analysis of 21 patients with recurrent IDH-wildtype glioblastoma.
- Regorafenib initiated at 80 mg/day on a 3-weeks-on/1-week-off schedule.
- Assessment of overall survival (OS1, OS2) and progression-free survival (PFS1, PFS2), toxicity (CTCAE v5.0).
Main Results:
- Median PFS2 was 5 months; median OS2 was 6 months; median OS1 was 21 months.
- No grade ≥ 3 adverse events were reported.
- No patients permanently discontinued treatment due to toxicity.
Conclusions:
- Reduced-dose regorafenib is feasible and well-tolerated in selected recurrent glioblastoma patients.
- These findings are hypothesis-generating and support further investigation.
- Prospective studies are needed to confirm the role of individualized regorafenib dosing.
