(HealthDay News) — Chronic convection-enhanced delivery (CED) of topotecan is feasible and well tolerated in patients with recurrent glioblastoma, according to a study published in The Lancet Oncology.
Researchers conducted a single-center, phase 1b clinical trial involving patients aged 18 years or older with solitary, histologically confirmed recurrent glioblastoma showing radiographic progression after surgery, radiotherapy, and chemotherapy.
Five patients had catheters stereotactically implanted into the glioma-infiltrated peritumoral brain. These were connected to subcutaneously implanted pumps that infused topotecan for 48 hours, followed by a washout period of 5 to 7 days before the next infusion. Four infusions were administered. The pump was removed, and the tumor was resected after the fourth infusion.
Chronic CED of topotecan was successfully completed in all 5 patients between January 22, 2018, and July 8, 2019. The treatment was considered well tolerated without substantial complications.
The only treatment-related adverse event was intraoperative supplemental motor area syndrome (n=1). No grade 4 adverse events occurred. Other serious adverse events were related to surgical resection.
Patients were followed for a median of 12 months from pump explant. Post-treatment tissue analysis indicated that, in all 5 patients, there was a significant reduction in proliferating tumor cells.
“This novel drug delivery strategy and innovative clinical trial framework overcomes limitations in delivery and treatment response assessment in patients with glioma, and larger studies are warranted to determine the effect of this drug delivery approach on clinical outcomes,” the authors wrote.
Several authors disclosed financial ties to the biopharmaceutical industry.