(ChemotherapyAdvisor) – Combination chemotherapy including thalidomide and irinotecan is not adequately effective for the treatment of aplastic glioma, according to a team of US-based researchers. This conclusion is based on a study entitled “Phase 2 trial of irinotecan and thalidomide in adults with recurrent anaplastic glioma,” which is published in the July 25 issue of Cancer.
In this study, eligible patients were adults with recurrent AG previously treated with radiation therapy, Karnofsky performance score ≥70, adequate organ function, with no history of taking enzyme-inducing anticonvulsants. Patients enrolled in this study were treated in 6-week cycles with irinotecan (125mg/m2, weekly, 4 weeks on/2 weeks off) and thalidomide (100mg, daily, increased to 400mg/day, as tolerated). Primary end point: progression-free survival rate at 6 months (PFS-6); secondary end points were overall survival (OS) and response rate (RR).
The investigators reported the following results. PFS-6 for the intent-to-treat population was 36% (95% CI=3%, 24%). Radiological findings included 2 complete responses, 2 partial responses, and 17 with stable disease. Median OS from study registration was 62 weeks, (95% CI=51, 144). Treatment-related toxicities (grade 3 or higher) included neutropenia, diarrhea, nausea, and fatigue; 6 patients experienced venous thromboembolism. Four deaths were attributable to treatment-related toxicities: 1 from pulmonary embolism, 2 from colitis, and 1 from urosepsis.
The investigators concluded: “The combination of thalidomide and irinotecan did not achieve sufficient efficacy to warrant further investigation against AG, although a subset of patients experienced prolonged PFS/OS. A trial of the more potent thalidomide analogue, lenalidomide, in combination with irinotecan against AG is currently ongoing.”