P17.50PHASE II STUDY OF ARSENIC TRIOXIDE AND TEMOZOLOMIDE IN COMBINATION WITH RADIATION THERAPY IN PATIENTS WITH MALIGNANT GLIOMAS
Other Scholarly Work
Kumthekar, P, Grimm, SA, Marymont, M et al. (2014). P17.50PHASE II STUDY OF ARSENIC TRIOXIDE AND TEMOZOLOMIDE IN COMBINATION WITH RADIATION THERAPY IN PATIENTS WITH MALIGNANT GLIOMAS
. NEURO-ONCOLOGY, 16(Suppl 2), ii99-ii99.
Kumthekar, P, Grimm, SA, Marymont, M et al. (2014). P17.50PHASE II STUDY OF ARSENIC TRIOXIDE AND TEMOZOLOMIDE IN COMBINATION WITH RADIATION THERAPY IN PATIENTS WITH MALIGNANT GLIOMAS
. NEURO-ONCOLOGY, 16(Suppl 2), ii99-ii99.
BACKGROUND: Current standard treatment for GBM is surgery followed by radiation (RT) and temozolomide (TMZ). We published phase I data of the addition of arsenic trioxide (ATO) to RT and TMZ. We now present the phase II data. METHODS: Patients with newly diagnosed malignant gliomas were eligible for treatment in this single arm phase II. Patients were treated with RT (60GY), TMZ (75 mg/m2 daily x 42 days) and ATO 0.20 mg/kg daily in week 1 then twice a week x 5 weeks. RESULTS: Twenty-five patients (14 M and 11 W) were enrolled with a median age of 56 (28-73). Histology was GBM 18, AA 6 and AO 1. All patients completed RT/TMZ/ATO. Median number of post RT cycles of TMZ was 3 (0-12); 9 patients completed 6 or more cycles. Median PFS was 6 m for GBM and 15 m for AG and median OS was 15 m for GBM and NR for AA. Response was SD in 20, PR in 1 and PD in 4. CONCLUSIONS: Adding ATO to RT and TMZ is feasible and tolerable but does not appear to improve outcome compared to RTOG 0525 data where OS is 16.6 months in newly diagnosed GBM. Tissue MGMT status is being analyzed for PFS and OS correlation.
