ACTR-52. TUMOR TREATING FIELDS (TTFIELDS) IN COMBINATION WITH LOMUSTINE (CCNU) IN THE EF-14 PHASE 3 CLINICAL STUDY – A SAFETY ANALYSIS

摘要

INTRODUCTION: TTFields are low intensity, intermediate frequency, alternating electric fields. The significant overall and progression-free survival benefit, shown in the EF-14 phase 3 study was seen in all patient-subgroups, independent of e.g. MGMT-promotor methylation-status or age. TTFields were not associated with additional systemic toxicity. At recurrence, patients were allowed to continue TTFields with second-line therapies. Here, we analyzed the safety data of TTFields + lomustine (CCNU) to evaluate safety and feasibility of this combination.METHODSPatients in the EF-14 trial received TTFields until second progression, or for 24 months. Change in chemotherapy regimen was allowed after tumor progression. We compared the patients who received lomustine as second-line chemotherapy in combination with TTFields (n=134) to the patients who received lomustine as monotherapy after first progression (n=39). We compared baseline characteristics and the adverse event profile between the groups.