ATCT-19SIGNIFICANCE OF TEMOZOLOMIDE RE-CHALLENGE AFTER PROGRESSION OF MALIGNANT GLIOMAS IN MAINTAINING PERFORMANCE STATUS OF THE PATIENTS – MULTICENTER COOPERATIVE STUDY

Abstract

BACKGROUND: Recent standard therapy for newly-diagnosed malignant gliomas consists of tumor resection, followed by chemotherapy with temozolomide (TMZ) concomitant with radiotherapy, and maintenance chemotherapy with TMZ. We found that continuous administration of TMZ did not deteriorate performance status (PS) of some patients who presented progressive disease (PD) during the maintenance therapy. In the present multicenter clinical study, we investigated whether continuous TMZ administration is effective for maintenance of PS compared to the therapy with other chemotherapeutic agents or no treatment in the patients showing PD in the maintenance chemotherapy with TMZ. METHODS: Patients diagnosed as grade 3 or 4 malignant gliomas who presented PD during the maintenance chemotherapy with TMZ were assigned to two groups; a continuous TMZ administration group (TMZ(+) ) or a group with other therapy (including no treatment) (TMZ(-) ) based on the will of patients. Between the two groups, KPS, median survival time from recurrence and adverse events were evaluated. The planned sample size was 39 (TMZ(+) group 26 patients, TMZ(-) group 13 patients). Registration period was 5.5 years and follow-up period was one year. (UMIN 000014688) RESULTS: Between 2009 and 2014, 43 patients have been registered. Suppression of PS deterioration in TMZ(+) group (30 patients) was maintained two or four months longer than that in TMZ(-) group (13 patients). Median survival time from recurrence in TMZ(+) group and TMZ(-) group were 14 and 9 months, respectively survival time of TMZ(+) group was significantly longer than that of TMZ(-) group (P < 0.05). There was no severe adverse events in TMZ(+) group. CONCLUSION: Re-challenge of TMZ in the patients with recurrent malignant glioma was effective for maintaining the PS for several months. Continuous TMZ treatment may be one of the treatment option at the time of relapse in keeping the QOL of patients.