ATCT-23MULTICENTER RETROSPECTIVE STUDY TO COMPARE CHEMORADIOTHERAPY WITH TEMOZOLOMIDE OR ACNU IN 535 ANAPLASTIC GLIOMAS.

BACKGROUND: Standard therapy for anaplastic gliomas (AG) is controversial. In Japan traditional treatment of patients with AG had been chemoradiotherapy with nimustine hydrochloride (RT/ACNU), but shifted to use of temozolomide (RT/TMZ) soon after its approval. Therefore, a retrospective analysis of the overall survival (OS) of patients with AG treated with RT/ACNU or RT/TMZ was performed. PATIENTS AND METHODS: Between 2001 and 2007, 724 patients with AG were treated by the members of Japan Clinical Oncology Group (JCOG). In this cohort 535 patients (median age, 48 years) received either RT/ACNU (439 cases) or RT/TMZ (96 cases). There were 289 anaplastic astrocytomas (AA), 126 anaplastic oligoastrocytomas (AOA), and 120 anaplastic oligodendrogliomas (AO). Multivariate analysis was performed using the Cox proportional hazard model, where covariates were age, KPS score, histology, extent of resection, and chemotherapy (ACNU vs. TMZ) at initial treatment and at recurrence. RESULTS: Medium survival time (MST) of 535 patients was 72 months and a 5-year survival rate was 54%. Univariate analysis showed that MST in the RT/ACNU subgroup (86 months) was significantly longer compared to RT/TMZ subgroup (46 months) (HR: 0.61; P 0.05). Subgroup analysis demonstrated that patients initially treated with RT/ACNU and second line chemotherapy with TMZ at recurrence, had significantly longer OS compared to those, who initially received RT/TMZ treatment followed by second line chemotherapy with various agents at recurrence (HR: 0.37; 95% CI: 0.25-0.57; P u003c 0.01). CONCLUSION: A randomized phase III study of chemoradiotherapy for anaplastic glioma using upfront TMZ or ACNU followed by second line TMZ at the time of recurrence is warranted and it has been started since May 2014 (JCOG 1016: SANTA).