Hypofractionated radiation therapy versus chemotherapy with temozolomide in patients affected by RPA class V and VI glioblastoma: a randomized phase II trial

INTRODUCTION: In RPA V-VI glioblastoma patients both hypofractionated radiotherapy and exclusive temozolomide can be used; the purpose of this trial is to compare these treatment regimens in terms of survival and quality of life. METHODS: Patients with histologic diagnosis of glioblastoma were randomized to hypofractionated radiotherapy (RT-30Gy in 6 fractions) and exclusive chemotherapy (CHT-emozolomide 200mg/m2/day 5days every 28days). Overall (OS) and progression free survival (PFS) were evaluated with Kaplan Maier curves and correlated with prognostic factors. Quality- adjusted survival (QaS) was evaluated according to the Murray model (Neurological Sign and Symptoms-NSS) RESULTS: From 2010 to 2015, 31 pts were enrolled (CHT: 17 pts; RT: 14pts). Four pts were excluded from the analysis. RPA VI (p=0.048) and absence of MGMT methylation (p=0.001) worsened OS significantly. Biopsy (p=0.048), RPA class VI (p=0.04) and chemotherapy (p=0.007) worsened PFS. In the two arms the initial NSS scores were overlapping (CHT: 12.23 and RT: 12.30) and progressively decreased in both group and became significantly worse after 5months in CHT arm (p=0.05). Median QaS was 104days and was significantly better in RT arm (p=0.01). CONCLUSIONS: The data obtained are limited by the poor accrual. Both treatments were well tolerated. Patients in RT arm have a better PFS and QaS, without significant differences in OS. The deterioration of the NSS score would seem an important parameter and coincide with disease progression rather than with the toxicity of the treatment.