PURPOSE: Radiotherapy (RT) and chemotherapy may prolong survival in older 
patients (age ≥70 years) with glioblastoma multiforme (GBM), although the 
survival benefits remain poor. This Phase II multicenter study was designed to 
evaluate the efficacy and safety of an abbreviated course of RT plus concomitant 
and adjuvant temozolomide (TMZ) in older patients with GBM.
PATIENTS AND METHODS: Seventy-one eligible patients 70 years of age or older 
with newly diagnosed GBM and a Karnofsky performance status ≥60 were treated 
with a short course of RT (40 Gy in 15 fractions over 3 weeks) plus TMZ at the 
dosage of 75 mg/m(2) per day followed by 12 cycles of adjuvant TMZ (150-200 
mg/m(2) for 5 days during each 28-day cycle). The primary endpoint was overall 
survival (OS). Secondary endpoints included progression-free survival and 
toxicity.
RESULTS: The Median OS was 12.4 months, and the 1-year and 2-year OS rates were 
58% and 20%, respectively. The median and 1-year rates of progression-free 
survival were 6 months and 20%, respectively. All patients completed the planned 
programme of RT. Grade 3 or 4 adverse events occurred in 16 patients (22%). 
Grade 3 and 4 neutropenia and/or thrombocytopenia occurred in 10 patients (15%), 
leading to the interruption of treatment in 6 patients (8%). Nonhematologic 
Grade 3 toxicity was rare, and included fatigue in 4 patients and cognitive 
disability in 1 patient.
CONCLUSIONS: A combination of an abbreviated course of RT plus concomitant and 
adjuvant TMZ is well tolerated and may prolong survival in elderly patients with 
GBM. Future randomized studies need to evaluate the efficacy and toxicity of 
different schedules of RT in association with chemotherapy.