Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
This trial was conducted to evaluate the efficacy, in terms of survival and quality of life,
and safety of up-front temozolomide in elderly GBM patients with poor performance status.
Patients of 70 years of age or older were eligible to participate in this prospective
non-randomised multicentric phase II study if they had newly diagnosed and histologically
proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between
30 and 60.
Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks
for a maximum of 12 cycles or until disease progression or prohibited toxicity.
Patients were assessed at least every month by means of physical and neurological
examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE.
Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the
earlier were also checked every 10 days during the first 2 cycles and every 2 weeks
afterwards. CT or MRI studies were repeated every 2 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
DELATTRE Jean-Yves, MD, PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health