Temozolomide in Elderly Patients With 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.

Inclusion criteria

• Histologically confirmed supratentorial glioblastoma
• Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
• Patients aged 70 years or older
• KPS above 30 and below 70
• Life expectancy higher than 4 weeks
• Clinical examination at baseline
• Affiliation to Social Security or mandatory beneficiary
• Patient being informed and obtention of written informed consent

Exclusion criteria

• Prior surgical resection dated more than 1 month before inclusion
• Prior brain radiotherapy or chemotherapy
• Severe underlying disease which could interfere with survival
• History of hypersensibility reaction on temozolomide components
• Severe bone marrow hypoplasia
• Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
• Absolute neutrophil count < 1.5x109 cells per liter
• Platelet count < 100x109 cells per liter
• Hemoglobin < 9 g/dl
• Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy