Treatment > Temozolomide Clinical Trials

Meeting Abstract

Promising Survival with Concomitant and Adjuvant Temozolomide [TMZ] for Newly Diagnosed Glioblastoma Multiforme [GBM]

Roger Stupp, Sandrine Ostermann Kraljevic, Pierre-Yves Dietrich, Alessia Pica, Ivan Maillard, Philippe Maeder, Raymond Miralbell, Claudia Collao, Jean-Guy Villemure, Nicolas de Tribolet, Rene Mirimanoff, Serge Leyvraz

Background. Temozolomide has been recently approved for the treatment of recurrent GBM and anaplastic astrocytoma. 
We investigated tolerance and efficacy when TMZ is given immediately after diagnosis concomitantly with radiotherapy and as adjuvant therapy. 

Treatment. TMZ 75 mg/m2 daily for 6 weeks and concomitant RT (1 x 200 cGy, 5d/wk for a total dose of 60 Gy). 
Twenty-eight days after completion of radiochemotherapy start of adjuvant chemotherapy with TMZ (200 mg/m2/d x 5 d), repeated every 28 days for 6 cycles. 
Prophylaxis with pentamidine inhalations was introduced for the last 20 patients after we observed two episodes of pneumocystis carinii pneumonia (PcP). 

Patients. Thirty-seven patients with newly diagnosed GBM have been included in this ongoing trial. 
Median age was 55 years, 20 patients had undergone prior complete resection, in 8 pts the resection was macroscopically incomplete and 9 pts had a biopsy only. Median Karnofsky PS at inclusion was 90% (range 60-100%). 

Results. The overall tolerance to the treatment was very good. 
The main toxicity during concomitant therapy was myelosuppression. 
One pt developed grade IV neutropenia and thrombocytopenia with a subsequent PcP. 
Another PcP was observed in a pt with an unresected tumor receiving high doses of corticosteroids. 
Lymphocytopenia grade IV was noted in 19/37 pts (50%) during the concomitant therapy. 
At a median follow up of 8 months (1-22) the estimated 1-year survival is 71%. 
Only 6 pts have died to date. 
Updated results will be presented. 

Conclusions. This first report of therapy with TMZ in newly diagnosed patients shows a promising 1-year survival and compares favorably to the reported 40-50% in the literature. 
Subjective toxicity is mild, severe myelosuppression with thrombocytopenia and neutropenia is rare. 
An international randomized trial of this regimen compared to standard RT will be activated in January 2000.

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