The outcomes of concomitant radiation plus temozolomide followed by adjuvant temozolomide for newly diagnosed high grade gliomas: the preliminary results of single center prospective study

Abstract

Purpose: Temozolomide (TMZ) is an oral alkylating agent with demonstrated efficacy as second-line therapy for patients with recurrent anaplastic astrocytoma and glioblastoma multiforme (GBM). We reported the preliminary results of the treatment with concomitant radiation therapy (RT) plus TMZ followed by adjuvant TMZ therapy in patients with newly diagnosed high grade gliomas (HGG) to determine the safety, tolerability, and efficacy.

Patients and methods: Between January, 2006 and December, 2007, a total of 27 patients over the age of 18 years with newly diagnosed, histologically confirmed HGG were assigned to receive oral TMZ (75 mg/m2/d x 7 d/wk for 6 weeks, from the first to the last day of RT) with fractionated RT (60 Gy total dose: 2 Gy x 5 d/wk for 6 weeks) followed by TMZ monotherapy (150 to 200 mg/m2/d x 5 days, every 28 days for six cycles) at Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital. The primary end point was overall survival; secondary end points were progression-free survival, safety and tolerability.

Results: At a median follow-up period of 17 months (range; 5-30 months), the median progression-free survival (PFS) for all patients with HGG was 11 months, and the one-year PFS rate was 43.14%. The median overall survival (OS) was 19 months and the one-year OS rate was 81.2%. Patients with GBM were analyzed separately from HGG, and the median overall survival (OS) was 17 months, and the one-year OS rate was 83.3%. The median PFS was 10 months, and the one-year PFS rate was 27.8%. The mean age was 50.2 years (standard deviation ±9.7284), and 44.4%of patients had undergone biopsy only. There was no mortality caused by drug toxicity. Patients younger than 50 years old and patients who underwent debulking surgery had the best survival outcome.

Conclusion: The addition of TMZ to RT followed by adjuvant TMZ was well tolerated, and has shown promising activity in the treatment of newly diagnosed HGG. Further investigation is warranted.