Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma (Stupp Protocol)
- This study aims to compare radiotherapy alone versus radiotherapy plus concomitant and adjuvant temozolomide for the treatment of glioblastoma.
- Multi-center, randomized, controlled trial.
- Patients with newly diagnosed, histologically confirmed glioblastoma were randomly divided into Radiotherapy alone, or Radiotherapy plus Temozolomide groups.
- Primary end point was overall survival. Secondary end points were progression-free survival, safety, and quality of life.
- Radiotherapy only group: 286 patients, received 60 Gy total, divided over 6 weeks, with 2 Gy given Monday through Friday.
- Radiotherapy plus temozolomide: 287 patients, during radiotherapy: they received temozolomide at a dose of 75 mg/m2 of body surface area, followed by a 4-week break, and post radiotherapy: received 150-200 mg/m2 of body surface area up to 6 cycles according to the standard 5-day schedule every 28 days.
- Results: For the radiotherapy-only group, median survival was 12.1 months and two year survival was 10.4%, as opposed to 14.6 months and 26.5% respectively for the radiotherapy-plus-temozolomide group.
- Safety: 7% of patients suffered grade 3 or 4 hematologic toxic effects in the radiotherapy-plus-temozolomide group, while no patients in the radiotherapy-only group suffered grade 3 or 4 effects. Overall, at a median follow up of 2 years, there was no evidence of increase in treatment-induced late toxic effects in the radiotherapy-plus-temozolomide group.