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Brain Cancer treatment details. Chemotherapy. Radiation. Food and Drug Administration, Rockville, MD, United States



Survival: 12.1 months
   
Toxicity Grade: 5
   
Treatments: Chemotherapy
Radiation
   
Drugs:
Country: United States
   
City/State/Province: Rockville, MD
   
Hospital: Food and Drug Administration
   
Journal: Link
   
Date: 10/2005

Description:
Patients: This Phase III study involved 573 adults with newly diagnosed glioblastoma multiforme. Most of the patients had undergone surgery, but none had received chemotherapy before the study. The patients were divided into two groups. Group A had 286 patients (109 women, 175 men, 1 did not answer) with a median age of 56 years. Furthermore, at the completion of treatment, 224 patients in both groups were kept on maintenance therapy.

Treatment: In Group A, treatment consisted of radiotherapy. Maintenance therapy consisted of the chemotherapeutic agent temozolomide.

Toxicity: Thirty-two patients died during or within 30 days after the end of treatment. In Group A, 74 patients (26%) reported having grade 3-4 toxicities, including fatigue, headaches, convulsions, confusion, dyspnea, blurred vision, and weakness.

During the maintenance phase, 82 patients (37%) reported having grade 3-4 toxicities, including fatigue, headache, thrombocytopenia, convulsions, vomiting, and weakness.

Results: For Group A (radiotherapy alone), the median overall survival was 368 days (12.1 months). For Group B (radiotherapy and temozolomide), the median overall survival was 444 days (14.6 months). By approving temozolomide, the authors concluded, "newly diagnosed glioblastoma multiforme patients receiving concomitant temozolomide + radiotherapy followed by maintenance temozolomide had significantly improved overall survival compared with patients receiving radiation therapy alone. Therapy was generally well tolerated. This trial represents an important stepping stone along the path of improved glioblastoma therapy."

Correspondence: Martin H. Cohen

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