According to results presented at the plenary session of the 40th annual meeting of the American Society of Clinical Oncology, the addition of Temodar® (temozolomide) to initial radiation therapy for glioblastoma multiforme (GBM) improves long-term survival with minimal side effects.

An international consortium reported the results of a multi-institutional clinical trial comparing standard radiation alone to concomitant and adjuvant Temodar® (temozolomide) following surgery or biopsy for patients with newly diagnosed GBM. The remarkable thing about this trial was that 573 patients were accrued over 18 months in 85 institutions in 14 countries.  This demonstration of rapid patient accrual is extremely important since this allows studies to be performed and reported very rapidly.  This study evaluated the administration of Temodar® during radiation therapy and following radiation therapy.  The average age of patients in this study was 56-57 years, two thirds were receiving steroids, 16-17% had a biopsy only while the remainder underwent de-bulking surgery. 

There was no interruption of radiation with the concomitant administration of chemotherapy and 88% of patients received greater than 90% of the intended doses administered during radiation. However, 50% of patients did not receive the full adjuvant course predominantly due to progressive disease.  Patients receiving Temodar® had an increased incidence of anemia and neutopenia. These researchers concluded that the addition of Temodar® to radiation therapy improves survival compared to radiation therapy alone as initial therapy for glioblastoma multiforme (see table 1).

Table 1 Addition of Temodar® to radiation therapy in GBM

Glioblastoma multiforme is a varied disease with multiple types. Importantly, benefit was observed with Temodar® for all subtypes.  Thus, this may be the standard by which future treatments are tested.

Reference: Stupp R, Mason W, Van Den Bent M, et al. Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group. Proceedings of the American Society of Clinical Oncology, June 2004; Abstract #2.