A Phase II Randomized Trial of Synchronous Radiotherapy With Temozolomide in Brain Metastases

Li Liu, MD
OncoLink Assistant Editor
Last Modified: October 23, 2000

Presenter: E. Paraskevaidis
Affiliation: Metaxas Cancer Hospital, Pireus, Greece


The majority of patients with brain metastases has a dismal survival of approximately 4 months. Various strategies have been investigated, including whole brain radiation therapy (WBRT), craniotomy, stereotactic radiosurgery boost, and chemotherapy, in an attempt to improve outcome. In this study, the researchers from France reported their Phase II randomized study of comparing WBRT with or without temozolomide (TMZ) in patients with brain metastases.


  • A total of 28 eligible patients were randomized to WBRT alone (13 patients) and WBRT + TMZ (15 patients).

  • Conventional WBRT consisted of a total dose of 40 Gy in 2 Gy daily fraction.

  • TMZ was administered daily at a dose of 75 mg/m2.


  • WBRT + TMZ appeared to have better radiological response assessed by CT scan.

  • Patients received WBRT + TMZ had better improvement of their major neurological symptoms compared with patients who had WBRT only.

Author's Conclusions:

In this study, patients who received combined treatment with WBRT+ TMZ achieved more significant response rates in patients with brain metastases than the ones who had WBRT only. Concurrent administration of TMZ with WBRT appeared to enhance WBRT efficacy in patients with brain metastases. Survival and pattern of failure results are needed to further assess the efficacy of this treatment regimen.