• Oncology Clinical Trials
• Breast Cancer
• Radiology
• Radiation Therapy

• Oncology Clinical Trials
• Oncology
• Breast Cancer
• Radiology
• Radiation Therapy

The addition of temozolomide (TMZ) does not improve the efficacy of whole-brain radiation therapy (WBRT) for the treatment of brain metastases from breast cancer. Kim I. Cao, Institut Curie, Paris, France, and colleagues presented data from a phase 2 prospective randomized multicenter study.

TMZ, an oral alkylating agent, has radiosensitizing properties and has demonstrated promise in previous phase 2 studies involving WBRT. However, these studies did not include sufficient samples of patients with brain metastases from breast cancer, despite the need for improved treatments for such patients. The present phase 2 trial was intended to determine whether concomitant TMZ with WBRT could improve outcomes for these patients.

Patients were eligible for this study if they had intra-parenchymal metastases from breast cancer that were newly diagnosed, inoperable, and not suitable for radiosurgery. A total of 100 patients were randomly assigned to 2 treatment groups, one of which received WBRT (3 Gy × 10 to 30 Gy) alone, while the other received WBRT concomitantly with 75 mg/m²/d of TMZ.

Radiologic objective response was the primary end point, determined by brain magnetic resonance imaging 6 weeks after the end of treatment. This end point was defined as a partial or complete response based upon World Health Organization-modified criteria. There were multiple secondary end points, including overall survival (OS) and local progression-free survival (PFS). Neurologic symptoms and safety data were also collected.

The primary end point was similar between the 2 study arms; the objective response rates were 30% and 36% for concomitant (WBRT + TMZ) therapy and for WBRT alone, respectively, which was not a significant difference. No patients showed complete response. Neither the median OS nor PFS was statistically significant. The median OS was 11.1 months in the WBRT arm compared with 9.4 months in the concomitant therapy arm. The median PFS was 7.4 months in the WBRT arm compared with 6.9 months in the concomitant therapy arm. The concomitant therapy arm did not show more neurologic improvement than the WBRT arm. Additionally, the concomitant therapy was well tolerated (reversible lymphopenia was the most serious acute toxicity).

The authors concluded that adding TMZ to WBRT did not significantly improve outcomes in patients with brain metastases from breast cancer on the basis of the outcomes studied.

• © 2014 MD Conference Express®