Brain metastases patients' radiographic response at 3 months predicts survival.

2004 NOV 4 - (NewsRx.com & NewsRx.net) -- For brain metastases patients undergoing whole brain radiation therapy (WBRT), radiographic response in the brain at 3 months is a statistically significant predictor of prolonged survival, according to study results presented today at the 46th Annual Meeting of the American Society for Therapeutic Radiation Oncology.

The findings were drawn from Allos Therapeutics' completed Phase 3 clinical trial of the investigational radiation sensitizer EFAPROXYN (efaproxiral) in patients with brain metastases.

Preliminary data from the phase 3 study, called REACH, were first announced in April 2003. Dino B. Stea, MD, PhD, director, Radiation Oncology, Arizona Cancer Center and the study's lead enroller presented the results in abstract #2126, titled "Response at 3 Months After Whole Brain Radiation Therapy Predicts Survival in Brain Metastases Patients."

Stea and colleagues conducted a retrospective analysis of the results from the REACH study to assess the validity of using response (complete or partial) in the brain after WBRT to predict subsequent survival in brain metastases patients. Results of the analysis indicated that response in the brain post WBRT (greater than or equal to 50% reduction in overall brain tumor size) at 90 days, as assessed by an independent central review, was a statistically significant predictor of survival compared to non-responders (HR=3D0.63, p=3D0.004).

Response at 1 month was not found to be a statistically significant predictor of subsequent survival. Moreover, the results demonstrated a statistically significant improvement in response rate at 3 months for patients in the EFAPROXYN arm versus control arm patients (28% vs. 20%, respectively; p=3D0.036).

"Our findings have significant implications for the design of future studies of patients with brain metastases and good performance status," said Stea. "This study affirms the validity of using a WBRT imaging assessment at 3 months to predict prolonged subsequent survival in brain metastases patients."

Results from Stea's retrospective analysis were incorporated into the study design of Allos' phase 3, randomized, open-label, multi-center trial, called ENRICH (ENhancing ...