Survival benefit confirmed in patients with brain metastases from breast cancer.

2004 DEC 2 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc. (ALTH) announced the presentation of updated results from its 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. John H. Suh, MD, director, Gamma Knife Center, clinical director, Radiation Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation, and the study's lead investigator, presented the findings in an oral presentation at the 29th Annual Meeting of the European Society for Medical Oncology.

In abstract #785, titled "Standard Whole Brain Radiation Therapy (WBRT) Plus Supplemental Oxygen (O2) with or without Efaproxiral (Efaproxyn) in Patients with Brain Metastases: Updated Survival Results of the Randomized REACH (RT-009) Study," Suh and colleagues presented an updated survival analysis of enrolled patients from the time of randomization until death or January 2004, whichever occurred first.

Results of the analysis indicated that the addition of Efaproxyn to whole brain radiation therapy (WBRT) led to a significant reduction in the risk of death for the co-primary patient populations (all eligible patients and all eligible lung and breast patients), consistent with results reported previously. Specifically, there was a 21% (95% confidence interval: 5%-35%) and 23% (95% confidence interval:I:5%-38%) reduction in the risk of death, for all eligible patients and all eligible lung and breast cancer patients respectively. Moreover, Suh's analysis affirmed a distinct survival benefit for patients with brain metastases originating from breast cancer in the Efaproxyn arm. Two-year survival for breast cancer patients was 17% in the Efaproxyn arm as compared to 0% in the control arm.

To further confirm the survival benefit observed in the breast cancer sub- group, in February 2004, Allos initiated a phase 3, randomized, open-label, multi-center trial, called ENRICH (ENhancing Whole Brain Radiation Therapy In ...