Allos Therapeutics has announced the presentation of new findings from its Phase 3 clinical trial of the investigational radiation sensitizer Efaproxyn (efaproxiral) in patients with brain metastases.
A retrospective analysis of the results from the study led to the identification of the strongest prognostic factors for survival in patients with brain metastases. John H. Suh, M.D., 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 today at the 46th Annual Meeting of the American Society for Therapeutic Radiation Oncology. Preliminary data from the Phase 3 study, called REACH, were first announced in April 2003.
In abstract #60, titled "Prognostic Factors for Survival in Patients with Brain Metastases Enrolled on a Worldwide Phase 3 Randomized Trial of 538 Patients," Dr. Suh and colleagues evaluated certain factors influencing long-term survival of brain metastases patients, including Karnofsky Performance Status (KPS), site of primary, age, presence of extra cranial metastases, control of primary, gender, presence of liver metastases, timing of brain metastases diagnosis, prior brain tumor resection and number of brain metastases. Results of the analysis indicated that KPS, prior brain tumor resection, the presence of extra cranial metastases and gender were the strongest variables in predicting outcome. Moreover, the analysis affirmed the effectiveness of the study drug, Efaproxyn, in improving survival time across a heterogeneous patient population.
"This study has significant implications for the design of future randomized trials in brain metastases patients," said Dr. Suh. "Our findings confirm the impact of certain variables in determining survival outcome for brain metastases patients. Moreover, the results demonstrated an improvement in survival for patients with brain metastases who received Efaproxyn and whole brain radiation therapy (WBRT) with supplemental oxygen over those who received WBRT with supplemental oxygen only."
Results from Dr. Suh's retrospective analysis were incorporated into the study design of Allos' Phase 3, randomized, open-label, multi-center trial, called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), designed to compare the effect of whole brain radiation therapy (WBRT) with supplemental oxygen with or without Efaproxyn in women with brain metastases from breast cancer. The trial, which was initiated in February 2004, incorporated certain identified prognostic factors into the stratification and design, including KPS and presence of liver metastases.