Positive survival, quality of life data presented on RSR13 phase III study.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc., (ALTH) announced the presentation of positive findings from its phase III clinical trial of the investigational radiation sensitizer RSR13 (efaproxiral).

The results demonstrate a significant survival benefit for women with breast cancer and brain metastases who received RSR13 plus whole brain radiation therapy (WBRT) versus WBRT alone. Baldassarre Stea, MD, PhD, head of the Department of Radiation Oncology at the Arizona Health Sciences Center in Tucson, presented the findings at the 26th Annual San Antonio Breast Cancer Symposium.

In poster number 175, entitled "Results from a subgroup analysis of patients with metastatic breast cancer (MBC) in a phase III, randomized, open-label, comparative study of standard whole brain radiation therapy (WBRT) with supplemental-oxygen, with or without RSR13, in patients with brain metastases," Stea and colleagues showed that adding RSR13 to WBRT with supplemental oxygen nearly doubled the median survival rate of patients with breast cancer and brain metastases to 8.67 months versus 4.57 months for patients who received WBRT alone (p=0.006).

Patients with breast cancer and brain metastases who were treated with RSR13 plus WBRT also achieved a higher response rate in the brain than the control group (71.7% vs. 49.1%; p=0.02). A statistically significant stable or improvement in quality of life at 3 months was observed in patients receiving RSR13, as assessed by the Karnofsky Performance Score (35% vs. 18%; p=0.001) and the Spitzer Index (37% vs. 24%; p=0.01). In general, patients experienced minimal serious adverse events with the most common being hypoxemia (3.4% n=266), which is dose-dependent and effectively managed with supplemental oxygen.

"The presentation of survival and quality of life data at this meeting validates the potential of RSR13 to increase the effectiveness of radiation therapy in breast cancer patients with brain metastases," said Michael E. Hart, president and CEO of Allos Therapeutics, Inc. "Brain metastases are devastating to patients and new therapies are desperately needed."

"You would ...