Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral)in patients with brain metastases: Results of the randomized REACH (RT-009) study

Abstract

1534 Background: Brain metastases represent a common cause of morbidity and mortality among cancer pts. The effectiveness of WBRT as primary therapy for brain metastases is limited by tissue hypoxia, which has been shown to cause radioresistance in solid tumors. RSR13 (efaproxiral) is a novel radiation sensitizer that acts as an allosteric modifier of hemoglobin, facilitates O2 release and decreases tissue hypoxia. Methods: A randomized, open-label Phase 3 study was conducted comparing RSR13 and WBRT to WBRT alone in pts. with newly diagnosed brain metastases from various solid tumors. In the RSR13 arm (n=271), pts. received RSR13 (75–100 mg/kg/d, IV) plus O2 followed by WBRT (30 Gy, 3 Gy/d x 10 days). In the Control arm (n=267), pts. received WBRT plus O2. The primary endpoint was survival. Secondary endpoints were RR in the brain, TTP, cause of death and QoL. Results: A total of 538 pts. were enrolled over 29 months at 82 sites in 12 countries. In the overall study population (n=538), the RSR13 arm demo...