Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: Results of a subgroup analysis

2004 
7115 Background: Brain metastases (BM) represent a common cause of morbidity and mortality among cancer patients. WBRT is the primary treatment for these patients; however, differences in the prognosis of these patients have been reported for those with synchronous disease (simultaneous diagnosis of primary tumor and BM within 1 month) versus metachronous (time of diagnosis > 1 month apart). RSR13 (efaproxiral), a novel radiation sensitizer, reduces tissue hypoxia and therefore enhances the efficacy of radiation therapy. Methods: A randomized, open-label phase 3 study compared the survival of patients receiving RSR13 (75–100 mg/kg) + O2 with standard WBRT (3 Gy/d fractions over 10 days) versus patients receiving WBRT + O2 alone. The primary endpoint of the study was survival. Results: The subset of patients with BM originating from NSCLC (n=299) was the largest of the 538 patients enrolled in the study. Patients in the RSR13 arm with NSCLC and metachronous disease (n=75) had an MST of 5.39 months compared...
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