Dose-dense @entity2903 regimen for the treatment of brain metastases from @entity320 , XXXX not amenable to surgery or radiosurgery: a multicenter phase II study.

@entity1 @entity0 @entity882 @entity5 @entity1149 @entity2903 @entity320
BACKGROUND: Brain metastases reduce survival because therapeutic options are limited. This phase II study evaluated the efficacy of single-agent therapy with alternating weekly, dose-dense @entity2903 in pretreated @entity1 with brain metastases prospectively stratified by primary @entity5 type. METHODS: Eligible @entity1 had bidimensionally measurable brain metastases from histologically/cytologically confirmed @entity320 , @entity0 ( @entity0 ), or @entity1149 ( @entity1149 ). Prior chemotherapy, radiotherapy, and whole-brain radiotherapy (WBRT) were allowed. @entity1 received @entity2903 150 mg/m(2)/day (days 1-7 and 15-21 every 28- or 35-day cycle). RESULTS: In the intent-to-treat population (N = 157; 53 @entity320 , 51 @entity0 , and 53 @entity1149 ), one @entity1 had complete response, nine (6%) had partial responses, and 31 (20%) had stable disease in the brain. Median progression-free survival was 56, 58, and 66 days for @entity320 , @entity0 , and @entity1149 , respectively. Median overall survival was 100 days for @entity320 , 172 days for @entity1149 , and not evaluable in the @entity0 group. @entity882 was the most common adverse event causing dose modification or treatment discontinuation. Grade 4 toxic effects were rare. CONCLUSIONS: This alternating weekly, dose-dense @entity2903 regimen was well tolerated and clinically active in heavily pretreated @entity1 with brain metastases, particularly in @entity1 with @entity320 . Combining @entity2903 with WBRT or other agents may improve clinical outcomes.
