@entity5747 and radiotherapy in newly diagnosed XXXX : phase 2 NABTT CNS Consortium study.

@entity1 @entity137 @entity64 @entity428 @entity5 @entity1313 @entity11 @entity5747 @entity463
@entity5747 is a polysulfonated naphthylurea that inhibits the function of growth factors and growth factor receptors implicated in @entity11 progression, angiogenesis, and radioresistance. The safety and benefits of combining inhibitors of angiogenesis and growth factors with cytotoxic therapies in @entity1 with @entity5 of the central nervous system remain unclear. The objectives of this phase 2 study were to determine the safety of administering @entity5747 with standard cranial radiotherapy (RT) and to estimate survival using this approach in @entity1 with newly diagnosed @entity463 ( @entity463 ). Fifty-five @entity1 with newly diagnosed @entity463 (Karnofsky performance status >or= 60) were enrolled in this multicenter phase 2 study. @entity1 received @entity5747 by a conventional intermittent fixed-dosing regimen for 1 week prior to and during cranial RT (60 Gy in 30 fractions, weeks 2-7). @entity1 with stable or responsive disease at week 18 received an additional 4 weeks of @entity5747 (weeks 19-22). The median survival for @entity5747 -treated @entity1 was 11.6 months, with 1-year and 18-month survival rates of 49% (95% confidence interval [CI], 36%-62%) and 18% (95% CI, 8%-28%), respectively. Overall, 55% of the @entity1 (30/55) had greater than grade 2 @entity137 at least possibly related to @entity5747 therapy. Two @entity1 died of possibly related neurologic events (i.e., @entity64 , @entity428 ). Otherwise, @entity137 were generally transient and self-limited. Administration of @entity5747 using an intermittent fixed-dosing regimen during cranial RT was generally well tolerated. However, overall survival is not significantly improved when compared with the New Approaches to @entity1313 Therapy @entity463 database or other comparable @entity1 populations.
