Phase II study of first-line chemotherapy with @entity2903 in recurrent XXXX : the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971.

@entity1 @entity4174 @entity137 @entity5 @entity2904 @entity11770 @entity816 @entity1891 @entity1485 @entity2903
PURPOSE: @entity5 are chemotherapy-sensitive @entity5 , with two thirds of @entity1 responding to combination chemotherapy with @entity4174 , @entity11770 , and @entity1891 ( @entity1485 ). @entity2903 ( @entity2904 ), a new alkylating and methylating agent, has demonstrated high response rates in @entity1 with recurrent @entity816 . We investigated @entity2904 as first-line chemotherapy in recurrent @entity5 ( @entity5 ) and @entity816 ( @entity816 ) after surgery and radiation therapy. @entity1 AND METHODS: In a prospective, nonrandomized, multicenter, phase II trial, @entity1 were treated with 200 mg/m2 of @entity2904 on days 1 through 5 in 28-day cycles for 12 cycles. @entity1 with a recurrence after prior surgery and radiotherapy, and with measurable and enhancing disease on magnetic resonance imaging (MRI) were eligible for this study. @entity1 with large lesions and mass effect or with new clinical deficits were not eligible. Pathology and the MRI scans of all responding @entity1 were centrally reviewed. RESULTS: Thirty-eight eligible @entity1 were included. In three @entity1 , pathology review did not confirm the presence of an @entity5 or @entity816 . @entity2904 was generally well tolerated. The most frequent side effects were hematologic; only one @entity1 discontinued treatment for @entity137 . In 20 (52.6%) of 38 @entity1 (95% exact confidence interval, 35.8% to 69.0%), a complete (n = 10) or partial response to @entity2904 was observed. The median time to progression was 10.4 months for all @entity1 and 13.2 months for responding @entity1 . At 12 months from the start of treatment, 40% of @entity1 were still free from progression. CONCLUSION: @entity2904 provides an excellent response rate with good tolerability in chemotherapy-naive @entity1 with recurrent @entity5 . A randomized phase III study comparing @entity1485 with @entity2904 is warranted.
