AT-59HIGH-DOSE MTX-BASED CHEMOTHERAPY FOR PRIMARY CNS LYMPHOMA: WITH OR WITHOUT WHOLE BRAIN RADIOTHERAPY? FINAL ANALYSIS OF G-PCNSL-SG-1

ABSTRACT: BACKGROUND: This is the final report of the G-PCNSL-SG-1 trial after a median follow-up of 81.2 months. METHODS: G-PCNSL-SG-1 (www.clinicaltrials.gov NCT00153530) had randomised immunocompetent patients with newly diagnosed PCNSL to high-dose methotrexate (HDMTX) - based chemotherapy followed by whole-brain radiotherapy (WBRT) or chemotherapy alone. We hypothesized that the omission of WBRT from first-line treatment would not compromise overall survival (OS; primary endpoint), using a non-inferiority design with a margin of 0.9. FINDINGS: Of 551 patients who entered the study 524 fulfilled the eligibility criteria, 410 entered the post-HDMTX phase (intention-to-treat, ITT population), and 320 were treated per protocol (PP). OS with versus without WBRT was different neither in the ITT (HR 0

SUBMITTER: Weller M 

PROVIDER: S-EPMC4217839 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature