207_Combined course Presentations

The study did not meet many standards… in design, undertaking, and interpretation.

 Poor protocol adherence (318/551 = 57.7%)

 Low statistical power because of exclusion of patients with protocol violations from the denominator in various analyses (PP vs ITT analyses)

 Long accrual period (2000-2009, 75 centers)

 Involvement of many centers with little experience in PCNSL (high rates of erroneous response assessment, patients lost to follow-up, and toxic deaths).

 Inconsistent data for iatrogenic neurotoxicity (exclusively assessed by MRI)

The G-PCNSL-SG-1 trial is compromised by several flaws and failed to prove its primary hypothesis.