Prognostic factors for response and survival in primary central nervous system lymphoma (PCNSL) from a randomized phase III trial (G-PCNSL-SG-1).

Abstract

2004 Background: The purpose of this study was to establish prognostic factors in newly diagnosed primary central nervous system lymphoma (PCNSL) in immunocompetent patients. Methods: Four-hundred and eleven patients (median age 63 years, median Karnofsky performance status (KPS) 70%) enrolled in a German multicenter randomized phase III trial (G-PCNSL-SG-1) between May 2000 and May 2009 were analyzed using univariate and multivariate logistic regression analyses to identify prognostic factors for overall response (OR) and progression-free (PFS) and overall survival (OS). Patients were treated upfront with high-dose methotrexate (HDMTX) or HDMTX plus ifosfamide and were whole-brain irradiated thereafter if randomized to radiotherapy and treated with high-dose cytarabine (patients without complete remission) or just followed-up (patients with complete remission) if randomized to chemotherapy alone. Results: On multivariate analysis, female gender (p = 0.003), no corticosteroid medication at study entry (p = 0.003) and <2 tumor lesions (p = 0.009) were highly predictive for OR. Age (<60 vs. ≥60 years; p = 0.007) and KPS (≥70 vs. <70%; p <0.001) were strongly associated with OS. Further favorable prognostic factors (0.05 >p ≥0.01) on multivariate analysis were: HDMTX plus ifosfamide vs. HDMTX monotherapy (for OR), body mass index ≤25 (for OS), <2 tumor lesions (for PFS and OS), and KPS ≥70% (for PFS). Conclusions: This is the first study that established prognostic factors for OR and survival in PCNSL derived from a multicenter, prospective, randomized phase III trial. The data, especially the strong association of age and KPS with OS, should be taken into consideration in the design of future studies in PCNSL.