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Phase II Multicenter Study of Brief Single-Agent Methotrexate Followed by Irradiation in Primary CNS Lymphoma

From the Trans-Tasman Radiation Oncology Group: Department of Radiation Oncology, Newcastle Mater Hospital, Newcastle, and Department of Radiation Oncology, Westmead Hospital, Westmead, New South Wales; Royal Adelaide Hospital Cancer Centre, Adelaide, South Australia; Queensland Radium Institute, Royal Brisbane Hospital and Mater Hospital, Brisbane, Queensland; Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia; and Department of Radiation Oncology, Waikato Hospital, Hamilton, New Zealand.

Address reprint requests to P. O’Brien, MD, Radiation Oncology Department, Newcastle Mater Hospital, Locked Bag 7, Hunter RMC New South Wales 2310, Australia; email mdpco{at}cc.newcastle.edu.au

PURPOSE: To assess, in a multi-institutional setting, the impact on relapse, survival, and toxicity of adding two cycles of intravenous methotrexate to cranial irradiation for immunocompetent patients with primary CNS lymphoma.

PATIENTS AND METHODS: Forty-six patients with a median age of 58 years and Eastern Cooperative Oncology Group performance status 0 to 3 were entered onto this phase II study. The protocol consisted of methotrexate 1 g/m² on days 1 and 8 followed by cranial irradiation on day 15. A whole-brain dose of 45 Gy was followed by a boost of 5.4 Gy. Intrathecal chemotherapy and spinal irradiation were given only to patients for whom cytologic examination of CSF was positive for CNS lymphoma. The median follow-up time was 36 months, with a minimum potential follow-up of 12 months.

RESULTS: Median survival was 33 months, with 2-year probability of survival 62% ± 15% (95% confidence interval). Twenty patients have relapsed. The predominant site of relapse was the brain. Neither performance status nor age was found to influence survival. Six patients developed a dementing illness at a median of 16 months after treatment, and three of these died as a consequence.

CONCLUSION: A brief course of intravenous methotrexate before cranial irradiation is associated with 2-year and median survival rates superior to those reported for radiotherapy alone and similar to more intensive combined-modality regimens. Neurotoxicity remains an important competing risk for these patients.

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