Phase II trial of temozolomide for leptomeningeal metastases: Safety and activity analysis.

e12528 Background: Leptomeningeal carcinomatosis represents a fatal complication of solid tumors. Unfortunately, therapeutic options remain limited, particularly for patients with chemoresistant tumors. Optimized treatment remains controversial and may rely upon a combination of chemotherapy (intrathecal and/or intravenous) and concurrent focal radiotherapy. We evaluated the response rate, survival, quality of life (QoL) and safety when temozolomide (TMZ) was used as first-line treatment in patients (pts) with solid tumors known to metastasize to the brain: leptomeningeal metastases (LM) of breast cancer (BC), non small cell lung cancer (NSCLC) and melanoma (MEL). Methods: Eligible pts had LM from BC, NSCLC and MEL documented by positive CSF cytology or compatible clinical syndrome with diagnostic MRI, with adequate hematologic and renal function. Prior therapy for LM was not permitted. Pts received oral TMZ (100 mg/m2 daily) week-on, week-off. CSF sampling was repeated every 4 weeks. MRI scans were repea...