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Salvage chemotherapy with temozolomide in primary CNS lymphomas: preliminary results of a phase II trial

2004; Elsevier BV; Volume: 40; Issue: 11 Linguagem: Inglês

10.1016/j.ejca.2004.03.008

1879-0852

Michele Reni, Warren Mason, Francesco Zaja, James Perry, Enrico Franceschi, Daniela Bernardi, Stefania Dell’Oro, Caterina Stelitano, Marco Candela, Antonio Abbadessa, Andrea Pace, Roberto Bordonaro, Giancarlo Latte, Eugenio Villa, Andrés J.M. Ferreri,

Lymphoma Diagnosis and Treatment

Temozolomide is a well-tolerated alkylating agent, that is able to permeate the blood-brain barrier (BBB), and has additive cytotoxicity when given with radiotherapy (RT). A phase II trial assessing temozolomide 150 mg/m(2)/day, for 5 days every 28 days in primary central nervous system (CNS) lymphoma (PCNSL) patients with negative human immunodeficiency virus (HIV) serology, Eastern Cooperative Oncology Group (ECOG) performance status (PS)<4, previously treated with high-dose methotrexate-containing (HD-MTX) chemotherapy and/or RT was started. Twenty-three patients were enrolled. Median age was 60 years. Five complete remissions (median duration 6+ months; range 2-36 months), one partial response, four stable disease (median duration 7.2 months, range 2-16.5 months), and 13 progressions were observed. No major toxicities were observed, apart grade 3 vomiting in a single cycle. Main grade 1-2 toxicities were: 15% nausea, 6% vomiting, 9% fatigue and 9% neurological symptoms. This is the first prospective trial assessing single-agent activity in PCNSL at failure. Although some patients had a poor PS and had been heavily pre-treated, temozolomide yielded 26% objective responses and was well tolerated without any major toxicity.