Salvage chemotherapy with temozolomide in primary CNS lymphomas: preliminary results of a phase II trial.
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.
Reni
Michele
M
Department of Radiochemotherapy, S. Raffaele Hospital Scientific Institute, Milan, Italy. reni.michele@hsr.it
Mason
Warren
W
Zaja
Francesco
F
Perry
James
J
Franceschi
Enrico
E
Bernardi
Daniele
D
Dell'Oro
Stefania
S
Stelitano
Caterina
C
Candela
Marco
M
Abbadessa
Antonio
A
Pace
Andrea
A
Bordonaro
Roberto
R
Latte
Giancarlo
G
Villa
Eugenio
E
Ferreri
Andrés J M
AJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D002493:Central Nervous System Diseases / Q000188:drug therapy*; D003606:Dacarbazine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016879:Salvage Therapy / Q000379:methods; D016019:Survival Analysis; D000077204:Temozolomide; D016896:Treatment Outcome
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide