title: Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801.
abstract: Nelarabine (506U78) is a soluble pro-drug of 9-beta-D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative. We treated 26 patients with T-cell acute lymphoblastic leukemia (T-ALL) and 13 with T-cell lymphoblastic lymphoma (T-LBL) with nelarabine. All patients were refractory to at least one multiagent regimen or had relapsed after achieving a complete remission. Nelarabine was administered on an alternate day schedule (days 1, 3, and 5) at 1.5 g/m(2)/day. Cycles were repeated every 22 days. The median age was 34 years (range, 16-66 years); 32 (82%) patients were male. The rate of complete remission was 31% (95% confidence interval [CI], 17%, 48%) and the overall response rate was 41% (95% CI, 26%, 58%). The principal toxicity was grade 3 or 4 neutropenia and thrombocytopenia, occurring in 37% and 26% of patients, respectively. There was only one grade 4 adverse event of the nervous system, which was a reversible depressed level of consciousness. The median disease-free survival (DFS) was 20 weeks (95% CI, 11, 56), and the median overall survival was 20 weeks (95% CI, 13, 36). The 1-year overall survival was 28% (95% CI, 15%, 43%). Nelarabine is well tolerated and has significant antitumor activity in relapsed or refractory T-ALL and T-LBL.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. ddeangelo@partners.org
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: DeAngelo
authors.forename: Daohai
authors.initials: D
authors.lastname: Yu
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Johnson
authors.forename: Steven E
authors.initials: SE
authors.lastname: Coutre
authors.forename: Richard M
authors.initials: RM
authors.lastname: Stone
authors.forename: Alison T
authors.initials: AT
authors.lastname: Stopeck
authors.forename: Jon P
authors.initials: JP
authors.lastname: Gockerman
authors.forename: Beverly S
authors.initials: BS
authors.lastname: Mitchell
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Appelbaum
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001087:Arabinonucleosides / Q000008:administration & dosage* / Q000633:toxicity; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015459:Leukemia-Lymphoma, Adult T-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000379:methods*; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D001087:Arabinonucleosides; C104457:nelarabine