Pilot study of nelarabine in combination with intensive chemotherapy in high-risk T-cell acute lymphoblastic leukemia: a report from the Children's Oncology Group. J Clin Oncol 2012 Aug 01;30(22):2753-9
Date
06/27/2012Pubmed ID
22734022Pubmed Central ID
PMC3402886DOI
10.1200/JCO.2011.40.8724Scopus ID
2-s2.0-84864566041 (requires institutional sign-in at Scopus site) 69 CitationsAbstract
PURPOSE: Children's Oncology Group study AALL00P2 was designed to assess the feasibility and safety of adding nelarabine to a BFM 86-based chemotherapy regimen in children with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).
PATIENTS AND METHODS: In stage one of the study, eight patients with a slow early response (SER) by prednisone poor response (PPR; ≥ 1,000 peripheral blood blasts on day 8 of prednisone prephase) received chemotherapy plus six courses of nelarabine 400 mg/m(2) once per day; four patients with SER by high minimal residual disease (MRD; ≥ 1% at day 36 of induction) received chemotherapy plus five courses of nelarabine; 16 patients with a rapid early response (RER) received chemotherapy without nelarabine. In stage two, all patients received six 5-day courses of nelarabine at 650 mg/m(2) once per day (10 SER patients [one by MRD, nine by PPR]) or 400 mg/m(2) once per day (38 RER patients; 12 SER patients [three by MRD, nine by PPR]).
RESULTS: The only significant difference in toxicities was decreased neutropenic infections in patients treated with nelarabine (42% with v 81% without nelarabine). Five-year event-free survival (EFS) rates were 73% for 11 stage one SER patients and 67% for 22 stage two SER patients treated with nelarabine versus 69% for 16 stage one RER patients treated without nelarabine and 74% for 38 stage two RER patients treated with nelarabine. Five-year EFS for all patients receiving nelarabine (n = 70) was 73% versus 69% for those treated without nelarabine (n = 16).
CONCLUSION: Addition of nelarabine to a BFM 86-based chemotherapy regimen was well tolerated and produced encouraging results in pediatric patients with T-ALL, particularly those with a SER, who have historically fared poorly.
Author List
Dunsmore KP, Devidas M, Linda SB, Borowitz MJ, Winick N, Hunger SP, Carroll WL, Camitta BMMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Antineoplastic Combined Chemotherapy Protocols
Arabinonucleosides
Child
Child, Preschool
Disease-Free Survival
Female
Humans
Infant
Male
Peripheral Nervous System Diseases
Pilot Projects
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
