nelarabine and Peripheral-Nervous-System-Diseases

Topics: Antineoplastic Agents; Arabinonucleosides; Child; Fecal Incontinence; Female; Humans; Paraplegia; Peripheral Nervous System Diseases; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Spinal Cord Diseases; Thoracic Vertebrae

Topics: Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Arabinonucleosides; Combined Modality Therapy; Humans; Magnetic Resonance Imaging; Male; Neurotoxicity Syndromes; Peripheral Nervous System Diseases; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Spinal Cord; Spinal Cord Diseases; Treatment Outcome

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).. 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]).. 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).. 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.

Topics: Adolescent; Adult; 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