title: Monthly pulses of vincristine and prednisone prevent bone marrow and testicular relapse in low-risk childhood acute lymphoblastic leukemia: a report of the CCG-161 study by the Childrens Cancer Study Group.
abstract: On study CCG-161 of the Childrens Cancer Study Group (CCSG), 631 children with acute lymphoblastic leukemia (ALL) at low risk for relapse were randomized to receive monthly pulses of vincristine-prednisone (VCR-PDN ) during maintenance therapy in addition to standard therapy with mercaptopurine (6MP) and methotrexate (MTX), and either cranial irradiation during consolidation or intrathecal (IT) MTX every 3 months during maintenance. All patients received six doses of IT MTX during induction and consolidation. With a minimum follow-up time of 4.25 years, 76.7% receiving VCR-PDN were in continuous complete remission at 5 years, in contrast to 63.9% receiving GMP-MTX alone (P = .002). The difference in relapse-free survival was due primarily to bone marrow relapse (P = .0008), and in boys also to testicular relapse (P = .003). Among the nonirradiated patients, the 5-year disease-free survival (DFS) was 79.4% for patients randomized to the VCR-PDN pulses, in contrast to 61.2% for the patients randomized to receive 6MP-MTX alone (P = .0002). Among the irradiated patients, the DFS was not significantly different. Of the four combinations of maintenance and CNS therapy studied, the highest DFS was achieved with VCR-PDN pulses and maintenance IT MTX.
authors.affiliation: Children's Hospital and Medical Center, Seattle, WA.
authors.forename: W A
authors.initials: WA
authors.lastname: Bleyer
authors.forename: H N
authors.initials: HN
authors.lastname: Sather
authors.forename: H J
authors.initials: HJ
authors.lastname: Nickerson
authors.forename: P F
authors.initials: PF
authors.lastname: Coccia
authors.forename: J Z
authors.initials: JZ
authors.lastname: Finklestein
authors.forename: D R
authors.initials: DR
authors.lastname: Miller
authors.forename: P S
authors.initials: PS
authors.lastname: Littman
authors.forename: J N
authors.initials: JN
authors.lastname: Lukens
authors.forename: S E
authors.initials: SE
authors.lastname: Siegel
authors.forename: G D
authors.initials: GD
authors.lastname: Hammond
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000517:prevention & control*; D001932:Brain Neoplasms / Q000517:prevention & control; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007278:Injections, Spinal; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage; D008727:Methotrexate / Q000008:administration & dosage; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D011241:Prednisone / Q000008:administration & dosage; D011897:Random Allocation; D012008:Recurrence; D012074:Remission Induction; D015996:Survival Rate; D013736:Testicular Neoplasms / Q000517:prevention & control*; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D015122:Mercaptopurine; D011241:Prednisone; D008727:Methotrexate