OBJECTIVETo improve the treatment outcome of children with acute lymphoblastic leukemia (ALL), and to evaluate the efficacy and safety of a modified induction chemotherapy between the two protocols used to treat children with ALL in Shanghai Children's Medical Center.

METHODSFrom Jan. 1st, 1999 to Mar. 1st, 2006, 311 patients with newly diagnosed childhood ALL, who underwent induction chemotherapy for over 10 days, were eligible for analysis. Group 99 (n = 243) patients who were admitted before May 1st, 2005, were treated with ALL-XH-99 Protocol, whereas 68 patients admitted afterwards, defined as Group 05, were treated with ALL Protocol 2005 which was based on ALL-XH-99 Protocol but the treatment intensity was reduced to decrease treatment associated mortality. Clinically, the distributions of the initial data from the patients, treatment responses, complete remission rates after therapy, and treatment-associated infections in the two groups were evaluated.

RESULTSPatients from the two groups obtained similar complete remission rate (91.8% vs. 95.6%, P = 0.29), while patients from Group 05 were benefited more from their therapy. They had lower therapy associated infection rate (23.5% vs. 54.7% in Group 99, P < 0.01), and no severe infection (0 vs. 9.1% in Group 99) and no infection related death occurred (0 vs. 3.7% in Group 99). Patients in the Group 05 also had shortened period from the beginning day of the initial therapy to complete remission (32.34 +/- 3.36 days vs. 34.18 +/- 4.96 days, P < 0.01).

CONCLUSIONSALL Protocol 2005 had the same efficacy as ALL-XH-99 Protocol had in the induction therapy in treating children with ALL, but it was safer than ALL-XH-99.