Anthracycline-free protocol for favorable-risk childhood ALL: A noninferiority comparison between Malaysia-Singapore ALL 2003 and ALL 2010 studies

Ariffin, Hany and Chiew, Edwynn Kean Hui and Oh, Bernice Ling Zhi and Lee, Shawn Hsien Ren and Lim, Evelyn Huizi and Kham, Shirley Kow Yin and Abdullah, Wan Ariffin and Chan, Lee Lee and Foo, Koon Mian and Lam, Joyce Ching Mei and Chan, Yiong Huak and Lin, Hai Peng and Quah, Thuan Chong and Tan, Ah Moy and Yeoh, Allen Eng Juh (2023) Anthracycline-free protocol for favorable-risk childhood ALL: A noninferiority comparison between Malaysia-Singapore ALL 2003 and ALL 2010 studies. Journal of Clinical Oncology, 41 (20). 3642+. ISSN 0732-183X, DOI https://doi.org/10.1200/JCO.22.02347.

Full text not available from this repository.

Abstract

PURPOSETo investigate whether, for children with favorable-risk B-cell precursor ALL (BCP-ALL), an anthracycline-free protocol is noninferior to a modified Berlin-Frankfurt-Muenster ALL-IC2002 protocol, which includes 120 mg/m2 of anthracyclines.PATIENTS AND METHODSThree hundred sixty-nine children with favorable-risk BCP-ALL (age 1-9 years, no extramedullary disease, and no high-risk genetics) who cleared minimal residual disease (& LE;0.01%) at the end of remission induction were enrolled into Ma-Spore (MS) ALL trials. One hundred sixty-seven standard-risk (SR) patients (34% of Malaysia-Singapore ALL 2003 study MS2003]) were treated with the MS2003-SR protocol and received 120 mg/m2 of anthracyclines during delayed intensification while 202 patients (42% of MS2010) received an anthracycline-free successor protocol. The primary outcome was a noninferiority margin of 1.15 in 6-year event-free survival (EFS) between the MS2003-SR and MS2010-SR cohorts.RESULTSThe 6-year EFS of MS2003-SR and MS2010-SR (anthracycline-free) cohorts was 95.2% & PLUSMN; 1.7% and 96.5% & PLUSMN; 1.5%, respectively (P = .46). The corresponding 6-year overall survival was 97.6% and 99.0% & PLUSMN; 0.7% (P = .81), respectively. The cumulative incidence of relapse was 3.6% and 2.6%, respectively (P = .42). After adjustment for race, sex, age, presenting WBC, day 8 prednisolone response, and favorable genetic subgroups, the hazard ratio for MS2010-SR EFS was 0.98 (95% CI, 0.84 to 1.14; P = .79), confirming noninferiority. Compared with MS2003-SR, MS2010-SR had significantly lower episodes of bacteremia (30% v 45.6%; P = .04) and intensive care unit admissions (1.5% v 9.5%; P = .004).CONCLUSIONIn comparison with MS2003-SR, the anthracycline-free MS2010-SR protocol is not inferior and was less toxic as treatment for favorable-risk childhood BCP-ALL.

Item Type: Article
Funders: Kementerian Sains, Teknologi dan Inovasi [Grant no. IF1019Q1148, RP049-17/HTM], A.E.J.Y. Singapore National Medical Research Council [Grant no. NMRC/CSA/0053/2008, NMRC/CSA/0053/2013], National University of Singapore [Grant no. NMRC/CG/NCIS/2010]
Uncontrolled Keywords: Anthracyclines; Antibiotics, Antineoplastic; Antineoplastic combined chemotherapy protocols; Child; Child, Preschool; Disease-free survival; Humans; Infant; Malaysia; Neoplasm recurrence, Local; Precursor cell lymphoblastic leukemia-lymphoma; Singapore; Treatment outcome
Subjects: R Medicine > RJ Pediatrics
Divisions: Faculty of Medicine > Paediatrics Department
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 11 Oct 2025 07:03
Last Modified: 11 Oct 2025 07:05
URI: http://eprints.um.edu.my/id/eprint/48212

Actions (login required)

View Item View Item