医学
蒽环类
内科学
累积发病率
危险系数
入射(几何)
外科
置信区间
队列
癌症
乳腺癌
光学
物理
作者
Hany Ariffin,Edwynn Kean Hui Chiew,Bernice Ling Zhi Oh,Shawn Hsien Ren Lee,Evelyn Huizi Lim,Shirley Kow Yin Kham,Wan Ariffin Bin Abdullah,Lee Lee Chan,Koon Mian Foo,Joyce Ching Mei Lam,Yiong Huak Chan,Hai Lin,Thuan Chong Quah,Ah Moy Tan,Allen Yeoh
摘要
PURPOSE To 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/m 2 of anthracyclines. PATIENTS AND METHODS Three 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 (≤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/m 2 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. RESULTS The 6-year EFS of MS2003-SR and MS2010-SR (anthracycline-free) cohorts was 95.2% ± 1.7% and 96.5% ± 1.5%, respectively ( P = .46). The corresponding 6-year overall survival was 97.6% and 99.0% ± 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). CONCLUSION In 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.
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