Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group.
Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group.
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DOI：
10.1038/bcj.2014.72
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发表时间：
2014-10-17
影响因子：
12.8
通讯作者：
Japan Adult Leukemia Study Group (JALSG)
中科院分区：
文献类型：
--
作者：
Hayakawa F;Sakura T;Yujiri T;Kondo E;Fujimaki K;Sasaki O;Miyatake J;Handa H;Ueda Y;Aoyama Y;Takada S;Tanaka Y;Usui N;Miyawaki S;Suenobu S;Horibe K;Kiyoi H;Ohnishi K;Miyazaki Y;Ohtake S;Kobayashi Y;Matsuo K;Naoe T;Japan Adult Leukemia Study Group (JALSG)
儿童方案治疗青少年急性淋巴细胞白血病（ALL）的优越性已得到证实，但其在年轻成人中的疗效仍不清楚。ALL 202-U方案旨在检查儿科方案在BCR-ABL阴性ALL青少年和年轻成人（AYA）中的有效性和可行性。年龄15-24岁的患者（n=139）采用与儿童B-ALL相同的方案进行治疗。本研究的主要目的是评估无病生存（DFS）率，次要目的是评估毒性、完全缓解（CR）率和总生存（OS）率。CR率为94%。5年DFS和OS率分别为67%（95%置信区间（CI）58-75%）和73%（95% CI 64-80%）。观察到严重不良事件的频率与接受相同方案治疗的儿童相似或更低。只有维持治疗不足使DFS显著恶化（危险比5.60，P<0.001）。这些结果表明，该方案可能是一个可行的和高效的治疗AYA与BCR-ABL阴性的ALL。
The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR–ABL-negative ALL. Patients aged 15–24 years (n=139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94%. The 5-year DFS and OS rates were 67% (95% confidence interval (CI) 58–75%) and 73% (95% CI 64–80%), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, P<0.001). These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR–ABL-negative ALL.