Frontline-Treatment Of Acute Lymphoblastic Leukemia (ALL) In Older Adolescents and Young Adults (AYA) Using a Pediatric Regimen Is Feasible: Toxicity Results of the Prospective US Intergroup Trial C10403 (Alliance)
Frontline-Treatment Of Acute Lymphoblastic Leukemia (ALL) In Older Adolescents and Young Adults (AYA) Using a Pediatric Regimen Is Feasible: Toxicity Results of the Prospective US Intergroup Trial C10403 (Alliance)
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使用儿科方案对老年青少年和年轻人 (AYA) 的急性淋巴细胞白血病 (ALL) 进行一线治疗是可行的：美国前瞻性组间试验 C10403 的毒性结果（联盟）
DOI：
10.1182/blood.v122.21.3903.3903
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发表时间：
2013
期刊：
影响因子：
20.3
通讯作者：
W. Stock
中科院分区：
文献类型：
--
作者：
B. Sanford;S. Luger;M. Devidas;Eric Larsen;M. Liedtke;P. Voorhees;M. Foster;D. Claxton;S. Geyer;E. Parker;Kristin Coffan;W. Carroll;N. Winick;S. Coutre;M. Tallman;F. Appelbaum;H. Erba;R. Stone;S. Hunger;R. Larson;W. Stock
背景：几项回顾性试验表明，急性淋巴细胞白血病（ALL）的青少年和年轻人（AYA）在接受儿科启发的治疗方案治疗时，预后较好。C10403是评估儿科方案可行性的最大前瞻性研究（儿童肿瘤组（COG） AALL0232: COG0232） （Larsen等）。JCO 2011;由成人血液学家/肿瘤学家（HO）治疗的ALL患者（16-39岁）。目的之一是确定可能限制这些方案适用性的特定治疗相关毒性的年龄相关增加。我们在此描述了C10403患者的不良事件（AE）概况，并将其与使用相同方案的≥16岁儿童COG0232试验报告的数据进行了比较。在COG研究中，AYA占入组患者的20%，其中66%年龄在16-21岁。方法C10403为单组研究。所有患者均接受来自AALL0232方案的“PC”（强的松/“Capizzi”甲氨蝶呤）临时维持（IM）组的治疗，并接受成人HO治疗。描述性统计用于总结毒性。在本报告中，我们关注的是至少可能与治疗有关的3-5级事件。COG0232的对照组包括159名随机分配到PC组的患者；然而，在COG0232中，与C10403患者相比，慢反应者接受了额外的治疗。结果2007年11月至2012年12月，美国16-39岁的318例患者被纳入3个合作组（CALGB、SWOG、ECOG）。61%为男性；74%是白人，10%是非裔美国人，16%是西班牙裔。中位年龄为25岁，比cog232 AYA患者年龄大。结论：这些数据表明，当成人HOs对40岁以下的AYA人群进行治疗时，儿科方案（C10403）是可行的。C10403可作为该人群后续试验设计的基础。(1)张建军，张建军，张建军，等。Blood， 2011年11月；118: 1510。信息披露：斯通；安进；咨询公司。
Background Several retrospective trials suggest a superior outcome for adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) when they are treated with pediatric-inspired therapeutic regimens. C10403 is the largest prospective study to evaluate the feasibility of a pediatric regimen (Children’s Oncology Group (COG) AALL0232: COG0232) (Larsen et al. JCO 2011; 29(18) suppl: 3) in AYA ALL patients (pts) (16-39 yrs of age) treated by adult hematologist/ oncologists (HO). One objective was to identify age-related increases in specific treatment-related toxicities that may limit the applicability of these regimens. We describe here the adverse event (AE) profiles by age cohorts for pts enrolled on C10403 and compare them with data reported from the pediatric COG0232 trial in pts ≥ 16 yrs of age using the same regimen. In the COG study, AYA comprised 20% of enrolled pts, 66% were ages 16-21. Methods C10403 was a single arm study. All pts received treatment with the “PC” (prednisone/ ‘Capizzi’ methotrexate) Interim Maintenance (IM) arm from the AALL0232 regimen and were treated by adult HO. Descriptive statistics were used to summarize toxicities. For this report, we focused on Grade 3-5 events with at least a possible relationship to treatment. The comparison group from COG0232 included 159 pts randomized to the PC arm; however, in COG0232 slow responders received additional treatment compared to C10403 pts. Results Between Nov 2007 and Dec 2012, 318 pts in the United States 16-39 yrs of age were enrolled by 3 cooperative groups (CALGB, SWOG, ECOG). 61% were male; 74% white, 10% African American, and 16% Hispanic. The median age was 25 yrs, older than the COG0232 AYA pts. 14% were Conclusions These data indicate that treatment with a pediatric regimen (C10403) is feasible when administered by adult HOs to an AYA population up to 40 years of age. C10403 can be used as a foundation for the design of successor trials in this pt population. (1) Larsen E, Salzer W, Nachman J, et al. Blood, Nov 2011; 118: 1510. Disclosures: Stone: Amgen: Consultancy.