Advani Anjali S, Larsen Eric, Laumann Kristina, Luger Selina M, Liedtke Michaela, Devidas Meenakshi, Chen Zhiguo, Yin Jun, Foster Matthew C, Claxton David, Coffan Kristin, Tallman Martin S, Appelbaum Frederick R, Erba Harry, Stone Richard M, Hunger Stephen P, McNeer Jennifer L, Loh Mignon L, Raetz Elizabeth, Winick Naomi, Carroll William, Larson Richard A, Stock Wendy
Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.
Maine Children's Cancer Program, Scarborough, ME.
Blood Adv. 2021 Jan 26;5(2):504-512. doi: 10.1182/bloodadvances.2020002439.
Adolescents and young adults (AYAs) with acute lymphoblastic leukemia have improved outcomes when treated with pediatric-inspired regimens. CALGB 10403 was the largest prospective study to evaluate the feasibility of using a pediatric regimen in AYAs with acute lymphoblastic leukemia up to 40 years of age. This article presents the toxicity events observed in the CALGB 10403 study and compares these toxicities vs those observed among AYAs treated on the same arm of the companion Children's Oncology Group (COG) AALL0232 study. Toxicities in CALGB 10403 were similar to those observed in COG AALL0232. Some grade 3 to 4 adverse events were more often reported in CALGB 10403 compared with COG AALL0232 (hyperglycemia, hyperbilirubinemia, transaminase elevation, and febrile neutropenia). Adverse events correlated with body mass index ≥30 kg/m2 and some with increasing age. The mortality rate in CALGB 10403 was low (4%) and similar to that in the COG AALL0232 trial. A caveat to this analysis is that only 39% of CALGB 10403 patients completed all planned protocol treatment. In COG AALL0232, although 74% of patients aged <18 years completed treatment, only 57% of patients aged ≥18 years completed treatment. This scenario suggests that issues associated with age and treating physician may be a factor. Due to its improved survival rates compared with historical controls, the CALGB 10403 regimen is now a standard of care. The hope is that the rate of protocol completion will increase as more familiarity is gained with this regimen. These trials were registered at www.clinicaltrials.gov as #NCT00558519 (CALGB 10403) and #NCT00075725 (COG AALL0232).
采用儿童启发式方案治疗时，急性淋巴细胞白血病的青少年和青年患者（AYAs）的治疗结局有所改善。CALGB 10403是评估在40岁及以下的AYAs急性淋巴细胞白血病患者中使用儿童方案可行性的最大规模前瞻性研究。本文介绍了CALGB 10403研究中观察到的毒性事件，并将这些毒性与在儿童肿瘤学组（COG）AALL0232研究同一组接受治疗的AYAs中观察到的毒性进行了比较。CALGB 10403中的毒性与COG AALL0232中观察到的毒性相似。与COG AALL0232相比，CALGB 10403中更常报告一些3至4级不良事件（高血糖、高胆红素血症、转氨酶升高和发热性中性粒细胞减少）。不良事件与体重指数≥30kg/m²相关，部分与年龄增长相关。CALGB 10403的死亡率较低（4%），与COG AALL0232试验中的死亡率相似。该分析的一个注意事项是，CALGB 10403中只有39%的患者完成了所有计划的方案治疗。在COG AALL0232中，虽然18岁以下的患者中有74%完成了治疗，但18岁及以上的患者中只有57%完成了治疗。这种情况表明，与年龄和治疗医生相关的问题可能是一个因素。由于与历史对照相比生存率有所提高，CALGB 10403方案现在已成为一种治疗标准。希望随着对该方案的更多熟悉，方案完成率将会提高。这些试验已在www.clinicaltrials.gov上注册，注册号分别为#NCT00558519（CALGB 10403）和#NCT00075725（COG AALL0232）。
