Gallardo-Pérez Moisés M, Gale Robert Peter, Reyes-Cisneros Oscar A, Sánchez-Bonilla Daniela, Fernández-Gutiérrez José A, Stock Wendy, Murrieta-Álvarez Iván, Olivares-Gazca Juan Carlos, Ruiz-Delgado Guillermo J, Fonseca Rafael, Ruiz-Argüelles Guillermo J
Centro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, Mexico.
Universidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, Mexico.
Front Oncol. 2023 Jun 16;13:1187268. doi: 10.3389/fonc.2023.1187268. eCollection 2023.
The therapy of children with acute lymphoblastic leukemia (ALL) in limited resource geospaces is challenging and must balance safety, efficacy, availability, and affordability. We modified the control arm of the St. Jude Total XI protocol for outpatient delivery including once-weekly daunorubicin and vincristine in initial therapy, postponing intrathecal chemotherapy until day 22, prophylactic oral antibiotics/antimycotics, use of generic drugs, and no central nervous system (CNS) radiation. Data were interrogated from 104 consecutive children ≤12 years (median, 6 years [interquartile range (IQR), 3, 9 years]. All therapies were given in an outpatient setting in 72 children. Median follow-up is 56 months (IQR 20, 126 months). A total of 88 children achieved a hematological complete remission. Median event-free survival (EFS) is 87 months [95% confidence interval (CI), 39, 60], 7.6 years in low-risk children (3.4, 8 years) whereas 2.5 years (1, 10 years) in high-risk children. The 5-year cumulative incidence of relapse (CIR) is 28% (18, 35%), 26% (14, 37%) in low-risk children and 35% (14, 52%) in high-risk children. Median survival for all subjects is not reached but must exceed 5 years. A total of 36 children relapsed at a median of 12 months (5, 23 months). Outcomes were comparable to those reported in the control arm of the Total Therapy XI study, but inferior to current treatment protocols in high-income countries. The average cost of the first 2 years of therapy was $28,500 USD compared with an average cost of approximately $150,000 USD in the US, an 80% saving. In conclusion, using an outpatient-based modification of the St. Jude Total XI protocol, we obtained good results with relatively few hospitalizations or adverse events and at a substantial saving. This model can be applied in other resource-poor geospaces.
在资源有限地区治疗儿童急性淋巴细胞白血病（ALL）具有挑战性，必须在安全性、有效性、可及性和可承受性之间取得平衡。我们对圣犹大儿童研究医院总方案XI的对照组进行了调整，以便在门诊进行治疗，包括初始治疗时每周一次的柔红霉素和长春新碱，将鞘内化疗推迟至第22天，预防性口服抗生素/抗真菌药，使用仿制药，且不进行中枢神经系统（CNS）放疗。我们对104名年龄≤12岁（中位年龄6岁[四分位间距（IQR），3, 9岁]）的连续患儿的数据进行了分析。72名患儿的所有治疗均在门诊进行。中位随访时间为56个月（IQR 20, 126个月）。共有88名患儿实现血液学完全缓解。中位无事件生存期（EFS）为87个月[95%置信区间（CI），39, 60]，低危患儿为7.6年（3.4, 8年），高危患儿为2.5年（1, 10年）。5年累积复发率（CIR）为28%（18, 35%），低危患儿为26%（14, 37%），高危患儿为35%（14, 52%）。所有受试者的中位生存期尚未达到，但肯定超过5年。共有36名患儿复发，中位复发时间为12个月（5, 23个月）。结果与总方案XI研究对照组报告的结果相当，但不如高收入国家目前的治疗方案。治疗前两年的平均费用为28,500美元，而在美国平均费用约为150,000美元，节省了80%。总之，通过对圣犹大儿童研究医院总方案XI进行基于门诊的调整，我们取得了良好的结果，住院次数和不良事件相对较少，且节省了大量费用。该模式可应用于其他资源匮乏地区。
