Adverse Family Outcomes in Children With B-Cell Acute Lymphoblastic Leukemia From the Multicenter Trial Children's Oncology Group AALL0932.
完整摘要 · 中文译文
背景：B细胞急性淋巴细胞白血病（B-ALL）的治疗持续超过2年，可能对家庭造成影响。儿童肿瘤学组多中心治疗试验AALL0932将NCI标准风险、平均风险B-ALL（NCI-SR AR B-ALL）患者随机分配至每4周或每12周接受维持期长春新碱/地塞米松治疗（分别为VCR/DEX4或VCR/DEX12）。本研究嵌入AALL0932中，旨在（1）纵向评估总体不良家庭结局，以及（2）确定接受VCR/DEX4方案（相较于VCR/DEX12）的患者是否具有更少的不良家庭结局。 方法：被邀请参加多中心随机对照治疗试验AALL0932的NCI-SR AR B-ALL患者年龄≥4岁，且有一名英语家长。在T1-T5（分别约为诊断后2、9、18、26和38个月；T5仅在男孩中评估）进行家长报告问卷调查，评估自白血病诊断以来的家庭变化、过去4周内白血病相关家庭支出、不健康家庭功能（家庭评估设备评分>2）以及家长感知的儿童脆弱性（儿童脆弱性量表≥10）。酌情使用广义线性混合模型和多变量logistic回归模型比较T3和T4时随机化后的结局，并调整种族和民族。 结果：在555名完成评估的参与者中，420名被随机化（平均[SD]年龄，6.0[1.6]岁；45.7%女性）。在T1时，56.2%的随机化参与者报告自诊断以来家庭发生变化 （81.2%在T4时），88.6%报告在过去4周内有≥100美元的白血病相关家庭支出（T4时为61.5%），19.0%存在不健康的家庭功能（T4时为23.9%），55.8%认为自己的孩子易受伤害（T4时为62.5%）。在多变量模型中，VCR/DEX4（相较于VCR/DEX12）报告过去4周内白血病相关支出≥100美元的可能性增加（比值比，1.73；95% CI，1.03-2.91），但其他结局在治疗组间相似。 结论：B-ALL家庭负担出现较早。减少维持期VCR/DEX频率可能降低支出，但不会改善其他结局。需要采取干预措施，在ALL治疗早期及全程为家庭提供支持。
完整摘要 · 英文原文
BACKGROUND: Treatment for B-cell acute lymphoblastic leukemia (B-ALL) lasts >2 years and can impact families. The Children's Oncology Group multicenter therapeutic trial AALL0932 randomized patients with NCI standard-risk, average-risk B-ALL (NCI-SR AR B-ALL) to receive maintenance vincristine/dexamethasone every 4 or 12 weeks (VCR/DEX4 or VCR/DEX12, respectively). Embedded in AALL0932, this study aimed to (1) longitudinally measure adverse family outcomes overall, and (2) determine whether patients on the VCR/DEX4 regimen (vs VCR/DEX12) had fewer adverse family outcomes. METHODS: Patients with NCI-SR AR B-ALL who were offered enrollment on the multicenter randomized-controlled therapeutic trial AALL0932 were aged ≥4 years with an English-speaking parent. Parent-reported surveys were administered at T1-T5 (approximately 2, 9, 18, 26, and 38 months after diagnosis, respectively; T5 was assessed only in boys) and assessed household changes since leukemia diagnosis, leukemia-related household expenses in the past 4 weeks, unhealthy family functioning (Family Assessment Device score >2), and parents' perceived child vulnerability (Child Vulnerability Scale ≥10). Postrandomization outcomes at T3 and T4 were compared between treatment groups using generalized linear mixed models and multivariable logistic regression models, as appropriate, adjusting for race and ethnicity. RESULTS: Among 555 participants with completed evaluations, 420 were randomized (mean [SD] age, 6.0 [1.6] years; 45.7% female). At T1, 56.2% of randomized participants reported household changes since diagnosis (81.2% by T4), 88.6% reported ≥$100 in leukemia-related household expenses in the past 4 weeks (61.5% at T4), 19.0% had unhealthy family functioning (23.9% at T4), and 55.8% perceived their child as vulnerable (62.5% at T4). In multivariable models, VCR/DEX4 (vs VCR/DEX12) had an increased likelihood of reporting ≥$100 in leukemia-related expenses in the past 4 weeks (odds ratio, 1.73; 95% CI, 1.03-2.91), but other outcomes were similar between treatment arms. CONCLUSIONS: B-ALL family burdens develop early. Reducing maintenance VCR/DEX frequency may decrease expenses but not other outcomes. Interventions are needed to support families early and throughout ALL therapy.
摘要 待译
BACKGROUND: Treatment for B-cell acute lymphoblastic leukemia (B-ALL) lasts >2 years and can impact families. The Children's Oncology Group multicenter therapeutic trial AALL0932 randomized patients with NCI standard-risk, average-risk B-ALL (NCI-SR AR B-ALL) to receive maintenance vincristine/dexamethasone every 4 or 12 weeks (VCR/DEX4 or VCR/DEX12, respectively). Embedded in AALL0932, this study aimed to (1) longitudinally measure adverse family outcomes overall, and (2) determine whether patients on the VCR/DEX4 regimen (vs VCR/DEX12) had fewer adverse family outcomes.…