Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
The Children's Oncology Group, Monrovia, California.
Cancer Med. 2019 Aug;8(9):4454-4464. doi: 10.1002/cam4.2337. Epub 2019 Jun 12.
Objectives were used to describe guardian proxy-report and child self-report quality of life (QoL) during chemotherapy for pediatric acute myeloid leukemia (AML) patients.
Patients enrolled on the phase 3 AML trial AAML1031 who were 2-18 years of age with English-speaking guardians were eligible. Instruments used were the PedsQL Generic Core Scales, Acute Cancer Module, and Multidimensional Fatigue Scale. Assessments were obtained at the beginning of Induction 1 and following completion of cycles 2-4. Potential predictors of QoL included the total number of nonhematological grade 3-4 Common Terminology Criteria for Adverse Event (CTCAE) submissions.
There were 505 eligible guardians who consented to participate and 348 of their children provided at least one self-report assessment. The number of submitted CTCAE toxicities was significantly associated with worse physical health summary scores (β ± standard error (SE) -3.00 ± 0.69; P < 0.001) and general fatigue (β ± SE -2.50 ± 0.66; P < 0.001). Older age was significantly associated with more fatigue (β ± SE -0.58 ± 0.25; P = 0.022). Gender, white race, Hispanic ethnicity, private insurance status, risk status, bortezomib assignment, and duration of neutropenia were not significantly associated with QoL.
The number of CTCAE toxicities was the primary factor influencing QoL among children with AML. Reducing toxicities should improve QoL; identifying approaches to ameliorate them should be a priority.
本研究旨在通过使用目标来描述儿科急性髓系白血病(AML)患者接受化疗期间监护人代理报告和儿童自我报告的生活质量(QoL)。
本研究纳入了正在进行的 3 期 AML 临床试验 AAML1031 中符合条件的患者。该试验招募了年龄在 2-18 岁之间、有英语交流能力的监护人的患儿。使用的工具包括 PedsQL 通用核心量表、急性癌症模块和多维疲劳量表。评估在诱导期 1 开始时和完成第 2-4 周期后进行。QoL 的潜在预测因素包括非血液学 3-4 级不良事件常用术语标准(CTCAE)报告的总数。
共有 505 名合格的监护人同意参与研究,其中 348 名患儿至少提供了一次自我报告评估。提交的 CTCAE 毒性数量与较差的身体健康总评分(β ± 标准误差(SE)-3.00 ± 0.69;P < 0.001)和一般疲劳(β ± SE-2.50 ± 0.66;P < 0.001)显著相关。年龄较大与疲劳程度增加显著相关(β ± SE-0.58 ± 0.25;P = 0.022)。性别、白种人、西班牙裔、私人保险状况、风险状况、硼替佐米治疗方案和中性粒细胞减少持续时间与 QoL 无显著相关性。
CTCAE 毒性的数量是影响 AML 患儿 QoL 的主要因素。减少毒性应能提高 QoL;应优先确定改善毒性的方法。