Department of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, NY.
Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.
J Clin Oncol. 2024 Oct;42(28):3330-3338. doi: 10.1200/JCO.24.00038. Epub 2024 Jul 26.
PURPOSEThere have been no previous longitudinal assessments of health-related quality of life (HRQoL) during treatment for pediatric Hodgkin lymphoma (HL). The addition of brentuximab vedotin (BV) to a multidrug chemotherapy backbone demonstrated superior efficacy to standard chemotherapy for patients with pediatric high-risk HL in the AHOD 1331 trial. However, the impact on HRQoL is unknown.PATIENTS AND METHODSAfter treatment random assignment, 268 participants older than 11 years were enrolled in a prespecified, longitudinal, patient-reported outcomes substudy. HRQoL was assessed using the seven-item Child Health Ratings Inventories (CHRIs)-Global scale before treatment (T1) and at cycle 2 (T2), cycle 5 (T3), and end of treatment (T4). A clinically meaningful increase in HRQoL was considered 7 points on the CHRIs-Global. Multivariable linear regression estimated associations between demographic/clinical variables and HRQoL at T1. Linear mixed models estimated changes in HRQoL across the treatment arm.RESULTSParticipant characteristics were balanced by treatment arm. Ninety-three percent of participants completed the CHRIs at T1, 92% at T2, 89% at T3, and 77% at T4. At T1, female sex and fever ( < .05) were each associated with worse HRQoL. By T2, participants in the BV arm experienced a statistically and clinically significant improvement in HRQoL (β = 7.3 [95% CI, 3.2 to 11.4]; ≤ .001), which was greater than the change in the standard arm (difference in change β = 5.1 [95% CI, -0.2 to 10.3]; = .057). The standard arm did not experience a statistically or clinically significant increase in HRQoL until T4 (β = 9.3 [95% CI, 4.7 to 11.5]; < .001).CONCLUSIONThese data demonstrate successful collection of serial HRQoL from youth with high-risk pediatric HL and improvement in HRQoL over the course of initial therapy, sooner and to a greater extent in the group receiving the novel agent BV.
此前尚无针对儿科霍奇金淋巴瘤（HL）治疗期间健康相关生活质量（HRQoL）的纵向评估。在 AHOD 1331 试验中，与标准化疗相比，在多药化疗基础上联合 Brentuximab Vedotin（BV）治疗高危儿科 HL 患者显示出更好的疗效。然而，其对 HRQoL 的影响尚不清楚。
在治疗随机分组后，268 名年龄大于 11 岁的参与者入组了一项预先指定的、纵向的、患者报告的结局子研究。在治疗前（T1）和第 2 周期（T2）、第 5 周期（T3）和治疗结束时（T4）使用 7 项儿童健康评分量表（CHRIs）-全球量表评估 HRQoL。认为 CHRIs-全球评分增加 7 分具有临床意义。多变量线性回归估计了 T1 时人口统计学/临床变量与 HRQoL 之间的关联。线性混合模型估计了治疗组之间 HRQoL 的变化。
治疗组间的参与者特征平衡。93%的参与者在 T1 时完成了 CHRIs，92%在 T2 时，89%在 T3 时，77%在 T4 时。在 T1 时，女性和发热（<0.05）与较差的 HRQoL 相关。到 T2 时，BV 组的参与者 HRQoL 有统计学和临床意义上的改善（β=7.3[95%CI，3.2 至 11.4]；<0.001），优于标准组的变化（变化差异β=5.1[95%CI，-0.2 至 10.3]；=0.057）。标准组直到 T4 才经历 HRQoL 的统计学或临床意义上的改善（β=9.3[95%CI，4.7 至 11.5]；<0.001）。
这些数据表明，成功地从高危儿科 HL 青年患者中连续收集了 HRQoL，并在初始治疗过程中改善了 HRQoL，在接受新型药物 BV 的组中改善得更早且更明显。
