Department of Gastrointestinal Medical Oncology (A.W.A.), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Department of Biostatistics (X.C., D.L.U.), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
J Pain Symptom Manage. 2024 Jan;67(1):59-68. doi: 10.1016/j.jpainsymman.2023.09.021. Epub 2023 Sep 26.
Corticosteroids are commonly prescribed in oncology, but few studies have examined its adverse events (AEs) compared to placebo control.
Using data from a double-blind, placebo-controlled randomized trial, we evaluated the association between the dose and duration of dexamethasone and serious AEs.
This is a pre-planned secondary analysis of the Alleviating Breathlessness in Cancer Patients with Dexamethasone (ABCD) trial in which patients were randomized to dexamethasone 8 mg BID x1 week, then 4 mg BID x1 week or placebo, followed by an optional open-label phase with 4 mg BID x1 week, then 2 mg BID x1 week. The primary outcome was Grade 3+ AEs (CTCAE v4.03). We evaluated the association between AEs and dexamethasone exposure using multivariable logistic regression.
Among 119 cancer patients, 32 received intervention followed by open label (mean exposure 243 mg over 27 days), 47 received intervention with no open label, 20 received placebo followed by open label, and 20 received no dexamethasone. The most common AEs included insomnia (31%), dyspepsia (21%), neuropsychiatric symptoms (18%), and infections (17%). Overall, 38 (32%) had Grade 3+ AEs and 27 (23%) were hospitalized. Patients with the greatest exposure to dexamethasone experienced more Grade 3+ AEs compared to those with no exposure (65% vs. 15%); odds ratio of 15.1 (95% CI 1.4-160.8, P = 0.01).
Greater dexamethasone exposure, even at moderate doses, was associated with more serious AEs. Prescribers should cautiously weigh the risks and benefits of dexamethasone use, especially when considering for palliation of symptoms.
皮质类固醇在肿瘤学中常被处方使用，但与安慰剂对照相比，很少有研究检查其不良事件（AE）。
使用来自一项双盲、安慰剂对照随机试验的数据，我们评估了地塞米松的剂量和持续时间与严重 AE 之间的关联。
这是缓解癌症患者呼吸困难使用地塞米松（ABCD）试验的一项预先计划的二次分析，其中患者被随机分配接受地塞米松 8mg BID x1 周，然后 4mg BID x1 周或安慰剂，随后是可选的开放标签阶段，4mg BID x1 周，然后 2mg BID x1 周。主要结局是 3+级 AE（CTCAE v4.03）。我们使用多变量逻辑回归评估 AE 与地塞米松暴露之间的关联。
在 119 名癌症患者中，32 名接受了干预治疗后进行了开放标签治疗（平均暴露 243mg 持续 27 天），47 名接受了干预治疗但没有开放标签治疗，20 名接受了安慰剂治疗后进行了开放标签治疗，20 名未接受地塞米松治疗。最常见的 AE 包括失眠（31%）、消化不良（21%）、神经精神症状（18%）和感染（17%）。总体而言，38 名（32%）患者发生 3+级 AE，27 名（23%）患者住院。与无暴露组相比，地塞米松暴露量最大的患者发生 3+级 AE 的比例更高（65%比 15%）；比值比为 15.1（95%CI 1.4-160.8，P=0.01）。
即使是中等剂量的地塞米松暴露也与更严重的 AE 相关。处方医生应谨慎权衡地塞米松使用的风险和益处，尤其是在考虑缓解症状时。
