PMID- 37769822 OWN - NLM STAT- MEDLINE DCOM- 20240115 LR - 20240115 IS - 1873-6513 (Electronic) IS - 0885-3924 (Linking) VI - 67 IP - 1 DP - 2024 Jan TI - Impact of Dosing and Duration of Dexamethasone on Serious Corticosteroid-Related Adverse Events. PG - 59-68 LID - S0885-3924(23)00710-8 [pii] LID - 10.1016/j.jpainsymman.2023.09.021 [doi] AB - CONTEXT: Corticosteroids are commonly prescribed in oncology, but few studies have examined its adverse events (AEs) compared to placebo control. OBJECTIVES: Using data from a double-blind, placebo-controlled randomized trial, we evaluated the association between the dose and duration of dexamethasone and serious AEs. METHODS: 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. RESULTS: 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). CONCLUSION: 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. CI - Copyright (c) 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. FAU - An, Amy W AU - An AW AD - Department of Gastrointestinal Medical Oncology (A.W.A.), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: aan@mdanderson.org. FAU - Chen, Xi AU - Chen X AD - Department of Biostatistics (X.C., D.L.U.), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. FAU - Urbauer, Diana L AU - Urbauer DL AD - Department of Biostatistics (X.C., D.L.U.), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. FAU - Bruera, Eduardo AU - Bruera E AD - Department of Palliative Care (E.B., D.H.), Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. FAU - Hui, David AU - Hui D AD - Department of Palliative Care (E.B., D.H.), Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20230926 PL - United States TA - J Pain Symptom Manage JT - Journal of pain and symptom management JID - 8605836 RN - 0 (Adrenal Cortex Hormones) RN - 7S5I7G3JQL (Dexamethasone) SB - IM MH - Humans MH - *Adrenal Cortex Hormones/adverse effects MH - Double-Blind Method MH - Dexamethasone/adverse effects MH - *Neoplasms/drug therapy OTO - NOTNLM OT - Adverse events OT - cancer OT - dexamethasone OT - palliation OT - symptom management EDAT- 2023/09/29 00:42 MHDA- 2024/01/15 12:43 CRDT- 2023/09/28 19:30 PHST- 2023/07/01 00:00 [received] PHST- 2023/09/07 00:00 [revised] PHST- 2023/09/14 00:00 [accepted] PHST- 2024/01/15 12:43 [medline] PHST- 2023/09/29 00:42 [pubmed] PHST- 2023/09/28 19:30 [entrez] AID - S0885-3924(23)00710-8 [pii] AID - 10.1016/j.jpainsymman.2023.09.021 [doi] PST - ppublish SO - J Pain Symptom Manage. 2024 Jan;67(1):59-68. doi: 10.1016/j.jpainsymman.2023.09.021. Epub 2023 Sep 26.