Adverse events (AEs) related to corticosteroid use among patients with advanced cancer are poorly reported, with only little data using validated tools available, according to a study published in Supportive Care in Cancer.1
Corticosteroid treatment is widespread in the management of advanced cancer and is used to treat symptoms such as anorexia, fatigue, and pain. It has also been associated with numerous AEs and risk-benefit analyses must be performed for this vulnerable population, but there is a lack of systematic AE reporting from clinical studies.
For this systematic review, the authors selected 27 randomized controlled trials (RCTs) and 12 consecutive observational studies evaluating the effects and toxicities of corticosteroids among patients with advanced cancer. Included studies assessed orally or intravenously administered dexamethasone, methylprednisolone, prednisone, prednisolone, or betamethasone.
In the RCTs, the most frequently assessed primary outcome was nausea and vomiting; 8 of 27 trials assessed for this AE. Nearly half of the RCTs evaluated dexamethasone administration. Among consecutive cohort studies, a wide distribution of primary outcomes were assessed, and dexamethasone was also the most commonly used steroid.
Among the 27 RCTs, 3 did not report any AEs and 6 reported that no AEs were observed. Sixteen RCTs did not mention any AE assessment methods. Only 4 RCTs repeated AE by grade, of which 2 used the Common Terminology Criteria for Adverse Events (CTCAE) and 2 used Likert scales. Fifteen RCTs did not mention the AE assessment timing; only 16 discussed AEs.
Of the 12 consecutive cohort studies, 7 did not discuss AE assessment methods. AE assessment methods were heterogeneous; the CTCAE, Likert scale, original checklists, and clinical impressions were used by 1 study each, and only 3 studies evaluated AEs by grade. Only 7 cohort studies discussed AEs in their reports, 3 did not make any mention of AEs at all, and 3 reported AE assessment timing.
Overall, only 2 and 1 of the selected RCTs and consecutive cohort studies, respectively, used validated AE assessment tools.
The authors concluded that “A consensus guideline of AE reporting in studies of people taking glucocorticoids in the setting of advanced cancer may be of benefit.”
Hatano Y, Matsuoka H, Lam L, Currow DC. Side effects of corticosteroids in patients with advanced cancer: a systematic review [published online July 6, 2018]. Support Care Cancer. doi: 10.1007/s00520-018-4339-2