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Current oncology
Par Trojan A, van Mackelenbergh M, Brucker C et 11 autres.
Contenu en anglais
(1)
the evaluation of app-based ePROs is increasingly being used in clinical trials with cancer patients while a medical effect for patients is a matter of controversy; (2)
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in the randomized (1:1) controlled PRO2 trial the effect of the mediduxTM app on the rate of "high-grade AEs" (HAEs, CTCAE severity ≥3) within patients receiving HER2-directed breast cancer treatment (arm A) was compared to a control-group that did not use the app (arm B); (3)
Among patients with observed (non-imputed) HAE data (n = 180 of N = 189 in the ITT population), the rates of documented HAEs were 21.51% in arm B and 17.24% in arm A. Logistic regression of HAE incidence in the full ITT population (N = 189), using reference-based multiple imputation for missing values, showed a positive tendency towards app use, but no significant difference (odds ratio arm (A/B): 0.797, 95% CI: 0.363, 1.752; p-value 0.569). Also, AE-related secondary endpoints "emergency consultations" (risk ratio arm (A/B): 0.842, 95% CI: 0.464, 1.522; p-value 0.570) and "hospitalizations" (risk ratio arm (A/B): 0.575, 95% CI: 0.237, 1.329; p-value 0.201) had no significant differences in negative binomial regression. (4)
Although the effect on HAE rates was not statistically significant, intensive app use was observed and adverse events recorded by participants corresponded well with the known drug-side-effect-profiles. These exploratory findings suggest a potential supporting role of the app during out-patient cancer treatment, which needs confirmation in adequately powered studies.
Publié dans Current oncology (Toronto, Ont.). Le résumé est reproduit tel qu’il a été publié et reste l’œuvre de ses auteurs ; lisez l’article complet à la source.
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