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Publications

Journal Article Randomized Controlled Trial Epublish

PubMed: 42930185 DOI: 10.3390/curroncol33100618

Incidence Rates of Adverse Events (CTCAE Severity ≥3) During HER2-Directed Breast Cancer Treatment Assessing the Impact of App-Based Electronic Patient-Reported Outcomes in the Randomized Controlled PRO2 Trial.

Curr Oncol 33(10)

Authors: Andreas Trojan, Marion van Mackelenbergh, Cosima Brucker, Helmut Forstbauer, Markus Thiel, Hans-Christian Kolberg, Manfred Welslau, Janine Kreiss-Sender, Stefan Dröse, Sven Roth, Philip Raeth, Marcus Vetter, David Blum, Peter A Fasching

Affiliations

  • Brustzentrum Zürichsee, Seestrase 80, 8810 Horgen, Switzerland. Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, 8008 Zurich, Switzerland.
  • Department of Gynecology and Obstetrics, Schleswig-Holstein University Hospital, Kiel Campus, 24105 Kiel, Germany.
  • Department of Gynecology and Obstetrics, Klinikum Nürnberg, University Hospital of Paracelsus Medical University, 90419 Nuremberg, Germany.
  • Practice Network Troisdorf, 53840 Troisdorf, Germany.
  • Practice Network for Hematology and Oncology, 66822 Lebach, Germany.
  • Knappschaft Kliniken Marienhospital Bottrop, 46236 Bottrop, Germany.
  • Oncology Aschaffenburg, 63739 Aschaffenburg, Germany.
  • Gynecological Oncology Practice, 38100 Braunschweig, Germany.
  • Palleos Healthcare GmbH, 65189 Wiesbaden, Germany.
  • Spital Zollikerberg, 8125 Zollikerberg, Switzerland.
  • Center of Oncology & Hematology, Cancer Center Baselland, Kantonsspital Baselland, 4410 Liestal, Switzerland.
  • Department of Radiation Oncology, University Hospital Zurich, 8008 Zurich, Switzerland.
  • Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), 91054 Erlangen, Germany.

Abstract

(1) Background: 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) Methods: in the randomized (1:1) controlled PRO2 trial the effect of the medidux TM 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) Results: 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) Conclusions: 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.

MeSH

Hospitalization, Breast Neoplasms, Incidence, Neoplasms, Drug-Related Side Effects And Adverse Reactions, Odds Ratio, Breast, Patient Reported Outcome Measures, Therapeutics