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.
14 affiliations
- 1Brustzentrum Zürichsee, Seestrase 80, 8810 Horgen, Switzerland.
- 2Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, 8008 Zurich, Switzerland.
- 3Department of Gynecology and Obstetrics, Schleswig-Holstein University Hospital, Kiel Campus, 24105 Kiel, Germany.
- 4Department of Gynecology and Obstetrics, Klinikum Nürnberg, University Hospital of Paracelsus Medical University, 90419 Nuremberg, Germany.
- 5Practice Network Troisdorf, 53840 Troisdorf, Germany.
- 6Practice Network for Hematology and Oncology, 66822 Lebach, Germany.
- 7Knappschaft Kliniken Marienhospital Bottrop, 46236 Bottrop, Germany.
- 8Oncology Aschaffenburg, 63739 Aschaffenburg, Germany.
- 9Gynecological Oncology Practice, 38100 Braunschweig, Germany.
- 10Palleos Healthcare GmbH, 65189 Wiesbaden, Germany.
- 11Spital Zollikerberg, 8125 Zollikerberg, Switzerland.
- 12Center of Oncology & Hematology, Cancer Center Baselland, Kantonsspital Baselland, 4410 Liestal, Switzerland.
- 13Department of Radiation Oncology, University Hospital Zurich, 8008 Zurich, Switzerland.
- 14Department 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 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) 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.
Related
- Assessing the accuracy and efficiency of an electronic platform for managing childhood illnesses in rural China: A cluster randomized controlled trial
- Search for the glycated hemoglobin target minimizing mortality among people with type 2 diabetes with rare incidence of treatment-related severe hypoglycemia – Epidemiologic analysis of J-DOIT3 randomized controlled trial
- Machined versus cast abutments for dental implants: a 1-year within-patient multicentre randomized controlled trial assessing marginal seal capacity and outcomes
- Assessing an educational strategy to improve community health provider-led provision of cervical cancer screening services in western Kenya: A secondary analysis of the Elimisha-HPV cluster-randomized controlled trial
- Controlled postoperative red wine intake versus abstinence in habitual wine drinkers undergoing elective urological surgery (WISE): a translational randomized controlled trial assessing quality of life, surgical outcomes and complications.
BibTeX
@article{trojan2026incidence,
title = {{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.}},
author = {Andreas Trojan and Marion van Mackelenbergh and Cosima Brucker and Helmut Forstbauer and Markus Thiel and Hans-Christian Kolberg and Manfred Welslau and Janine Kreiss-Sender and Stefan Dröse and Sven Roth and Philip Raeth and Marcus Vetter and David Blum and Peter A Fasching},
journal = {Current oncology (Toronto, Ont.)},
year = {2026},
month = oct,
doi = {10.3390/curroncol33100618},
url = {https://europepmc.org/article/MED/42930185},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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.
AU - Andreas Trojan
AU - Marion van Mackelenbergh
AU - Cosima Brucker
AU - Helmut Forstbauer
AU - Markus Thiel
AU - Hans-Christian Kolberg
AU - Manfred Welslau
AU - Janine Kreiss-Sender
AU - Stefan Dröse
AU - Sven Roth
AU - Philip Raeth
AU - Marcus Vetter
AU - David Blum
AU - Peter A Fasching
PY - 2026
DA - 2026/10/14
JO - Current oncology (Toronto, Ont.)
DO - 10.3390/curroncol33100618
UR - https://europepmc.org/article/MED/42930185
AB - (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 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) 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.
SN - 1198-0052
SN - 1718-7729
ER -