Favorable impact of therapy management by an interactive eHealth system on severe adverse events in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy

Harbeck N, Kates R, Schinköthe T, Schumacher J, Wuerstlein R, Degenhardt T, Lüftner D, Räth P, Hoffmann O, Lorenz R, Decker T, Reinisch M, Göhler T, Staib P, Gluz O, Fasching P, Schmidt M (2023)

Publication Type: Journal article, Review article

Publication year: 2023

Journal

Cancer Treatment Reviews WB Saunders

Book Volume: 121

Article Number: 102631

DOI: 10.1016/j.ctrv.2023.102631

Abstract

Background: Oral cancer medications offer advantages but also pose challenges for therapy management and adherence. An eHealth-based platform such as CANKADO can help to support therapy management by probing the patient's quality of life (QoL) continuously throughout the course of treatment. Material and Methods: AGO-B WSG PreCycle (NCT03220178) is a multicenter, randomized phase IV intergroup trial evaluating the impact of eHealth-based Patient-Reported Outcome (ePRO) assessment on QoL in patients with hormone receptor-positive (HR + )/HER2-negative (HER2-) advanced breast cancer treated with palbociclib and endocrine therapy. Patients were randomized (2:1) to CANKADO-active arm (supported by CANKADO PRO-React) or CANKADO-inform arm (drug intake documentation only) This exploratory analysis reports the impact of CANKADO PRO-React on safety. Time to first serious adverse event (SAE) was estimated taking competing risks into account. Results: While distributions of adverse events (AEs) were similar by arm overall, patients in the CANKADO-active arm had a favorable hazard ratio of 0.67 (95%CI 0.46–0.97; p = 0.04) for time to first SAE and were significantly less likely overall to suffer an SAE than patients in the inform arm. At 24 months, 22.9% [17.9%-27.8%] of patients in CANKADO-active had suffered an SAE vs. 30.3% [22.6%-38.0%] in CANKADO-inform. AE-related dose reductions affected approximately 20% of patients (CANKADO-active: 18.2%, CANKADO-inform: 21.1%). Conclusion: Exploratory safety analysis of PreCycle demonstrates for the first time in a randomized prospective trial that interactive autonomous eHealth-based support has a substantial favorable impact on the risk of SAEs and mitigates their severity for patients with advanced HR+/HER2- breast cancer on oral tumor therapy.

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

Klinikum der Universität München DE Germany (DE) Westdeutsche Studiengruppe GmbH (WSG) / Women's healthcare Study Group DE Germany (DE) Cankado Service GmbH DE Germany (DE) palleos healthcare GmbH DE Germany (DE) Immanuel Klinik Märkische Schweiz DE Germany (DE) Universitätsklinikum Essen DE Germany (DE) Helmholtz-Zentrum für Infektionsforschung (HZI) DE Germany (DE) Kliniken Essen-Mitte DE Germany (DE) Onkozentrum Dresden/Freiberg DE Germany (DE) St.-Antonius-Hospital Eschweiler DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE)

How to cite

APA:

Harbeck, N., Kates, R., Schinköthe, T., Schumacher, J., Wuerstlein, R., Degenhardt, T.,... Schmidt, M. (2023). Favorable impact of therapy management by an interactive eHealth system on severe adverse events in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy. Cancer Treatment Reviews, 121. https://dx.doi.org/10.1016/j.ctrv.2023.102631

MLA:

Harbeck, Nadia, et al. "Favorable impact of therapy management by an interactive eHealth system on severe adverse events in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy." Cancer Treatment Reviews 121 (2023).

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