التفاصيل البيبلوغرافية
| العنوان: |
Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2− metastatic breast cancer patients receiving palbociclib and endocrine therapy: primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial |
| المؤلفون: |
Harbeck, N.1,2 (AUTHOR) nadia.harbeck@med.uni-muenchen.de, Fasching, P.A.3 (AUTHOR), Wuerstlein, R.1,2 (AUTHOR), Degenhardt, T.1,4 (AUTHOR), Lüftner, D.5,6 (AUTHOR), Kates, R.E.2 (AUTHOR), Schumacher, J.7 (AUTHOR), Räth, P.7 (AUTHOR), Hoffmann, O.8 (AUTHOR), Lorenz, R.9 (AUTHOR), Decker, T.10 (AUTHOR), Reinisch, M.11,12 (AUTHOR), Göhler, T.13 (AUTHOR), Staib, P.14 (AUTHOR), Gluz, O.2 (AUTHOR), Schinköthe, T.15,16 (AUTHOR), Schmidt, M.17 (AUTHOR) |
| المصدر: |
Annals of Oncology. Aug2023, Vol. 34 Issue 8, p660-669. 10p. |
| مصطلحات موضوعية: |
*HORMONE receptor positive breast cancer, *METASTATIC breast cancer, *HORMONE therapy, *EPIDERMAL growth factor receptors, *PATIENT participation, *CANCER patients |
| الشركة/الكيان: |
EUROPEAN Union |
| مستخلص: |
The multicenter, randomized, phase IV, intergroup AGO-B WSG PreCycle trial (NCT03220178) evaluated the impact of CANKADO-based electronic patient-reported outcome (ePRO) assessment on quality of life (QoL) in hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer (MBC) patients receiving palbociclib and an aromatase inhibitor or palbociclib + fulvestrant. CANKADO PRO-React, a European Union-registered medical device, is an interactive autonomous application reacting to patient self-reported observations. Between 2017 and 2021, 499 patients (median age 59 years) from 71 centers were randomized (2 : 1, stratified by therapy line) between an active version of CANKADO PRO-React (CANKADO-active arm) and a version with limited functionality (CANKADO-inform arm). A total of 412 patients (271 CANKADO-active; 141 CANKADO-inform) were available for analysis of the primary endpoint, time to deterioration (TTD) of QoL [10-point drop on the Functional Assessment of Cancer Therapy—General (FACT-G) score], using an Aalen–Johansen estimator for cumulative incidence function of TTD DQoL (QoL deterioration) with 95% pointwise confidence intervals (CIs). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and DQoL. In all patients [intention-to-treat (ITT)-ePRO], cumulative incidence of DQoL was significantly more favorable (lower) in the CANKADO-active arm (hazard ratio 0.698, 95% CI 0.506-0.963). Among first-line patients (n = 295), the corresponding hazard ratio was 0.716 (0.484-1.060; P = 0.09), and in second-line patients (n = 117) it was 0.661 (0.374-1.168; P = 0.2). Absolute patient numbers declined in later visits; FACT-G completion rates were 80% and higher until about visit 30. Mean FACT-G scores showed a steady decline from baseline and an offset in favor of CANKADO-active. No significant differences in clinical outcome were observed between arms: median PFS (ITT population) was 21.4 (95% CI 19.4-23.7) (CANKADO-active) and 18.7 (15.1-23.5) months (CANKADO-inform); median OS was not reached (CANKADO-active) and 42.6 months (CANKADO-inform). PreCycle is the first multicenter randomized eHealth trial demonstrating a significant benefit for MBC patients receiving oral tumor therapy when using an interactive autonomous patient empowerment application. • PreCycle evaluated the impact of an autonomous symptom monitoring application on TTD of QoL. • Primary endpoint was TTD of QoL in HR+/HER2- MBC treated with endocrine therapy + palbociclib. • Deterioration of QoL was significantly delayed with interactive CANKADO PRO-React-based ePRO assessment. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
