CANKADO PRO-React eHealth support in patients with HR+ HER2- metastatic breast cancer receiving palbociclib and endocrine therapy and the affect on time to deterioration of quality of life: Primary outcome analysis of the multicenter randomized PreCycle trial.

Nadia Harbeck Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany info_outline Nadia Harbeck, Peter A. Fasching, Rachel Wuerstlein, Tom Degenhardt, Diana Lüftner, Ronald E. Kates, Johannes Schumacher, Philip Raeth, Oliver Hoffmann, Ralf Lorenz, Thomas Decker, Mattea Reinisch, Thomas Göhler, Peter Staib, Oleg Gluz, Timo Schinkoethe, Marcus Schmidt

Authors Nadia Harbeck Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany info_outline Nadia Harbeck, Peter A. Fasching, Rachel Wuerstlein, Tom Degenhardt, Diana Lüftner, Ronald E. Kates, Johannes Schumacher, Philip Raeth, Oliver Hoffmann, Ralf Lorenz, Thomas Decker, Mattea Reinisch, Thomas Göhler, Peter Staib, Oleg Gluz, Timo Schinkoethe, Marcus Schmidt Organizations Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany, Department of Gynaecology and Obstetrics, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, Germany, University Hospital Munich, Department of Obstetrics and Gynecology, Breast Center and CCC Munich, LMU, Munich, Germany, Joint practice Wolfratshausen, Wolfratshausen, Germany, Immanuel Klinik Märkische Schweiz, Medical University of Brandenburg, Buckow, Germany, West German Study Group, Moenchengladbach, Germany, Palleos Healthcare GmbH, Wiesbaden, Germany, palleos healthcare, Wiesbaden, Germany, Department of Obstetrics and Gynecology, University Hospital Essen, Essen, Germany, Community practice Lorenz-Hecker-Wesche, Braunschweig, Germany, Onkologie Ravensburg, Ravensburg, Germany, Breast Unit, Kliniken Essen Mitte, Essen, Germany, Onkozentrum Dresden/Freiberg, Dresden, Germany, St. Antonius-Hospital, Clinic for Haematology and Oncology, Eschweiler, Germany, CANKADO Service GmbH, Kirchheim Bei München, Germany, University Hospital Mainz, Clinic and Polyclinic for Obstetrics and Women's Health, Mainz, Germany Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Pfizer Background: The multicenter, randomized phase IV Intergroup PreCycle trial (NCT03220178) evaluated the impact of CANKADO-based ePRO assessment on quality of life (QoL) in HR+/HER2- locally advanced or metastatic breast cancer (MBC) patients (pts) treated with palbociclib (P) and an aromatase inhibitor or P+fulvestrant. CANKADO PRO-React, an EU- registered medical device, is an autonomous application reacting to changes in pt self- reported QoL. Methods: Between 2017 and 2021, 499 pts (median age 59y) from 71 centers were randomized (2:1, stratified by therapy line) between an active (A; CANKADO PRO-React) or an inactive arm (B; inform; limited CANKADO functionality). 412 pts (271 A; 141 B) were available for analysis of the primary endpoint, i.e. time to deterioration (TTD) of QoL (10-point drop on FACT-G), using an Aalen-Johansen estimator for cumulative incidence function of TTD DQoL with 95% pointwise confidence intervals (CI). Secondary endpoints included PFS, OS, and DQoL (QoL deterioration). Results: In all pts (ITT-ePRO), a significantly decreased risk (HR 0.6982) for the CANKADO active arm A with 95% CI [0.5059, 0.9635] regarding DQoL was observed (p=0.03). In 1stL pts (n=295), the decreased risk for arm A was 0.7162 (0.4839, 1.06; p=0.09), in 2ndL pts (n=117) 0.6614 (0.3744, 1.168; p=0.2). Absolute pt numbers declined in later visits; until about visit 30, FACT- G completion rates were 80% and higher; mean total scores were similar between arms; the change from baseline showed a linear decline and a nearly constant offset in favor of arm A, particularly in 1st L. No significant differences in clinical outcome were observed between arms: Median PFS (ITT population) was 21.4 (95% CI 19.4-23.7) (A) and 18.7 (15.1.-23.5) months (B); median OS was not reached (A) and 42.6 months (B). Conclusions: PreCycle is the first multicenter randomized eHealth trial demonstrating a significant benefit of an interactive autonomous patient empowerment application on QoL in MBC pts receiving oral tumor therapy. Clinical trial information: NCT03220178.