The PreCycle study is the first large, multicenter, randomized eHealth study to show a substantial benefit of an interactive, autonomous patient empowerment application regarding quality of life of patients with metastatic breast cancer receiving oral tumor therapy with a cyclin 4/6 inhibitor palbociclib in combination with endocrine therapy. It is also the first study that palleos healthcare has successfuly conducted as a sposor although it was terminated prematurely due to COVID pandemic in 2021. The results of this study have been recently published in the peer review journals Annals of Oncology, and Cancer Treatment Reviews.
PreCycle (NCT03220178) was a multicenter, randomized phase IV intergroup trial evaluating the impact of electronic patient-reported outcome (ePRO) assessment using an autonomous eHealth support application (CANKADO PRO-React) on quality of life (QoL) in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer (MBC) treated with palbociclib and an aromatase inhibitor (first line) or palbociclib and fulvestrant (later line). Patients were randomized (2:1, stratified by therapy line) to an active arm (CANKADO PRO-React) or an inform arm (autonomous eHealth application supporting drug intake documentation only). The primary endpoint was time to deterioration (TTD) of QoL defined as a 10-point drop on the Functional Assessment of Cancer Therapy – General (FACT-G) score. The secondary endpoints included progression-free survival (PFS), overall survival (OS), QoL deterioration (DQoL) and safety (Degenhardt et al. Trials. 2023).
A total of 499 patients (median age 59 years) were randomized in 71 centers between August 2017 and June 2021 (331 in active arm vs. 169 in inform arm). The reduction from the target of 960 patients occurred because of the COVID-19 pandemic-related termination of the trial. The ITT-PRO population (randomized patients available for analysis of primary endpoint) comprised 412 patients (271 in active arm; 141 in inform arm). The analysis of the primary endpoint demonstrated a significantly longer TTD of QoL with the autonomous eHealth support application (hazard ratio of 0.70 [95%CI 0.51-0.96] in favor of the active arm). No significant differences in clinical outcome (PFS and OS) were observed between arms (Harbeck et al. Ann Oncol. 2023).
An exploratory analysis of the impact of CANKADO PRO-React on safety has been recently published (Harbeck et al. Cancer Treat Rev. 2023). The safety population (all patients who received at least one dose of palbociclib) comprised 479 patients (318 in active arm, 161 in inform arm). Time to first serious adverse event (SAE) was estimated taking competing risks into account. While distributions of adverse events (AEs) were similar by arm overall, patients in the 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 the active arm had suffered an SAE vs. 30.3% [22.6%-38.0%] in the inform arm.
These findings demonstrate for the first time in a randomized prospective trial that interactive autonomous eHealth-based application has a substantial benefit regarding QoL and a favorable impact on the risk of SAEs for patients with HR+/HER2- MBC receiving oral tumor therapy.