背景:疗效和生活质量(QoL)是转移性乳腺癌(MBC)治疗选择的关键标准。在激素受体阳性(HR+)人表皮生长因子受体2阴性(HER2-)MBC中,添加靶向口服药物,如依维莫司或细胞周期蛋白依赖性激酶4/6(CDK4/6)抑制剂(例如,palbociclib,ribociclib,abemaciclib)的内分泌治疗可显着延长无进展生存期,在CDK4/6i的情况下,也可延长总生存期。然而,先决条件是在整个治疗过程中坚持治疗。然而,特别是新的口服药物,依从性对疾病管理提出了挑战。在这种情况下,影响依从性的因素包括维持患者满意度和早期发现/管理副作用。需要为肿瘤患者提供持续支持的新策略。基于eHealth的平台可以帮助支持治疗管理和医患互动。
方法:前周期是一个多中心,随机化,HR+HER2-MBC的IV期试验。所有患者(n=960)首先(62.5%)或之后(37.5%)接受CDK4/6抑制剂palbociclib以及内分泌治疗(AI,富维司坦)根据国家指南。PreCycle评估和比较由具有实质性不同功能的eHealth系统支持的患者的QoL恶化时间(TTD):CANKADO活动与告知。CANKADOactive是功能齐全的基于CANKADO的eHealth治疗支持系统。CANKADO通知是基于CANKADO的eHealth服务,具有个人登录功能,每日药物摄入量的文件,但没有进一步的功能。要评估QoL,FACT-B问卷在每次访视时完成.由于对行为之间的关系知之甚少(例如,坚持),遗传背景,和药物功效,该试验包括患者报告的结果和生物标志物筛查,以发现依从性的预测模型,症状,QoL,无进展生存期(PFS),总生存率(OS)。
结论:PreCycle的主要目的是根据DQoL=“生活质量恶化”(FACT-G量表),检验在由eHealth治疗管理系统(CANKADOactive)支持的患者与仅接受基于eHealth的信息(CANKADOinform)的患者中的恶化时间(TTD)优势假设。EudraCT编号:2016-004191-22。
BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 -) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients\' satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.
METHODS: PreCycle is a multicenter, randomized, phase IV trial in HR + HER2 - MBC. All patients (n = 960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).
CONCLUSIONS: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = \"Deterioration of quality of life\" (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22.