Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany; West German Study Group, Moenchengladbach, Germany.
West German Study Group, Moenchengladbach, Germany.
Cancer Treat Rev. 2023 Dec;121:102631. doi: 10.1016/j.ctrv.2023.102631. Epub 2023 Oct 18.
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.
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.
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%).
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.
口腔癌药物在治疗管理和依从性方面具有优势，但也带来了挑战。基于电子健康的平台，如 CANKADO，可以通过在整个治疗过程中持续探测患者的生活质量（QoL），帮助支持治疗管理。
AGO-B WSG PreCycle（NCT03220178）是一项多中心、随机、四期分组临床试验，旨在评估基于电子健康的患者报告结果（ePRO）评估对接受帕博西利和内分泌治疗的激素受体阳性（HR+）/人表皮生长因子受体 2 阴性（HER2-）晚期乳腺癌患者生活质量的影响。患者按 2:1 随机分配至 CANKADO-活跃组（由 CANKADO PRO-React 支持）或 CANKADO-信息组（仅药物摄入记录）。本探索性分析报告了 CANKADO PRO-React 对安全性的影响。首次严重不良事件（SAE）的时间采用竞争风险进行估计。
尽管总体上两组的不良事件（AE）分布相似，但 CANKADO-活跃组患者首次 SAE 的风险比为 0.67（95%CI 0.46-0.97；p=0.04），总体上发生 SAE 的可能性明显低于信息组。在 24 个月时，CANKADO-活跃组有 22.9%（17.9%-27.8%）的患者发生 SAE，CANKADO-信息组有 30.3%（22.6%-38.0%）的患者发生 SAE。AE 相关剂量减少约影响 20%的患者（CANKADO-活跃组：18.2%，CANKADO-信息组：21.1%）。
PreCycle 的探索性安全性分析首次在一项随机前瞻性试验中证明，交互式自主基于电子健康的支持对 SAE 风险具有显著的有利影响，并减轻了接受口服肿瘤治疗的晚期 HR+/HER2-乳腺癌患者的严重程度。
