Eli Lilly, Neuilly sur Seine, France.
Health Qual Life Outcomes. 2013 Oct 3;11:163. doi: 10.1186/1477-7525-11-163.
Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting.
Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011.
This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment.
ClinicalTrials.gov: NCT01473563.
肿瘤学的家庭护理主要保留给生命末期的患者。欧洲各国对细胞毒素的家庭配送规定不同，大多数国家缺乏实践指南。这导致缺乏关于细胞毒性化疗的家庭管理可行性的数据。在晚期非鳞状非小细胞肺癌中，培美曲塞在一线化疗后被批准用于维持治疗。在这种情况下，患者有可能长期接受维持治疗，只要没有不可接受的毒性，就会继续治疗，直到疾病进展。培美曲塞良好的安全性和每 3 周静脉输注 10 分钟的易用性使其成为家庭环境下给药的合适选择。
对与细胞毒治疗的家庭配送相关的文献和法规进行了审查，并设计了培美曲塞维持治疗家庭给药的 II 期可行性研究。需要至少 50 名患有晚期非鳞状非小细胞肺癌、东部合作肿瘤学组表现状态 0-1 和在接受铂类为基础的一线治疗 4 个周期后没有疾病进展的患者，以允许调查培美曲塞维持治疗的家庭给药的可行性（每 3 周 500mg/m2，直到疾病进展或不可接受的毒性）。可行性评估是基于对家庭给药过程的依从性（主要终点）、患者安全性、对患者生活质量的影响、患者和医生对家庭护理的满意度、以及医疗保健资源的使用和成本。该研究于 2011 年 12 月开始在英国和瑞典招募患者，这两个国家的家庭护理相对发达。
这项可行性研究解决了维持治疗的一个重要方面，即患者在长期家庭化疗中的舒适度。研究设计需要不寻常的方法和特定的物流来解决与家庭给药方法相关的结果。本文介绍了一种家庭化疗的新颖且可重复的模型，并提供了关于这种治疗类型的最新文献综述。
ClinicalTrials.gov：NCT01473563。
