Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design

Abstract

BackgroundHome-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.MethodsLiterature 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/m2 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.DiscussionThis 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.Trial registrationClinicalTrials.gov: NCT01473563

Feasibility of home delivery of pemetrexed in patients with advanced non-squamous non-small cell lung cancer

“…The median number of maintenance treatment cycles (including Cycle 1) was 4 (range [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19]. The majority of patients (73%) discontinued treatment before Cycle 6.…”

“…During screening, 5 patients failed to meet enrolment criteria (3 patients had progressed after 4 cycles of induction treatment, 1 patient received induction treatment outside the inclusion window, 1 patient had symptomatic central nervous system metastasis) and 1 patient was not treated due to a baseline AE (sinus bradycardia); the remaining 52 patients, who received at least 1 dose of study treatment, were analyzed. After Cycle 1 (hospital administered), 45 patients received at least 1 cycle at home: 1 patient felt safer continuing treatment at hospital and was considered per definition as a HD failure [14], and 6 other patients discontinued pemetrexed after Cycle 1: 4 due to AEs (CTCAE Grade 2 haemoptysis [n = 1], Grade 2 nausea [n = 1], and Grade 1 blood creatinine increased [n = 2]), 1 due to patient decision, and 1 patient died of atypical pneumonia. Among these 45 patients with at least 1 cycle at home, only 1 patient reverted to hospital administration (after Cycle 6, investigator decision due to repeated non-compliance to oral dexamethasone) and was considered another HD failure.…”

“…Patient satisfaction with HD and hospital administration, as well as investigator satisfaction with distant management of the patient, was documented (described in [14]) at Cycle 4, and 30-day postdiscontinuation visit for all patients who received at least 1 HD cycle.…”

“…Healthcare resource use was evaluated by: duration of treatment delivery (by nurses and patients) and travel time (by nurses), and unplanned resource use (hospitalizations, diagnostic tests, and visits to healthcare facilities) [14].…”

“…The 5 individual dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with 3 levels each: no, some, or major problems) as well as the visual analog scale (VAS) score (worst [0] to best [100] imaginable health state) were recorded and the health utility index was calculated using the UK population-based weights [18]. Disease-related symptoms and overall QoL were measured using the lung cancer symptom scale (LCSS) [14,19]. The LCSS scale focuses on symptoms (loss of appetite, fatigue, cough, dyspnoea, haemoptysis, and pain) and their effect on the patient (symptom distress, interference with activity level, and overall quality of life).…”