Administration of 24-h intravenous infusions of trabectedin in ambulatory patients with mesenchymal tumors via disposable elastomeric pumps: an effective and patient-friendly palliative treatment option.

BACKGROUND: Patients with progressive mesenchymal tumours after standard chemotherapy have poor outcome. Trabectedin is approved in Europe as 24-h intravenous (i.v.) infusion q3w in this setting. We report the use of disposable elastomeric pumps for ambulatory treatment with trabectedin.
MATERIAL AND METHODS: Pre-treated sarcoma patients were offered trabectedin 1.5 mg/m(2) as 24-h i.v. infusion via port catheter, either as inpatients using electronic pumps or as outpatients using the Baxter LV10 pump. Co-medication consisted of antiemetics including dexamethasone.
RESULTS: 21/28 patients with distant metastasis and/or local relapse elected outpatient therapy and received 130 cycles (median 3, range 1-24). Dose reductions were done in 60 cycles, mainly due to laboratory adverse events (AEs). Best response (Response Evaluation Criteria in Solid Tumours (RECIST)) was 4 cases of confirmed partial remission (PR), 6 cases of stable disease (SD), and 11 cases of progressive disease (PD). Grade 3/4 (Common Toxicity Criteria (CTC)) AEs were limited to 1 case each of haemorrhage and lung embolism; other AEs were in line with published trabectedin experience. 1 port catheter contamination required replacement, 1 catheter thrombosis occurred and 1 extravasation due to needle dislocation was observed.
CONCLUSIONS: Outpatient administration of trabectedin as 24-h infusion using Baxter LV10 pumps is preferred by the vast majority of patients; it is feasible, safe, effective, cost efficient, and should be considered as routine practice in this clinical setting.