4.0 Article

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

Journal

ONKOLOGIE
Volume 35, Issue 1-2, Pages 14-17

Publisher

KARGER
DOI: 10.1159/000335879

Keywords

Sarcoma; Trabectedin; Outpatient chemotherapy; Drug delivery; Elastomeric pump

Categories

Funding

  1. PharmaMar SA, Spain

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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.

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