NDLI: Safety of a new, single, integrated, closed photopheresis system in patients with cutaneous T-cell lymphoma.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Bisaccia, E. Vonderheid, E. C. Geskin, L.
Description	Country affiliation: United States Author Affiliation: Bisaccia E ( Morristown Memorial Hospital, Morristown, NJ 07960, USA. emil.bisaccia@atlantichealth.org)
Abstract	BACKGROUND: Extracorporeal photopheresis (ECP) is an approved palliative treatment for cutaneous T-cell lymphoma (CTCL). The THERAKOS CELLEX (continuous flow separation) system (Therakos, Exton, PA, U.S.A.) has been developed from the current THERAKOS UVAR XTS system. It is designed to reduce treatment times and extracorporeal volumes, and allows the use of either a single- or a dual-needle configuration. OBJECTIVES: To assess the safety of the THERAKOS CELLEX system to provide ECP for patients with CTCL. METHODS: Patients received ECP with the THERAKOS CELLEX system for up to 6 months. The treatment schedule was defined by their current treatment and response to ECP. At least 150 treatments were required to assess safety of the new system. Safety was assessed using reports of adverse device effects (ADEs) and unanticipated ADEs (UADEs), device malfunctions and defects, vital signs, laboratory parameters and physical examinations. RESULTS: Thirteen patients were enrolled and 12 completed the study; 155 ECP treatments were initiated and 153 completed. There were no ADEs or UADEs reported during the study. The mean treatment time was shorter for patients who received dual- compared with single-needle treatments (74.4 vs. 103.0 min, P < 0.0001) and the extracorporeal volume was lower (216 vs. 266 mL). CONCLUSIONS: This new ECP system provides lower extracorporeal volumes, faster treatment times, and flexibility to use either single- or dual-needle access, while not being associated in this study with any ADEs, and therefore having a positive benefit-risk ratio for patients with CTCL.
File Format	HTM / HTML
ISSN	00070963
Issue Number	1
Volume Number	161
e-ISSN	13652133
Journal	British Journal of Dermatology
Language	English
Publisher	Wiley-Blackwell (on behalf of British Association of Dermatologists)
Publisher Date	2009-07-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Dermatology Lymphoma, T-cell, Cutaneous Therapy Photopheresis Methods Skin Neoplasms Adolescent Adult Aged Aged, 80 And Over Antineoplastic Agents Therapeutic Use Drug Administration Schedule Equipment Failure Female Humans Male Methoxsalen Middle Aged Adverse Effects Young Adult Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Dermatology

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