Jagasia, Madan, Scheid, Christof, Socie, Gerard, Ayuk, Francis Ayuketang, Tischer, Johanna, Donato, Michele L., Batai, Arpad, Chen, Heidi, Chen, Sheau-Chiann, Chin, Thomas, Boodee, Henri, Mitri, Ghaith and Greinix, Hildegard T. (2019). Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv., 3 (14). S. 2218 - 2230. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 2473-9537
Full text not available from this repository.Abstract
The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use. This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment. Adult patients with new-onset (<= 3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT). Other outcomes included quality of life (QoL) measures and safety. Sixty patients were randomized; ITT included 53 patients (SoC+ECP: 29; SoC: 24). Week 28 ORR was 74.1% (SoC+ECP) and 60.9% (SoC). Investigator-assessed ORR was 56.0% (SoC+ECP) and 66.7% (SoC). Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients. Most frequent treatment-emergent adverse events (TEAEs) in SoC+ECP patients were hypertension (31.0%), cough (20.7%), dyspnea (17.2%), and fatigue (17.2%). Seventeen patients (SoC+ECP: 8; SoC: 9) experienced 35 serious adverse events (SAEs). No TEAEs or SAEs were considered related to the ECP instrument or methoxsalen. The encouraging short-term results of this study could inform the design of subsequent studies.
Item Type: | Journal Article | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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URN: | urn:nbn:de:hbz:38-134778 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DOI: | 10.1182/bloodadvances.2019000145 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Journal or Publication Title: | Blood Adv. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Volume: | 3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number: | 14 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Page Range: | S. 2218 - 2230 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Date: | 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Publisher: | AMER SOC HEMATOLOGY | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Place of Publication: | WASHINGTON | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ISSN: | 2473-9537 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Language: | English | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Faculty: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Divisions: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subjects: | no entry | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Refereed: | Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
URI: | http://kups.ub.uni-koeln.de/id/eprint/13477 |
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