Universität zu Köln

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

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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
Creators:	Creators Email ORCID ORCID Put Code Jagasia, Madan UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheid, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Socie, Gerard UNSPECIFIED UNSPECIFIED UNSPECIFIED Ayuk, Francis Ayuketang UNSPECIFIED UNSPECIFIED UNSPECIFIED Tischer, Johanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Donato, Michele L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Batai, Arpad UNSPECIFIED UNSPECIFIED UNSPECIFIED Chen, Heidi UNSPECIFIED UNSPECIFIED UNSPECIFIED Chen, Sheau-Chiann UNSPECIFIED UNSPECIFIED UNSPECIFIED Chin, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Boodee, Henri UNSPECIFIED UNSPECIFIED UNSPECIFIED Mitri, Ghaith UNSPECIFIED UNSPECIFIED UNSPECIFIED Greinix, Hildegard T. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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
Uncontrolled Keywords:	Keywords Language VERSUS-HOST-DISEASE; QUALITY-OF-LIFE; CONSENSUS DEVELOPMENT PROJECT; HEMATOPOIETIC-CELL TRANSPLANTATION; MEASURING THERAPEUTIC RESPONSE; EXTRACORPOREAL PHOTOPHERESIS; CLINICAL-TRIALS; CRITERIA; PREDNISONE; CYCLOSPORINE Multiple languages Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/13477