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Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD

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Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. / Jagasia, Madan; Scheid, Christof; Socié, Gérard; Ayuk, Francis Ayuketang; Tischer, Johanna; Donato, Michele L; Bátai, Árpád; Chen, Heidi; Chen, Sheau-Chiann; Chin, Thomas; Boodée, Henri; Mitri, Ghaith; Greinix, Hildegard T.

In: Blood Adv, Vol. 3, No. 14, 23.07.2019, p. 2218-2229.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Jagasia, M, Scheid, C, Socié, G, Ayuk, FA, Tischer, J, Donato, ML, Bátai, Á, Chen, H, Chen, S-C, Chin, T, Boodée, H, Mitri, G & Greinix, HT 2019, 'Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD', Blood Adv, vol. 3, no. 14, pp. 2218-2229. https://doi.org/10.1182/bloodadvances.2019000145

APA

Jagasia, M., Scheid, C., Socié, G., Ayuk, F. A., Tischer, J., Donato, M. L., Bátai, Á., Chen, H., Chen, S-C., Chin, T., Boodée, H., Mitri, G., & Greinix, H. T. (2019). Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv, 3(14), 2218-2229. https://doi.org/10.1182/bloodadvances.2019000145

Vancouver

Jagasia M, Scheid C, Socié G, Ayuk FA, Tischer J, Donato ML et al. Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv. 2019 Jul 23;3(14):2218-2229. https://doi.org/10.1182/bloodadvances.2019000145

Bibtex

@article{f992ce067a3c43fab57eb2a1eff83287,
title = "Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD",
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. This trial was registered at www.clinicaltrials.gov as #NCT01380535.",
author = "Madan Jagasia and Christof Scheid and G{\'e}rard Soci{\'e} and Ayuk, {Francis Ayuketang} and Johanna Tischer and Donato, {Michele L} and {\'A}rp{\'a}d B{\'a}tai and Heidi Chen and Sheau-Chiann Chen and Thomas Chin and Henri Bood{\'e}e and Ghaith Mitri and Greinix, {Hildegard T}",
note = "{\textcopyright} 2019 by The American Society of Hematology.",
year = "2019",
month = jul,
day = "23",
doi = "10.1182/bloodadvances.2019000145",
language = "English",
volume = "3",
pages = "2218--2229",
journal = "BLOOD ADV",
issn = "2473-9529",
publisher = "Elsevier BV",
number = "14",

}

RIS

TY - JOUR

T1 - Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD

AU - Jagasia, Madan

AU - Scheid, Christof

AU - Socié, Gérard

AU - Ayuk, Francis Ayuketang

AU - Tischer, Johanna

AU - Donato, Michele L

AU - Bátai, Árpád

AU - Chen, Heidi

AU - Chen, Sheau-Chiann

AU - Chin, Thomas

AU - Boodée, Henri

AU - Mitri, Ghaith

AU - Greinix, Hildegard T

N1 - © 2019 by The American Society of Hematology.

PY - 2019/7/23

Y1 - 2019/7/23

N2 - 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. This trial was registered at www.clinicaltrials.gov as #NCT01380535.

AB - 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. This trial was registered at www.clinicaltrials.gov as #NCT01380535.

U2 - 10.1182/bloodadvances.2019000145

DO - 10.1182/bloodadvances.2019000145

M3 - SCORING: Journal article

C2 - 31332045

VL - 3

SP - 2218

EP - 2229

JO - BLOOD ADV

JF - BLOOD ADV

SN - 2473-9529

IS - 14

ER -