Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease

Shinichiro Okamoto, Takanori Teshima, Mizuha Kosugi-Kanaya, Kaoru Kahata, Naomi Kawashima, Jun Kato, Takehiko Mori, Yukiyasu Ozawa, Koichi Miyamura

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

There are few established therapies for chronic graft-versus-host disease (cGVHD) refractory to first-line treatment with steroids. We evaluated the efficacy and safety of extracorporeal photopheresis (ECP) with a third-generation TC-V device in Japanese patients with cGVHD. Fifteen patients with steroid-resistant or -intolerant cGVHD after allogeneic hematopoietic stem cell transplantation participated in this multicenter open-label study. Extracorporeal photopheresis was conducted on days 1–3, week 1; days 1–2, weeks 2–12; and days 1–2, weeks 16, 20, and 24. The composite primary endpoint consisted of evaluation of response and changes in steroid dose 24 weeks after ECP initiation. Secondary endpoints included response over time, concomitant drug dose, quality of life, and safety. Twelve patients completed scheduled ECP therapy; eight (66.7%) showed a response at week 24. In all 15 patients, the mean (± standard deviation) steroid dose decreased 0.115 ± 0.230 mg/kg/day from screening to week 24. Five serious, potentially treatment-related adverse events (heart failure, thrombosis in the device, pneumonia, edema, and wheezing) occurred; none were fatal. This study confirmed that ECP using the TC-V device was effective, with an acceptable toxicity profile. Further studies in larger cohorts are clearly warranted to determine its optimal use in Japanese patients with cGVHD.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalInternational Journal of Hematology
DOIs
Publication statusAccepted/In press - 2018 Jun 29

Fingerprint

Photopheresis
Graft vs Host Disease
Steroids
Equipment and Supplies
Safety
Hematopoietic Stem Cell Transplantation
Respiratory Sounds
Therapeutics
Edema
Pneumonia
Thrombosis
Heart Failure
Quality of Life
Pharmaceutical Preparations

Keywords

  • Chronic graft-versus-host disease
  • Extracorporeal photopheresis (ECP)
  • Hematopoietic stem cell transplantation
  • Steroid resistant

ASJC Scopus subject areas

  • Hematology

Cite this

Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease. / Okamoto, Shinichiro; Teshima, Takanori; Kosugi-Kanaya, Mizuha; Kahata, Kaoru; Kawashima, Naomi; Kato, Jun; Mori, Takehiko; Ozawa, Yukiyasu; Miyamura, Koichi.

In: International Journal of Hematology, 29.06.2018, p. 1-8.

Research output: Contribution to journalArticle

Okamoto, Shinichiro ; Teshima, Takanori ; Kosugi-Kanaya, Mizuha ; Kahata, Kaoru ; Kawashima, Naomi ; Kato, Jun ; Mori, Takehiko ; Ozawa, Yukiyasu ; Miyamura, Koichi. / Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease. In: International Journal of Hematology. 2018 ; pp. 1-8.
@article{c5aa5e22049e4cf2956f8f5babba637e,
title = "Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease",
abstract = "There are few established therapies for chronic graft-versus-host disease (cGVHD) refractory to first-line treatment with steroids. We evaluated the efficacy and safety of extracorporeal photopheresis (ECP) with a third-generation TC-V device in Japanese patients with cGVHD. Fifteen patients with steroid-resistant or -intolerant cGVHD after allogeneic hematopoietic stem cell transplantation participated in this multicenter open-label study. Extracorporeal photopheresis was conducted on days 1–3, week 1; days 1–2, weeks 2–12; and days 1–2, weeks 16, 20, and 24. The composite primary endpoint consisted of evaluation of response and changes in steroid dose 24 weeks after ECP initiation. Secondary endpoints included response over time, concomitant drug dose, quality of life, and safety. Twelve patients completed scheduled ECP therapy; eight (66.7{\%}) showed a response at week 24. In all 15 patients, the mean (± standard deviation) steroid dose decreased 0.115 ± 0.230 mg/kg/day from screening to week 24. Five serious, potentially treatment-related adverse events (heart failure, thrombosis in the device, pneumonia, edema, and wheezing) occurred; none were fatal. This study confirmed that ECP using the TC-V device was effective, with an acceptable toxicity profile. Further studies in larger cohorts are clearly warranted to determine its optimal use in Japanese patients with cGVHD.",
keywords = "Chronic graft-versus-host disease, Extracorporeal photopheresis (ECP), Hematopoietic stem cell transplantation, Steroid resistant",
author = "Shinichiro Okamoto and Takanori Teshima and Mizuha Kosugi-Kanaya and Kaoru Kahata and Naomi Kawashima and Jun Kato and Takehiko Mori and Yukiyasu Ozawa and Koichi Miyamura",
year = "2018",
month = "6",
day = "29",
doi = "10.1007/s12185-018-2483-6",
language = "English",
pages = "1--8",
journal = "International Journal of Hematology",
issn = "0925-5710",
publisher = "Springer Japan",

}

TY - JOUR

T1 - Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease

AU - Okamoto, Shinichiro

AU - Teshima, Takanori

AU - Kosugi-Kanaya, Mizuha

AU - Kahata, Kaoru

AU - Kawashima, Naomi

AU - Kato, Jun

AU - Mori, Takehiko

AU - Ozawa, Yukiyasu

AU - Miyamura, Koichi

PY - 2018/6/29

Y1 - 2018/6/29

N2 - There are few established therapies for chronic graft-versus-host disease (cGVHD) refractory to first-line treatment with steroids. We evaluated the efficacy and safety of extracorporeal photopheresis (ECP) with a third-generation TC-V device in Japanese patients with cGVHD. Fifteen patients with steroid-resistant or -intolerant cGVHD after allogeneic hematopoietic stem cell transplantation participated in this multicenter open-label study. Extracorporeal photopheresis was conducted on days 1–3, week 1; days 1–2, weeks 2–12; and days 1–2, weeks 16, 20, and 24. The composite primary endpoint consisted of evaluation of response and changes in steroid dose 24 weeks after ECP initiation. Secondary endpoints included response over time, concomitant drug dose, quality of life, and safety. Twelve patients completed scheduled ECP therapy; eight (66.7%) showed a response at week 24. In all 15 patients, the mean (± standard deviation) steroid dose decreased 0.115 ± 0.230 mg/kg/day from screening to week 24. Five serious, potentially treatment-related adverse events (heart failure, thrombosis in the device, pneumonia, edema, and wheezing) occurred; none were fatal. This study confirmed that ECP using the TC-V device was effective, with an acceptable toxicity profile. Further studies in larger cohorts are clearly warranted to determine its optimal use in Japanese patients with cGVHD.

AB - There are few established therapies for chronic graft-versus-host disease (cGVHD) refractory to first-line treatment with steroids. We evaluated the efficacy and safety of extracorporeal photopheresis (ECP) with a third-generation TC-V device in Japanese patients with cGVHD. Fifteen patients with steroid-resistant or -intolerant cGVHD after allogeneic hematopoietic stem cell transplantation participated in this multicenter open-label study. Extracorporeal photopheresis was conducted on days 1–3, week 1; days 1–2, weeks 2–12; and days 1–2, weeks 16, 20, and 24. The composite primary endpoint consisted of evaluation of response and changes in steroid dose 24 weeks after ECP initiation. Secondary endpoints included response over time, concomitant drug dose, quality of life, and safety. Twelve patients completed scheduled ECP therapy; eight (66.7%) showed a response at week 24. In all 15 patients, the mean (± standard deviation) steroid dose decreased 0.115 ± 0.230 mg/kg/day from screening to week 24. Five serious, potentially treatment-related adverse events (heart failure, thrombosis in the device, pneumonia, edema, and wheezing) occurred; none were fatal. This study confirmed that ECP using the TC-V device was effective, with an acceptable toxicity profile. Further studies in larger cohorts are clearly warranted to determine its optimal use in Japanese patients with cGVHD.

KW - Chronic graft-versus-host disease

KW - Extracorporeal photopheresis (ECP)

KW - Hematopoietic stem cell transplantation

KW - Steroid resistant

UR - http://www.scopus.com/inward/record.url?scp=85049147154&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85049147154&partnerID=8YFLogxK

U2 - 10.1007/s12185-018-2483-6

DO - 10.1007/s12185-018-2483-6

M3 - Article

SP - 1

EP - 8

JO - International Journal of Hematology

JF - International Journal of Hematology

SN - 0925-5710

ER -