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

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 st...

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Bibliographic Details
Published in:International journal of hematology 2018-09, Vol.108 (3), p.298-305
Main Authors: Okamoto, Shinichiro, Teshima, Takanori, Kosugi-Kanaya, Mizuha, Kahata, Kaoru, Kawashima, Naomi, Kato, Jun, Mori, Takehiko, Ozawa, Yukiyasu, Miyamura, Koichi
Format: Article
Language:English
Subjects:
Apheresis
Edema
Graft versus host disease
Graft-versus-host reaction
Heart diseases
Hematology
Hematopoietic stem cells
Medical treatment
Medicine
Medicine & Public Health
Oncology
Original Article
Patients
Photodynamic therapy
Quality of life
Safety
Stem cell transplantation
Steroid hormones
Steroids
Thromboembolism
Thrombosis
Toxicity
Transplantation
Wheezing
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Summary: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.
ISSN:0925-5710
1865-3774
DOI:10.1007/s12185-018-2483-6