Extracorporeal photopheresis with TC-V in Japanese patients with steroid-resistant chronic graft-versus-host disease
Tóm tắt
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.
Tài liệu tham khảo
citation_journal_title=Biol Blood Marrow Transplant; citation_title=National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. The 2014 diagnosis and staging working group report; citation_author=MH Jagasia, HT Greinix, M Arora, KM Williams, D Wolff, EW Cowen; citation_volume=21; citation_publication_date=2015; citation_pages=389-401.e1; citation_doi=10.1016/j.bbmt.2014.12.001; citation_id=CR1
citation_journal_title=J Clin Oncol; citation_title=Long-term survival and late deaths after allogeneic hematopoietic cell transplantation; citation_author=JR Wingard, NS Majhail, R Brazauskas, Z Wang, KA Sobocinski, D Jacobsohn; citation_volume=29; citation_publication_date=2011; citation_pages=2230-2239; citation_doi=10.1200/JCO.2010.33.7212; citation_id=CR2
citation_journal_title=J Clin Oncol; citation_title=Biomarker panel for chronic graft-versus-host disease; citation_author=J Yu, BE Storer, K Kushekhar, M Abu Zaid, Q Zhang, PR Gafken; citation_volume=34; citation_publication_date=2016; citation_pages=2583-2590; citation_doi=10.1200/JCO.2015.65.9615; citation_id=CR3
citation_journal_title=Ther Adv Hematol; citation_title=Treatment and management of graft-versus-host disease: improving response and survival; citation_author=C Garnett, JF Apperley, J Pavlu; citation_volume=4; citation_publication_date=2013; citation_pages=366-378; citation_doi=10.1177/2040620713489842; citation_id=CR4
citation_journal_title=Blood; citation_title=Duration of immunosuppressive treatment for chronic graft-versus-host disease; citation_author=BL Stewart, B Storer, J Storek, HJ Deeg, R Storb, JA Hansen; citation_volume=104; citation_publication_date=2004; citation_pages=3501-3506; citation_doi=10.1182/blood-2004-01-0200; citation_id=CR5
citation_journal_title=N Engl J Med; citation_title=Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results; citation_author=R Edelson, C Berger, F Gasparro, B Jegasothy, P Heald, B Wintroub; citation_volume=316; citation_publication_date=1987; citation_pages=297-303; citation_doi=10.1056/NEJM198702053160603; citation_id=CR6
citation_journal_title=Bone Marrow Transplant; citation_title=Extracorporeal photopheresis in 62 patients with acute and chronic GVHD: results of treatment with the COBE Spectra System; citation_author=AH Hautmann, D Wolff, J Hahn, M Edinger, N Schirmer, J Ammer; citation_volume=48; citation_publication_date=2013; citation_pages=439-445; citation_doi=10.1038/bmt.2012.156; citation_id=CR7
citation_journal_title=Transfusion; citation_title=Extracorporeal photopheresis for graft-versus-host disease: the role of patient, transplant, and classification criteria and hematologic values on outcome-results from a large single-center study; citation_author=M Berger, R Albiani, B Sini, F Fagioli; citation_volume=55; citation_publication_date=2015; citation_pages=736-747; citation_doi=10.1111/trf.12900; citation_id=CR8
citation_journal_title=Bone Marrow Transplant; citation_title=Impact of extracorporeal photopheresis on skin scores and quality of life in patients with steroid-refractory chronic GVHD; citation_author=FL Dignan, S Aguilar, JJ Scarisbrick, BE Shaw, MN Potter, J Cavenagh; citation_volume=49; citation_publication_date=2014; citation_pages=704-708; citation_doi=10.1038/bmt.2014.21; citation_id=CR9
citation_journal_title=Transplantation; citation_title=Extracorporeal photopheresis for treatment of acute and chronic graft versus host disease: an Italian multicentric retrospective analysis on 94 patients on behalf of the Gruppo Italiano Trapianto di Midollo Osseo; citation_author=M Malagola, V Cancelli, C Skert, PF Leali, E Ferrari, A Tiburzi; citation_volume=100; citation_publication_date=2016; citation_pages=e147-e55; citation_doi=10.1097/TP.0000000000001466; citation_id=CR10
citation_journal_title=Biol Blood Marrow Transplant; citation_title=Extracorporeal photopheresis in steroid-refractory acute or chronic graft-versus-host disease: results of a systematic review of prospective studies; citation_author=I Abu-Dalle, T Reljic, T Nishihori, A Antar, A Bazarbachi, B Djulbegovic; citation_volume=20; citation_publication_date=2014; citation_pages=1677-1686; citation_doi=10.1016/j.bbmt.2014.05.017; citation_id=CR11
citation_journal_title=Biol Blood Marrow Transplant; citation_title=Progressive improvement in cutaneous and extracutaneous chronic graft-versus-host disease after a 24-week course of extracorporeal photopheresis—results of a crossover randomized study; citation_author=HT Greinix, K Besien, AH Elmaagacli, U Hillen, A Grigg, R Knobler; citation_volume=17; citation_publication_date=2011; citation_pages=1775-1782; citation_doi=10.1016/j.bbmt.2011.05.004; citation_id=CR12
citation_journal_title=Bone Marrow Transplant; citation_title=Extracorporeal photopheresis therapy in the management of steroid-refractory or steroid-dependent cutaneous chronic graft-versus-host disease after allogeneic stem cell transplantation: feasibility and results; citation_author=N Apisarnthanarax, M Donato, M Korbling, D Couriel, J Gajewski, S Giralt; citation_volume=31; citation_publication_date=2003; citation_pages=459-465; citation_doi=10.1038/sj.bmt.1703871; citation_id=CR13
citation_journal_title=J Clin Apher; citation_title=Treatment of extensive chronic graft-versus-host disease with extracorporeal photochemotherapy; citation_author=E Bisaccia, M Palangio, J Gonzalez, KR Adler, R Scarborough, SL Goldberg; citation_volume=21; citation_publication_date=2006; citation_pages=181-187; citation_doi=10.1002/jca.20084; citation_id=CR14
citation_journal_title=Bone Marrow Transplant; citation_title=Extracorporeal photopheresis (ECP) in the treatment of chronic graft-versus-host disease (GVHD); citation_author=FJ Child, R Ratnavel, P Watkins, D Samson, J Apperley, J Ball; citation_volume=23; citation_publication_date=1999; citation_pages=881-887; citation_doi=10.1038/sj.bmt.1701733; citation_id=CR15
citation_journal_title=Blood; citation_title=Extracorporeal photochemotherapy for the treatment of steroid-resistant chronic GVHD; citation_author=DR Couriel, C Hosing, R Saliba, EJ Shpall, P Anderlini, B Rhodes; citation_volume=107; citation_publication_date=2006; citation_pages=3074-3080; citation_doi=10.1182/blood-2005-09-3907; citation_id=CR16
citation_journal_title=Transfusion; citation_title=Response and survival of patients with chronic graft-versus-host disease treated by extracorporeal photochemotherapy: a retrospective study according to classical and National Institutes of Health classifications; citation_author=C Fante, L Scudeller, G Viarengo, P Bernasconi, C Perotti; citation_volume=52; citation_publication_date=2012; citation_pages=2007-2015; citation_doi=10.1111/j.1537-2995.2011.03542.x; citation_id=CR17
citation_journal_title=Bone Marrow Transplant; citation_title=Efficacy of bimonthly extracorporeal photopheresis in refractory chronic mucocutaneous GVHD; citation_author=FL Dignan, D Greenblatt, M Cox, J Cavenagh, H Oakervee, JF Apperley; citation_volume=47; citation_publication_date=2012; citation_pages=824-830; citation_doi=10.1038/bmt.2011.186; citation_id=CR18
citation_journal_title=Blood; citation_title=A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease; citation_author=ME Flowers, JF Apperley, K Besien, A Elmaagacli, A Grigg, V Reddy; citation_volume=112; citation_publication_date=2008; citation_pages=2667-2674; citation_doi=10.1182/blood-2008-03-141481; citation_id=CR19
citation_journal_title=Bone Marrow Transplant; citation_title=Prospective study of extracorporeal photopheresis in steroid-refractory or steroid-resistant extensive chronic graft-versus-host disease: analysis of response and survival incorporating prognostic factors; citation_author=FM Foss, GM DiVenuti, K Chin, K Sprague, H Grodman, A Klein; citation_volume=35; citation_publication_date=2005; citation_pages=1187-1193; citation_doi=10.1038/sj.bmt.1704984; citation_id=CR20
citation_journal_title=Haematologica; citation_title=Extracorporeal chemophototherapy for the treatment of graft-versus-host disease: hematologic consequences of short-term, intensive courses; citation_author=F Garban, P Drillat, C Makowski, MC Jacob, MJ Richard, M Favrot; citation_volume=90; citation_publication_date=2005; citation_pages=1096-1101; citation_id=CR21
citation_journal_title=Blood; citation_title=Successful use of extracorporeal photochemotherapy in the treatment of severe acute and chronic graft-versus-host disease; citation_author=HT Greinix, B Volc-Platzer, W Rabitsch, B Gmeinhart, C Guevara-Pineda, P Kalhs; citation_volume=92; citation_publication_date=1998; citation_pages=3098-3104; citation_id=CR22
citation_journal_title=Blood Res; citation_title=Extracorporeal photopheresis for chronic graft-versus-host disease: a systematic review and meta-analysis; citation_author=MI Malik, M Litzow, W Hogan, M Patnaik, MH Murad, LJ Prokop; citation_volume=49; citation_publication_date=2014; citation_pages=100-106; citation_doi=10.5045/br.2014.49.2.100; citation_id=CR23
citation_journal_title=Bone Marrow Transplant; citation_title=Extracorporeal photopheresis for the treatment of steroid refractory acute GVHD; citation_author=P Perfetti, P Carlier, P Strada, F Gualandi, D Occhini, MT Lint; citation_volume=42; citation_publication_date=2008; citation_pages=609-617; citation_doi=10.1038/bmt.2008.221; citation_id=CR24
citation_journal_title=Br J Haematol; citation_title=Role of extracorporeal photochemotherapy in patients with refractory chronic graft-versus-host disease; citation_author=P Rubegni, A Cuccia, P Sbano, G Cevenini, MR Carcagni, G D’Ascenzo; citation_volume=130; citation_publication_date=2005; citation_pages=271-275; citation_doi=10.1111/j.1365-2141.2005.05586.x; citation_id=CR25
citation_journal_title=Biol Blood Marrow Transplant; citation_title=Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease; citation_author=EP Smith, I Sniecinski, AC Dagis, PM Parker, DS Snyder, AS Stein; citation_volume=4; citation_publication_date=1998; citation_pages=27-37; citation_doi=10.1016/S1083-8791(98)90007-6; citation_id=CR26
citation_journal_title=Transplant Proc; citation_title=Steroid-sparing effect of extracorporeal photopheresis in the therapy of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation; citation_author=M Ussowicz, J Musial, M Mielcarek, A Tomaszewska, B Nasilowska-Adamska, K Kalwak; citation_volume=45; citation_publication_date=2013; citation_pages=3375-3380; citation_doi=10.1016/j.transproceed.2013.07.053; citation_id=CR27
citation_journal_title=Haematologica; citation_title=Comparison of graft-versus-host disease-free, relapse-free survival according to a variety of graft sources: antithymocyte globulin and single cord blood provide favorable outcomes in some subgroups; citation_author=Y Inamoto, F Kimura, J Kanda, J Sugita, K Ikegame, H Nakasone; citation_volume=101; citation_publication_date=2016; citation_pages=1592-1602; citation_doi=10.3324/haematol.2016.149427; citation_id=CR28
citation_journal_title=Bone Marrow Transplant; citation_title=Risk factors and organ involvement of chronic GVHD in Japan; citation_author=J Kanda, H Nakasone, Y Atsuta, T Toubai, H Yokoyama, T Fukuda; citation_volume=49; citation_publication_date=2014; citation_pages=228-235; citation_doi=10.1038/bmt.2013.151; citation_id=CR29
citation_journal_title=Biol Blood Marrow Transplant; citation_title=National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report; citation_author=AH Filipovich, D Weisdorf, S Pavletic, G Socie, JR Wingard, SJ Lee; citation_volume=11; citation_publication_date=2005; citation_pages=945-956; citation_doi=10.1016/j.bbmt.2005.09.004; citation_id=CR30
citation_journal_title=Biol Blood Marrow Transplant; citation_title=The clinical benefit of response in chronic graft-versus-host disease; citation_author=Y Inamoto, PJ Martin, X Chai; citation_volume=18; citation_issue=10; citation_publication_date=2012; citation_pages=1517-1524; citation_doi=10.1016/j.bbmt.2012.05.016; citation_id=CR31
citation_journal_title=Blood; citation_title=Chronic graft-versus-host disease: biological insights from preclinical and clinical studies; citation_author=KPA MacDonald, GR Hill, BR Blazar; citation_volume=129; citation_issue=1; citation_publication_date=2017; citation_pages=13-21; citation_doi=10.1182/blood-2016-06-686618; citation_id=CR32