Imatinib Mesylate for the Treatment of Steroid-Refractory Sclerotic-Type Cutaneous Chronic Graft-versus-Host Disease
Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multiki...
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| Published in | Biology of blood and marrow transplantation Vol. 21; no. 6; pp. 1083 - 1090 |
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| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.06.2015
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1083-8791 1523-6536 1523-6536 |
| DOI | 10.1016/j.bbmt.2015.03.006 |
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| Abstract | Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multikinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open-label pilot phase II trial of imatinib in children and adults with corticosteroid-refractory ScGVHD. Twenty patients were enrolled in a 6-month trial. Eight received a standard dose (adult, 400 mg daily; children, 260 mg/m2 daily). Because of poor tolerability, 12 additional patients underwent a dose escalation regimen (adult, 100 mg daily initial dose up to 200 mg daily maximum; children, initial dose 65 mg/m2 daily up to 130 mg/m2 daily). Fourteen patients were assessable for primary response, improvement in joint ROM deficit, at 6 months. Primary outcome criteria for partial response was met in 5 of 14 (36%), stable disease in 7 of 14 (50%), and progressive disease in 2 of 14 (14%) patients. Eleven patients (79%), including 5 with partial response and 6 with stable disease, demonstrated a positive gain in ROM (range of 3% to 94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (interquartile range, 15.5% to 30.5%; P = .011). This trial is registered at http://clinicaltrials.gov as NCT007020689.
•We prospectively studied imatinib mesylate in steroid-refractory sclerotic-type chronic GVHD.•Primary endpoint was improvement in joint range-of-motion (ROM) at 6 months.•ROM improved in 11/14 evaluable patients (range 3 to 94% improvement).•Imatinib was poorly tolerated at the 400mg dose.•Imatinib serum levels were higher than expected at the 200mg dose. |
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| AbstractList | Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multikinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open-label pilot phase II trial of imatinib in children and adults with corticosteroid-refractory ScGVHD. Twenty patients were enrolled in a 6-month trial. Eight received a standard dose (adult, 400 mg daily; children, 260 mg/m2 daily). Because of poor tolerability, 12 additional patients underwent a dose escalation regimen (adult, 100 mg daily initial dose up to 200 mg daily maximum; children, initial dose 65 mg/m2 daily up to 130 mg/m2 daily). Fourteen patients were assessable for primary response, improvement in joint ROM deficit, at 6 months. Primary outcome criteria for partial response was met in 5 of 14 (36%), stable disease in 7 of 14 (50%), and progressive disease in 2 of 14 (14%) patients. Eleven patients (79%), including 5 with partial response and 6 with stable disease, demonstrated a positive gain in ROM (range of 3% to 94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (interquartile range, 15.5% to 30.5%; P = .011). This trial is registered at http://clinicaltrials.gov as NCT007020689.
•We prospectively studied imatinib mesylate in steroid-refractory sclerotic-type chronic GVHD.•Primary endpoint was improvement in joint range-of-motion (ROM) at 6 months.•ROM improved in 11/14 evaluable patients (range 3 to 94% improvement).•Imatinib was poorly tolerated at the 400mg dose.•Imatinib serum levels were higher than expected at the 200mg dose. Abstract Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multikinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open-label pilot phase II trial of imatinib in children and adults with corticosteroid-refractory ScGVHD. Twenty patients were enrolled in a 6-month trial. Eight received a standard dose (adult, 400 mg daily; children, 260 mg/m2 daily). Because of poor tolerability, 12 additional patients underwent a dose escalation regimen (adult, 100 mg daily initial dose up to 200 mg daily maximum; children, initial dose 65 mg/m2 daily up to 130 mg/m2 daily). Fourteen patients were assessable for primary response, improvement in joint ROM deficit, at 6 months. Primary outcome criteria for partial response was met in 5 of 14 (36%), stable disease in 7 of 14 (50%), and progressive disease in 2 of 14 (14%) patients. Eleven patients (79%), including 5 with partial response and 6 with stable disease, demonstrated a positive gain in ROM (range of 3% to 94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (interquartile range, 15.5% to 30.5%; P = .011). This trial is registered at http://clinicaltrials.gov as NCT007020689. Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multikinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open-label pilot phase II trial of imatinib in children and adults with corticosteroid-refractory ScGVHD. Twenty patients were enrolled in a 6-month trial. Eight received a standard dose (adult, 400 mg daily; children, 260 mg/m(2) daily). Because of poor tolerability, 12 additional patients underwent a dose escalation regimen (adult, 100 mg daily initial dose up to 200 mg daily maximum; children, initial dose 65 mg/m(2) daily up to 130 mg/m(2) daily). Fourteen patients were assessable for primary response, improvement in joint ROM deficit, at 6 months. Primary outcome criteria for partial response was met in 5 of 14 (36%), stable disease in 7 of 14 (50%), and progressive disease in 2 of 14 (14%) patients. Eleven patients (79%), including 5 with partial response and 6 with stable disease, demonstrated a positive gain in ROM (range of 3% to 94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (interquartile range, 15.5% to 30.5%; P = .011). This trial is registered at http://clinicaltrials.gov as NCT007020689. Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multikinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open-label pilot phase II trial of imatinib in children and adults with corticosteroid-refractory ScGVHD. Twenty patients were enrolled in a 6-month trial. Eight received a standard dose (adult, 400 mg daily; children, 260 mg/m(2) daily). Because of poor tolerability, 12 additional patients underwent a dose escalation regimen (adult, 100 mg daily initial dose up to 200 mg daily maximum; children, initial dose 65 mg/m(2) daily up to 130 mg/m(2) daily). Fourteen patients were assessable for primary response, improvement in joint ROM deficit, at 6 months. Primary outcome criteria for partial response was met in 5 of 14 (36%), stable disease in 7 of 14 (50%), and progressive disease in 2 of 14 (14%) patients. Eleven patients (79%), including 5 with partial response and 6 with stable disease, demonstrated a positive gain in ROM (range of 3% to 94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (interquartile range, 15.5% to 30.5%; P = .011). This trial is registered at http://clinicaltrials.gov as NCT007020689. Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of motion (ROM) restriction. No superior second-line therapy has been established for steroid-refractory disease. Imatinib mesylate is a multi-kinase inhibitor of several signaling pathways implicated in skin fibrosis with in vitro antifibrotic activity. We performed an open label pilot Phase 2 trial of imatinib in children and adults with corticosteroid refractory ScGVHD. Twenty patients were enrolled in a 6 month trial. Eight received a standard dose (adult: 400 mg daily; children: 260 mg/m2 daily). Due to poor tolerability, 12 additional patients underwent a dose escalation regimen (adult: 100 mg daily initial dose up to 200 mg daily maximum; children initial dose 65 mg/m2 daily up to 130 mg/m2 daily). Fourteen patients were evaluable for primary response, improvement in joint range of motion (ROM) deficit, at 6 months. Primary outcome criteria for partial response (PR) was met in 5/14 (36%), stable disease (SD) in 7/14 (50%), and progressive disease (PD) in 2/14 (14%) patients. Eleven (79%) patients, including 5 PR and 6 with SD, demonstrated a positive gain in ROM (range 3–94% improvement in deficit). Of 13 patients with measurable changes at 6 months, the average improvement in ROM deficit was 24.2% (IQR: 15.5% to 30.5%; p=0.011). This trial is registered at http://clinicaltrials.gov as NCT007020689. |
| Author | Baird, Kristin Yao, Lawrence Cowen, Edward W. Mitchell, Sandra A. Flanders, Kathleen C. Sarantopoulos, Stefanie Figg, William D. Takebe, Naoko Comis, Leora E. Hakim, Fran T. Rose, Jeremy J. Pavletic, Steven Z. Joe, Galen O. Booher, Susan Steinberg, Seth M. |
| AuthorAffiliation | 6 Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 11 Autoimmunity and Mucosal Immunology Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD 1 Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 7 Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD 4 Experimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 12 Dermatology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 3 Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, MD 10 Department of Medicine, Division of Hematologic Malignancy and Cell Therapy and Duke Cancer Institute, Duke University, Durham, NC 2 Rehabilitation Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD 9 Cancer Therapy Evaluation Prog |
| AuthorAffiliation_xml | – name: 2 Rehabilitation Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD – name: 12 Dermatology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 6 Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 1 Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 5 Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville MD – name: 8 Laboratory of Cancer Biology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 7 Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD – name: 4 Experimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 9 Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 3 Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, MD – name: 10 Department of Medicine, Division of Hematologic Malignancy and Cell Therapy and Duke Cancer Institute, Duke University, Durham, NC – name: 11 Autoimmunity and Mucosal Immunology Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25771402$$D View this record in MEDLINE/PubMed |
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| Keywords | Graft-versus-host disease Allogeneic hematopoietic stem cell transplantation Sclerosis Fasciitis Imatinib mesylate |
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| Snippet | Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint range of... Abstract Sclerotic skin manifestations of chronic graft-versus-host disease (ScGVHD) lead to significant morbidity, including functional disability from joint... |
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| SubjectTerms | Adolescent Adult Allogeneic hematopoietic stem cell transplantation Antineoplastic Agents - therapeutic use Child Drug Administration Schedule Fasciitis Fasciitis - immunology Fasciitis - pathology Fasciitis - therapy Female Graft vs Host Disease - immunology Graft vs Host Disease - pathology Graft vs Host Disease - therapy Graft-versus-host disease Hematology, Oncology and Palliative Medicine Hematopoietic Stem Cell Transplantation Humans Imatinib mesylate Imatinib Mesylate - therapeutic use Joints - drug effects Joints - immunology Joints - pathology Leukemia - immunology Leukemia - pathology Leukemia - therapy Male Middle Aged Mycophenolic Acid - analogs & derivatives Mycophenolic Acid - therapeutic use Pilot Projects Prednisone - therapeutic use Range of Motion, Articular - drug effects Recurrence Sclerosis Skin Diseases - immunology Skin Diseases - pathology Skin Diseases - therapy Tacrolimus - therapeutic use Transplantation, Homologous |
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| Title | Imatinib Mesylate for the Treatment of Steroid-Refractory Sclerotic-Type Cutaneous Chronic Graft-versus-Host Disease |
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