1. ¹Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
2. ²Divisione Universitaria di Ematologia, Azienda Ospedaliera San Giovanni Battista, Turin, Italy
3. ³Departments of Medicine and Pediatrics, University of Washington, Seattle, WA, USA
4. ⁴Bone Marrow Transplantation Unit, Federal University of Parana, Parana, Brazil

Correspondence: Dr MED Flowers, Clinical Research Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., D5-290, PO Box 19024, Seattle, WA, USA. E-mail: mflowers@fhcrc.org

Received 7 December 2004; Accepted 30 March 2005; Published online 20 June 2005.

Abstract

Low-dose methotrexate (MTX) is widely used in autoimmune diseases because of its anti-inflammatory activity. We report here the results of a retrospective study to review the outcomes of low-dose MTX used for treatment of refractory chronic graft-versus-host disease GVHD, with the goal of reducing the amount of prednisone needed to control the disease. In all, 14 patients with refractory chronic GVHD received MTX at a dose of 7.5 mg/m²/weekly for 3–50 weeks. Also, 11 patients had skin involvement, often with scleroderma or fasciitis. The median duration of chronic GVHD at the start of MTX was 38 (range 1–135) months. In this retrospective review, we found no grade 3–4 toxicities, and none of the patients needed blood transfusion or growth factors. In 10 patients (71%), GVHD could be adequately controlled with prednisone at doses below 1 mg/kg every other day without the addition of other agents. Four patients decreased the amount of concomitant immunosuppressive treatment, five continued with the same regimen, four required an increase in immunosuppressive treatment, and one decided to discontinue all treatment. From this preliminary analysis, MTX appears to be a well-tolerated, inexpensive and possibly steroid-sparing agent that is worthy of further evaluation in prospective trials for treatment of chronic GVHD.