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| Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors |
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| Author(s): Nash RA, Antin JH, Karanes C, Fay JW, Avalos BR, Yeager AM, Przepiorka D, Davies S, Petersen FB, Bartels P, Buell D, Fitzsimmons W, Anasetti C, Storb R, Ratanatharathorn V |
| Source: BLOOD Volume: 96 Issue: 6 Pages: 2062-2068 Published: SEP 15 2000 |
| Times Cited: 164 References: 57 |
| Abstract: After the transplantation of unmodified marrow from human leukocyte antigen-, matched unrelated donors receiving cyclosporine (CSP) and methotrexate (MTX), the incidence of acute graft-versus-host disease (GVHD) is greater than 75%, Tacrolimus is a macrolide compound that, in previous preclinical and clinical studies, was effective in combination with MTX for the prevention of acute GVHD, Between March 1995 and September 1996, 180 patients were randomized in a phase 3, open-label, multicenter study to determine whether tacrolimus combined with a short course of MTX (n = 90), more than CSP and a short course of MTX (n = 90), would reduce the incidence of acute GVHD after marrow transplantation from unrelated donors, There was a significant trend toward decreased severity of acute GVHD across all grades (P =.005), Based on the Kaplan-Meier estimate, the probability of grade II-IV acute GVHD in the tacrolimus group (56%) was significantly lower than in the CSP group (74%; P =.0002). Use of glucocorticoids for the management of GVHD was significantly lower with tacrolimus than with CSP (65% vs 81%, respectively; P =.019). The number of patients requiring dialysis in the first 100 days was similar (tacrolimus, 9; CSP, 8), Overall and relapse-free survival rates for the tacrolimus and CSP arms at 2 years was 54% versus 50% (P =.46) and 47% versus 42% (P =.58), respectively. The combination of tacrolimus and MTX after unrelated donor marrow transplantation significantly decreased the risk for acute GVHD than did the combination of CSP and MTX, with no significant increase in toxicity, infections, or leukemia relapse.(Blood. 2000;96:2062-2068) (C) 2000 by The American Society of Hematology. |
| Document Type: Article |
| Language: English |
| Reprint Address: Nash, RA (reprint author), Fred Hutchinson Canc Res Ctr, Div Clin Res, 1100 Fairview Ave N,D1-100,POB 19024, Seattle, WA 98109 USA |
Addresses:
1. Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
2. Univ Washington, Dept Med, Seattle, WA USA
3. Dana Farber Canc Inst, Boston, MA 02115 USA
4. Brigham & Womens Hosp, Boston, MA 02115 USA
5. Wayne State Univ, Detroit, MI USA
6. Baylor Univ, Sammons Canc Ctr, Dallas, TX USA
7. Ohio State Univ Hosp, Columbus, OH 43210 USA
8. Emory Clin, Atlanta, GA 30322 USA
9. Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA
10. Fairview Univ Hosp, Minneapolis, MN USA
11. Univ Utah, Sch Med, Salt Lake City, UT USA
12. Fujisawa Healthcare, Deerfield, IL USA
13. Univ Michigan, Ann Arbor, MI 48109 USA |
| Publisher: AMER SOC HEMATOLOGY, 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA |
| Subject Category: Hematology |
| IDS Number: 358VN |
| ISSN: 0006-4971 |
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