A prospective randomized toxicity study to compare reduced-intensity and myeloablative conditioning in patients with myeloid leukaemia undergoing allogeneic haematopoietic stem cell transplantation

Journal of Internal Medicine

Volumn 274, Issue 2, 2013, Pages 153-162

  Ringden O ^a   Erkers, T ^a   Aschan, J ^a   Garming Legert, K ^a   Le Blanc, K ^a   Hagglund H ^a   Omazic, B ^a   Svenberg, P ^a   Dahllof G ^a   Mattsson, J ^a   Ljungman, P ^a   Remberger, M ^a  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Acute myeloid leukaemia; Haematopoietic stem cell transplantation; Myeloablative conditioning; Randomized trial; Reduced intensity conditioning; Toxicity

Indexed keywords

BUSULFAN; CYCLOPHOSPHAMIDE; CYCLOSPORIN; FLUDARABINE; FOSCARNET; GANCICLOVIR; METHOTREXATE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY; VALGANCICLOVIR;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ARTICLE; CANCER MORTALITY; CANCER SURVIVAL; CHIMERA; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; CYTOGENETICS; CYTOMEGALOVIRUS INFECTION; ERYTHROCYTE TRANSFUSION; FEMALE; GRAFT VERSUS HOST REACTION; HEMORRHAGIC CYSTITIS; HUMAN; LEUKEMIA RELAPSE; MALE; MUCOSA INFLAMMATION; MYELOABLATIVE CONDITIONING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REDUCED INTENSITY CONDITIONING; THROMBOCYTE TRANSFUSION; TOTAL PARENTERAL NUTRITION;

ACUTE MYELOID LEUKAEMIA; HAEMATOPOIETIC STEM CELL TRANSPLANTATION; MYELOABLATIVE CONDITIONING; RANDOMIZED TRIAL; REDUCED-INTENSITY CONDITIONING; TOXICITY;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BUSULFAN; CYCLOPHOSPHAMIDE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; KAPLAN-MEIER ESTIMATE; LEUKEMIA, MYELOID, ACUTE; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; STATISTICS, NONPARAMETRIC; SURVIVAL ANALYSIS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME;

EID: 84880326355     PISSN: 09546820     EISSN: 13652796     Source Type: Journal    
DOI: 10.1111/joim.12056     Document Type: Article

References (28)

1. Niederwieser D, Maris M, Shizuru JA et al. Low-dose total body irradiation (TBI) and fludarabine followed by hematopoietic cell transplantation (HCT) from HLA-matched or mismatched unrelated donors and postgrafting immunosuppression with cyclosporine and mycophenolate mofetil (MMF) can induce durable complete chimerism and sustained remissions in patients with hematological diseases. Blood 2003; 101: 1620-9.
2. Slavin S, Nagler A, Naparstek E et al. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood 1998; 91: 756-63.
3. Aoudjhane M, Labopin M, Gorin NC et al. Comparative outcome of reduced intensity and myeloablative conditioning regimen in HLA identical sibling allogeneic haematopoietic stem cell transplantation for patients older than 50 years of age with acute myeloblastic leukaemia: a retrospective survey from the Acute Leukemia Working Party (ALWP) of the European group for Blood and Marrow Transplantation (EBMT). Leukemia 2005; 19: 2304-12.
4. Luger SM, Ringden O, Zhang MJ et al. Similar outcomes using myeloablative vs reduced-intensity allogeneic transplant preparative regimens for AML or MDS. Bone Marrow Transplant 2012; 47: 203-11.
5. Mohty M, Bay JO, Faucher C et al. Graft-versus-host disease following allogeneic transplantation from HLA-identical sibling with antithymocyte globulin-based reduced-intensity preparative regimen. Blood 2003; 102: 470-6.
6. Ringden O, Labopin M, Ehninger G et al. Reduced intensity conditioning compared with myeloablative conditioning using unrelated donor transplants in patients with acute myeloid leukemia. J Clin Oncol 2009; 27: 4570-7.
7. Martino R, Caballero MD, Perez-Simon JA et al. Evidence for a graft-versus-leukemia effect after allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning in acute myelogenous leukemia and myelodysplastic syndromes. Blood 2002; 100: 2243-5.
8. Tauro S, Craddock C, Peggs K et al. Allogeneic stem-cell transplantation using a reduced-intensity conditioning regimen has the capacity to produce durable remissions and long-term disease-free survival in patients with high-risk acute myeloid leukemia and myelodysplasia. J Clin Oncol 2005; 23: 9387-93.
9. Kolb HJ, Mittermuller J, Clemm C et al. Donor leukocyte transfusions for treatment of recurrent chronic myelogenous leukemia in marrow transplant patients. Blood 1990; 76: 2462-5.
10. Ringden O, Ruutu T, Remberger M et al. A randomized trial comparing busulfan with total body irradiation as conditioning in allogeneic marrow transplant recipients with leukemia: a report from the Nordic Bone Marrow Transplantation Group. Blood 1994; 83: 2723-30.
11. Schaffer M, Aldener-Cannava A, Remberger M, Ringden O, Olerup O. Roles of HLA-B, HLA-C and HLA-DPA1 incompatibilities in the outcome of unrelated stem-cell transplantation. Tissue Antigens 2003; 62: 243-50.
12. Ringden O, Remberger M, Persson U et al. Similar incidence of graft-versus-host disease using HLA-A, -B and -DR identical unrelated bone marrow donors as with HLA-identical siblings. Bone Marrow Transplant 1995; 15: 619-25.
13. Svahn BM, Remberger M, Myrback KE et al. Home care during the pancytopenic phase after allogeneic hematopoietic stem cell transplantation is advantageous compared with hospital care. Blood 2002; 100: 4317-24.
14. Suciu S, Mandelli F, de Witte T et al. Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): an intention-to-treat analysis of the EORTC/GIMEMAAML-10 trial. Blood 2003; 102: 1232-40.
15. WHO. WHO Handbook for Reporting Results of Cancer Treatment. Geneva: World Health Organization, 1979.
16. Hassan Z, Remberger M, Svenberg P et al. Hemorrhagic cystitis: a retrospective single-center survey. Clin Transplant 2007; 21: 659-67.
17. NCI. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Cancer Therapy Evaluation Program. March 31, 2003. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf). [accessed 14 March 2013].
18. Ringden O, Uzunel M, Sundberg B et al. Tissue repair using allogeneic mesenchymal stem cells for hemorrhagic cystitis, pneumomediastinum and perforated colon. Leukemia 2007; 21: 2271-6.
19. Mattsson J, Uzunel M, Tammik L, Aschan J, Ringden O. Leukemia lineage-specific chimerism analysis is a sensitive predictor of relapse in patients with acute myeloid leukemia and myelodysplastic syndrome after allogeneic stem cell transplantation. Leukemia 2001; 15: 1976-85.
20. Ringden O, Okas M, Uhlin M, Uzunel M, Remberger M, Mattsson J. Unrelated cord blood and mismatched unrelated volunteer donor transplants, two alternatives in patients who lack an HLA-identical donor. Bone Marrow Transplant 2008; 42: 643-8.
21. Dazzi F, Szydlo RM, Craddock C et al. Comparison of single-dose and escalating-dose regimens of donor lymphocyte infusion for relapse after allografting for chronic myeloid leukemia. Blood 2000; 95: 67-71.
22. Garming-Legert K. Conditioning associated effects on oral mucosa and salivary function in allogeneic hematopoietic stem cell recipients. Thesis, Karolinska Institutet, Stockholm, Sweden, 2011.
23. Paulin T, Ringden O, Lonnqvist B. Faster immunological recovery after bone marrow transplantation in patients without cytomegalovirus infection. Transplantation 1985; 39: 377-84.
24. Ferrara JL, Levy R, Chao NJ. Pathophysiologic mechanisms of acute graft-vs.-host disease. Biol Blood Marrow Transplant 1999; 5: 347-56.
25. Couriel DR, Saliba RM, Giralt S et al. Acute and chronic graft-versus-host disease after ablative and nonmyeloablative conditioning for allogeneic hematopoietic transplantation. Biol Blood Marrow Transplant 2004; 10: 178-85.
26. Clift RA, Buckner CD, Appelbaum FR et al. Allogeneic marrow transplantation in patients with chronic myeloid leukemia in the chronic phase: a randomized trial of two irradiation regimens. Blood 1991; 77: 1660-5.
27. Martino R, Iacobelli S, Brand R et al. Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood 2006; 108: 836-46.
28. Burnett AK, Wheatley K, Goldstone AH et al. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol 2002; 118: 385-400.