Quality of life associated with sirolimus for prevention of graft-versus-host disease: Results from a randomized trial

Haematologica

Volumn 99, Issue 3, 2014, Pages 548-553

  Jim, Heather S L ^a   Barata, Anna ^a,b   Small, Brent J ^c   Jacobsen, Paul B ^a   Pidala, Joseph ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUSULFAN; FLUDARABINE; MELPHALAN; METHOTREXATE; PENTOSTATIN; RAPAMYCIN; TACROLIMUS; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGED; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ARTICLE; CANCER THERAPY; CLINICAL EVALUATION; DEMOGRAPHY; FEMALE; FOLLOW UP; GRAFT VERSUS HOST REACTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PSYCHOLOGICAL WELL BEING; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; ADVERSE EFFECTS; ALLOTRANSPLANTATION; CLINICAL TRIAL; COMPLICATION; CONTROLLED STUDY; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; MIDDLE AGED; PHASE 2 CLINICAL TRIAL; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; FEMALE; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; QUALITY OF LIFE; SIROLIMUS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84895751788     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2013.088781     Document Type: Article

References (36)

1. Gratwohl A, Brand R, Apperley J, Biezen Av Av, Bandini G, Devergie A, et al. Graft-versus-host disease and outcome in HLA-identical sibling transplantations for chronic myeloid leukemia. Blood. 2002;100(12): 3877-86.
2. Arai S, Jagasia M, Storer B, Chai X, Pidala J, Cutler C, et al. Global and organ-specific chronic graft-versus-host disease severity according to the 2005 NIH Consensus Criteria. Blood. 2011;118(15):4242-9.
3. Levine JE, Logan B, Wu J, Alousi AM, Ho V, Bolanos-Meade J, et al. Graft-versus-host disease treatment: predictors of survival. Biol Blood Marrow Transplant. 2010;16(12): 1693-9.
4. Worel N, Biener D, Kalhs P, Mitterbauer M, Keil F, Schulenburg A, et al. Long-term outcome and quality of life of patients who are alive and in complete remission more than two years after allogeneic and syngeneic stem cell transplantation. Bone Marrow Transplant. 2002;30(9):619-26.
5. Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, et al. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006;108(8):2867-73.
6. Syrjala KL, Chapko MK, Vitaliano PP, Cummings C, Sullivan KM. Recovery after allogeneic marrow transplantation: prospective study of predictors of long-term physical and psychosocial functioning. Bone Marrow Transplant. 1993;11(4):319-27.
7. Lee SJ, Kim HT, Ho VT, Cutler C, Alyea EP, Soiffer RJ, et al. Quality of life associated with acute and chronic graft-versus-host disease. Bone Marrow Transplant. 2006;38(4): 305-10.
8. Kiss TL, Abdolell M, Jamal N, Minden MD, Lipton JH, Messner HA. Long-term medical outcomes and quality-of-life assessment of patients with chronic myeloid leukemia followed at least 10 years after allogeneic bone marrow transplantation. J Clin Oncol. 2002;20(9):2334-43.
9. Chiodi S, Spinelli S, Ravera G, Petti AR, Van Lint MT, Lamparelli T, et al. Quality of life in 244 recipients of allogeneic bone marrow transplantation. Br J Haematol. 2000;110(3): 614-9.
10. Pidala J, Anasetti C, Jim H. Quality of life after allogeneic hematopoietic cell transplantation. Blood. 2009;114(1):7-19.
11. Pidala J, Kurland B, Chai X, Majhail N, Weisdorf DJ, Pavletic S, et al. Patient-reported quality of life is associated with severity of chronic graft-versus-host disease as measured by NIH criteria: report on baseline data from the Chronic GVHD Consortium. Blood. 117(17):4651-7.
12. Antin JH, Kim HT, Cutler C, Ho VT, Lee SJ, Miklos DB, et al. Sirolimus, tacrolimus, and low-dose methotrexate for graft-versus-host disease prophylaxis in mismatched related donor or unrelated donor transplantation. Blood. 2003;102(5):1601-5.
13. Furlong T, Kiem HP, Appelbaum FR, Carpenter PA, Deeg HJ, Doney K, et al. Sirolimus in combination with cyclosporine or tacrolimus plus methotrexate for prevention of graft-versus-host disease following hematopoietic cell transplantation from unrelated donors. Biol Blood Marrow Transplant. 2008;14(5):531-7.
14. Cutler C, Kim HT, Hochberg E, Ho V, Alyea E, Lee SJ, et al. Sirolimus and tacrolimus without methotrexate as graft-versus-host disease prophylaxis after matched related donor peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2004;10(5):328-36.
15. Cutler C, Li S, Ho VT, Koreth J, Alyea E, Soiffer RJ, et al. Extended follow-up of methotrexate-free immunosuppression using sirolimus and tacrolimus in related and unrelated donor peripheral blood stem cell transplantation. Blood. 2007;109(7):3108-14.
16. Rosenbeck LL, Kiel PJ, Kalsekar I, Vargo C, Baute J, Sullivan CK, et al. Prophylaxis with sirolimus and tacrolimus +/-antithymocyte globulin reduces the risk of acute graft-versus-host disease without an overall survival benefit following allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2011;17(6):916-22.
17. Rodriguez R, Nakamura R, Palmer JM, Parker P, Shayani S, Nademanee A, et al. A phase II pilot study of tacrolimus/sirolimus GVHD prophylaxis for sibling donor hematopoietic stem cell transplantation using 3 conditioning regimens. Blood. 115(5):1098-105.
18. Pidala J, Kim J, Jim H, Kharfan-Dabaja MA, Nishihori T, Fernandez HF, et al. A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation. Haematologica. 2012;97(12):1882-9.
19. Cutler C, Logan BR, Nakamura R, Johnston L, Choi SW, Porter DL, et al. Tacrolimus/Sirolimus Vs. Tacrolimus/Methotrexate for Graft-Vs.-Host Disease Prophylaxis After HLA-Matched, Related Donor Hematopoietic Stem Cell Transplantation: Results of Blood and Marrow Transplant Clinical Trials Network Trial 0402. American Society of Hematology. Atlanta, GA, 2012.
20. Cutler C, Li S, Kim HT, Laglenne P, Szeto KC, Hoffmeister L, et al. Mucositis after allogeneic hematopoietic stem cell transplantation: a cohort study of methotrexate-and non-methotrexate-containing graft-versushost disease prophylaxis regimens. Biol Blood Marrow Transplant. 2005;11(5):383-8.
21. Cutler C, Stevenson K, Kim HT, Richardson P, Ho VT, Linden E, et al. Sirolimus is associated with veno-occlusive disease of the liver after myeloablative allogeneic stem cell transplantation. Blood. 2008;112(12):4425-31.
22. Cutler C, Henry NL, Magee C, Li S, Kim HT, Alyea E, et al. Sirolimus and thrombotic microangiopathy after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2005;11(7):551-7.
23. McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, et al. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997;19(4):357-68.
24. Kopp M, Schweigkofler H, Holzner B, Nachbaur D, Niederwieser D, Fleischhacker WW, et al. EORTC QLQ-C30 and FACTBMT for the measurement of quality of life in bone marrow transplant recipients: a comparison. Eur J Haematol. 2000;65(2):97-103.
25. Pidala J, Kurland B, Chai X, Majhail N, Weisdorf DJ, Pavletic S, et al. Patient-reported quality of life is associated with severity of chronic graft-versus-host disease as measured by NIH criteria: report on baseline data from the Chronic GVHD Consortium. Blood. 2011;117(17):4651-7.
26. Askew RL, Xing Y, Palmer JL, Cella D, Moye LA, Cormier JN. Evaluating minimal important differences for the FACT-Melanoma quality of life questionnaire. Value Health. 2009;12(8):1144-50.
27. Cella D, Nichol MB, Eton D, Nelson JB, Mulani P. Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy--Prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value Health. 2009;12(1):124-9.
28. Pidala J, Vogelsang G, Martin P, Chai X, Storer B, Pavletic S, et al. Overlap subtype of chronic graft-versus-host disease is associated with an adverse prognosis, functional impairment, and inferior patient-reported outcomes: a Chronic Graft-versus-Host Disease Consortium study. Haematologica. 2012;97(3):451-8.
29. Decaens T, Luciani A, Itti E, Hulin A, Roudot-Thoraval F, Laurent A, et al. Phase II study of sirolimus in treatment-naive patients with advanced hepatocellular carcinoma. Dig Liver Dis. 2012;44(7):610-6.
30. Venuta F, De Giacomo T, Rendina EA, Quattrucci S, Mercadante E, Cimino G, et al. Recovery of chronic renal impairment with sirolimus after lung transplantation. Ann Thorac Surg. 2004;78(6):1940-3.
31. Brattstrom C, Sawe J, Tyden G, Herlenius G, Claesson K, Zimmerman J, et al. Kinetics and dynamics of single oral doses of sirolimus in sixteen renal transplant recipients. Ther Drug Monit. 1997;19(4):397-406.
32. Wilson RW, Jacobsen PB, Fields KK. Pilot study of a home-based aerobic exercise program for sedentary cancer survivors treated with hematopoietic stem cell transplantation. Bone Marrow Transplant. 2005;35(7):721-7.
33. Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, et al. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011;46(9):1245-55.
34. Baumann FT, Kraut L, Schule K, Bloch W, Fauser AA. A controlled randomized study examining the effects of exercise therapy on patients undergoing haematopoietic stem cell transplantation. Bone Marrow Transplant. 2010;45(2):355-62.
35. Baumann FT, Zopf EM, Nykamp E, Kraut L, Schule K, Elter T, et al. Physical activity for patients undergoing an allogeneic hematopoietic stem cell transplantation: benefits of a moderate exercise intervention. Eur J Haematol. 2011;87(2):148-56.
36. DeFor TE, Burns LJ, Gold EM, Weisdorf DJ. A randomized trial of the effect of a walking regimen on the functional status of 100 adult allogeneic donor hematopoietic cell transplant patients. Biol Blood Marrow Transplant. 2007;13(8):948-55.