A 3-day short course of palifermin before HDT reduces toxicity and need for supportive care after autologous blood stem-cell transplantation in patients with multiple myeloma

Annals of Oncology

Volumn 21, Issue 9, 2010, Pages 1898-1904

  Kobbe, G ^a   Bruns, I ^a   Schroeder, T ^a   Czibere, A ^a   Warnecke, J ^a   Hieronimus, N ^a   Safaian, N ^a   Kondakci, M ^a   Saure, C ^a   Germing, U ^a   Haas, R ^a   Fenk, R ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

High dose therapy; Multiple myeloma; Palifermin; Pegfilgrastin; Stem cell transplantation

Indexed keywords

ANTIBIOTIC AGENT; ANTIFUNGAL AGENT; DIPYRONE; GRANULOCYTE COLONY STIMULATING FACTOR; MELPHALAN; NARCOTIC ANALGESIC AGENT; PALIFERMIN; PARACETAMOL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ANALGESIA; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; CANCER PAIN; CONTROLLED STUDY; DRUG MEGADOSE; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; FEMALE; FEVER; GRAND MAL SEIZURE; HIGH RISK PATIENT; HUMAN; KIDNEY FAILURE; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE MYELOMA; PARENTERAL NUTRITION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SHORT COURSE THERAPY; SKIN MANIFESTATION; TASTE DISORDER;

EID: 77956130803     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq059     Document Type: Article

References (35)

1. Attal M, Harousseau JL, Stoppa AM et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med 1996; 335: 91-97.
2. Child JA, Morgan GJ, Davies FE et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 2003; 348: 1875-1883.
3. Bellm LA, Epstein JB, Rose-Ped A et al. Patient reports of complications of bone marrow transplantation. Support Care Cancer 2000; 8: 33-39.
4. Rapoport AP, Miller Watelet LF, Linder T et al. Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants. J Clin Oncol 1999; 17: 2446-2453.
5. Fenk R, Schneider P, Kropff M et al. High-dose idarubicin, cyclophosphamide and melphalan as conditioning for autologous stem cell transplantation increases treatment-related mortality in patients with multiple myeloma: results of a randomised study. Br J Haematol 2005; 130: 588-594.
6. Sonis ST, Oster G, Fuchs H et al. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol 2001; 19: 2201-2205.
7. Sonis ST, Elting LS, Keefe D et al. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 2004; 100: 1995-2025.
8. Spielberger R, Stiff P, Bensinger W et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 2004; 351: 2590-2598.
9. Grazziutti ML, Dong L, Miceli MH et al. Oral mucositis in myeloma patients undergoing melphalan-based autologous stem cell transplantation: incidence, risk factors and a severity predictive model. Bone Marrow Transplant 2006; 38: 501-506.
10. Blijlevens N, Schwenkglenks M, Bacon P et al. Prospective oral mucositis audit: oral mucositis in patients receiving high-dose melphalan or BEAM conditioning chemotherapy-European Blood and Marrow Transplantation Mucositis Advisory Group. J Clin Oncol 2008; 26: 1519-1525.
11. Blazar BR, Weisdorf DJ, DeFor T et al. Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood 2006; 108: 3216-3222.
12. Levine JE, Blazar BR, DeFor T et al. Long-term follow-up of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT). Biol Blood Marrow Transplant 2008; 14: 1017-1021.
13. Schmidt E, Thoennissen NH, Rudat A et al. Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Ann Oncol 2008; 19: 1644-1649.
14. Rosen LS, Abdi E, Davis ID et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracilbased chemotherapy. J Clin Oncol 2006; 24: 5194-5200.
15. Fenk R, Hieronimus N, Steidl U et al. Sustained G-CSF plasma levels following administration of pegfilgrastim fasten neutrophil reconstitution after high-dose chemotherapy and autologous blood stem cell transplantation in patients with multiple myeloma. Exp Hematol 2006; 34: 1296-1302.
16. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization 1979.
17. Gratwohl A, Baldomero H, Frauendorfer K et al. The EBMT activity survey 2006 on hematopoietic stem cell transplantation: focus on the use of cord blood products. Bone Marrow Transplant 2008; 41: 687-705.
18. San Miguel JF, Schlag R, Khuageva NK et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 2008; 359: 906-917.
19. Palumbo A, Bringhen S, Liberati AM et al. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood 2008; 112: 3107-3114.
20. Facon T, Mary JY, Hulin C et al. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet 2007; 370: 1209-1218.
21. Ruescher TJ, Sodeifi A, Scrivani SJ et al. The impact of mucositis on alphahemolytic streptococcal infection in patients undergoing autologous bone marrow transplantation for hematologic malignancies. Cancer 1998; 82: 2275-2281.
22. McCann S, Schwenkglenks M, Bacon P et al. The prospective oral mucositis audit: relationship of severe oralmucositis with clinical and medical resource use outcomes in patients receiving high-dose melphalan or BEAM-conditioning chemotherapy and autologous SCT. Bone Marrow Transplant 2009; 43(2): 141-147.
23. Lilleby K, Garcia P, Gooley T et al. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant 2006; 37: 1031-1035.
24. Aisa Y, Mori T, Kudo M et al. Oral cryotherapy for the prevention of high-dose melphalan-induced stomatitis in allogeneic hematopoietic stem cell transplant recipients. Support Care Cancer 2005; 13: 266-269.
25. Keefe DM, Schubert MM, Elting LS et al. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer 2007; 109: 820-831.
26. Bensinger W, Schubert M, Ang KK et al. NCCN Task Force Report. Prevention and management of mucositis in cancer care. J Natl Compr Canc Netw 2008; 6 (Suppl 1): S1-S21.
27. Blijlevens N, Sonis S. Palifermin (recombinant keratinocyte growth factor-1): a pleiotropic growth factor with multiple biological activities in preventing chemotherapy-and radiotherapy-induced mucositis. Ann Oncol 2007; 18: 817-826.
28. Spielberger R, Stiff P, Emanouilidis C et al. Efficacy of recombinant human keratinocyte growth factor in reducing mucositis in patients with hematologic malignancies undergoing autologous peripheral plod progenitor transplantation after radiation-based conditioning-results of a phase II study. Proc Am Soc Clin Oncol 2001; 30: 3 (Abstr 25).
29. Stokman MA, Sonis ST, Dijkstra PU et al. Assessment of oral mucositis in clinical trials: impact of training on evaluators in a multi-centre trial. Eur J Cancer 2005; 41: 1735-1738.
30. Meropol NJ, Somer RA, Gutheil J et al. Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. J Clin Oncol 2003; 21: 1452-1458.
31. Carlson K. Melphalan 200 mg/m2 with blood stem cell support as first-line myeloma therapy: impact of glomerular filtration rate on engraftment, transplantation-related toxicity and survival. Bone Marrow Transplant 2005; 35: 985-990.
32. Badros A, Barlogie B, Siegel E et al. Results of autologous stem cell transplant in multiple myeloma patients with renal failure. Br J Haematol 2001; 114: 822-829.
33. Raab MS, Breitkreutz I, Hundemer M et al. The outcome of autologous stem cell transplantation in patients with plasma cell disorders and dialysis-dependent renal failure. Haematologica 2006; 91: 1555-1558.
34. Bird JM, Fuge R, Sirohi B et al. The clinical outcome and toxicity of high-dose chemotherapy and autologous stem cell transplantation in patients with myeloma or amyloid and severe renal impairment: a British Society of Blood and Marrow Transplantation study. Br J Haematol 2006; 134: 385-390.
35. Gillespie B, Zia-Amirhosseini P, Salfi M et al. Effect of renal function on the pharmacokinetics of palifermin. J Clin Pharmacol 2006; 46: 1460-1468.