A phase I trial: Dose escalation of melphalan in the "BEAM" regimen using amifostine cytoprotection

Biology of Blood and Marrow Transplantation

Volumn 17, Issue 7, 2011, Pages 1033-1042

  Phillips, Gordon L ^a   Bernstein, Steven H ^a   Liesveld, Jane L ^a   Abboud, Camille N ^a,b   Becker, Michael W ^a   Constine, Louis S ^a   Ifthikharuddin, J J ^a   Loughner, John E ^a   Milner, Laurie A ^a   Vesole, David H ^c   Friedberg, Jonathan W ^a  

^a STRONG MEMORIAL HOSPITAL   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c John Theurer Cancer Center at HUMC   (United States)

Author keywords

Amifostine; Autologous stem cell; Melphalan; Phase I; Regimen related toxicity

Indexed keywords

AMIFOSTINE; CARMUSTINE; CREATININE; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; ETOPOSIDE; GLUCONATE CALCIUM; MELPHALAN;

ADULT; AGED; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; BRONCHIOLITIS OBLITERANS; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER SURVIVAL; CELL PROTECTION; CLINICAL ARTICLE; CREATININE BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; FEMALE; FLUSHING; GASTROINTESTINAL TOXICITY; HEART ATRIUM FIBRILLATION; HODGKIN DISEASE; HUMAN; HYPOXIA; LIVER FUNCTION TEST; NAUSEA AND VOMITING; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PANCYTOPENIA; PHASE 1 CLINICAL TRIAL; SALVAGE THERAPY; SIDE EFFECT; SNEEZING; STOMATITIS;

ADULT; AGED; AMIFOSTINE; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ATRIAL FIBRILLATION; CARMUSTINE; COMBINED MODALITY THERAPY; CYTARABINE; CYTOPROTECTION; DOSE-RESPONSE RELATIONSHIP, DRUG; ETOPOSIDE; FEMALE; HUMANS; LYMPHOMA; MALE; MAXIMUM TOLERATED DOSE; MELPHALAN; MIDDLE AGED; MUCOSITIS; PANCYTOPENIA; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; POSTOPERATIVE COMPLICATIONS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, AUTOLOGOUS; YOUNG ADULT;

EID: 79958749844     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2010.11.003     Document Type: Article

References (56)

1. Philip T., Guglielmi C., Hagenbeek A., et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 1995, 333:1540-1545.
2. Linch D.C., Winfield D., Goldstone A.H., et al. Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin's disease: results of a BNLI randomized trial. Lancet 1993, 341:1051-1054.
3. Hahn T., Wolff S.N., Czuczman M., et al. The role of cytotoxic therapy with hematopoietic stem cell transplantation in the therapy of diffuse large cell B-cell non-Hodgkin's lymphoma: an evidence-based review. Biol Blood Marrow Transplant 2001, 7:308-331.
4. Brusamolino E., Bacigalupo A., Barosi G., et al. Classical Hodgkin's lymphoma in adults: guidelines of the Italian Society of Hematology, the Italian Society of Experimental Hematology, and the Italian Group for Bone Marrow Transplantation on initial work-up, management, and followup. Haematologica 2009, 94:550-565.
5. Moskowitz A.J., Moskowitz C.H. Controversies in the treatment of lymphoma with autologous transplantation. Oncologist 2009, 14:921-929.
6. Fernandez H.F., Escalón M.P., Pereira D., Lazarus H.M. Autotransplant conditioning regimens for aggressive lymphoma: are we on the right road?. Bone Marrow Transplant 2007, 40:505-513.
7. Sehn L.H., Donaldson J., Chhanabhai M., et al. Introduction of combined CHOP plus rituximab therapy dramatically improved outcome of diffuse large B-cell lymphoma in British Columbia. J Clin Oncol 2005, 23:5027-5033.
8. Engert A., Diehl V., Franklin J., et al. Escalated-dose BEACOPP in the treatment of patients with advanced-stage Hodgkin's lymphoma: 10 years of follow-up of the GHSG HD9 study. J Clin Oncol 2009, 27:4548-4554.
9. Gisselbrecht C., Glass B., Mounier N., et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol 2010, 28:4184-4190.
10. Fenske T.S., Hari P.N., Carreras J., et al. Impact of pre-transplant rituximab on survival after autologous hematopoietic stem cell transplantation for diffuse large B cell lymphoma. Biol Blood Marrow Transplant 2009, 15:1455-1464.
11. Liu H.W., Seftel M.D., Rubinger M., et al. Total body irradiation compared with BEAM: long-term outcomes of peripheral blood autologous stem cell transplantation for non-Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys 2010, 78:513-520.
12. Salar A., Serra J., Gandarillas M., et al. Autologous stem cell transplantation for clinically aggressive non-Hodgkin's lymphoma: the role of preparative regimens. Bone Marrow Transplant 2001, 27:405-412.
13. Ulrickson M., Aldridge J., Kim H.T., et al. Busulfan and cyclophosphamide (Bu/Cy) as a preparative regimen for autologous stem cell transplantation in patients with non-Hodgkin lymphoma: a single-institution experience. Biol Blood Marrow Transplant 2009, 15:1447-1454.
14. Mills W., Strang J., Goldstone A.H., Linch D.C. Dose intensification of etoposide in the BEAM ABMT protocol for malignant lymphoma. Leuk Lymphoma 1995, 17:263-270.
15. Zhang M.M., Gopal A.K. Radioimmunotherapy-based conditioning regimens for stem cell transplantation. Semin Hematol 2008, 45:118-125.
16. Bearman S.I., Appelbaum F.R., Buckner C.D., et al. Regimen-related toxicity in patients undergoing bone marrow transplantation. J Clin Oncol 1988, 6:1562-1568.
17. Bearman S.I., Appelbaum F.R., Back A., et al. Regimen-related toxicity and early posttransplant survival in patients undergoing marrow transplantation for lymphoma. J Clin Oncol 1989, 7:1288-1294.
18. Herzig G.P. Autologous marrow transplantation for cancer therapy. Prog Clin Biol Res 1984, 149:19-25.
19. Kovaris J.R., Louloulias V.E., Vlahos L.J. Amifostine: the first selective-target and broad-spectrum radioprotector. Oncologist 2007, 12:738-747.
20. Phillips G.L. The potential of amifostine in high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Semin Oncol 2002, 29(Suppl 19):53-56.
21. Phillips G.L., Meisenberg B., Reece D.E., et al. Amifostine and autologous hematopoietic stem cell support of escalating-dose melphalan: a phase I study. Biol Blood Marrow Transplant 2004, 10:473-483.
22. Samuels B.L., Bitran J.D. High-dose intravenous melphalan: a review. J Clin Oncol 1995, 13:1786-1799.
23. Phillips G.L., Meisenberg B.R., Reece D.E., et al. Activity of single-agent melphalan 220-300 mg/m2 with amifostine cytoprotection and autologous hematopoietic stem cell support in non-Hodgkin and Hodgkin lymphoma. Bone Marrow Transplant 2004, 33:781-787.
24. Caballero M.D., Rubio V., Rifon J., et al. BEAM chemotherapy followed by autologous stem cell support in lymphoma patients: analysis of efficacy, toxicity and prognostic factors. Bone Marrow Transplant 1997, 20:451-458.
25. Mills W., Chopra R., McMillan A., Pearce R., Linch D.C., Goldstone A.H. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol 1995, 13:588-595.
26. 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.
27. Phillips G.L., Abboud C.N., Bernstein S.H., et al. Phase I study for poor-prognosis lymphoma: augmentation of the " BEAM" regimen with escalating dose melphalan using amifostine cytoprotection and autologous hematopoietic stem cell transplantation-a preliminary report. Semin Oncol 2004, 31(Suppl 18):59-61.
28. Margolin K., Synold T., Longmate J., Doroshow J.H. Methodologic guidelines for the design of high-dose chemotherapy regimens. Biol Blood Marrow Transplant 2001, 7:414-432.
29. Phillips K.A., Tannock I.F. Design and interpretation of clinical trials that evaluate agents that may offer protection from the toxic effects of cancer chemotherapy. J Clin Oncol 1998, 16:3179-3190.
30. Sakiyama M., Kami M., Hori A., et al. Regimen-related toxicity following reduced-intensity stem-cell transplantation (RIST): comparison between Seattle criteria and National Cancer Center Common Toxicity Criteria (NCI-CTC) version 2.0. Bone Marrow Transplant 2004, 34:787-794.
31. Cheson B.D., Horning S.J., Coiffier B., et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999, 17:1244.
32. Harris N.L., Jaffe E.S., Diebold J. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol 1999, 17:3835-3849.
33. Manufacturer's (MedImmune Pharma BV) professional package insert, January 2009.
34. 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.
35. Capelli D., Santini G., De Souza C., et al. Amifostine can reduce mucosal damage after high-dose melphalan conditioning for peripheral blood progenitor cell autotransplant: a retrospective study. Br J Haematol 2000, 110. 300-207.
36. Hartmann J.T., von Vangerow A., Fels L.M., et al. A randomized trial of amifostine in patients with high-dose VIC chemotherapy plus autologous blood stem cell transplantation. Br J Cancer 2001, 84:313-320.
37. Jantunen E., Kuittinen T., Nousiainen T. A pilot study on feasibility and efficacy of amifostine preceding high-dose melphalan with autologous stem cell support in myeloma patients. Leuk Lymphoma 2002, 43:1961-1965.
38. Stocchi R., Damiani D., Masolini P., et al. Amifostine feasibility and efficacy in autologous stem cell transplantation for multiple myeloma. Haematologica 2004, 89:ELT02.
39. Sastry P., Bhagwat R., Biswas G., et al. Trial of amifostine in autologous stem cell transplant. Bone Marrow Transplant 2006, 37:117-118.
40. Gabriel D.A., Shea T.C., Serody J.S., et al. Cytoprotection by amifostine during autologous stem cell transplantation for advanced refractory hematologic malignancies. Biol Blood Marrow Transplant 2005, 11:1022-1030.
41. Jones R.B., Stockerl-Goldstein K.E., Klein J., et al. A randomized trial of amifostine and carmustine-containing chemotherapy to assess lung-protective effects. Biol Blood Marrow Transplant 2004, 10:276-282.
42. Ozkaynak M.F., Sahdev I., Gross T.G., et al. A pilot study of addition of amifostine to melphalan, carboplatin, etoposide, and cyclophosphamide with autologous hematopoietic stem cell transplantation in pediatric solid tumors-a Pediatric Blood and Marrow Transplant Consortium study. J Pediatr Hematol Oncol 2008, 30:204-209.
43. Stiff P.J., Emmanouilides C., Bensinger W.I., et al. Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. J Clin Oncol 2006, 24:186-193.
44. Johansson J.E., Hasséus B., Johansson P., Eklöf C., Ohman D., Stockelberg D. Gut protection by palifermin during autologous haematopoietic SCT. Bone Marrow Transplant 2009, 43:807-811.
45. Pandya C.M., Soubani A.O. Bronchiolitis obliterans following hematopoietic stem cell transplantation: a clinical update. Clin Transplant 2010, 24:291-306.
46. Paz H.L., Crilley P., Patchefsky A., Schiffman R.L., Brodsky I. Bronchiolitis obliterans after autologous bone marrow transplantation. Chest 1992, 101:775-778.
47. Twohig K.J., Matthay R.N. Pulmonary effects of cytotoxic agents other than bleomycin. Clin Chest Med 1990, 11:31-54.
48. Sica S., Chiusolo P., Salutari P. Autologous graft-versus-host disease. J Hematother Stem Cell Res 2000, 9:375-379.
49. Olivieri A., Corvatta L., Montanari M., et al. Paroxysmal atrial fibrillation after high-dose melphalan in five patients autotransplanted with blood progenitor cells. Bone Marrow Transplant 1998, 21:1049-1053.
50. Morandi P., Ruffini P.A., Benvenuto G.M., et al. Cardiac toxicity of high-dose chemotherapy. Bone Marrow Transplant 2005, 35:323-334.
51. Neumeister P., Jaeger G., Eibl M., Sormann S., Zinke W., Linkesch W. Amifostine in combination with erythropoietin and G-CSF promotes multilineage hematopoiesis in patients with myelodysplastic syndrome. Leuk Lymphoma 2001, 40:345-349.
52. Schanz J., Jung H., Wörmann B., et al. Amifostine has the potential to induce haematologic responses and decelerate disease progression in individual patients with low- and intermediate-1-risk myelodysplastic syndromes. Leuk Res 2009, 33:1183-1188.
53. Biswas T., Dhakal S., Chen R., et al. Involved field radiation after autologous stem cell transplant for diffuse large B-cell lymphoma in the rituximab era. Int J Radiat Oncol Biol Phys 2010, 77:79-85.
54. Tsirigotis P., Dray L., Resnick I.B., et al. Post-autologous stem cell transplantation administration of rituximab improves the outcome of patients with aggressive B cell non-Hodgkin's lymphoma. Ann Hematol 2010, 89:263-272.
55. Carella A., Cavaliere M., Lerma E., et al. Autografting followed by nonmyeloablative immunosuppressive chemotherapy and allogeneic peripheral-blood hematopoietic stem-cell transplantation as treatment of resistant Hodgkin's disease and non-Hodgkin's lymphoma. J Clin Oncol 2000, 18:3918-3924.
56. Derenzini E., Musuraca G., Fanti S., et al. Pretransplantation emission tomography scan is the main predictor of autologous stem cell transplantation outcome in aggressive B-cell non-Hodgkin lymphoma. Cancer 2008, 113:2496-2503.