Neutropenia and neoplasia: An overview of the pharmacoeconomics of sargramostim in cancer therapy

Clinical Therapeutics

Volumn 19, Issue 4, 1997, Pages 847-865

  Desch, Christopher E ^a   Ozer, Howard ^b  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DREXEL UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

Cost effectiveness; Neutropenia; Pharmacoeconomics; Sargramostim

Indexed keywords

RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR;

ACUTE GRANULOCYTIC LEUKEMIA; ARTICLE; AUTOLOGOUS BONE MARROW TRANSPLANTATION; COST BENEFIT ANALYSIS; HOSPITALIZATION; HUMAN; INFECTIOUS COMPLICATION; NEUTROPENIA; PHARMACOECONOMICS;

EID: 0030867434     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(97)80108-7     Document Type: Article

References (73)

1. American Society of Clinical Oncology. American Society of Clinical Oncology recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based, clinical practice guidelines. J Clin Oncol. 1994;12:2471-2508.
2. Yim JM, Matuszewski KA, Vermeulen LC, et al. Surveillance of colony-stimulating factor use in US academic health centers. Ann Pharmacother. 1995;29(5): 475-481.
3. Goa KL, Bryson HM. Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF): An appraisal of its pharmacoeconomic status in neutropenia associated with chemotherapy and autologous bone marrow transplant. PharmacoEconomics. 1994;5:56-77.
4. Grant SM, Heel RC. Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF): A review of its pharmacological properties and prospective role in the management of myelosuppression. Drugs. 1992;43(4):516-560.
5. Demetri GD, Antman KHS. Granulocyte-macrophage colony-stimulating factor (GM-CSF): Preclinical and clinical investigations. Semin Oncol. 1992;19(4): 362-385.
6. Gasson JC. Molecular physiology of granulocyte-macrophage colony-stimulating factor. Blood. 1991;77(6):1131-1145.
7. Rowe JM, Rubin A, Mazza JJ, et al. Incidence of infections in adult patients (>55 years) with acute myeloid leukemia treated with yeast-derived GM-CSF (sargramostim): Results of a double-blind prospective study by the Eastern Cooperative Oncology Group. In: Hiddemann W, et al, eds. Acute Leukemias V: Experimental Approaches and Management of Refractory Diseases. Berlin: Springer-Verlag; 1996:178-184.
8. Rowe JM, Andersen JW, Mazza JJ, et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (>55 to 70 years of age) with acute myelogenous leukemia: A study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86(2):457-462.
9. Büchner T, Hiddemann W, Koenigsmann M, et al. Recombinant human granulocyte-macrophage colony-stimulating factor after chemotherapy in patients with acute myeloid leukemia at higher age or after relapse. Blood. 1991;78:1190-1197.
10. Passos-Coelho JL, Braine HC, Davis JM, et al. Predictive factors for peripheral-blood progenitor-cell collections using a single large-volume leukapheresis after cyclophosphamide and granulocyte-macrophage colony-stimulating factor mobilization. J Clin Oncol. 1995;13: 705-714.
11. Kessinger A, Bierman P, Bishop M, et al. Effects of GM-CSF used for mobilization and after peripheral stem cell transplant (PSCT) for patients with previously treated low grade non-Hodgkin lymphoma. Blood. 1993;82(Suppl 1):633a. Abstract.
12. Kessinger A, Jackson J, Anderson J, et al. High dose therapy and autologous peripheral stem cell transplantation (PSCT) for low grade non-Hodgkin lymphoma (NHL): Effect of GM-CSF on the autograft. Blood. 1992;80(Suppl 1):332a. Abstract.
13. Bishop MR, Anderson JR, Jackson JD, et al. High-dose therapy and peripheral blood progenitor cell transplantation: Effects of recombinant human granulocyte-macrophage colony-stimulating factor on the autograft. Blood. 1994;83:610-616.
14. Nemunaitis J, Rabinowe SN, Singer JW, et al. Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. NEJM. 1991; 324:1773-1778.
15. Nemunaitis J, Anasetti C, Storb R, et al. Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors. Blood. 1992;79(10):2572-2577.
16. Nemunaitis J, Anasetti C, Buckner CD, et al. Long-term follow-up of 103 patients who received recombinant human granulocyte-macrophage colony-stimulating factor after unrelated donor bone marrow transplantation. Blood. 1993;81:865. Letter.
17. Nemunaitis J, Rosenfeld CS, Ash R, et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant. 1995;15: 949-954.
18. Anasetti C, Anderson G, Appelbaum FR, et al. Phase III study of rhGM-CSF in allogeneic marrow transplantation from unrelated donors. Blood. 1993;82(Suppl 1): 454a. Abstract.
19. Nemunaitis J, Singer JW, Buckner CD, et al. Use of recombinant human granulocyte-macrophage colony-stimulating factor in graft failure after bone marrow transplantation. Blood. 1990;76:245-253.
20. Jones S, Schottstaedt M, Duncan L, et al. A randomized prospective trial to evaluate the effects of rhu GM-CSF versus placebo in a high dose FAC adjuvant chemotherapy program for stage II and stage III breast cancer. Prog Proc Am Soc Clin Oncol. 1995;14:106. Abstract.
21. Collins C, Ellis G, Petersdorf S, et al. Effect of GM-CSF schedule on recovery of absolute neutrophil count (ANC) after high dose chemotherapy with cyclophosphamide (CTX), VP-16, and cisplatin (CDDP) (CEP) in women with ovarian and breast carcinoma. Prog Proc Am Soc Clin Oncol. 1992;11:127. Abstract.
22. Yau J, Neidhart JA, Triozzi P, et al. Randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating-factor support for dose-intensive cyclophosphamide, etoposide, and cisplatin. Am J Hematol. 1996;51:289-295.
23. Neidhart JA, Mangalik A, Stidley CA, et al. Dosing regimen of granulocyte-macrophage colony-stimulating factor to support dose-intensive chemotherapy. J Clin Oncol. 1992;10:1460-1469.
24. Jones SE, Schottstaedt MW, Duncan LA, et al. Randomized double-blind prospective trial to evaluate the effects of sargramostim versus placebo in a moderate-dose fluorouracil, doxorubicin, and cyclophosphamide adjuvant chemotherapy program for stage II and III breast cancer. J Clin Oncol. 1996;14:2976-2983.
25. Weber RJ. Pharmacoeconomic issues in the use of granulocyte-macrophage colony-stimulating factor for bone marrow transplantation or chemotherapy-induced neutropenia. Clin Ther. 1993;15(1): 180-191.
26. Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966;64:328-340.
27. Livingston RB. Dose intensity and high dose therapy: Two different concepts. Cancer. 1994;74:1177-1183.
28. Neidhart JA. Dose-intensive treatment of breast cancer supported by granulocyte-macrophage colony-stimulating factor (GM-CSF). Breast Cancer Res Treat. 1991;20:S15-S23.
29. Petros WP, Peters WP. Hematopoietic colony-stimulating factors and dose intensity. Semin Oncol. 1993;20(1):94-99.
30. Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984;2 (11):1281-1288.
31. Vadhan-Raj S, Broxmeyer HE, Hittelman WN, et al. Abrogating chemotherapy-induced myelosuppression by recombinant granulocyte-macrophage colony-stimulating factor in patients with sarcoma: Protection at the progenitor cell level. J Clin Oncol. 1992;10:1266-1277.
32. Miller JA, Beveridge RA. A comparison of efficacy of GM-CSF and G-CSF in the therapeutic setting of chemotherapy-induced neutropenia. Blood. 1994;84(Suppl 1):22a. Abstract.
33. Bunn PA, Crowley J, Hazuka M, et al. The role of GM-CSF in limited stage SCLC: A randomized phase III study of the Southwest Oncology Group (SWOG). Prog Proc Am Soc Clin Oncol. 1992;11: 292. Abstract.
34. Bodey GP. Infection in cancer patients: A continuing association. Am J Med. 1986; 81(Suppl 1A):11-26.
35. Esparza L, Yap HY, Smith T, et al. Quantitative relationship between degree of myelosuppression and infection in patients with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol. 1983;2:89. Abstract.
36. Young RC, Bennett JE, Geelhoed GW, Levine AS. Fungemia and compromised host resistance: A study of 70 cases. Ann Intern Med. 1974;80:605-612.
37. Bodey GP. Fungal infections complicating acute leukemia. J Chronic Dis. 1966; 19:667-687.
38. Torack RM. Infections associated with antibiotic and steroid therapy. Am J Med. 1957;22:872-882.
39. Horn R, Wong B, Kiehn TE, Armstrong D. Fungemia in a cancer hospital: Changing frequency, earlier onset, and results of therapy. Rev Infect Dis. 1985;7:646-655.
40. Pizzo PA, Robichaud KJ, Gill FA, et al. Empiric antibiotic and antifungal therapy for cancer patients with prolonged fever and granulocytopenia. Am J Med. 1982; 72:101-111.
41. Sable CA, Donowitz GR. Infections in bone marrow transplant recipients. Clin Infect Dis. 1994;18:273-284.
42. Mayer RJ, Davis RB, Schiffer CA, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia. NEJM. 1994;331:896-903.
43. Stone RM, Berg DT, George SL, et al. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. NEJM. 1995;332: 1671-1677.
44. Dillman RO, Davis RB, Green MR, et al. A comparative study of two different doses of cytarabine for acute myeloid leukemia: A phase III trial of Cancer and Leukemia Group B. Blood. 1991;78:2520-2526.
45. Estey EH, Keating MJ, McCredie KB, et al. Causes of initial remission induction failure in acute myelogenous leukemia. Blood. 1982;60:309-315.
46. Peters BG, Adkins DR, Harrison BR, et al. Antifungal effects of yeast-derived rhu-GM-CSF in patients receiving high-dose chemotherapy given with or without autologous stem cell transplantation: A retrospective analysis. Bone Marrow Transplant. 1996;18:93-102.
47. Lechner AJ, Lamprech KE, Potthoff LH, et al. Recombinant GM-CSF reduces lung injury and mortality during neutropenic Candida sepsis. Am J Physiol. 1994;266: L561-L568.
48. Mayer P, Schütze E, Lam C, et al. Recombinant murine granulocyte-macrophage colony-stimulating factor augments neutrophil recovery and enhances resistance to infections in myelosuppressed mice. J Infect Dis. 1991;163:584-590.
49. Roilides E, Holmes A, Blake C, et al. Antifungal activity of elutriated human monocytes against Aspergillus fumigatus hyphae: Enhancement by granulocyte-macrophage colony-stimulating factor and interferon-gamma. J Infect Dis. 1994;170: 894-899.
50. Kowanko IC, Ferrante A, Harvey DP, Carman KL. Granulocyte-macrophage colony-stimulating factor augments neutrophil killing of Torulopsis glabrata and stimulates neutrophil respiratory burst and degranulation. Clin Exp Immunol. 1991; 83:225-230.
51. Smith PD, Lamerson CL, Banks SM, et al. Granulocyte-macrophage colony-stimulating factor augments human monocyte fungicidal activity for Candida albicans. J Infect Dis. 1990;161:999-1005.
52. Godwin JE, Kopecky KJ, Head DR, et al. A double-blind placebo controlled trial of G-CSF in elderly patients with previously untreated acute myeloid leukemia. A Southwest Oncology Group Study. Blood. 1994;86(Suppl 1):434a. Abstract.
53. Nemunaitis J, Buckner CD, Dorsey KS,et al. Retrospective analysis of infectious disease in patients who received Leukine versus patients not receiving a cytokine who underwent autologous bone marrow transplant (ABMT) for treatment of lymphoid cancer. Blood. 1995;86(Suppl 1): 221a. Abstract.
54. Russell NH, Pacey S. Economic evaluation of peripheral blood stem cell transplantation for lymphoma. Lancet. 1992; 340:1290. Letter.
55. Smith TJ, Hillner BE, Yanovich S, et al. Economic analysis of peripheral blood progenitor cell (PBPC) or autologous bone marrow (ABM) transplant in relapsed Hodgkin disease (HD) and non-Hodgkin lymphoma (NHL). Prog Proc Am Soc Clin Oncol. 1995;14:314. Abstract.
56. Harousseau JL, Fiére D, Bezwoda WR, et al. GM-CSF instead of autologous stem cell transplantation after high dose melphalan (HDM) in multiple myeloma (MM). Blood. 1994;84(Suppl 1):181a. Abstract.
57. American Society of Clinical Oncology. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol. 1996;14:671-679.
58. Zittoun R, Suciu S, Mandelli F, et al. Granulocyte-macrophage colony-stimulating factor associated with induction treatment of acute myelogenous leukemia: A randomized trial by the European Organization for Research and Treatment of Cancer Leukemia Cooperative Group. J Clin Oncol. 1996;14(7):2150-2159.
59. Dombret H, Chastang C, Fenaux P, et al. A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia. NEJM. 1995; 332:1678-1683.
60. Witz F, Harousseau JL, Cahn JY, et al. GM-CSF during and after remission induction treatment for elderly patients with acute myeloid leukemia (AML). Blood. 1994;84(Suppl 1):231a. Abstract.
61. Heil G, Hoelzer D, Sanz MA, et al. Results of a randomised, double-blind placebo controlled phase III study of filgrastim in remission induction and early consolidation therapy for adults with denovo acute myeloid leukaemia. Blood. 1994;86(Suppl 1):267a. Abstract.
62. Ohno R, Tomonaga M, Kobayashi T, et al. Effect of granulocyte colony-stimulating factor after intensive induction therapy in relapsed or refractory acute leukemia. NEJM. 1990;323:871-877.
63. Luce BR, Singer JW, Weschler JM, et al. Recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. An economic analysis of a randomised, double-blind, placebo-controlled trial. PharmacoEconomics. 1994;6:42-48.
64. Bennett CL, Golub R, Waters T, et al. Economic analyses of phase III Cooperative Cancer Group clinical trials: Are they feasible? Cancer Invest. 1997. In press.
65. Gulati SC, Bennett CL. Granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy in relapsed Hodgkin disease. Ann Intern Med. 1992; 116(3):177-182.
66. Bootman JL, Townsend RJ, McGhan WF. Principles of Pharmacoeconomics. 2nd ed. Cincinnati, Ohio: Harvey Whitney Books; 1996.
67. Leese B, Collin R, Clark DJ. The costs of treating febrile neutropenia in patients with malignant blood disorders. PharmacoEconomics. 1994;6:233-239.
68. Glaspy JA, Bleecker G, Crawford J, et al. The impact of therapy with filgrastim (recombinant granulocyte colony-stimulating factor) on the health care costs associated with cancer chemotherapy. Eur J Cancer. 1993;29A(Suppl 7):S23-S30.
69. Montero MC, Valdivia ML, Carvajal E, et al. Economic study of neutropenia induced by myelotoxic chemotherapy. Pharm World Sci. 1994;16:187-192.
70. Welch HG, Larson EB. Cost-effectiveness of bone marrow transplantation in acute nonlymphocytic leukemia. NEJM. 1989; 321:807-812.
71. Lawless GD. Cost-effectiveness of autologous bone marrow transplantation. Am J Health-Syst Pharm. 1995;52(Suppl 4): S11-S14.
72. American Society of Clinical Oncology. Update of recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based clinical practice guidelines. J Clin Oncol. 1996;14(6):1957-1960.
73. Frampton JE, Faulds D. Filgrastim. A reappraisal of pharmacoeconomic considerations in the prophylaxis and treatment of chemotherapy-induced neutropenia. PharmacoEconomics. 1996;9(1):76-96.