Randomized, placebo-controlled, multicenter trial of granulocyte- macrophage colony-stimulating factor as infection prophylaxis in oncologic surgery

Journal of Clinical Oncology

Volumn 16, Issue 3, 1998, Pages 1167-1173

  Meropol, Neal J ^a   Wood, Douglas E ^a   Nemunaitis, John ^a   Petrelli, Nicholas J ^a   Lipman, Brian J ^a   Agosti, Jan M ^a   Whitmore, James B ^a  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR;

ADULT; AGED; ANTIBIOTIC PROPHYLAXIS; ARTICLE; CANCER PATIENT; CANCER SURGERY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; INFECTION PREVENTION; INFECTION RATE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SUBCUTANEOUS DRUG ADMINISTRATION; SURGICAL INFECTION; TREATMENT OUTCOME;

EID: 0031911498     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1998.16.3.1167     Document Type: Article

References (54)

1. Galandiuk S, Polk HC Jr, Jagelman DG, et al: Re-emphasis of priorities in surgical antibiotic prophylaxis. Surg Gynecol Obstet 169:219-222, 1989
2. Rotstein C, Ferguson R, Cummings KM, et al: Determinants of clean surgical wound infections for breast procedures at an oncology center. Infect Control Hosp Epidemiol 13:207-214, 1992
3. Busch E, Verazin G, Antkowiak JG, et al: Pulmonary complication in patients undergoing thoracotomy for lung carcinoma. Chest 105:760-766, 1994
4. Robbins KT, Favrot S, Hanna D, et al: Risk of wound infection in patients with head and neck cancer. Head Neck 12:143-148, 1990
5. Meguid MM, Debonis D, Meguid V, et al: Complications of abdominal operations for malignant disease. Am J Surg Oncol 156:341-345, 1988
6. Campbell LA, Ferguson R, Cummings KM, et al: Clean surgical wound infections at an oncology center. Infect Med 11:282-286, 1994
7. Lieschke GJ, Maher D, Cebon J, et al: Effects of bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor in patients with advanced malignancy. Ann Intern Med 110:357-364, 1989
8. Fleischmann J, Golde DW, Weisbart RH, et al: Granulocyte-macrophage colony-stimulating factor enhances phagocytosis of bacteria by human neutrophils. Blood 68:708-711, 1986
9. Verheof G, Boogaerts M: In vivo administration of granulocyte-macrophage colony-stimulating factor enhances neutrophil function in patients with myelodysplastic syndromes. Br J Hematol 79:177-184, 1991
10. Weisbart RH, Kwan L, Golde DW, et al: Human GM-CSF primes neutrophils for enhanced oxidative metabolism in response to the major physiological chemoattractants. Blood 69:18-21, 1987
11. Coleman DL, Chodakewitz JA, Bartiss AH, et al: Granulocyte-macrophage colony-stimulating factor enhances selective effector functions of tissue-derived macrophages. Blood 72:573-578, 1988
12. Grabstein KH, Rudal DL, Tushinski RJ, et al: Induction of macrophage tumoricidal activity by granulocyte-macrophage colony-stimulating factor. Science 232:506-508, 1986
13. Cannistra SA, Rambaldi A, Spriggs DR, et al: Human granulocyte-macrophage colony-stimulating factor induces expression of the tumor necrosis factor gene by the U937 cell line and by normal human monocytes. J Clin Invest 79:1720-1728, 1987
14. Fischer H-G, Frosch S, Reske K, et al: Granulocyte-macrophage colony-stimulating factor activates macrophages derived from bone marrow cultures to synthesis of MHC class II molecules and to augmented antigen presentation function. J Immunol 141:3882-3888, 1988
15. Arnaout MA, Wang EA, Clark SC, et al: Human recombinant granulocyte-macrophage colony-stimulating factor increases cell-to-cell adhesion and surface expression of adhesion-promoting surface glycoproteins on mature granulocytes. J Clin Invest 78:597-601, 1986
16. Lopez AF, Williamson J, Gamble JR, et al: Recombinant human granulocyte-macrophage colony-stimulating factor stimulates in vitro mature human neutrophil and eosinophil function, surface receptor expression, and survival. J Clin Invest 78:1220-1228, 1986
17. Caux C, Dezutter-Dambuyant C, Schmitt D: GM-CSF and TNF-α cooperate in the generation of dendritic Langerhans cells. Nature 360:258-261, 1992
18. Elliott MJ, Strasser A, Metcalf D: Selective up-regulation of macrophage function in granulocyte-macrophage colony-stimulating factor transgenic mice. J Immunol 147:2597, 1991
19. Markowitz S, Engleman E: Granulocyte-macrophage colony-stimulating factor promotes differentiation and survival of human peripheral blood dendritic cells in vitro. J Clin Invest 85:955-961, 1990
20. Sallusto F, Lanzavecchia A: Efficient presentation of soluble antigen by cultured human dendritic cells is maintained by granulocyte-macrophage colony-stimulating factor plus interleukin-4 and downregulated by tumor necrosis factor-α. J Exp Med 179:1109-1118, 1994
21. Tazi A, Bouchonnet F, Grandsaigne M: Evidence that granulocyte-macrophage colony-stimulating factor regulates the distribution and differentiated state of dendritic cells: Langerhans cells in human lung and lung cancers. J Clin Invest 91:566-576, 1993
22. Witmer-Pack MD, Olivier W, Valinsky J: Granulocyte-macrophage colony-stimulating factor is essential for the viability and function of cultured murine epidermal Langerhans cells. J Exp Med 166:1484-1498, 1987
23. Burgess AW, Begley CG, Johnson GR, et al: Purification and properties of bacterially synthesized human granulocyte-macrophage colony-stimulating factor. Blood 69:43-51, 1987
24. Tanaka T, Okamura S, Okada K, et al: Protective effect of recombinant murine granulocyte-macrophage colony-stimulating factor against Pseudomonas aeruginosa infection in leukocytopenic mice. Infect Immun 57:1792-1799, 1989
25. Bermudez LE, Martinelli JC, Gascon R, et al: Protection against gram-negative bacteremia in neutropenic mice with recombinant granulocyte-macrophage colony-stimulating factor. Cytokine 2:287-293, 1990
26. Mayer P, Schutze 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 Disease 163:584-590, 1991
27. Frenck RW, Sarman G, Harper TE, et al: The ability of recombinant murine granulocyte-macrophage colony-stimulating factor to protect neonatal rats from septic death due to Staphylococcus aureus. J Infect Dis 162:109-114, 1990
28. Bleiberg I, Riklis I, Fabian I: Enhanced resistance of bone marrow transplanted mice to bacterial infection induced by recombinant granulocyte-macrophage colony-stimulating factor. Blood 75:1262-1266, 1990
29. Morrissey PJ, Charrier K: GM-CSF administration augments the survival of ity-resistant A/J mice, but not ity-susceptible C57BL/6 mice, to a lethal challenge with Salmonella typhimurium. J Immunol 144:557-561, 1990
30. Gennari R, Alexander JW, Gianotti L, et al: Granulocyte-macrophage colony-stimulating factor improves survival in two models of gut-derived sepsis by improving gut barrier function and modulating bacterial clearance. Ann Surg 220:68-76, 1994
31. Molloy RG, Nestor M, Mannick J, et al: GM-CSF: A therapeutic role in the prevention of mortality after burn sepsis. FASEB J 5:1669, 1991 (abstr 7539)
32. Meropol NJ, Petrelli NJ, Lipman BJ, et al: Granulocyte-macrophage colony-stimulating factor as infection prophylaxis in high-risk oncologic surgery. Am J Surg 172:299-302, 1996
33. Antimicrobial prophylaxis in surgery. The Medical Letter 34:5-8, 1992
34. Camporesi EM, Greeley WJ, Lumb PD, et al: Anesthesia, in Sabiston DC (ed): Textbook of Surgery: The Biological Basis of Modern Surgical Practice. Philadelphia, PA, Saunders, 1991, p 156
35. Chow AW, Hall CB, Klein JO, et al: Evaluation of new anti-infective drugs for the treatment of respiratory tract infections. Clin Infect Dis 15:62-88, 1992
36. Brand B, Johnson JT, Myers EN, et al: Prophylactic perioperative antibiotics in contaminated head and neck surgery. Otolaryngol Head Neck Surg 90:315-318, 1982
37. Rubin RH, Shapiro ED, Andriole VT, et al: Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Clin Infect Dis 15:216-227, 1992
38. Fisher CJ, Slotman GJ, Opal SM, et al: Initial evaluation of human recombinant interleukin-1 receptor antagonist in the treatment of sepsis syndrome: A randomized, open-label, placebo-controlled multicenter trial. Crit Care Med 22:12-21, 1994
39. Franson TR, Zak O, Yen den Broek P: Evaluation of new anti-infective drugs for the treatment of vascular access device-associated bacteremia and fungemia. Clin Infect Dis 17:789-793, 1993
40. Solomkin JS, Hemsell DL, Sweet R, et al: Evaluation of new anti-infective drugs for the treatment of intraabdominal infections. Clin Infect Dis 15:33-42, 1992
41. Mantel N, Haenszel W: Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 22:719-748, 1959
42. Fleiss JL: Statistical Methods for Rates and Proportions, New York, NY, Wiley Interscience (ed 2). 1981, p 264
43. Cole RR, Robbins KT, Cohen JI, et al: A predictive model for wound sepsis in oncologic surgery of the head and neck. Otolaryngol Head Neck Surg 96:165-171, 1987
44. Ginsberg RJ, Hill LD, Eagan RT, et al: Modern thirty-day operative mortality for surgical resections in lung cancer. J Thorac Cardiovasc Surg 86:654-658, 1983
45. Nagasaki F, Flehinger BJ, Martini N, et al: Complications of surgery in the treatment of carcinoma of the lung. Chest 82:25-29, 1982
46. Barber GR, Brown AE: Surgical site infections in the cancer patient. Infect Med 11:20-26, 1994
47. Leape LL, Brennan TA, Laird N, et al: The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 324:377-384, 1991
48. Horan TC, Culver DH, Gaynes RP, et al: Nosocomial infections in surgical patients in the United States, January 1986-June 1992. Infect Control Hosp Epidemiol 14:73-80, 1993
49. Gadish M, Kletter Y, Flidel O, et al: Effects of recombinant human granulocyte and granulocyte-macrophage colony-stimulating factors on neutrophil function following autologous bone marrow transplantation. Leuk Res 15:1175-1182, 1991
50. Fabian I, Kletter Y, Bleiberg I, et al: Effect of exogenous recombinant human granulocyte and granulocyte-macrophage colony-stimulating factor on neutrophil function following allogeneic bone marrow transplantation. Exp Hematol 19:868-873, 1991
51. Wang M, Friedman H, Djeu JY: Enhancement of human monocyte function against Candida albicans by the colony-stimulating factors (CSF): IL-3, granulocyte-macrophage-CSF, and macrophage-CSF. J Immunol 143:671-677, 1989
52. Nemunaitis J, Rabinowe SN, Singer JW, et al: Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. N Engl J Med 324:1773-1778, 1991
53. Nemunaitis J, Rosenfeld CR, Ash R, et al: Phase III randomized, double-blind, placebo-controlled trial of recombinant human granulocyte-macrophage colony-stimulating factor following allogeneic bone marrow transplantation. Bone Marrow Transplant 15:666-673, 1995
54. 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 86:457-462, 1995