The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901

International Journal of Radiation Oncology Biology Physics

Volumn 67, Issue 3, 2007, Pages 643-650

  Ryu, Janice K ^a   Swann, Suzanne ^b   LeVeque, Francis ^c   Scarantino, Charles W ^d   Johnson, Darlene ^e   Chen, Allan ^a   Fortin, Andre ^f   Pollock, JonDavid ^g   Kim, Harold ^c   Ang, Kian K ^h  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b RADIATION THERAPY ONCOLOGY GROUP   (United States)

^c WAYNE STATE UNIVERSITY   (United States)

^d Rex Healthcare Breast Care Center   (United States)

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

^f NOTRE DAME HOSPITAL   (Canada)

^g WHEELING HOSPITAL   (United States)

^h UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

GM CSF; Head and neck cancer; Radiation mucositis

Indexed keywords

CHEMOTHERAPY; PATIENT TREATMENT; TOXICITY; TUMORS;

HEAD-AND-NECK CANCER; MUCOSAL REACTION; RADIATION MUCOSITIS;

RADIOTHERAPY;

GRANULOCYTE COLONY STIMULATING FACTOR; PLACEBO;

ADULT; AGED; ALLERGIC REACTION; ARTICLE; BLOOD TOXICITY; BONE MARROW TOXICITY; CANCER PATIENT; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; EYE DISEASE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HEAD AND NECK CARCINOMA; HEARING DISORDER; HEART ARRHYTHMIA; HUMAN; INFECTION; LIVER TOXICITY; LUNG DISEASE; LYMPHATIC SYSTEM; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MOUTH CAVITY; MUCOSA INFLAMMATION; MUSCULOSKELETAL DISEASE; NEPHROTOXICITY; NEUROTOXICITY; PAIN; PRIORITY JOURNAL; SKIN TOXICITY;

ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MIDDLE AGED; MOUTH MUCOSA; PROSPECTIVE STUDIES; RADIATION INJURIES; RADIATION-PROTECTIVE AGENTS; STOMATITIS;

EID: 33846849180     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2006.09.043     Document Type: Article

References (21)

1. Sonis S.T. Oral complications. In: Holland J.F., Bast Jr. R.C., Morton D.L., et al. (Eds). Cancer medicine (1997), Williams & Wilkins, Baltimore, MD 3255-3264
2. Nusrat A., Delp C., and Madar J.L. Intestinal epithelial restitution. J Clin Invest 89 (1992) 1501-1511
3. Woo S.B., Sonis S.T., Monopoli M.M., et al. A longitudinal study of oral ulcerative mucositis in BMT patients. Cancer 72 (1993) 1612-1617
4. Sonis S.T., Elting L., Keefe D., et al. Perspective on cancer therapy-induced mucosal injury: Pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 100 9 Suppl (2004) 1995-2025
5. LeVeque F.G., Parzuchowski J., Redding S., et al. Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy. J Clin Oncol 10 (1992) 1963-1968
6. Foote R.L., Loprinzi C.L., Frank A.R., et al. Randomized trial of a chlorhexadine mouthwash for alleviation of radiation-induced mucositis. J Clin Oncol 12 (1994) 2630-2633
7. Symonds R.P., McIilroy P., Khorrama J., et al. The reduction of radiation mucositis by selective decontamination antibiotic pastilles: A placebo-controlled double-blind trial. Br J Canc 74 (1996) 312-317
8. Schonwetter B.S., Stolzenberg E.D., and Zasloff M.A. Epithelial antibiotics induced at sites of inflammation. Science 267 (1995) 1645-1648
9. Pourreau-Schneider N., Soudry M., Franquin J.C., et al. Soft-laser therapy for iatrogenic mucositis in cancer patients receiving high-dose fluorouracil: A preliminary report. J Natl Canc Inst 84 (1992) 358-359
10. Dignass A.U., and Podolsky D.K. Cytokine modulation of intestinal epithelial cell restitution: Central role of transforming growth factor β. Gastroenterology 105 (1993) 1323-1332
11. Chi K.H., Chen S.Y., Chan V.K., et al. Effects of granulocyte macrophage colony stimulating factor (GM-CSF) on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leukovorin chemotherapy. J Clin Oncol 13 (1995) 2620-2628
12. Kannan V., Bapsy P.P., Anatha N., et al. Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. Int J Radiat Oncol Biol Phys 37 (1997) 1005-1010
13. Throuvalas N., Antonadou D., Pullizi M., et al. Evaluation of efficacy and safety of GM-CSF on the frequency and severity of radiation-induced mucositis. Eur J Cancer 41A (1997) 431 (Abstr)
14. Dunphy F., Kim H., Dunleavy T., et al. Granulocyte macrophage colony stimulating factor (GM-CSF) ameliorates radiation mucositis. Proc Am Soc Hematol 90 10, Suppl. 1 (1997) 184b Abstract
15. Sonis S.T., Epstein J., LeVeque F.G., et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation and chemotherapy. Cancer 85 (1999) 2103-2113
16. Lieschke G.J., and Burgess A.W. Granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor. First part. N Engl J Med 327 (1992) 28-35
17. Lieschke G.J., and Burgess A.W. Granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor. Second part. N Engl J Med 327 (1992) 99-106
18. Makkonen T.A., Minn H., Jekunen A., et al. Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: A prospective randomized study. Int J Radiat Oncol Biol Phys 46 (1997) 525-534
19. Sprinzl G.M., Galvan O., de Vries A., et al. Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis. Eur J Cancer 37 (2001) 2004-2009
20. Saarilahti K., Kajanti M., Joensuu T., et al. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: A double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys 54 (2002) 479-485
21. Mantovani G., Massa E., Astara G., et al. Phase II clinical trial of local use of GM-CSF for prevention and treatment of chemotherapy- and concomitant chemoradiotherapy-induced severe oral mucositis in advanced head and neck cancer patients: An evaluation of effectiveness, safety and costs. Oncol Reports 10 (2003) 197-206