Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study

Makkonen, Tanja; Minn, Heikki; Jekunen, Antti; Vilja, Pekka; Tuominen, Juhani; Joensuu, Heikki

doi:10.1016/s0360-3016(99)00452-6

Cited by 75 publications

(42 citation statements)

References 33 publications

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“…Thirdly, GM-CSF was effective in reducing the severity of treatment-induced mucositis in all considered studies except that by Makkonen et al [25]. This is confirmed by the results of our investigation.…”

Section: Discussionsupporting

confidence: 90%

“…In a prospective randomised study, 40 head and neck cancer patients were randomly assigned to use either GM-CSF and sucralfate mouthwashes or sucralfate alone during radiotherapy. GM-CSF 150–300 µg s.c. was administered daily without a significant difference compared with the control group in the prevention of oral mucositis or oral pain [25]. …”

Section: Review Of the Literaturementioning

confidence: 99%

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Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen

Rossi

Rosati

Colarusso³

et al. 2003

Oncology

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Objective: To test the activity of subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF) administration in patients with colorectal cancer treated with adjuvant 5-fluorouracil (5-FU) plus leucovorin (LV) and suffering from mucositis. Methods: Thirty-one patients treated with adjuvant 5-FU 370 mg/m² and LV 100 mg/m² for 5 days every 4 weeks and reporting grade ≧2 mucositis participated in the study. Subcutaneous GM-CSF 4 µg/kg/day from days 6 to 10 was administered without chemotherapy dose reductions in the cycle that followed the cycle during which mucositis was reported. The disappearance of mucositis or a decrease by ≧1 grade was recorded as a therapeutic success. Baseline toxicity was: grade 2 stomatitis in 12 patients and grade 3 in 9; grade 4, 3 and 2 diarrhoea in 1, 4 and 8 patients, respectively. Results: Seventy-seven GM-CSF cycles were administered. A success was achieved in 20 (64.5%) patients. The efficacy was assessable in 5 (16.1%) patients with grade 2 and in 8 (25.8%) with grade 3 stomatitis, respectively, as well as in 1 (3.2%) and 5 (16.1%) patients with grade 3 and 2 diarrhoea, respectively. Success (3.2%) was reported in 2 patients suffering from both grade 2 stomatitis and diarrhoea. In 7 (22.5%) patients there was no evidence of efficacy. In 4 (12.9%) patients the treatment was stopped after the first administration of GM-CSF due to a grade 2 allergic reaction. Conclusions: The subcutaneous administration of GM-CSF relieved patients from symptoms of 5-FU/LV-induced mucositis with acceptable side effects permitting the maintenance of full-dose chemotherapy.

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Section: Discussionsupporting

confidence: 90%

Section: Review Of the Literaturementioning

confidence: 99%

Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen

Rossi

Rosati

Colarusso³

et al. 2003

Oncology

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“…One study found a benefit of this drug in H&N cancer patients treated with CT [62]. Whereas some studies found a benefit for preventative use of systemic GM-CSF in H&N cancer patients undergoing (C)RT [63][64][65][66], others did not confirm such effect [67,68]. In addition, two studies indicated a benefit for systemically administered GM-CSF to prevent mucositis in the adult HSCT setting [69,70], although in the latter study, oral mucositis was not a primary outcome.…”

Section: Granulocyte Colony-stimulating Factormentioning

confidence: 99%

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Raber-Durlacher

Bültzingslöwen²,

Logan

et al. 2012

Support Care Cancer

112

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Purpose The aim of this project was to review the literature and define clinical practice guidelines for the use of cytokines and growth factor agents for the prevention or treatment of oral mucositis induced by cancer chemotherapy or radiotherapy. Care Cancer (2013) 21:343-355 DOI 10.1007/s00520-012-1594 following three guideline determinations was possible: Recommendation, Suggestion, No guideline possible. Results Sixty-four clinical studies across 11 interventions were evaluated. A recommendation was made for the use of recombinant human KGF-1 (palifermin) at a dose of 60 μg/kg per day for 3 days prior to conditioning treatment and for 3 days post-transplant for prevention of oral mucositis in patients receiving high-dose chemotherapy and total body irradiation followed by autologous stem cell transplantation for hematological malignancies. A suggestion was made against using granulocyte macrophage colony-stimulating factor mouthwash for the prevention of oral mucositis in the setting of high-dose chemotherapy followed by autologous or allogeneic stem cell transplantation. No guideline was possible for any other cytokine or growth factor agents due to inconclusive evidence. Conclusions Of the cytokine and growth factor agents studied for oral mucositis, the evidence only supports use of palifermin in the specific population listed above. Additional welldesigned research is needed on other cytokine and growth factor interventions and in other cancer treatment settings. Methods

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“…difference in mucositis incidence historical controls Nemunaitis et al 170 yes/yes/yes P myeloablative CT ± GM-CSF sig. lower incidence of severe mucositis Gordon et al 169 no/yes/no P HD-CT±TBI±GM-CSF shorter duration of mucositis in TBI+GM-CSF vs. TBI alone RT Wagner et al 176 no/yes/no P RT + GM-CSF vs. significant lower severity of mucositis historical control Makkonen et al 177 yes/yes/no P sucralfate ± GM-CSF no difference Kannan et al 230 no/yes/no P RT+GM-CSF lower incidence of severe mucositis CT+RT Rosso et al…”

Section: Cryotherapymentioning

confidence: 99%

Oral Mucositis Complicating Chemotherapy and/or Radiotherapy: Options for Prevention and Treatment

Köstler

Hejna

Wenzel

et al. 2001

CA: A Cancer Journal for Clinicians

285

252

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The incidence and severity of oral mucositis is influenced by the type of antineoplastic treatment administered and by patient-related factors. Severe courses of oral mucositis are observed during simultaneous radiochemotherapy, which Oral Mucositis Complicating Chemotherapy and/or Radiotherapy: Options for Prevention and TreatmentWolfgang J. Köstler, MD; Michael Hejna, MD; Catharina Wenzel, MD; and Christoph C. Zielinski, MD 290 CA A Cancer Journal for Clinicians ABSTRACT Chemotherapy-and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients. This side effect causes significant morbidity and may delay the treatment plan, as well as increase therapeutic expenses.The pathogenesis of this debilitating side effect can be attributed to the direct mucosal toxicity of cytotoxic agents and ionizing radiation and to indirect mucosal damage caused by a concomitant inflammatory reaction exacerbated in the presence of neutropenia, and the emergence of bacterial, mycotic, and viral infections. affects virtually all patients with head and neck cancer who receive this therapeutic modality. 8 However, up to 40% of patients treated with conventional chemotherapy and the more than 70% of patients undergoing conditioning therapy for bone marrow transplantation also experience oral treatment-related complications. 9,10The pathogenesis of oral mucositis is not fully understood, yet it is thought to involve direct and indirect mechanisms. Direct mucosal injury by radiation and chemotherapy interfere with the average 5-to 14-day turnover time of the oral epithelium 11 and induce apoptosis. Indirect stomatotoxic effects that result from the release of inflammatory mediators, loss of protective salivary constituents, and therapyinduced neutropenia have been postulated to contribute to the development of oral mucositis and also promote the emergence of bacteria, fungi, and viruses on damaged mucosa.12 Although a linear relationship among the occurrence of oral mucositis, oral and systemic granulocyte counts, and a coincidence of resolution of mucositis with neutrophil recovery, has been demonstrated, 10,[13][14][15] significant mucositis can occur in the absence of myelotoxicity. 16,17 In addition, the prophylactic or therapeutic elimination of the pathogenic mucosal flora frequently observed in patients developing oral mucositis by various antiseptic and antimicrobial agents can at most alleviate the course of oral mucositis (see Antimicrobal Agents p. 302).Based upon these considerations, newer pathophysiologic concepts have emerged characterizing oral mucositis as having an initial inflammatory/vascular phase, an epithelial phase, a (pseudomembraneous) ulcerative/bacteriological phase and a healing phase.18 During the inflammatory phase, tissue injury induces release of free radicals, modified proteins and proinflammatory cytokines including interleukin-1β, prostaglandins and tumor necrosis factor-α (TNF-α) by epithelial, endothelial, and connective tissue cells. These ...

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Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study

Cited by 75 publications

References 33 publications

Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen

Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Oral Mucositis Complicating Chemotherapy and/or Radiotherapy: Options for Prevention and Treatment

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