Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study

Dazzi, Claudio; Cariello, Anna; Giovanis, Petros; M, Monti; Vertogen, Bernadette; Leoni, Maurizio; Tienghi, A.; Turci, D.; Rosti, G.; Nanni, Oriana; Rondoni, C.; Marangolo, M.

doi:10.1093/annonc/mdg177

Cited by 62 publications

(37 citation statements)

References 21 publications

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“…This conclusion was mainly based on the results of a robust RCT by Dazzi et al [54]. In the present update, an additional RCT by van der Lelie et al [55] has been included, which provided additional evidence that GM-CSF mouthwashes are not effective to prevent oral mucositis in the HSCT setting.…”

Section: Granulocyte Colony-stimulating Factormentioning

confidence: 96%

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

113

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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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Section: Granulocyte Colony-stimulating Factormentioning

confidence: 96%

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

113

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“…Grade 4 neutropenia occurred in 72 (70%) patients: 28 (74%) in the filgrastim arm, 19 (53%) the lenograstim arm and 25 (86%) in the molgramostim, respectively. Median duration to recovery of ANC40.5 Â 10 9 /l was 4 days (range, 1-18) in the filgrastim arm, 3 days (range, 1-15) in the lenograstim arm and 6 days (range, [3][4][5][6][7][8][9][10][11] in the molgramostim arm. The difference among the three treatment arms was statistically significant in favor of lenograstim for both parameters: frequency and duration of neutropenia (P ¼ 0.001 and 0.0005, respectively).…”

Section: Patientsmentioning

confidence: 99%

“…6 GM-CSF has been used in this context with satisfying results on PBPC harvesting and possible reduction of duration of thrombocytopenia and mucositis. [7][8][9][10] We conducted a prospective randomized study to compare the mobilizing efficacy of two forms of G-CSF, one non-glycosylated (filgrastim) and one glycosylated (lenograstim), and a non-glycosylated form of GM-CSF (molgramostim), following administration of a disease-specific chemotherapy. We evaluated number of CD34 þ cells, the subtypes CD34 þ /CD33À, CD34 þ / CD38À and CD34 þ /Thy1 þ harvested, and time to hemopoietic recovery of absolute neutrophil count (ANC)4500/ml and platelets 420 000/ml after mobilizing chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

A randomized study comparing filgrastim versus lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization

Kopf

Giorgi

Vertogen

et al. 2006

Bone Marrow Transplant

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We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/ etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or molgramostim at 5 lg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1-3) was performed. The median number of CD34 þ cells obtained after mobilization was 8.4 Â 10 6 /kg in the filgrastim arm versus 5.8 Â 10 6 /kg in the lenograstim arm versus 4.0 Â 10 6 /kg in the molgramostim arm (P ¼ 0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) (Po0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (Po0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34 þ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.

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“…No relevant statistical difference was observed reducing oral mucositis (12)(13)(14) . Granulokine® (Filgrastim G-CSF), a human granulocyte colony stimulating factor whose action over the bone marrow increases the production and mobilization of neutrophils, did not present a significant statistical difference reducing the mucositis seriousness (15)(16)(17)(18) . A study which compared the intensive oral hygiene regime (IOH) with limited oral hygiene (LOH) did not present significant statistical difference (19) .…”

Section: Resultsmentioning

confidence: 99%

Tratamento da mucosite em pacientes submetidos a transplante de medula óssea: uma revisão sistemática

Ferreira¹,

Gamba

Saconato

et al. 2011

Acta paul. enferm.

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Objective: To identify therapeutic measures to reduce the severity of oral mucositis in adult patients undergoing bone marrow transplantation (BMT). Methods: A systematic review using the following databases: LILACS, MEDLINE, CINAHL, EMBASE, CENTRAL (Cochrane Central) and DARE (Database of abstracts of reviews of effects), for the period between 1972 to July 2010, using the key words mucositis, stomatitis and bone marrow transplantation. Results: We identified 3,839 abstracts, 22 of which were included in the systematic review; these articles identified 14 topical and systemic interventions, among which eight showed statistical significance for the reduction of this complication. The topical therapies were: cryotherapy, chlorhexidine, glutamine, laser and Traumeel ®. The systemic therapies were: amifostine, Granulokine ®, and palifermin. Conclusion: The heterogeneity of the results of these interventions and the lack of better elucidation for healthcare practice indicate the need for more accurate research to identify the effectiveness of topical therapies for repair of mucosal cells.

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Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study

Abstract: We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied.

Cited by 62 publications

References 21 publications

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

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

A randomized study comparing filgrastim versus lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization

Tratamento da mucosite em pacientes submetidos a transplante de medula óssea: uma revisão sistemática

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