Keratinocyte growth factor is effective in the prevention of intestinal mucositis in patients with hematological malignancies treated with high-dose chemotherapy and autologous hematopoietic SCT: a video-capsule endoscopy study

Tsirigotis, Panagiotis; Triantafyllou, Konstantinos; Girkas, Konstantinos; Giannopoulou, Vassiliki; Ioannidou, Eleni; Chondropoulos, Spiros; Kalli, Theodora; Papaxoinis, George; Pappa, Vasiliki; Papageorgiou, Efstathios; Economopoulos, T.; Ladas, Spiros D.; Dervenoulas, John

doi:10.1038/bmt.2008.168

Cited by 33 publications

(12 citation statements)

References 25 publications

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“…Our recommendation is based on the findings of a well-designed randomized clinical trial (RCT) [26,27]. Evidence on the efficacy of palifermin in autologous HSCT without TBI conditioning is conflicting [28][29][30][31][32][33][34], and these rather small studies did not allow a guideline. In addition, no guideline could be provided for the use of palifermin in the setting of allogeneic HSCT with or without TBI [28,[35][36][37].…”

Section: Resultsmentioning

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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Section: Resultsmentioning

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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“…Recombinant human keratinocyte growth factor (KGF; palifermin) is a truncated recombinant protein with biological activity similar to the native molecule, a member of the fibroblast growth factor family with keratinocyte growth stimulatory properties (Rubin et al, 1989). The role of palifermin as a mucosal protectant in oncology has been evaluated in several clinical trials in the setting of haemopoietic stem cell transplant in patients at high risk of severe oral mucositis, with reduction in the severity of mucositis, use of analgesics and parenteral nutrition and hospital stay in patients receiving palifermin in combination with high dose conditioning therapy, predominantly involving the use of total body irradiation (Spielberger et al, 2004;Stiff et al, 2006;Tsirigotis et al, 2008;Johansson et al, 2009;Kobbe et al, 2010;Abidi et al, 2012;Goldberg et al, 2013). However, no study has been reported evaluating the role of palifermin as a mucosal protectant in the setting of intensive induction chemotherapy for AML.…”

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A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia

et al. 2014

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SummaryGastrointestinal toxicity, including oral mucositis, is a frequent complication of intensive combination chemotherapy for acute myeloid leukaemia (AML) and contributes substantially to treatment-related mortality. We conducted a placebo-controlled randomized trial to evaluate the efficacy of palifermin (keratinocyte growth factor), given at 60 lg/kg per daily IV for 3 d before and after chemotherapy, for mucosal protection in adult patients with previously untreated AML receiving induction therapy with idarubicin, high-dose cytarabine and etoposide. Among 155 randomized patients, there was no statistically significant difference in the rate of grade 3 and 4 oral mucositis (primary study endpoint) between the two treatment arms (three in palifermin arm (4%), 8 in placebo arm (10%; P = 0Á21); however, when considering the severity of oral mucositis (World Health Organization grade 0-4), there was evidence of reduced rates of higher grades of oral mucositis in the palifermin arm (P = 0Á0007, test for trend). There was a statistically significantly lower rate of grades 3 and 4 gastrointestinal adverse events in the palifermin arm (21% vs. 44% in placebo arm; P = 0Á003), mainly due to a reduction in severe diarrhoea (8% palifermin, 26% placebo; P = 0Á01). Palifermin has activity as a mucosal protectant in AML patients receiving intensive chemotherapy. This trial is registered at ACTRN012605000095662.

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“…Therefore, the development of recombinant biological stimulants for intestinal mucosal recovery offered some promise for the amelioration of oral and intestinal mucositis and, thus, for decreasing the risk for IFD (Langner et al, 2008). In patients receiving intensive chemotherapy or undergoing autologous HSCT, recombinant human keratinocyte growth factor (palifermin) has been shown to reduce the incidence and severity of oral mucositis and some of its clincical consequences (Spielberger et al, 2004;Tsirigotis et al, 2008).…”

Section: Mucosal Barriermentioning

confidence: 99%

Immunotherapy Against Invasive Fungal Diseases in Stem Cell Transplant Recipients

Lehrnbecher

Tramsen

Koehl

et al. 2011

Immunological Investigations

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Despite the availability of new antifungal compounds, morbidity and mortality of invasive fungal disease in allogeneic hematopoietic stem cell recipients are still unacceptably high. Over the past decade, one could witness an exciting improvement of the understanding of the molecular pathogenesis and of the complexity of host antifungal immune responses. This, in turn, provides critical information to augment host immunity against fungal pathogens. Strategies for enhancing the immune system include the administration of effector and regulatory cells (e.g., granulocytes, antigen-specific T cells, dendritic cells) as well as the administration of recombinant cytokines, interferons and growth factors (e.g., interferon-γ, keratinocyte growth factor, granulocyte- and granulocyte-macrophage colony stimulating factor). One has to recognize at the same time, however, that data of in vitro assays and animal models cannot necessarily be transferred into the clinical setting. In addition, meaningful clinical trials in allogeneic stem cell recipients suffering from invasive fungal disease require sufficiently large and homogenous cohorts of patients and can only be performed in international collaboration, but may ultimately improve the outcome of allogeneic transplant recipients with invasive fungal disease.

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Keratinocyte growth factor is effective in the prevention of intestinal mucositis in patients with hematological malignancies treated with high-dose chemotherapy and autologous hematopoietic SCT: a video-capsule endoscopy study

Cited by 33 publications

References 25 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 trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia

Immunotherapy Against Invasive Fungal Diseases in Stem Cell Transplant Recipients

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