Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Recombinant Human Intestinal Trefoil Factor Oral Spray for Prevention of Oral Mucositis in Patients With Colorectal Cancer Who Are Receiving Fluorouracil-Based Chemotherapy

Peterson, Douglas E.; Barker, N.; Akhmadullina, L. I.; Rodionova, I.; Sherman, N Z; Давиденко, Ірина; Rakovskaya, Galina N.; Gotovkin, E.; Шинкарев, С. А.; Kopp, Mikhail V.; Kulikov, Eugeny P.; Moiseyenko, Vladimir; Gertner, Joseph M.; Firsov, Igor; Tuleneva, Tamara; Yarosh, A. O.; Woon, Chee-Wai

doi:10.1200/jco.2008.21.2381

Cited by 58 publications

(37 citation statements)

References 37 publications

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“…ATL-104 mouthwash reduced the duration of oral mucositis, whereas its effect on the incidence of mucositis was unclear [88]. Recombinant human intestinal trefoil factor oral spray was found to be safe and effective for the reduction of CT-induced oral mucositis in patients with colorectal cancers [89], but these limited data did not permit a guideline.…”

Section: Granulocyte Colony-stimulating Factormentioning

confidence: 99%

“…TFF peptides protect mucosal cells from injury as well as contribute to epithelial reconstitution and should be considered as promising anti-mucositis agents [89]. A preclinical study suggested that a mouth rinse with genetically modified bacteria engineered to secrete human TFF-1 may provide future management tools [94].…”

Section: Recommendations For Future Researchmentioning

confidence: 99%

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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: 99%

Section: Recommendations For Future Researchmentioning

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

113

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“…Evidence has shown that TFF3 can act on the epidermal growth factor receptor (EGFR), which then activates several downstream signaling pathways, including mitogen-activated protein kinases and the phosphatidylinositol 3-kinase (PI3K)/AKT pathway (Baus-Loncar and Giraud, 2005). TFF3 stimulated epithelial migration by phosphorylating EGFRs and then activating downstream pathways (Peterson et al, 2009). The previous studies of TFF3 have focused on its maintenance of mucosal integrity and the promotion of repair.…”

Section: Introductionmentioning

confidence: 99%

“…Evidence suggests that TFF3 serves as an initiator of mucosal healing to enable the acute restoration of cellular continuity, and TFF3-deficient mice showed an impaired capacity for mucosal recovery after colonic injury even after exposure to antineoplastic agents and total body radiation (Beck et al, 2004;Mashimo et al, 1996). Additionally, a recent clinical report showed that a recombinant human TFF3 (rhTFF3) oral spray formulation was safe and effective for the treatment of chemotherapyassociated oral mucositis in patients with colorectal cancer (Peterson et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

PI3K/Akt Signaling Pathway in the Basolateral Amygdala Mediates the Rapid Antidepressant-like Effects of Trefoil Factor 3

Shi

Zhu

Liu

et al. 2012

Neuropsychopharmacol

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“…TFF3 increases migration of oral epithelial cells [12]. TFF3 can serve as a potential tool for the prevention and healing of mucosal ulcerations [27,28]. Considering these results, TFF3 may enhance oral mucosal repair mechanisms and may have future therapeutic implications for the treatment of patients with oral ulcerations.…”

Section: Discussionmentioning

confidence: 99%

Brief communication (Original). Trefoil factor expression by immunohistochemistry in patients with oral lichen planus

et al. 2014

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Background: Oral lichen planus (OLP) is a chronic immune-mediated inflammatory disease that usually causes oral mucosal damage. OLP has been considered to be a potentially malignant disorder associated with an increased risk for oral cancer. Trefoil factors (TFFs) are mainly synthesized by mucin-producing epithelial cells. Expression of TFFs in oral epithelia is thought to be an essential factor in protection against oral mucosal damage. However, very little is known about the connection between tissue damage of oral mucosa in OLP patients and expression of TFFs. Objectives: To determine levels of TFF expression in oral mucosa from patients with OLP. Methods: Tissue samples were collected from 35 patients with normal oral mucosa (controls) and 35 patients with OLP. An immunohistochemical method was used to determine the expression of the 3 TFFs (TFF1, 2, and 3) in mucosal tissues of the oral cavity. Results: TFF2 and TFF3 expression in oral epithelia were significantly decreased in OLP patients (MannWhitney U test; P = 0.006, and P = 0.002, respectively). There were no significant differences in TFF1 expression between OLP patients and control subjects. Conclusion:The present study demonstrated reduced expression of TFF2 and TFF3 in oral epithelia of OLP patients. These outcomes support our previous observations that chronic inflammation may play a major role in downregulation of TFF expression, which may be associated with oral mucosal damage in OLP patients.

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Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Recombinant Human Intestinal Trefoil Factor Oral Spray for Prevention of Oral Mucositis in Patients With Colorectal Cancer Who Are Receiving Fluorouracil-Based Chemotherapy

Cited by 58 publications

References 37 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

PI3K/Akt Signaling Pathway in the Basolateral Amygdala Mediates the Rapid Antidepressant-like Effects of Trefoil Factor 3

Brief communication (Original). Trefoil factor expression by immunohistochemistry in patients with oral lichen planus

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