Defining mechanisms of action of interleukin-11 on the progression of radiation-induced oral mucositis in hamsters

Sonis, Stephen T.; Peterson, Ron L.; Edwards, Laura; Lucey, Charles; Wang, L; Mason, Leoanrd; Login, Gary R.; Ymamkawa, M; Moses, Geraldine; Bouchard, Page; Hayes, Lori; Bedrosian, Camille L.; Dorner, Andrew J.

doi:10.1016/s1368-8375(00)00012-9

Cited by 207 publications

(149 citation statements)

References 11 publications

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“…It was administered before the start of conditioning based on data from animal models. 14,15 The IL-11 is a clear, colorless solution with no infusional toxicities making it indistinguishable from placebo. All patients were treated in HEPA environments in reverse isolation using gut decontamination and acyclovir prophylaxis.…”

Section: Patients Materials and Methodsmentioning

confidence: 99%

“…It is intrinsically valuable to reduce mucositis for patient comfort; however, it may contribute to a reduction in GVHD directly by improving barrier function and reduce the risk of intestinal hemorrhage and infection by maintaining intestinal integrity. [14][15][16][17] To determine whether these effects would translate into improved outcome after human transplantation, we conducted a randomized, double-blind pilot study of rhIL-11 administered with standard cyclosporine/MTX prophylaxis after cytoxan/TBI conditioning for hematologic malignancies.…”

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confidence: 99%

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A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation

Antin

Lee

Neuberg

et al. 2002

Bone Marrow Transplant

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Summary:Interleukin-11 (IL-11) decreases cytokine release and increases survival in murine BMT models. In these systems, it reduces gut permeability, partially polarizes T cells to a Th2 phenotype, down-regulates IL-12, prevents mucositis, and accelerates recovery of oral and bowel mucosa. We conducted a randomized doubleblind pilot study of rhIL-11 administered with cyclosporine/MTX prophylaxis after cytoxan/TBI conditioning and allogeneic stem cell transplantation for hematologic malignancies. Patients received rhIL-11, 50 g/kg subcutaneously daily or placebo in a 3:1 ratio. Treatment was administered prior to the start of conditioning and continued up to 21 days. The study was designed to assess safety with stopping rules for cardiac arrhythmias and mortality. Although projected to accrue 20 patients, only 13 patients (10 IL-11, three placebo) were enrolled because the early stopping rule for mortality was triggered. Of 10 evaluable patients who received IL-11, four died by day 40 and one died on day 85. Deaths were attributable to transplant-related toxicity. One of three placebo recipients died of suicide, the other two are alive. Patients receiving IL-11 had severe fluid retention and early mortality, making it impossible to determine whether IL-11 given in this schedule can reduce the rate of GVHD. Grade B-D acute GVHD occurred in two of eight evaluable patients on IL-11 and one of three patients on placebo. The primary adverse events of the study were severe fluid retention resistant to diuresis (average weight gain 9 ± 4%) and multiorgan failure in five of 10 evaluable patients. The use of IL-11 as GVHD prophylaxis in allogeneic transplantation cannot be recommended as administered in this trial.

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Section: Patients Materials and Methodsmentioning

confidence: 99%

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confidence: 99%

A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation

Antin

Lee

Neuberg

et al. 2002

Bone Marrow Transplant

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“…In murine HSCT models, IL-11 reduces gut permeability, induces T helper-2 cell differentiation, and accelerates recovery of oral and bowel mucosa [16]. IL-11 also favorably modulated RT-induced oral mucositis in a hamster model by attenuating pro-inflammatory cytokine expression [17].…”

Section: Introductionmentioning

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

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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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“…Oral mucositis is a frequent stomatologic complication in patients under antineoplastic chemotherapy, especially in those with leukemias. Mucositis is a complex condition resulting from the interaction between antineoplastic agents and epithelial cells, the action of proinflammatory cytokines, oral microbiota, overlapping local trauma, unsatisfactory oral hygiene conditions, and the deficient immune status of the patient [8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Prevention of oral lesions in children with acute lymphoblastic leukemia

Pinto

Souza

Gordón-Núñez

et al. 2006

International Journal of Pediatric Otorhinolaryngology

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Summary Acute lymphoblastic leukemia (ALL) is the most common form of cancer in children and is responsible for severe stomatologic complications. Treatment consists of four phases of chemotherapy, the main side effect of methotrexate, the drug most used during the intensification phase, is oral mucositis. Objective: To evaluate the clinical aspects of the oral mucosa of children with ALL and to determine the effect of 0.12% chlorhexidine gluconate on the prevention of stomatologic complications in these patients. Patients and methods: Thirty-three children treated for ALL ranging in age from 2 to 15 years, without distinction of gender or race, were submitted to visual examination, digital palpation of the oral mucosa and cytologic examination of the buccal mucosa, and divided into two groups: group I consisted of 23 children using an oral solution of 0.12% chlorhexidine gluconate twice a day, and group II consisted of 10 children who did not receive this solution. All children received daily oral hygiene care guided by the dentist throughout treatment. Results: Mucositis was observed in six children of group I and eight of group II, and was characterized by erythema, edema and ulcers. Uniform cytologic findings were

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Defining mechanisms of action of interleukin-11 on the progression of radiation-induced oral mucositis in hamsters

Cited by 207 publications

References 11 publications

A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation

A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation

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

Prevention of oral lesions in children with acute lymphoblastic leukemia

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