A 3-day short course of palifermin before HDT reduces toxicity and need for supportive care after autologous blood stem-cell transplantation in patients with multiple myeloma

Kobbe, Guido; Bruns, Ingmar; Schroeder, Thomas; Czibere, Akos; Warnecke, J.; Hieronimus, Nadine; Safaian, Nancy; Kondakci, Mustafa; Saure, Christian; Germing, Ulrich; Haas, Rainer; Fenk, Roland

doi:10.1093/annonc/mdq059

Cited by 21 publications

(13 citation statements)

References 32 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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“…15 In a retrospective cohort study, severe OM was 24% after a 3-day course of palifermin preceding HDM, comparable with the result in the pre-HDM arm. 16 The third dose was given 2 days before HDM without increasing toxicity. In contrary to our study, palifermin prophylaxis reduced significantly days of hospitalization, use of parenteral nutrition and narcotics, and need for erythrocyte transfusions but OM data were not available for the historical control group.…”

Section: Discussionmentioning

confidence: 99%

In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient’s burden

Blijlevens

Chateau

Kriván

et al. 2012

Bone Marrow Transplant

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on behalf of the CLWP of the EBMT This randomized-controlled trial studied the efficacy of palifermin in a chemotherapy-only, high-dose Melphalan (HDM) transplant setting, to reduce oral mucositis (OM) and its sequelae measured by patient-reported outcomes (PRO) and medical resource use. Palifermin, relative to placebo was given either pre-/post-HDM or pre-HDM in patients with multiple myeloma (MM) undergoing auto-SCT at 39 European centers. Oral cavity assessment (WHO) and PRO questionnaires (oral mucositis daily questionnaire (OMDQ) and EQ 5D) were used in 281 patients (mean age 56, ± s.d. ¼ 8 years). 57 patients received placebo. One hundred and fifteen subjects were randomized to pre-/post-HDM receiving palifermin on 3 consecutive days before HDM and after auto-SCT and 109 patients were randomized to pre-HDM, receiving palifermin (60 mg/kg/day) i.v. for 3 consecutive days before HDM. There was no statistically significant difference in maximum OM severity. Severe OM occurred in 37% (placebo), 38% (pre-/post-HDM) and 24% (pre-HDM) of patients. No significant difference was observed with respect to PRO assessments or medical resource use, but more infections and fever during neutropenia were reported in pre-/post-HDM vs placebo (for example, 51 and 26%). To conclude, palifermin was unable to reduce OM or OM-related patient's burden in MM transplant patients.

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“…These epithelial barriers often recover quickly posttransplant but protective secretions such as IgA or lysozyme can be chronically subnormal in those with chronic GVHD [1]. Mucosal integrity early posttransplant can be improved by peritransplant administration of palifermin [76] or by phototherapy [77,78]. It is not known whether these strategies lead to decreased infections or GVHD.…”

Section: Innate Immunitymentioning

confidence: 99%

Immune reconstitution after hematopoietic cell transplantation

Bosch

Khan

Storek

2012

Current Opinion in Hematology

187

172

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A 3-day short course of palifermin before HDT reduces toxicity and need for supportive care after autologous blood stem-cell transplantation in patients with multiple myeloma

Abstract: In conclusion, a short 3-day course of palifermin may be able to reduce the toxicity of HDT and ASCT in patients with MM. Patients with impaired renal function at the time of HDT need additional strategies to further reduce the incidence of severe mucositis.

Cited by 21 publications

References 32 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

In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient’s burden

Immune reconstitution after hematopoietic cell transplantation

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