The Efficacy of Palifermin on Oral Mucositis and acute GVHD after Hematopoietic Stem Cell Transplantation in Hematologic Malignancy Patients: A Systematic Review and Meta-analysis study

Authors

  • Mehrdad Payandeh Department of Hematology and Medical Oncology, Kermanshah University of Medical Sciences, Kermanshah, Iran
  • Masoud Sadeghi Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; Students Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran http://orcid.org/0000-0002-3586-3012
  • Mazaher Ramezani Molecular Pathology Research Center, Emam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran
  • Hamid Reza Mozaffari Department of Oral and Maxillofacial Medicine, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran http://orcid.org/0000-0001-9351-1499

DOI:

https://doi.org/10.15419/bmrat.v4i10.373

Keywords:

Hematologic Malignancy, Oral Mucositis, Palifermin, Stem Cell Transplantation, Stem cell, Regenerative medicine

Abstract

Oral mucositis (OM) is one of the most common side effects after hematopoietic stem cell transplantation (HSCT) and palifermin is used for prophylactic use to prevent OM. We conducted a meta-analysis study that evaluates the efficacy of palifermin on OM after HSCT in hematologic malignancy patients. Databases of PubMed/Medline, Web of Science and Cochrane Library for English-language publications were searched for finding the relevant studies. The RevMan 5.3 software with random-effects models (odds ratio (ORs) and 95% confidence intervals (CIs)) was used for to estimate of the efficacy of palifermin in palifermin group compared with control group. Begg's and Egger's tests were used for assessment of bias between the studies. Ten studies were included in the meta-analysis study. The results of the meta-analyses showed that there were significant differences in OM (grade 1-4) [odds ratio (OR) = 0.17; 95%CI= 0.10,0.29; p <0.00001], OM (grade 2-4) [OR= 0.11; 95%CI= 0.05,0.24; p <0.00001], OM (grade 3-4) [OR= 0.22; 95%CI= 0.15,0.33; p <0.00001], after auto-HSCT for OM (grade 1-4) [OR= 0.13; 95%CI= 0.04, 0.35; p <0.0001], OM (grade 2-4) [OR= 0.03; 95%CI= 0.00, 0.21; p =0.0006] or OM (grade 3-4) [OR= 0.25; 95%CI= 0.13, 0.48; p <0.0001],  after allo-HSCT for OM (grade 1-4) [OR= 0.23; 95%CI= 0.11, 0.51; p =0.0002], OM (grade 2-4) [OR= 0.14; 95%CI= 0.03, 0.74; p =0.012] or OM (grade 3-4) [OR= 0.19; 95%CI= 0.08, 0.46; p =0.0002] and fever [OR=0.51; 95%CI=0.29, 0.87; p = 0.01], but there were no significant differences in acute graft versus host disease (aGVHD) grades, infection and blood stream infection between two groups. The meta-analysis showed that palifermin was associated with reductions in the incidence and severity of OM and also was effective and safe on OM after allo- or auto-HSCT, but did not seem to effect on the incidence and severity of aGVHD.

Author Biography

  • Hamid Reza Mozaffari, Department of Oral and Maxillofacial Medicine, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran
    mozaffari20@yahoo.com

References

<ol>
<li class="show">Blazar, B. R., Weisdorf, D. J., Defor, T., Goldman, A., Braun, T., Silver, S., &amp; Ferrara, J. L. (2006). Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood, 108(9), 3216–3222. <a href="https://doi.org/10.1182/blood-2006-04-017780">https://doi.org/10.1182/blood-2006-04-017780</a></li>
<li class="show">Blijlevens, N., Schwenkglenks, M., Bacon, P., D’Addio, A., Einsele, H., Maertens, J., . . . McCann, S. (2008). Prospective oral mucositis audit: Oral mucositis in patients receiving high-dose melphalan or BEAM conditioning chemotherapy—European Blood and Marrow Transplantation Mucositis Advisory Group. Journal of Clinical Oncology, 26(9), 1519–1525. <a href="https://doi.org/10.1200/JCO.2007.13.6028">https://doi.org/10.1200/JCO.2007.13.6028</a></li>
<li class="show">Cutler, C., Li, S., Kim, H. T., Laglenne, P., Szeto, K. C., Hoffmeister, L., . . . Antin, J. H. (2005). Mucositis after Allogeneic Hematopoeitic Stem Cell Transplantation: A Cohort Study of Methotrexate- and Non-Methotrexate-Containing Graft-versus-Host Disease Prophylaxis Regimens. Biology of Blood and Marrow Transplantation, 11(5), 383–388. <a href="https://doi.org/10.1016/j.bbmt.2005.02.006">https://doi.org/10.1016/j.bbmt.2005.02.006</a></li>
<li class="show">Czyzewski, K., Debski, R., Krenska, A., Wysocki, M., &amp; Styczynski, J. (2014). Palifermin in children undergoing autologous stem cell transplantation: A matched-pair analysis. Anticancer Research, 34, 7379–7382.</li>
<li class="show">Dazzi, C., Cariello, A., Giovanis, P., Monti, M., Vertogen, B., Leoni, M., . . .. (2003). 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, placebocontrolled study. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 14(4), 559–563. <a href="https://doi.org/10.1093/annonc/mdg177">https://doi.org/10.1093/annonc/mdg177</a></li>
<li class="show">Egger, M., Smith, G., Schneider, M., &amp; Minder, C. (1997). Bias in meta-analysis detected by a simple, graphical test. BMJ (Clinical Research Ed.), 315(7109), 629–634. <a href="https://doi.org/10.1136/bmj.315.7109.629">https://doi.org/10.1136/bmj.315.7109.629</a></li>
<li class="show">Epstein, J. B., Thariat, J., Bensadoun, R. J., Barasch, A., Murphy, B. A., Kolnick, L., . . . Maghami, E. (2012). Oral complications of cancer and cancer therapy: From cancer treatment to survivorship. Cancer J Clin, 62(6), 400–422. <a href="https://doi.org/10.3322/caac.21157">https://doi.org/10.3322/caac.21157</a></li>
<li class="show">Fenk, R., Schneider, P., Kropff, M., Huenerlituerkoglu, A. N., Steidl, U., Aul, C., . . . Kobbe, G. (2005). High-dose idarubicin, cyclophosphamide and melphalan as conditioning for autologous stem cell transplantation increases treatment-related mortality in patients with multiple myeloma: Results of a randomised study. British Journal of Haematology, 130(4), 588–594. <a href="https://doi.org/10.1111/j.1365-2141.2005.05641.x">https://doi.org/10.1111/j.1365-2141.2005.05641.x</a></li>
<li class="show">Filicko, J., Lazarus, H. M., &amp; Folmenberg, N. (2003). Mucosal injury in patients undergoing hematopoietic progenitor cell transplantation: New approaches to prophylaxis and treatment. Bone Marrow Transplantation, 31(1), 1–10. <a href="https://doi.org/10.1038/sj.bmt.1703776">https://doi.org/10.1038/sj.bmt.1703776</a></li>
<li class="show">Gil, L., Styczynski, G., &amp; Komarnicki, M. (2007). Infectious complication In 314 patients after high dose therapy and autologous hematopoietic stem cell transplantation: Risk factor analysis and outcome. Infection, 35(6), 421–427. <a href="https://doi.org/10.1007/s15010-007-6350-2">https://doi.org/10.1007/s15010-007-6350-2</a></li>
<li class="show">Grazziutti, M. L., Dong, L., Miceli, M. H., Krishna, S. G., Kiwan, E., Syed, N., . . . Anaissie, E. J. (2006). Oral mucositis in myeloma patients undergoing melphalan-based autologous stem cell transplantation: Incidence, risk factors and a severity predictive model. Bone Marrow Transplantation, 38(7), 501–506. <a href="https://doi.org/10.1038/sj.bmt.1705471">https://doi.org/10.1038/sj.bmt.1705471</a></li>
<li class="show">Hensley, M. L., Hagerty, K. L., Kewalramani, T., Green, D. M., Meropol, N. J., Wasserman, T. H., . . . Schuchter, L. M. (2008). American Society of Clinical Oncology 2008 Clinical Practice Guideline Update: Use of Chemotherapy and Radiation Therapy Protectants. Journal of Clinical Oncology, 27(1), 127–145. <a href="https://doi.org/10.1200/JCO.2008.17.2627">https://doi.org/10.1200/JCO.2008.17.2627</a></li>
<li class="show">Herbers, A. H., van der Velden, W. J., de Haan, A. F., Donnelly, J. P., &amp; Blijlevens, N. M. (2014). Impact of palifermin on intestinal mucositis of HSCT recipients after BEAM. Bone Marrow Transplantation, 49(1), 8–10. <a href="https://doi.org/10.1038/bmt.2013.118">https://doi.org/10.1038/bmt.2013.118</a></li>
<li class="show">Hołowiecki, J. (2008). Indications for hematopoietic stem cell transplantation. Polskie Archiwum Medycyny Wewnetrznej, 118, 658–663.</li>
<li class="show">Horsley, P., Bauer, J. D., Mazkowiack, R., Gardner, R., &amp; Bashford, J. (2007). Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation. Supportive Care in Cancer, 15(1), 105–109. <a href="https://doi.org/10.1007/s00520-006-0105-y">https://doi.org/10.1007/s00520-006-0105-y</a></li>
<li class="show">Jilani, S., Kanaan, Z., Agarwal, R., Tageja, N., &amp; Abidi, M. H. (2014). Palifermin for Prevention of Oral Mucositis in Hematological Malignancies: Present Position and Future Perspectives. Austin J Cancer Clin Res, 1, 1010.</li>
<li class="show">Krijanovski, O. I., Hill, G. R., Cooke, K. R., Teshima, T., Crawford, J. M., Brinson, Y. S., &amp; Ferrara, J. L. (1999). Keratinocyte growth factor separates graft-versus-leukemia effects from graft-versus-host disease. Blood, 94, 825–831.</li>
<li class="show">Kobbe, G., Bruns, I., Schroeder, T., Czibere, A., Warnecke, J., Hieronimus, N., . . . Fenk, R. (2010). 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. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 21(9), 1898–1904. <a href="https://doi.org/10.1093/annonc/mdq059">https://doi.org/10.1093/annonc/mdq059</a></li>
<li class="show">Kolb, H. J. (2017). Hematopoietic stem cell transplantation and cellular therapy. HLA, 89(5), 267–277. <a href="https://doi.org/10.1111/tan.13005">https://doi.org/10.1111/tan.13005</a></li>
<li class="show">Kolbe, K., Domkin, D., Derigs, H. G., Bhakdi, S., Huber, C., &amp; Aulitzky, W. E. (1997). Infectious complications during neutropenia subsequent to peripheral blood stem cell transplantation. Bone Marrow Transplantation, 19(2), 143–147. <a href="https://doi.org/10.1038/sj.bmt.1700621">https://doi.org/10.1038/sj.bmt.1700621</a></li>
<li class="show">Langner, S., Staber, P., Schub, N., Gramatzki, M., Grothe, W., Behre, G., . . . Neumeister, P. (2008). Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplantation, 42(4), 275–279. <a href="https://doi.org/10.1038/bmt.2008.157">https://doi.org/10.1038/bmt.2008.157</a></li>
<li class="show">Lauritano, D., Petruzzi, M., Di Stasio, D., &amp; Lucchese, A. (2014). Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: A case-control study. International Journal of Oral Science, 6(1), 27–30. <a href="https://doi.org/10.1038/ijos.2013.93">https://doi.org/10.1038/ijos.2013.93</a></li>
<li class="show">Lucchese, A., Matarese, G., Ghislanzoni, L. H., Gastaldi, G., Manuelli, M., &amp; Gherlone, E. (2016). Efficacy and effects of palifermin for the treatment of oral mucositis in patients affected by acute lymphoblastic leukemia. Leukemia &amp; Lymphoma, 57(4), 820–827. <a href="https://doi.org/10.3109/10428194.2015.1081192">https://doi.org/10.3109/10428194.2015.1081192</a></li>
<li class="show">Mossad, S. B., Longworth, D. L., Goormastic, M., Serkey, J. M., Keys, T. F., &amp; Bolwell, B. J. (1996). Early infectious complications in autologous bone marrow transplantation: A review of 219 patients. Bone Marrow Transplantation, 18, 265–271.</li>
<li class="show">Nasilowska-Adamska, B., Rzepecki, P., Manko, J., Czyz, A., Markiewicz, M., Federowicz, I., . . . Marianska, B. (2007). The influence of palifermin (Kepivance) on oral mucositis and acute graft versus host disease in patients with hematological diseases undergoing hematopoietic stem cell transplant. Bone Marrow Transplantation, 40(10), 983–988. <a href="https://doi.org/10.1038/sj.bmt.1705846">https://doi.org/10.1038/sj.bmt.1705846</a></li>
<li class="show">Nasilowska-Adamska, B., Szydlo, R., Rzepecki, P., Czyz, A., Tomaszewska, A., Markiewicz, M., . . . Jedrzejczak, W. W. (2011). Palifermin does not influence the incidence and severity of GvHD nor long-term survival of patients with hematological diseases undergoing HSCT. Annals of Transplantation, 16(4), 47–54. <a href="https://doi.org/10.12659/AOT.882218">https://doi.org/10.12659/AOT.882218</a></li>
<li class="show">Nguyen, D. T., Shayani, S., Palmer, J., Dagis, A., Forman, S. J., Epstein, J., &amp; Spielberger, R. (2015). Palifermin for prevention of oral mucositis in allogeneic hematopoietic stem cell transplantation: A single-institution retrospective evaluation. Supportive Care in Cancer, 23(11), 3141–3147. <a href="https://doi.org/10.1007/s00520-015-2688-7">https://doi.org/10.1007/s00520-015-2688-7</a></li>
<li class="show">Panoskaltsis-Mortari, A., Lacey, D. L., Vallera, D. A., &amp; Blazar, B. R. (1998). Keratinocyte growth factor administered before conditioning ameliorates graft-versus-host disease after allogeneic bone marrow transplantation in mice. Blood, 92, 3960–3967.</li>
<li class="show">Radtke, M. L., &amp; Kolesar, J. M. (2005). Palifermin (Kepivance) for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support. Journal of Oncology Pharmacy Practice, 11(3), 121–125. <a href="https://doi.org/10.1191/1078155205jp159oa">https://doi.org/10.1191/1078155205jp159oa</a></li>
<li class="show">Schmidt, E., Thoennissen, N. H., Rudat, A., Bieker, R., Schliemann, C., Mesters, R. M., . . . Berdel, W. E. (2008). Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 19(9), 1644–1649. <a href="https://doi.org/10.1093/annonc/mdn179">https://doi.org/10.1093/annonc/mdn179</a></li>
<li class="show">Spielberger, R., Stiff, P., Bensinger, W., Gentile, T., Weisdorf, D., Kewalramani, T., . . . Emmanouilides, C. (2004). Palifermin for oral mucositis after intensive therapy for hematologic cancers. The New England Journal of Medicine, 351(25), 2590–2598. <a href="https://doi.org/10.1056/NEJMoa040125">https://doi.org/10.1056/NEJMoa040125</a></li>
<li class="show">Sonis, S., &amp; Clark, J. (1991). Prevention and management of oral mucositis induced by antineoplastic therapy. Oncology (Williston Park, N.Y.), 5, 11–18.</li>
<li class="show">Sonis, S. T., Elting, L. S., Keefe, D., Peterson, D. E., Schubert, M., Hauer-Jensen, M., . . . Rubenstein, E. B. (2004). Perspectives on cancer therapy-induced mucosal injury: Pathogenesis, measurement, epidemiology, and consequences for patients. Cancer, 100(S9), 1995–2025. <a href="https://doi.org/10.1002/cncr.20162">https://doi.org/10.1002/cncr.20162</a></li>
<li class="show">Stiff, P. J., Erder, H., Bensinger, W. I., Emmanouilides, C., Gentile, T., Isitt, J., . . . Spielberger, R. (2006). Reliability and validity of a patient selfadministered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplantation, 37(4), 393–401. <a href="https://doi.org/10.1038/sj.bmt.1705250">https://doi.org/10.1038/sj.bmt.1705250</a></li>
<li class="show">Stiff, P. (2001). Mucositis associated with stem cell transplantation: Current status and innovative approaches to management. Bone Marrow Transplantation, 27, S3–S11. <a href="https://doi.org/10.1038/sj.bmt.1702863">https://doi.org/10.1038/sj.bmt.1702863</a></li>
<li class="show">Tsirigotis, P., Triantafyllou, K., Girkas, K., Giannopoulou, V., Ioannidou, E., Chondropoulos, S., . . . Dervenoulas, J. (2008). 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. Bone Marrow Transplantation, 42(5), 337–343. <a href="https://doi.org/10.1038/bmt.2008.168">https://doi.org/10.1038/bmt.2008.168</a></li>
<li class="show">Vitale, K. M., Violago, L., Cofnas, P., Bishop, J., Jin, Z., Bhatia, M., . . . Satwani, P. (2014). Impact of palifermin on incidence of oral mucositis and healthcare utilization in children undergoing autologous hematopoietic stem cell transplantation for malignant diseases. Pediatric Transplantation, 18(2), 211–216. <a href="https://doi.org/10.1111/petr.12192">https://doi.org/10.1111/petr.12192</a></li>
<li class="show">Woo, S. B., Sonis, S. T., Monopoli, M. M., &amp; Sonis, A. L. (1993). A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients. Cancer, 72(5), 1612–1617. <a href="https://doi.org/10.1002/1097-0142(19930901)72:53.0.CO;2-Q">https://doi.org/10.1002/1097-0142(19930901)72:53.0.CO;2-Q</a></li>
</ol>
<p>&nbsp;</p>

Published

2017-10-14

Issue

Section

Review

How to Cite

The Efficacy of Palifermin on Oral Mucositis and acute GVHD after Hematopoietic Stem Cell Transplantation in Hematologic Malignancy Patients: A Systematic Review and Meta-analysis study. (2017). Biomedical Research and Therapy, 4(10), 1676-1692. https://doi.org/10.15419/bmrat.v4i10.373

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