Efficacy of palifermin on oral mucositis and aGVHD for hematological malignancy patients undergoing hematopoietic stem cell transplantation: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Ying ^1,3 , ZHOU Chunlan ^2,3 ,  ZHAO Jie ¹ , OU Jiexia ²

1. Department of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, 510515, P.R.China;
2. Nursing Department, Nanfang Hospital of Southern Medical University, Guangzhou, 510515, P.R.China;
3. Nanfang Nursing Centre for Evidence-based Practice: A Joanna Briggs Institute Affiliated Group, Guangzhou, 510515, P.R.China;

Corresponding author：

ZHAO Jie, Email: 1113722345@qq.com

Keywords：

Palifermin; Hematological malignancy; Hematopoietic stem cell transplantation; Acute graft versus host disease; Oral mucositis; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.201812096

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Objectives To systematically review the efficacy and safety of palifermin on oral mucositis (OM) and acute graft versus host disease (aGVHD) for hematological malignancy patients undergoing hematopoietic stem cell transplantation (HSCT).Methods PubMed, The Cochrane Library, Web of Science, EMbase, Clinicaltrials.gov, CNKI and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy of palifermin on OM and aGVHD for hematological malignancy patients undergoing HSCT from inception to September 30^th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.Results A total of 7 RCTs involving 904 patients were included. The results of meta-analysis showed that: palifermin could reduce the duration of OM grade 2 to 4 (MD=−4.21, 95%CI −7.83 to −0.58, P=0.02), OM grade 3 to 4 (MD=−2.54, 95%CI −4.61 to −0.46, P=0.02) significantly for hematological malignancy patients undergoing HSCT. However, no significant difference was found in the prevalence of aGVHD grade 2 to 4 (RR=1.29, 95%CI 0.95 to 1.75, P=0.11), aGVHD grade 3 to 4 (RR=0.99, 95%CI 0.55 to 1.77, P=0.97), OM grade 2 to 4 (RR=0.86, 95%CI 0.72 to 1.03, P=0.11) and OM grade 3 to 4 (RR=0.82, 95%CI 0.65 to 1.03, P=0.08) between palifermin group and placebo group. The prevalence of paresthesia (RR=4.24, 95%CI 1.24 to 14.56, P=0.02) and erythema (RR=1.49, 95%CI 1.06 to 2.09, P=0.02) were significantly higher in palifermin group.Conclusions The durations of OM grade 2 to 4, 3 to 4 are significantly reduce in patients receiving palifermin compared with those receiving a placebo, however, no statistically significant difference are found in the incidence of aGVHD grade 2 to 4, 3 to 4, OM grade 2 to 4, 3 to 4. Parethesia and erythema are more prevalent among patients using palifermin. Therefore, advantages and disadvantages of palifermin should be considered when used in clinical.

Citation： LIU Ying, ZHOU Chunlan, ZHAO Jie, OU Jiexia. Efficacy of palifermin on oral mucositis and aGVHD for hematological malignancy patients undergoing hematopoietic stem cell transplantation: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2019, 19(4): 439-447. doi: 10.7507/1672-2531.201812096 Copy

1.	Filicko J, Lazarus HM, Flomenberg N. Mucosal injury in patients undergoing hematopoietic progenitor cell transplantation: new approaches to prophylaxis and treatment. Bone Marrow Transplant, 2003, 31(1): 1-10.
2.	Bowen JM, Wardill HR. Advances in the understanding and management of mucositis during stem cell transplantation. Curr Opin Support Palliat Care, 2017, 11(4): 341-346.
3.	Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer, 2014, 120(10): 1453-1461.
4.	Raber-Durlacher JE, Laheij AM, Epstein JB, et al. Periodontal status and bacteremia with oral viridans streptococci and coagulase negative staphylococci in allogeneic hematopoietic stem cell transplantation recipients: a prospective observational study. Support Care Cancer, 2013, 21(6): 1621-1627.
5.	Hensley ML, Hagerty KL, Kewalramani T, et al. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. J Clin Oncol, 2008, 27(1): 127-145.
6.	Epstein JB, Thariat J, Bensadoun RJ, et al. Oral complications of cancer and cancer therapy: from cancer treatment to survivorship. CA Cancer J Clin, 2012, 62(6): 400-422.
7.	Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med, 2004, 351(25): 2590-2598.
8.	Elting LS, Cooksley C, Chambers M, et al. The burdens of cancer therapy: clinical and economic outcomes of chemotherapy-induced mucositis. Cancer, 2003, 98(7): 1531-1539.
9.	Sonis ST, Oster G, Fuchs H, et al. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol, 2001, 19(8): 2201-2205.
10.	Nasilowska-Adamska B, Rzepecki P, Manko J, et al. 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 Transplant, 2007, 40(10): 983-988.
11.	Blazar BR, Weisdorf DJ, Defor T, et al. Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood, 2006, 108(9): 3216-3222.
12.	Blijlevens N, de Château M, Krivan G, et al. In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient's burden. Bone Marrow Transplant, 2013, 48(7): 966-971.
13.	Jagasia MH, Abonour R, Long GD, et al. Palifermin for the reduction of acute GVHD: a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplant, 2012, 47(10): 1350-1355.
14.	Lucchese A, Matarese G, Ghislanzoni LH, et al. Efficacy and effects of palifermin for the treatment of oral mucositis in patients affected by acute lymphoblastic leukemia. Leuk Lymphoma, 2016, 57(4): 820-827.
15.	Lucchese A, Matarese G, Manuelli M, et al. Reliability and efficacy of palifermin in prevention and management of oral mucositis in patients with acute lymphoblastic leukemia: a randomized, double-blind controlled clinical trial. Minerva Stomatol, 2016, 65(1): 43-50.
16.	Schmidt V, Niederwieser D, Schenk T, et al. Efficacy and safety of keratinocyte growth factor (palifermin) for prevention of oral mucositis in TBI-based allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant, 2018, 53(9): 1188-1192.
17.	侯晓雯, 时景璞, 陈欣. 在 Meta 分析中如何利用中位数、极差和样本量估算均数、标准差. 中国循证医学杂志, 2015, 15(4): 484-487.
18.	Goldberg JD, Zheng J, Castro-Malaspina H, et al. Palifermin is efficacious in recipients of TBI-based but not chemotherapy-based allogeneic hematopoietic stem cell transplants. Bone Marrow Transplant, 2013, 48(1): 99-104.
19.	Langner S, Staber P, Schub N, et al. Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant, 2008, 42(4): 275-279.
20.	Niscola P, Scaramucci L, Giovannini M, et al. Palifermin in the management of mucositis in hematological malignancies: current evidences and future perspectives. Cardiovasc Hematol Agents Med Chem, 2009, 7(4): 305-312.
21.	Sakellari I, Angelopoulou M, Tsopra O, et al. A prospective study of incidence, clinical and quality of life consequences of oral mucositis post palifermin prophylaxis in patients undergoing high-dose chemotherapy and autologous hematopoietic cell transplantation. Ann Hematol, 2015, 94(10): 1733-1740.
22.	Czyzewski K, Debski R, Krenska A, et al. Palifermin in children undergoing autologous stem cell transplantation: a matched-pair analysis. Anticancer Res, 2014, 34(12): 7379-7382.
23.	Keefe DM, Schubert MM, Elting LS, et al. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer, 2007, 109(5): 820-831.
24.	Nguyen DT, Shayani S, Palmer J, et al. Palifermin for prevention of oral mucositis in allogeneic hematopoietic stem cell transplantation: a single-institution retrospective evaluation. Support Care Cancer, 2015, 23(11): 3141-3147.
25.	Fliedner M, Baguet B, Blankart J, et al. Palifermin for patients with haematological malignancies: shifting nursing practice from symptom relief to prevention of oral mucositis. Eur J Oncol Nurs, 2007, 11(Suppl 1): S19-S26.
26.	Mozaffari HR, Payandeh M, Ramezani M, et al. Efficacy of palifermin on oral mucositis and acute GVHD after hematopoietic stem cell transplantation (HSCT) in hematology malignancy patients: a meta-analysis of trials. Contemp Oncol (Pozn), 2017, 21(4): 299-305.

1. Filicko J, Lazarus HM, Flomenberg N. Mucosal injury in patients undergoing hematopoietic progenitor cell transplantation: new approaches to prophylaxis and treatment. Bone Marrow Transplant, 2003, 31(1): 1-10.
2. Bowen JM, Wardill HR. Advances in the understanding and management of mucositis during stem cell transplantation. Curr Opin Support Palliat Care, 2017, 11(4): 341-346.
3. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer, 2014, 120(10): 1453-1461.
4. Raber-Durlacher JE, Laheij AM, Epstein JB, et al. Periodontal status and bacteremia with oral viridans streptococci and coagulase negative staphylococci in allogeneic hematopoietic stem cell transplantation recipients: a prospective observational study. Support Care Cancer, 2013, 21(6): 1621-1627.
5. Hensley ML, Hagerty KL, Kewalramani T, et al. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. J Clin Oncol, 2008, 27(1): 127-145.
6. Epstein JB, Thariat J, Bensadoun RJ, et al. Oral complications of cancer and cancer therapy: from cancer treatment to survivorship. CA Cancer J Clin, 2012, 62(6): 400-422.
7. Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med, 2004, 351(25): 2590-2598.
8. Elting LS, Cooksley C, Chambers M, et al. The burdens of cancer therapy: clinical and economic outcomes of chemotherapy-induced mucositis. Cancer, 2003, 98(7): 1531-1539.
9. Sonis ST, Oster G, Fuchs H, et al. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol, 2001, 19(8): 2201-2205.
10. Nasilowska-Adamska B, Rzepecki P, Manko J, et al. 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 Transplant, 2007, 40(10): 983-988.
11. Blazar BR, Weisdorf DJ, Defor T, et al. Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood, 2006, 108(9): 3216-3222.
12. Blijlevens N, de Château M, Krivan G, et al. In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient's burden. Bone Marrow Transplant, 2013, 48(7): 966-971.
13. Jagasia MH, Abonour R, Long GD, et al. Palifermin for the reduction of acute GVHD: a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplant, 2012, 47(10): 1350-1355.
14. Lucchese A, Matarese G, Ghislanzoni LH, et al. Efficacy and effects of palifermin for the treatment of oral mucositis in patients affected by acute lymphoblastic leukemia. Leuk Lymphoma, 2016, 57(4): 820-827.
15. Lucchese A, Matarese G, Manuelli M, et al. Reliability and efficacy of palifermin in prevention and management of oral mucositis in patients with acute lymphoblastic leukemia: a randomized, double-blind controlled clinical trial. Minerva Stomatol, 2016, 65(1): 43-50.
16. Schmidt V, Niederwieser D, Schenk T, et al. Efficacy and safety of keratinocyte growth factor (palifermin) for prevention of oral mucositis in TBI-based allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant, 2018, 53(9): 1188-1192.
17. 侯晓雯, 时景璞, 陈欣. 在 Meta 分析中如何利用中位数、极差和样本量估算均数、标准差. 中国循证医学杂志, 2015, 15(4): 484-487.
18. Goldberg JD, Zheng J, Castro-Malaspina H, et al. Palifermin is efficacious in recipients of TBI-based but not chemotherapy-based allogeneic hematopoietic stem cell transplants. Bone Marrow Transplant, 2013, 48(1): 99-104.
19. Langner S, Staber P, Schub N, et al. Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant, 2008, 42(4): 275-279.
20. Niscola P, Scaramucci L, Giovannini M, et al. Palifermin in the management of mucositis in hematological malignancies: current evidences and future perspectives. Cardiovasc Hematol Agents Med Chem, 2009, 7(4): 305-312.
21. Sakellari I, Angelopoulou M, Tsopra O, et al. A prospective study of incidence, clinical and quality of life consequences of oral mucositis post palifermin prophylaxis in patients undergoing high-dose chemotherapy and autologous hematopoietic cell transplantation. Ann Hematol, 2015, 94(10): 1733-1740.
22. Czyzewski K, Debski R, Krenska A, et al. Palifermin in children undergoing autologous stem cell transplantation: a matched-pair analysis. Anticancer Res, 2014, 34(12): 7379-7382.
23. Keefe DM, Schubert MM, Elting LS, et al. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer, 2007, 109(5): 820-831.
24. Nguyen DT, Shayani S, Palmer J, et al. Palifermin for prevention of oral mucositis in allogeneic hematopoietic stem cell transplantation: a single-institution retrospective evaluation. Support Care Cancer, 2015, 23(11): 3141-3147.
25. Fliedner M, Baguet B, Blankart J, et al. Palifermin for patients with haematological malignancies: shifting nursing practice from symptom relief to prevention of oral mucositis. Eur J Oncol Nurs, 2007, 11(Suppl 1): S19-S26.
26. Mozaffari HR, Payandeh M, Ramezani M, et al. Efficacy of palifermin on oral mucositis and acute GVHD after hematopoietic stem cell transplantation (HSCT) in hematology malignancy patients: a meta-analysis of trials. Contemp Oncol (Pozn), 2017, 21(4): 299-305.

Chinese Journal of Evidence-Based Medicine

Efficacy of palifermin on oral mucositis and aGVHD for hematological malignancy patients undergoing hematopoietic stem cell transplantation: a meta-analysis

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