Journal Information
Vol. 34. Issue 4.
Pages 163-169 (January 2010)
Vol. 34. Issue 4.
Pages 163-169 (January 2010)
Original article
Full text access
Effectiveness of palifermin in the prevention of oral mucositis in patients with haematological cancers
Efectividad de la palifermina en la prevención de la mucositis oral en pacientes oncohematológicos
Visits
2376
D. Ayago Flores
Corresponding author
daflo@postal.uv.es

Corresponding author.
, R. Ferriols Lisart
Servicio de Farmacia, Hospital General de Castellón, Castellón, Spain
This item has received
Article information
Abstract
Bibliography
Download PDF
Statistics
Abstract
Objective

To assess the effectiveness of palifermin for the prevention of oral mucositis in patients with haematological cancers.

Method

Retrospective observational study of cohorts of patients with haematological cancer undergoing cytotoxic therapy causing hematopoietic ablation. The main variable assessed was the duration of the oral mucositis. Secondary variables assessed were incidence of mucositis, febrile or septic neutropenia and the administration of opioids and parenteral nutrition.

Results

We included 36 patients in this study, 11 in the group that received palifermin and 25 in the control group. The duration of oral mucositis was 4.6±3.1 days (median: 5 days) in the patients treated with palifermin in comparison with 7.4±4.0 days (median: 6 days) in patients treated with conventional prophylactic therapy (P<.05). However, no significant differences were seen in the incidence of mucositis, febrile or septic neutropenia, opioid administration of the use of parenteral nutrition.

Conclusions

Prophylactic treatment with palifermin reduces the duration of oral mucosities in patients with haematological cancer. Further studies are necessary with larger samples to be able to assess palifermin and its influence on other variables, such as incidence of mucositis, sepsis, febrile neutropenia, etc.

Keywords:
Mucositis
Keratinocyte growth factor (KGF)
Palifermin
Prevention
Chemotherapy
Haematological cancers
Stem cell transplantation
Resumen
Objetivo

Evaluar la efectividad de la palifermina en la prevención de la mucositis oral (MO) en pacientes oncohematológicos.

Método

Estudio observacional retrospectivo de cohortes en pacientes con neoplasias hematológicas, sometidos a tratamiento mieloablativo de acondicionamiento y posterior trasplante autólogo de progenitores hematopoyéticos, y que reciben como profilaxis de la mucositis palifermina u otro tratamiento convencional. La variable principal evaluada fue la duración de la MO. Las variables secundarias fueron la incidencia de mucositis, neutropenia febril o sepsis y la administración de opiáceos o nutrición parenteral.

Resultados

Se incluyeron 36 pacientes en el estudio, 11 en el grupo de palifermina y 25 en el grupo control. La duración de la MO fue de 4,6±3,1 días (mediana: 5 días) en los pacientes tratados con palifermina respecto a 7,4±4,0 días (mediana: 6 días) en los tratados con profilaxis convencional (p<0,05). A pesar de todo, no se observaron diferencias significativas en la incidencia de mucositis, sepsis o neutropenia febril, la administración de opiáceos o la utilización de nutrición parenteral.

Conclusiones

El tratamiento profiláctico con palifermina permite reducir la duración de la MO en pacientes oncohematológicos. Se necesitan más estudios y con un tamaño muestral mayor para poder evaluar el papel de la palifermina sobre otras variables, tales como la incidencia de la mucositis, sepsis, neutropenia febril, etc.

Palabras clave:
Mucositis
Factor estimulante de queratinocitos
Palifermina
Prevención
Quimioterapia
Neoplasias hematológicas
Trasplante de células madre
Full text is only available in PDF
References
[1.]
S.T. Sonis, G. Oster, H. Fuchs, L. Bellm, W.Z. Bradford, J. Edelsber, et al.
Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation.
Journal of Clinical Oncology, 19 (2001), pp. 2201-2205
[2.]
L.S. Eltin, C. Cooksley, M. Chambers, S.B. Cantor, E. Manzullo.
The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis.
Cancer, 98 (2003), pp. 1531-1539
[3.]
S.R. Fanning, L. Rybicki, M. Kalaycio, S. Andersen, E. Kuczkowski, B. Pohlman, et al.
Severe mucositis is associated with reduced survival after autologous stem cell transplantation for lymphoid malignacies.
[4.]
S.B. Woo, S.T. Sonis, M.M. Monopoli, A.L. Sonis.
A longitudinal study of oral ulcerative mucositis in bone marrow transplant reciepients.
Cancer, 72 (1993), pp. 1612-1617
[5.]
S.T. Sonis.
Mucositis as a biological process: a new hypotesis for the development of chemotherapy induced stomatotoxicity.
Oral Oncol, 34 (1998), pp. 39-43
[6.]
P. Horsley, J.D. Bauer, R. Mazkowiack, R. Gardner, J. Bashford.
Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation.
Support Care Center, 15 (2007), pp. 105-109
[7.]
R. Spielberger, P. Stiff, W. Bensinger, T. Gentile, D. Weisdorf, T. Kewlmarani, et al.
Palifermin for oral mucositis after intensive therapy for hematologic cancers.
N Eng J Med, 351 (2004), pp. 2590-2598
[8.]
R. Gutiérrez Ramos, M. Ruano Encinar, A. Herrero Ambrosio, E. Jimenéz Caballero.
Prevención y tratamiento de las lesiones de la mucosa oral secundarias a quimioterapia.
Farm Clin, 14 (1997), pp. 588-598
[9.]
P.J. Stiff, C.H. Emmanouilides, W.I. Bensinger, T. Gentile, B. Blazar, T.C. Shea, et al.
Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic Stem-Cell transplantation setting.
J Clin Oncol, 24 (2006), pp. 5186-5193
[10.]
E.B. Rubenstein, D.E. Peterson, M. Schubert, D. Keefe, J. Epstein, D. McGuire, et al.
Mucositis Study Section of the Multinational Association for Supportive Care in Cancer and the International Society for Oral Oncology. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis.
Cancer, 100 (2004), pp. 995-2025
[11.]
WHO Toxic effects.
Who handbook for reporting results of cancer treatments, pp. 15-22
[12.]
J.P. Donelly, N.M. Blijlevens, C.A. Verhagen.
Can anything be done about oral mucositis?.
Ann Oncol, 14 (2003), pp. 505-507
[13.]
Worthington HV, Clarkson JE, Eden OB. Intervenciones para la prevención de la mucositis oral en pacientes que reciben tratamiento para el cáncer (Revisión Cochrane traducida). In: La Biblioteca Cochrane Plus, 2008 Núm. 4. Oxford: Update Software Ltd. Available from: http://www.update-software.com.(translated from The Cochrane Library, 2008 Issue 3. Chichester, UK: John Wiley & Sons, Ltd.).
[14.]
P. Zia-Amirhosseini, M. Salfi, P. Leese, W. Yates, D.M. Danilenko, B. Ring, et al.
Pharmacokinetics, pharmacodynamics, and safety assessment of palifermin (rHuKGF) in healthy volunteers.
Clin Pharmacol Ther, 79 (2006), pp. 558-569
[15]
Prescribing information for Kepivance®. http://www.agemed.eswww.agemed.es.
[17.]
M.L. Hensley, K.L. Hagerty, T. Kewalramani, D.M. Green, N.J. Meropol, T.H. Wasserman, et al.
American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants.
J Clin Oncol, 27 (2008), pp. 127-145
[18.]
Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, et al. Mucositis: perspectives and clinical practice guidelines. Perspectives on cancer therapy-induced mucosal injury. Pathogenesis, measurement, epidemiology and consecuences for patients. Available from: http://www.interscience.wiley.comwww.interscience.wiley.com.
[19.]
D.M. Keefe, M.M. Schubert, L.S. Elting, S.T. Sonis, J.B. Epstein, J.E. Raber- Durlacher, et al.
Musositis Study Section of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology. Updated clinical practice guidelines for the prevention and treatment of mucositis.
Cancer, 109 (2007), pp. 820-831
[20.]
I. Romero Crespo, A. Albert Marí, C. Borrás Almenar, M. Climente Martí, N.V. Jiménez Torres.
Aproximación a la efectividad y seguridad de la palifermina en la prevención de la mucositis oral.
Aten Farm, 11 (2009), pp. 8-15
[21.]
L.S. Elting, Y.C. Shih, P.J. Stiff, W. Bensinger, S.B. Cantor, C. Cooksley, et al.
Economic impact of palifermin on the costs of hospitalization for autologous hematopoietic stem-cell transplant: analysis of phase 3 trial results.
Biol Blood Marrow Transplant, 15 (2007), pp. 491-496
[22.]
B.A. Murphy.
Clinical and economic consequences of mucositis induced by chemotherapy and/or radiation therapy.
J Support Oncol, 5 (2007), pp. 13-21
Copyright © 2010. Sociedad Española de Farmacia Hospitalaria
Download PDF
Idiomas
Farmacia Hospitalaria
Article options
Tools
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

es en
Política de cookies Cookies policy
Utilizamos cookies propias y de terceros para mejorar nuestros servicios y mostrarle publicidad relacionada con sus preferencias mediante el análisis de sus hábitos de navegación. Si continua navegando, consideramos que acepta su uso. Puede cambiar la configuración u obtener más información aquí. To improve our services and products, we use "cookies" (own or third parties authorized) to show advertising related to client preferences through the analyses of navigation customer behavior. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here.