A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia

Bradstock, Kenneth F., Link, Emma, Collins, Marnie, Di Iulio, Juliana, Lewis, Ian D., Schwarer, Anthony, Enno, Arno, Marlton, Paula, Hahn, Uwe, Szer, Jeff, Cull, Gavin and Seymour, John F. (2014) A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia. British Journal of Haematology, 167 5: 618-625. doi:10.1111/bjh.13086


Author Bradstock, Kenneth F.
Link, Emma
Collins, Marnie
Di Iulio, Juliana
Lewis, Ian D.
Schwarer, Anthony
Enno, Arno
Marlton, Paula
Hahn, Uwe
Szer, Jeff
Cull, Gavin
Seymour, John F.
Title A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia
Journal name British Journal of Haematology   Check publisher's open access policy
ISSN 0007-1048
1365-2141
Publication date 2014-12
Year available 2014
Sub-type Article (original research)
DOI 10.1111/bjh.13086
Open Access Status
Volume 167
Issue 5
Start page 618
End page 625
Total pages 8
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Collection year 2015
Language eng
Abstract Gastrointestinal toxicity, including oral mucositis, is a frequent complication of intensive combination chemotherapy for acute myeloid leukaemia (AML) and contributes substantially to treatment-related mortality. We conducted a placebo-controlled randomized trial to evaluate the efficacy of palifermin (keratinocyte growth factor), given at 60 μg/kg per daily IV for 3 d before and after chemotherapy, for mucosal protection in adult patients with previously untreated AML receiving induction therapy with idarubicin, high-dose cytarabine and etoposide. Among 155 randomized patients, there was no statistically significant difference in the rate of grade 3 and 4 oral mucositis (primary study endpoint) between the two treatment arms (three in palifermin arm (4%), 8 in placebo arm (10%; P = 0·21); however, when considering the severity of oral mucositis (World Health Organization grade 0-4), there was evidence of reduced rates of higher grades of oral mucositis in the palifermin arm (P = 0·0007, test for trend). There was a statistically significantly lower rate of grades 3 and 4 gastrointestinal adverse events in the palifermin arm (21% vs. 44% in placebo arm; P = 0·003), mainly due to a reduction in severe diarrhoea (8% palifermin, 26% placebo; P = 0·01). Palifermin has activity as a mucosal protectant in AML patients receiving intensive chemotherapy. This trial is registered at ACTRN012605000095662.
Keyword Palifermin
Keratinocyte growth factor
Acute myeloid leukaemia
Mucositis
Chemotherapy
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
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