A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia
Kenneth F Bradstock, Emma Link, Marnie Collins, Juliana Di Iulio, Ian D Lewis, Anthony Schwarer, Arno Enno, Paula Marlton, Uwe Hahn, Jeff Szer, Gavin Cull, John F Seymour
British Journal of Haematology | WILEY | Published : 2014
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 endp..View full abstract
Awarded by National Health and Medical Research Council of Australia
This study was funded in part from Project Grant 302133 from the National Health and Medical Research Council of Australia. Study drug and placebo were provided by Amgen Australia. The following physicians contributed patients to this study: Royal North Shore Hospital, Sydney: Chris Arthur, Chris Ward, Naomi Mackinley, Matthew Greenwood; St Vincents Hospital, Sydney: Tony Dodds, Sam Milliken, Keith Fay; Westmead Hospital, Sydney: Mark Hertzberg, Warwick Benson, Fiona Kwok, Ian Kerridge, Amanda Johnson; Concord Hospital, Sydney: Judith Trotman, Liu Yam Kwan:; Newcastle Mater Hospital, Newcastle: Philip Rowlings, Michael Seldon, Anoop Enjeti, Sandra Deveridge; Wollongong Hospital, Wollongong: Kim Cartwright, Peter Presgrave; Gosford Hospital, Gosford: Campbell Tiley; Canberra Hospital, Canberra: Philip Crispin, James D'Rozario, Michael Pidcock, Ian Prosser; Peter MacCallum Cancer Institute, Melbourne: Henry Januszewicz, Miles Prince; Alfred Hospital Melbourne: Andrew Wei, Andrew Spencer; Geelong Hospital, Geelong: Phillip Campbell; Royal Adelaide Hospital, Adelaide: Luen Bik To, Nigel Patton, Giri Pratyush, Naomi Horvath; Queen Elizabeth Hospital, Adelaide: Peter Bardy, Simon Macrae, Michelle Kee; Royal Perth Hospital, Perth: Paul Cannell, Julian Cooney; Sir Charles Gairdiner Hospital, Perth: Bradley Auguston, David Joske, Julie Crawford, Steven Ward; Princess Alexandra Hospital, Brisbane: Tony Mills, Devinder Gill, Robert Bird, Aaron Hansen, Sally Mapp; Townsville Hospital, Townsville: Ian Irving; Royal Hobart Hospital, Hobart: Rosemary Harrup.