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Palifermin Helps Reduce Incidence of Oral Mucositis in Patients Undergoing HSCT; More Studies Needed: Presented at MASCC/ISOO

By Louise Gagnon

TORONTO, CANADA -- June 27, 2006 -- Palifermin reduces the incidence of oral mucositis than does standard therapy in patients undergoing haematopoietic stem cell transplantation (HSCT), but larger studies are needed to warrant its use on a wider scale, according to an Australian study presented here at the meeting of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO).

Mucositis is a complication that occurs commonly in patients who undergo HSCT, said Pam Horsley, a dietician with the Wesley Hospital in Brisbane, Queensland, Australia, and principal investigator of the study.

The study compared treatment with palifermin, a recombinant form of human keratinocyte growth factor, in 32 patients and 27 historical controls to determine if the drug would improve severe mucositis, swallowing problems, and nutritional intake, amongst other indicators. Patients who have undergone HSCT are typically on analgesic opioids, such as morphine, to provide pain relief, noted Ms Horsley.

"There was a significant decline in oral mucositis [48% vs 3%, standard care vs palifermin, respectively, P = .003]," said Ms Horsley. "We also found there to be a significant difference in length of stay, [18 vs 14 days, respectively, P = .026] as well as the number of nutrition impact symptoms [4.9 vs. 6.0, respectively, P = .003]."

There were, however, no significant differences in the rate of infection, nutritional status, dietary intake, use of total parenteral nutrition, analgesic dose and duration of administration of opioid analgesics, and time to engraftment, between patients who received palifermin and controls.

Despite the difference in nutrition impact symptoms between patients on palifermin and controls, there was no gain in dietary intake or nutritional status, noted Horsley.

"Looking at it from a nutritionist's point of view, there was no significant different in oral intake," said Ms Horsley. "We expected to see a decrease in infection with palifermin because previous research has shown this, but we did not see any reduction."

The study has not resulted in the adoption of palifermin at Wesley Hospital on a widespread basis, but has been limited to patients judged to be at high-risk for severe mucositis.

"We still need to do larger trials to confirm our results in terms of efficacy and side effects," concluded Ms Horsley.

Amgen, makers of palifermin, supplied the drug for the study, but did not provide additional financing.


[Presentation title: Palifermin Improves Severe Mucositis, Swallowing Problems, Nutrition Impact Symptoms and Length of Stay in Patients Undergoing Hematopoietic Stem Cell Transplant, abstract 16-096]

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