Oral mucositis is a complication of intensive chemotherapy and radiotherapy with no effective treatment.
Dr Spielberger and colleagues from across America undertook a study in order to test the ability of palifermin (recombinant human keratinocyte growth factor) to decrease oral mucosal injury induced by cytotoxic therapy.
The researchers designed a double-blind study to compare the effect of palifermin with that of a placebo on the development of oral mucositis in 212 patients with hematologic cancers.
The investigators administered palifermin (60 µg per kilogram of body weight per day) to 106 patients.
The researchers gave 106 participants a placebo intravenously for 3 consecutive days.
These participants received a placebo immediately before the initiation of conditioning therapy (fractionated total-body irradiation plus high-dose chemotherapy) and after autologous hematopoietic stem-cell transplantation.
The research team evaluated oral mucositis every day for 28 days after transplantation.
| Incidence of oral mucositis was 63% in the palifermin group and 98% in the placebo group|
|New England Journal of Medicine|
The researchers found that the incidence of oral mucositis of World Health Organization (WHO) grade 3 or 4 was 63% in the palifermin group and 98% in the placebo group.
Among patients with this degree of mucositis, the research team noted that the median duration of mucositis was 6 days in the palifermin group and 9 days in the placebo group.
The researchers found that among all patients, regardless of the occurrence of mucositis, the median duration of oral mucositis of WHO grade 3 or 4 was 3 days in the palifermin group and 9 days in the placebo group.
As compared with placebo, the research team found that palifermin was associated with significant reductions in the incidence of grade 4 oral mucositis and patient-reported soreness of the mouth and throat.
The use of opioid analgesics and the incidence of use of total parenteral nutrition was also reduced.
The researchers noted that any adverse events, mainly rash, pruritus, erythema, mouth and tongue disorders, and taste alteration, were mild to moderate in severity and were transient.
Dr Spielberger concluded, "Palifermin reduced the duration and severity of oral mucositis after intensive chemotherapy and radiotherapy for hematologic cancers."