Lauritano, D., Petruzzi, M., Di Stasio, D., & Lucchese, A. (2014). Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: A case-control study. International Journal of Oral Science, 6, 27–30. 

To evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy for pediatric patients with acute lymphoblastic leukemia

Twenty patients received palifermin and other 20 patients didn’t. The palifermin group received a 60 mg/kg IV bolus per day for three consecutive days before and three consecutive days after transplant (a total of six doses). All patients were evaluated for 30 days.

• N = 40  
• MEDIAN AGE = 11 years
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia
• OTHER KEY SAMPLE CHARACTERISTICS: Pediatric, allogeneic stem cell transplant

• SITE: Single-site    
• SETTING TYPE: Inpatient

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Case-controlled study

• World Health Organization (WHO) grading scale
• Average duration of episode of oral mucositis, duration of use of total parenteral nutrition, infection rate, 100-day survival rate

This study demonstrated a statistically significant reduction in the duration of parenteral nutrition (p = .002), duration of mucositis (p = .003), and the average grade of mucositis (p = .03). Other measures were not significant. The statistical analysis showed that the drug decreased the severity of mucositis.

These data suggest that palifermin could be a valid therapeutic adjuvant to improve quality of life for pediatric patients with leukemia.

• Small sample (< 100)
• Risk of bias (no random assignment)

Palifermin decreased the duration of oral mucositis in pediatric patients being treated for leukemia. Nurses should be aware that this intervention may compliment other interventions to reduce oral mucositis in this population.