Vitale, K.M., Violago, L., Cofnas, P., Bishop, J., Jin, Z., Bhatia, M., ... Satwani, P. (2014). Impact of palifermin on incidence of oral mucositis and healthcare utilization in children undergoing autologous hematopoietic stem cell transplantation for malignant diseases. Pediatric Transplantation, 18, 211–216. 

DOI Link

Study Purpose

To determine if administration of palifermin during autologous hematopoietic stem cell transplantation (AHSCT) in children will lower incidence of oral mucositis and shorter duration of hospitalization

Intervention Characteristics/Basic Study Process

Patients received palifermin 60 µg/kg/day IV for the three consecutive days prior to myeloablative conditioning and for the three consecutive days after the end of chemotherapy. All patients received six total doses. Treating physicians were responsible for the decision to administer palifermin. Data were collected using electronic and paper medical charts.

Sample Characteristics

  • N = 58  
  • AGE RANGE = 6.85–7.96 years
  • MALES: 58.3%, FEMALES: 39.2%
  • KEY DISEASE CHARACTERISTICS: Brain tumor, solid tumor, lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Prior radiation, conditioning regimens (e.g., carboplatin, thiotepa, etoposide)

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: NewYork-Presbyterian Morgan Stanley Children’s Hospital

Phase of Care and Clinical Applications

  • APPLICATIONS: Pediatrics

Study Design

  • Retrospective analysis

Measurement Instruments/Methods

  • World Health Organization (WHO) grading for mucositis

Results

No statistical difference in grades III-IV mucositis (p = 1.0), lower incidence in grades III–IV (p = 0.047) in patients receiving solid tumor regimen, and no difference in length of hospitalization

Conclusions

Palifermin administration did not result in a statistically significant decrease in incidence and grade of oral mucositis, nor did it result in shorter hospitalization.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Retrospective analysis

Nursing Implications

High doses of chemotherapy prior to AHSCT causes significant morbidity due to oral mucositis. A larger study is needed to confirm findings of lower incidence of grades III and IV mucositis in the solid tumor regimens.