Schmidt, E., Thoennissen, N.H., Rudat, A., Bieker, R., Schliemann, C., Mesters, R.M., … Berdel, W.E. (2008). Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Annals of Oncology, 19, 1644–1649.

DOI Link

Intervention Characteristics/Basic Study Process

IV palifermin 60 mcg/kg per day was given for three consecutive days before chemotherapy cycle A2 or B2 and then for three consecutive days after chemotherapy. All patients received granulocyte colony-stimulating factor (G-CSF). Prophylactic treatment consisted of a number of agents, including tetracaine, chamomile, oral hygiene, and amphotericin B suspensions. Authors used previous studies as historical controls.

Sample Characteristics

This study used a retrospective series of 10 patients with B cell acute lymphocytic leukemia (ALL) or aggressive B cell lymphoma. Patients had World Health Organization (WHO) Oral Mucositis grades of 3 or 4 during cycle A1 or B1 of high-dose methotrexate (HDMTX).

Setting

Patients were selected retrospectively from September 2004 to March 2007.

Measurement Instruments/Methods

  • WHO mucositis grading was obtained daily.
  • Opioid use was recorded.

Results

  • Sixteen episodes of grade 4 and one episode of grade 3 mucositis were observed without palifermin.
  • One episode of grade 4, four episodes of grade 3, and four episodes of grade 2 mucositis were observed with palifermin (p < 0.05).
  • IV opioids were reduced from 2,403 mg to 640 mg morphine (p < 0.05).
  • Duration of higher grade mucositis was reduced slightly from 12.9 days to 11 days (not significant).

Limitations

  • The sample size was very small.
  • Historical controls were used.
  • Other prophylactic measures may have had effects.
  • No discussion of cost was provided.