Vadhan-Raj, S., Trent, J., Patel, S., Zhou, X., Johnson, M.M., Araujo, D., … Benjamin, R.S. (2010). Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. Annals of Internal Medicine, 153, 358–367.
To evaluate the efficacy and safety of palifermin given as a single dose before each cycle in patients receiving doxorubicin-based multicycle chemotherapy
Patients were randomly assigned in a 2:1 ratio to receive palifermin or placebo.
This study was conducted at a single-site at the University of Texas M.D. Anderson Cancer Center.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blind, placebo-controlled trial.
Palifermin significantly reduced the incidence of moderate to severe (grade 2 or higher) mucositis (44% versus 88%; p <0.001) and severe mucositis (13% versus 51%; p < 0.002).
A single dose of palifermin before each cycle reduced the incidence and severity of mucositis. It also demonstrated effectiveness as secondary prophylaxis in a few patients with severe mucositis.
Mucositis and the pain it causes can significantly impact patients with cancer during treatment. Further research is needed to establish the alleviation of pain and the improved ability to drink, eat, and talk. If the mucosal lining is maintained, it would be important to establish if there are fewer infections, use of total parenteral nutrition (TPN) to maintain nutrition, and use of opiod patient-controlled analgesia (PCA) for pain control.