Le, Q.T., Kim, H.E., Schneider, C.J., Murakozy, G., Skladowski, K., Reinisch, S., … Henke, M. (2011). Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: A randomized, placebo-controlled study. Journal of Clinical Oncology, 29, 2808–2814.
To evaluate the efficacy and safety of palifermin in the reduction of oral mucositis (OM) associated with definitive chemoradiotherapy for locally advanced head and neck cancer (HNC)
The study was conducted in a multi-institutional setting.
Patients were undergoing the active treatment phase of care.
This was a randomized, placebo-controlled study.
The incidence of severe OM was significantly lower in patients receiving palifermin than those receiving placebo (54% versus 69%). In the palifermin arm, the median time to severe OM was delayed, median duration of severe OM was shortened, and the incidence of xerostomia at grade 2 or more was lower, favoring palifermin; however, the differences were not significant after multiplicity adjustment.
Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms.
Adverse events were similar between arms. The most common study drug related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between the treatment arms.
There was no mention as to whether the study was blinded to the researchers.
Oral mucositis is a severe complication of treatment for head and neck cancer, and effective treatment strategies are still needed. Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemotherapy remains unclear. Effective treatment strategies to manage OM associated with high-dose chemoradiotherapy still are needed.