showed a trendP = 0.06
The first study randomized 81 patients with metastatic colorectal cancer treated with fluorouracil (5-FU) to escalating doses of palifermin (2:1 randomization of palifermin to placebo) and showed a trend towards a decreased frequency of ulcerative mucositis (WHO grade 2–4): 43% versus 67%, P = 0.06.