Irsogladine helps limit chemotherapy-induced oral mucositis
medwireNews: Irsogladine maleate is a promising drug for the management of oral mucositis in patients undergoing 5-fluorouracil (5-FU)-based chemotherapy, results of a randomized placebo-controlled trial indicate.
Irsogladine maleate given either by continuous infusion or bolus was well tolerated and offered significant protection against oral mucositis, a common and painful side effect of chemotherapy.
"Our study adds to the evidence suggesting that irsogladine maleate is useful in prevention of oral mucositis," write M Nomura (Kansai Medical University, Hirakata, Japan) and fellow researchers in the Annals of Oncology.
Irsogladine maleate works by reinforcing intercellular communication at gap junctions and is already used to treat gastric ulcers and aphthous stomatitis. In this study, Nomura and team evaluated the drug in 66 cancer patients who were scheduled to start chemotherapy with 5-FU and platinum.
The patients were randomly assigned to receive either irsogladine maleate 4 mg/day given orally or placebo, started on the first day of chemotherapy and continued for 14 days.
Compliance was 100% in both treatment arms and no patient required a reduction in chemotherapy dose, Nomura and co-authors remark.
The study's primary endpoint - incidence of oral mucositis of grade 1 or higher - was 27.3% in the irsogladine group and 72.7% in the placebo group. This difference was highly statistically significant with a hazard ratio of 0.14.
A secondary outcome measure - the maximum severity of oral mucositis - also supported the efficacy of irsogladine, with 73% of irsogladine-treated patients experiencing no worse than grade 0 mucositis. In the placebo group, 27% and 42% of patients experienced grade 0 and grade 1 mucositis, respectively.
Multivariate analysis failed to identify any baseline patient factors that predicted the development of oral mucositis and the frequency of adverse events was similar in both irsogladine and placebo groups.
Commenting on their data, Nomura and co-authors note that irsogladine maleate has an efficacy similar to that of palifermin but admit that the precise mechanism of action of irsogladine is unclear.
There are several potential pathways, they say, including inhibition of reactive oxygen species production in neutrophils, inhibition of tumor necrosis factor-α release, and inhibition of the production of proinflammatory cytokines.
"For validation, additional prospective, multicenter phase III studies with large numbers of patients with adenocarcinoma or squamous cell carcinoma are needed," they conclude.
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Joanna Lyford, Senior medwireNews Reporter