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Palifermin Can Prevent Severe Oral Mucositis During Chemotherapy FREE

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The summary below is from the full report titled “Single-Dose Palifermin Prevents Severe Oral Mucositis During Multicycle Chemotherapy in Patients With Cancer. A Randomized Trial.” It is in the 21 September 2010 issue of Annals of Internal Medicine (volume 153, pages 358-367). The authors are S. Vadhan-Raj, J. Trent, S. Patel, X. Zhou, M.M. Johnson, D. Araujo, J.A. Ludwig, S. O'Roark, A.M. Gillenwater, C. Bueso-Ramos, A.K. El-Naggar, and R.S. Benjamin.


Ann Intern Med. 2010;153(6):I-44. doi:10.7326/0003-4819-153-6-201009210-00001
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What is the problem and what is known about it so far?

Patients who receive certain types of medications to treat cancer (chemotherapy) can often experience severe irritation and inflammation in the mouth and throat, a side effect called mucositis. When mucositis is severe, patients have great pain when swallowing. This side effect can require the physician to stop or change the dose of chemotherapy to allow the mouth to heal and to reduce the recurrence and severity of mucositis. Current treatments for mucositis include pain medication, antibiotics, prescription mouth rinses, and ice. However, despite these approaches, many patients often suffer moderate or severe mucositis, especially when they have to take multiple cycles of certain types of chemotherapy.

Why did the researchers do this particular study?

To evaluate a new drug, palifermin, that may help reduce mucositis in patients receiving cancer treatment. Palifermin is a man-made form of a natural growth factor for the cells that line the mouth and intestinal tract. It is given by vein.

Who was studied?

48 patients with a form of cancer called sarcoma who were receiving multiple cycles of chemotherapy that included the drug doxorubicin, which often causes mucositis.

How was the study done?

The investigators conducted a randomized, controlled trial in which they gave palifermin or a placebo by vein before the patients received each cycle of chemotherapy.

What did the researchers find?

Patients who received palifermin had fewer episodes of moderate to severe mucositis and completed more chemotherapy cycles than those who received placebo. The most common side effect was thickening of the lining of the mouth and a change in taste.

What were the limitations of the study?

This is a small, single-center study of patients with 1 type of cancer. The side effects may have helped patients figure out that they were receiving palifermin. The study did not compare palifermin with other treatments, such as a supersaturated oral calcium phosphate rinse.

What are the implications of the study?

Palifermin needs to be evaluated in larger, more varied groups of patients to confirm this initial evidence that the drug can help patients better tolerate multiple cycles of chemotherapy that causes mucositis.

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