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| New Drug for Mouth Sores after Bone Marrow Transplants |
![ACS News Center]() |
| Palifermin Approved for Leukemia, Lymphoma Patients |
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December 29, 2004 07:13:29 AM PST
, ACS News Center |
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| Leukemia and lymphoma patients who need a bone marrow transplant
now have a drug to help them cope with one of the treatment's most
common side effects: mouth sores (called oral mucositis). Most patients
develop these mouth sores, which are often painful enough to need
treatment with intravenous narcotics. The US Food and Drug
Administration has approved palifermin (sold as Kepivance), after a
study showed it cut the severity of mouth sores and helped them heal
faster. The study was published in the New England Journal of Medicine (Vol. 351, No. 25: 2590-2598). The
drug is the first to be approved to treat this painful side effect of
the high-dose chemotherapy and radiation needed before a bone marrow
transplant. "Until now the most we could do for our patients
was to give them ice chips and narcotics to try and manage their pain,"
said Patrick Stiff, MD, in a statement. He was one of the study's lead
investigators and is director of the Cardinal Bernardin Cancer Center
at Loyola University Health System. Less Pain with Palifermin Stiff and his colleagues studied 212 people with leukemia, Hodgkin disease, non-Hodgkin lymphoma, or multiple myeloma who were having a bone marrow or stem cell transplant. Half the patients received palifermin, and half were given a placebo. Nearly
all the patients in the study developed some degree mouth sores. But
severe mouth sores were less common and healed more quickly in the
people who received palifermin. Just 68% of those patients developed
grade 3 sores (where the patient can only swallow liquid) or grade 4
sores (where the patient can't eat at all and must be fed through a
vein). By contrast, 98% of the people on placebo reported grade 3 or 4
sores. The sores lasted about 6 days in the patients on palifermin, and
9 days in those on placebo. The people who took palifermin also
had less pain than people on placebo; they used less narcotic pain
medication and didn't need to use it for as long a time. And, fewer
palifermin patients needed vein feeding. Side effects of the
drug included rash, itching, skin tingling and redness, taste changes,
and tongue thickness. These side effects were not severe. The research was funded by Amgen, the drug's maker. Drug Makes Cells Grow Palifermin
is a type of drug known as a keratinocyte growth factor. It is a form
of a human protein. The drug helps the cells lining the mouth grow and
multiply. This action counteracts the damage to the lining of the mouth
caused by the high-dose chemotherapy and radiation given before a bone
marrow transplant. Palifermin is given directly into a vein.
Patients get the drug on each of the 3 days just before high-dose
chemotherapy and radiation, and for 3 more days right after the bone
marrow transplant. So far, palifermin is only approved for use
in patients with leukemia, myeloma or lymphoma who receive high doses
of chemotherapy and radiation therapy followed by stem cell rescue.
Amgen said about 11,000 US adults with blood cancers receive bone
marrow transplants each year. Palifermin is being tested in patients with other types of cancer.
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Dec 29, 2004Dec 23, 2004Dec 22, 2004Dec 17, 2004Dec 13, 2004Dec 09, 2004Dec 06, 2004Nov 29, 2004Nov 23, 2004Nov 22, 2004Nov 19, 2004Nov 12, 2004Nov 08, 2004Oct 25, 2004Oct 22, 2004Oct 11, 2004Oct 05, 2004Oct 01, 2004Sep 27, 2004Sep 24, 2004Sep 21, 2004Sep 07, 2004Sep 03, 2004Aug 27, 2004Aug 26, 2004Aug 19, 2004Aug 18, 2004Aug 17, 2004Aug 05, 2004Jul 29, 2004Jul 28, 2004Jul 26, 2004Jul 23, 2004Jul 15, 2004Jul 14, 2004Jul 13, 2004Jul 06, 2004Jun 30, 2004Jun 28, 2004Jun 24, 2004Jun 18, 2004Jun 14, 2004Jun 09, 2004Jun 07, 2004Jun 01, 2004May 28, 2004May 27, 2004May 26, 2004May 24, 2004May 19, 2004May 14, 2004May 13, 2004May 06, 2004May 03, 2004Apr 30, 2004Apr 27, 2004Apr 26, 2004Apr 19, 2004Apr 16, 2004Apr 07, 2004Apr 05, 2004Mar 30, 2004Mar 18, 2004Mar 16, 2004Mar 15, 2004Mar 10, 2004Mar 05, 2004Mar 04, 2004Mar 03, 2004Mar 02, 2004Mar 01, 2004Feb 27, 2004Feb 24, 2004Feb 20, 2004Feb 17, 2004Feb 13, 2004Feb 10, 2004Feb 09, 2004Feb 06, 2004Feb 03, 2004Jan 28, 2004Jan 27, 2004Jan 22, 2004Jan 16, 2004Jan 13, 2004Jan 09, 2004Jan 07, 2004Dec 23, 2003Dec 22, 2003Dec 19, 2003Dec 18, 2003Dec 16, 2003Dec 03, 2003Dec 02, 2003Dec 01, 2003Nov 26, 2003Nov 25, 2003Nov 19, 2003Nov 17, 2003Nov 13, 2003Nov 12, 2003Nov 06, 2003Nov 05, 2003Nov 04, 2003Nov 03, 2003Oct 29, 2003Oct 27, 2003Oct 23, 2003Oct 22, 2003Oct 17, 2003Oct 15, 2003Oct 13, 2003Oct 10, 2003Oct 09, 2003Oct 06, 2003Oct 02, 2003Sep 30, 2003Sep 24, 2003Sep 17, 2003Sep 15, 2003Sep 12, 2003Sep 10, 2003Sep 03, 2003Aug 04, 2003 |
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