ROCHESTER, MINN. ó Mayo Clinic Cancer Center is one of nine medical centers nationwide who participated in a multicenter study leading to a new drug therapy now available for patients with carcinoid syndrome. The new drug therapy, a long-acting formulation of octreotide acetate, recently received Food and Drug Administration approval for widespread use. During the multicenter study, nine medical centers monitored 78 patients suffering from carcinoid syndrome, 24 of whom were seen at Mayo Clinic. Carcinoid syndrome is a rare condition ó approximately five new cases in every one million people are diagnosed each year ó resulting from metastatic carcinoid tumors. These neuroendocrine tumors are generally slow growing and may not cause symptoms initially, but in some individuals they secrete excess hormones that cause severe diarrhea, pronounced flushing and wheezing. Individuals with carcinoid syndrome can experience 12 or more episodes of severe diarrhea in one day, a condition that is not only debilitating but could be life-threatening if left untreated.
Previous drug therapy using octreotide acetate required patients to give themselves three subcutaneous injections per day to control symptoms. Octreotide acetate LAR (long-acting release) is a formulation that will relieve the symptoms of carcinoid syndrome with a single, monthly intramuscular injection given at a physicianÃs office.
Octreotide acetate mimics the naturally occurring hormone somatostatin. Somatostatin regulates several important functions in the body, including inhibiting release of growth hormone and insulin growth factor (IGF-1). It can also have an effect on secretions and motility of the bowel.
Joseph Rubin, M.D., Mayo Clinic medical oncologist, and a team of Mayo Clinic physicians and allied health staff, studied the effectiveness of octreotide acetate LAR for the relief of carcinoid syndrome. "This study looked at three different dose levels of the long-acting preparation as well as a control group using the subcutaneous preparation and found that the once-monthly injection was as effective as the three-times-daily preparation," says Dr. Rubin. "The study also showed that it was safe and well tolerated. Many patients stated they felt much better on the LAR. It is not known whether this was because of higher maintained levels of the drug or simply because they werenÃt reminded of their cancer as they injected themselves three times a day."
Edward Bosworth, a patient from Ridgway, Colo., who participated in the study conducted by Dr. Rubin at Mayo Clinic, said he is looking forward to the FDA approval of this drug therapy. "ItÃs primarily a matter of convenience and also an improvement over the three-times-a-day subcutaneous injection," said Bosworth. "ItÃs not only much more convenient; it seems to be much more effective." Other patients are also enthusiastic about the commercial availability of octreotide acetate LAR. "A number of patients with carcinoid syndrome who were unable to participate in the study are anxiously awaiting the availability of the new preparation and ask their Mayo Clinic physicians at each visit how much longer they will have to wait," Dr. Rubin reports. "The approval of octreotide acetate LAR will be good news for them."
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