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      New Cancer Drugs, Azacitidine and Kepivance, Benefit Patients But May Present Challenges for Oncology Nurses: Presented at ONS

      By Bonnie Darves

      PHOENIX, AZ -- November 14, 2005 -- The rate at which new cancer drugs have come on to the market in recent years is a boon for patients who have failed other therapies but can present challenges for nurses who are trying to keep up with developments in this fast-changing arena.

      In their new drug update here at the Oncology Nursing Society 6th Annual Institutes of Learning (ONS), presenters highlighted 5 new drugs that are delivering a therapeutic advantage in the treatment of rare and common cancers and discussed the potential adverse effects that patients may experience.

      "I kiddingly say that I'm the pessimist of the group, always looking at what does or can go wrong with medications," said Debbie Sisson, RPh, MS, a pharmacist at St. Mary's Medical Center, and an educator, University of Minnesota College of Pharmacy, Duluth, Minnesota, in a presentation on November 11th.

      "The new agents have many benefits," she said. But she cautioned that nurses must know what to look for before starting patients on treatment, and the kinds of adverse effects and drug interactions they are at risk of developing.

      Copresenter Deb Thompson, RN, BA, oncology clinical research nurse, Duluth Clinic Cancer Center, Duluth, Minnesota, discussed the advantages to the patient of the agents approved in the last 18 months in the context of the nursing and medical management challenges they pose.

      Azacitidine (Vidaza)
      This new antineoplastic agent, which works by interfering with nucleic acid metabolism, and thus disrupting DNA, was developed primarily to treat myelodysplastic syndrome (MDS) -- its only Food and Drug Administration (FDA)-approved use.

      Prior to its May 2004 approval, patients with MDS had no active treatment options. Ms. Sisson noted that Vidaza is also being used with some success for treatment of refractory acute myelogenous leukemia (AML), and is being considered for other blood disorders and some solid tumors. "I think there is great potential for Vidaza in other tumors, too," she said.

      "One of the biggest benefits is that Vidaza eliminates the need for transfusions," Ms. Thompson said. She added that the drug, primarily given intravenously but also subcutaneously as appropriate, is contraindicated for patients with malignant hepatic tumors and may be dangerously toxic to those with liver impairment.

      The drug is generally administered in once-monthly 7-day cycles, at a dose of 75 mg/m2, but may be increased to 100 mg after 2 treatment cycles.

      Azacitidine: Monitoring and Management
      Like many other cancer agents, azacitidine's chief adverse effect is nausea, which can be severe and affects up to 70% of patients. Ms. Thompson noted that it is imperative to premedicate patients to prevent the nausea and potential vomiting before administering the drug.

      Anemia and thrombocytopenia also occur frequently, and about half of patients also develop pyrexia and leukopenia.

      Between 50% and 95% of azacitidine metabolites are excreted through the kidneys, so patients should be checked for renal function prior to the drug's administration and periodically throughout and immediately following the 7-day regimen. "This is especially important for older patients," Ms. Thompson said.

      Hepatic function should also be monitored frequently, even in patients without known impairment, Ms. Sisson urged.

      Ms. Thompson also recommended advising patients to increase fluids and fiber intake before starting the drug because of the potential for diarrhea.

      Kepivance (palifermin)
      This new agent, which targets and stimulates growth in epithelial cells in the mouth and gastrointestinal (GI) tract, has emerged as a promising new treatment for the notoriously difficult-to-treat mucositis that occurs in patients with hematologic malignancies undergoing chemotherapy.

      Kepivance, which is a human keratinocyte growth factor produced by recombinant DNA technology in Escherichia coli, is currently under investigation for treatment of oral mucositis in patients with solid tumors, especially head and neck.

      "Until now, we only had ice chips and narcotics to [manage] mucositis, so that is what makes this drug unique -- it's a new way to help our patients feel better," Ms. Thompson said.

      Studies have found that Kepivance can decrease both the incidence and duration of severe mucositis by up to 50%. The drug also has been found to decrease the need for opioids and total parenteral nutrition, enabling patients to return to eating sooner.

      The drug is generally given in intravenous doses of 60 mcg/kg once daily for 3 days before and 3 days after chemotherapy. Pediatric use is not approved but is being considered by the FDA.

      Kepivance: Monitoring and Management
      One of the chief concerns with Kepivance is timing of administration. It should never be given within 24 hours of chemotherapy initiation because of the possibility that it could worsen the mucositis, Ms. Thompson noted. "There is the possibility that the drug could essentially 'attack' what we're trying to fix" with chemotherapy, Ms. Sisson added.

      Another chief consideration is that Kepivance binds to heparin.

      The drug's most common adverse effects are skin problems such as rash and itching, and tongue changes -- ranging from thickness and discoloration to taste disturbances.

      "When you're trying to get people to eat, and make sure they get their nutrition going, having a taste disturbance isn't a side effect you want them to have," Ms. Thompson said. She added, however, that the skin effects were both the most frequent (between approximately 30% and 60% developed them) and most serious of the adverse events.

      However, patients can "prepare" for those potential adverse effects because they tend to emerge about a week after the first 3 doses, she noted. The taste disturbance lasts roughly 5 days.

      Edema and fever occur in approximately 30% and 40% of patients, respectively.

      Ms. Sisson cautioned that longer-term data on the drug should be sought because of the fact that it stimulates cell growth -- which could be a concern if the drug were found to spur cell growth in areas outside the mouth and GI tract.


      [Presentation title: New Drug Update.]



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