According to results from a Phase III trial, the use of Aranesp® (darbepoetin alfa) in patients with small cell lung cancer (SCLC) being treated with chemotherapy results in improved levels of hemoglobin without affecting progression-free survival or overall survival.

Anemia is a common side effect of chemotherapy and cancer. It is characterized by low levels of circulating red blood cells, which are responsible for delivering oxygen to tissues throughout the body. Anemia is often measured by levels of hemoglobin, which is a component of red blood cells. Common symptoms of anemia are severe fatigue, shortness of breath, diminished activity levels, and a reduced overall feeling of well-being.

Severe anemia often requires treatment with blood transfusions, which have associated risks of infection, rejection, and increased medical costs. Furthermore, severe anemia may cause a delay in cancer treatment, resulting in less favorable chances of a cure or optimal long-term survival.

Use of medications to treat anemia caused by chemotherapy has been shown to have several benefits in cancer patients, including improved quality of life and decreased need for blood transfusions. Medications such as Procrit® (epoetin alfa) and Aranesp® (darbepoetin alfa) stimulate the body to produce more red blood cells, ultimately reducing anemia and its long-term effects. Controlled clinical trials have already demonstrated Aranesp’s ability to reduce the need for blood transfusions and improve quality of life among patients with various types of cancers whose anemia is caused by treatment with chemotherapy. Aranesp is currently approved by the FDA for the treatment of patients with non-hematologic (not originating from the blood) cancers who have anemia caused by treatment with chemotherapy.

Results from a recent study evaluating Aranesp among cancer patients with anemia caused by the disease itself versus anemia caused by treatment with chemotherapy demonstrated that Aranesp did not improve outcomes and may have reduced survival among these patients. However, because results from previous studies have demonstrated that Aranesp reduces blood transfusions and may improve survival when used according to its FDA indication, researchers continue to evaluate Aranesp in cancer patients treated with chemotherapy.

Recently, researchers conducted a Phase III, multi-center trial, referred to as the “145 study” to further evaluate Aranesp in the treatment of patients with SCLC. This trial included 600 patients who were treated with initial chemotherapy including a platinum compound (Platinol® or Paraplatin®). One group of patients received Aranesp while the other group received placebo (inactive substitute). Patients were treated with Aranesp or received placebo every week for the first four weeks, followed by once every three weeks for 24 weeks or until their hemoglobin reached a target level.

  • There were no significant differences in progression-free survival or overall survival between the two groups of patients.
  • Patients treated with Aranesp had a greater improvement in hemoglobin levels than those who received placebo.
  • Red blood cell transfusions were reduced by 60% among patients treated with Aranesp compared with those who received placebo.

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The researchers concluded that these results provide further evidence that when Aranesp is used among cancer patients who are undergoing chemotherapy, hemoglobin levels may be improved and red blood cell transfusions may be significantly reduced without affecting survival. However, it is important for patients with cancer undergoing treatment to discuss with their physician their individual risks and benefits of treatment with Aranesp.

Reference: Amgen. Aranesp® “145 Study” shows no difference in survival in patients with small-cell lung cancer. Available at: . Accessed April 2007.

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