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The United States Food and Drug Administration (FDA) has approved an oral capsule formulation of the chemotherapy agent Hycamtin® (topotecan) for the treatment of relapsed small cell lung cancer (SCLC).

Small cell lung cancer accounts for approximately 25% of all lung cancers. “Small cell” refers to the type of cell within the lung where the cancer originated. SCLC is considered a very aggressive type of cancer and responds well to chemotherapy. However, a large portion of patients who respond to initial therapy will experience a recurrence, or relapse of their disease.

Following a relapse, patients often respond to subsequent chemotherapy. However, the usual intravenous (IV) formulation of chemotherapy must be administered during an office visit, which places time and financial burdens on patients and medical facilities. As well, IV administration in associated with the potential for pain, anxiety, and infection. An oral formulation of chemotherapy that the patient is able to take at home may relieve many negative factors associated with IV administration.

The clinical trial that prompted the FDA approval of oral Hycamtin included 141 patients with SCLC who had received prior chemotherapy. Patients were not considered eligible for IV therapy. One group of patients was treated with best supportive care (care to maintain quality of life and reduce symptoms), and one group was treated with Hycamtin plus best supportive care (BSC).

  • Patients treated with Hycamtin had a 36% reduced risk of death compared with those treated with BSC.
  • Median survival was nearly 26 weeks for patients treated with Hycamtin compared with nearly 14 weeks for those treated with BSC only.
  • Low levels of blood cells and nausea were the most common side effects associated with Hycamtin.
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The researchers concluded: “This was the first randomized study ever to demonstrate that patients with relapsed SCLC live longer when they are treated with BSC and chemotherapy compared to BSC alone.” Patients with relapsed SCLC may wish to speak with their physician regarding their individual risks and benefits of oral Hycamtin.

Reference: GlaxoSmithKline. GSK receives approval for Hycamtin® (topotecan) capsules for the treatment of relapsed small cell lung cancer. Available at: . Accessed October 2007.

Related News:Hycamtin® Improves Survival in Patients with Relapsed Small Cell Lung Cancer (12/6/2006)

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