According to results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology, oral administration of the chemotherapy agent Hycamtin (topotecan) produces comparable anti-cancer responses in relapsed non-small cell lung cancer as the intravenous administration of the chemotherapy agent Taxotere® (docetaxel).

Lung cancer remains the leading cause of cancer-related deaths in the United States and Europe. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 75 percent to 80 percent of all lung cancer. Lung cancer type is determined by different types of cells within the lung where the cancer originated. Relapsed NSCLC refers to cancer that has returned or progressed following prior therapy.

The cornerstone of therapy for relapsed NSCLC is chemotherapy. Researchers continue to evaluate novel agents or formulations of agents to improve upon the duration of survival and/or quality of life for patients with this disease. One new approach is the use of chemotherapy agents in oral form instead of intravenous administration (into a vein). Oral administration can save patients visits to medical centers, reduce risks of pain and infection and control medical costs.

A large, multicenter international trial was recently conducted to compare the chemotherapy agent Taxotere to the oral form of Hycamtin in the treatment of relapsed NSCLC. Taxotere is a commonly used chemotherapy agent for relapsed NSCLC that is administered intravenously. Hycamtin is a chemotherapy agent that is approved for intravenous administration in small-cell lung cancer and ovarian cancer. An oral form of Hycamtin is now being evaluated in clinical trials for the treatment of various types of cancers. In this trial, 829 patients with relapsed NSCLC from 140 centers around the world were treated with either oral Hycamtin or intravenous Taxotere.

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Overall, anti-cancer responses or disease stabilization was achieved in 32 percent of patients treated with Hycamtin and in 41 percent of patients treated with Taxotere. The average duration of survival was nearly equal between the two groups of patients: 28 weeks for those treated with Hycamtin and 30 weeks for those treated with Taxotere. Survival at one year was also similar: 25 percent for patients treated with Hycamtin and 29 percent for those treated with Taxotere. Severe side effects included low levels of red blood cells and platelets as well as gastrointestinal symptoms for the group treated with Hycamtin. The Taxotere group experienced low levels of immune cells and alterations in the nervous system. Full-body infections (sepsis) occurred in only 1 percent of patients treated with Hycamtin, whereas 5 percent of patients treated with Taxotere had such complications.

The researchers concluded that oral Hycamtin has significant anti-cancer activity in patients with relapsed NSCLC and has the benefit of an oral formulation. Patients with recurrent NSCLC may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating oral Hycamtin.

Reference: Ramlau R, Gervais M, Drzakowski M, et al. Oral topotecan demonstrates clinical activity in relapsed non-small cell lung cancer. Results from an open-label, phase III study (387) comparing oral topotecan to intravenous docetaxel. Proceedings of the 2005 meeting of the American Society of Clinical Oncology: abstract number 7017.

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