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| |  ASCO MEETING: Hycamtin Shows Positive Study Results In First-Line Ovarian Cancer Therapy ATLANTA, GA -- May 17, 1999 -- New study results demonstrate that treatment with SmithKline Beecham's Hycamtin(R) (topotecan hydrochloride for injection) and cisplatin followed by treatment with paclitaxel and cisplatin shows activity as first-line therapy in patients suffering from advanced epithelial ovarian cancer (EOC). The results, presented today at the 35th annual meeting of the American Society for Clinical Oncology (ASCO), showed an 81 percent response rate in patients treated sequentially with Hycamtin and cisplatin, followed by cisplatin and paclitaxel. Hycamtin is indicated for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. Hycamtin is not currently indicated for first-line ovarian cancer therapy. The study, presented by Paul Hoskins, M.D., for the National Cancer Institute of Canada Clinical Trials Group, was designed to assess the efficacy and safety of the combination of Hycamtin and cisplatin in sequence with cycles of cisplatin and paclitaxel in patients with advanced epithelial ovarian cancer, a disease that is rarely curable. More than 25,000 women are diagnosed with ovarian cancer in the United States and nearly 15,000 women die from the disease each year. EOC accounts for 85 to 90 percent of ovarian cancers. "There is a critical need to identify new agents that can be used to treat advanced EOC. These pilot data show that by adding Hycamtin to the current standard therapy of cisplatin and paclitaxel, we can achieve high clinical response rates," said Elizabeth Eisenhauer, M.D., director, investigational new drug program, National Cancer Institute of Canada, Clinical Trials Group, Queens University in Ontario. "This approach allows the incorporation of an additional active agent in the treatment of patients with ovarian cancer but needs further evaluation before we can know if it leads to improved outcomes." In this phase II study, patients with advanced EOC received cisplatin 50 mg/m (squared) intravenously on day one and Hycamtin .75 mg/m2 intravenously over 30 minutes daily for five days for four 21-day cycles, followed by paclitaxel 135 mg/m2 over 24 hours on day one and cisplatin 75 mg/m2 on day two for four cycles. Of the evaluable patients who completed treatment, 81 percent responded to treatment, confirmed by second-look surgery. In addition, 64 percent of evaluable patients who began the study had CA 125 normalisation (a common ovarian cancer marker) during the first four cycles of Hycamtin and cisplatin, indicating positive responses to the treatment. The non-hematologic toxicity was primarily grade 1/2. Non-hematologic grade 3/4 toxicities were primarily gastrointestinal (such as nausea, loss of appetite, constipation). Eighty-six percent of patients experienced grade 3/4 neutropenia while receiving the Hycamtin/cisplatin combination. Dose reductions for topotecan were required in 12 percent of courses and the treatment was delayed in 46 percent of courses. Ovarian cancer is one of the most common gynaecological cancers and the fifth most common cancer among women in the U.S. Ovarian cancer starts in the ovary, the female reproductive organ that is the main source of the hormones estrogen and progesterone. There are three main types of ovarian tumours, each named for the type of cells they start from. EOC starts in the epithelial cells, which are the cells that cover the surface of the ovary. Most ovarian cancers are of this type. Women who are at a higher risk for ovarian cancer include women over 60, women who have never had children and women who have been diagnosed with breast, intestinal or rectal cancer. If diagnosed and treated at an early stage, the five-year survival rate from ovarian cancer is 90 percent. However, the five-year survival rate for all stages combined is 42 percent because only 23 percent of cases are detected at an early stage. Hycamtin was the first in a class of drugs known as topoisomerase I inhibitors that kill cancer cells by inhibiting the enzyme topoisomerase I, which is essential in the replication of DNA in human cells. Hycamtin has been studied in over 200 clinical trials and is under clinical investigation for a number of other cancers including as first-line combination chemotherapy in patients with ovarian cancer, non-small cell lung cancer, and colorectal cancer, as well as lymphoma, myeloma and leukemia, breast cancer and pediatric cancers. Related Links: Hycamtin, SmithKline Beecham
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