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Hycamtin (Topotecan) Shows Efficacy In Some Ovarian Cancer Patients PHILADELPHIA, PA -- February 29, 2000 -- New study results demonstrate that one-third of patients with recurrent ovarian cancer who are categorized as platinum-sensitive respond to treatment with Hycamtin(R) (topotecan hydrochloride for injection). The multicenter study, conducted by the Gynecologic Oncology Group (GOG) and published this week in the March issue of the Journal of Clinical Oncology, is the first to evaluate the efficacy of Hycamtin specifically in the platinum-sensitive patient population (defined as those patients who experience a relapse six or more months after prior treatment). The study results provide a potential alternative to platinum-based retreatment for this population. Patients treated with multiple courses of platinum-based chemotherapies are at increasing risk for cumulative adverse events with each additional course of therapy. Designed to evaluate the efficacy and safety of Hycamtin among platinum-sensitive patients, the study elicited a response rate of 33 percent, with an additional 48 percent of patients experiencing stable disease. The median duration of response for all responders was 11.2 months. "Given its non-cumulative toxicity profile and the response rates seen in this study, Hycamtin offers patients an effective and tolerable alternative to retreatment with first-line agents," said lead investigator William McGuire, M.D., director of chemotherapy services, Gynecologic Oncology Center, Mercy Medical Center, Baltimore, MD, and clinical professor of medicine, University of Mississippi School of Medicine, Jackson, Miss. "The encouraging response rate and median duration of response seen in this study further indicates that use of Hycamtin, already known to be an active drug in ovarian cancer, offers another therapeutic option in platinum-sensitive patients." The study enrolled 48 patients who were administered Hycamtin intravenously for 30 minutes at a starting dose of 1.5mg/m2 daily for five consecutive days every three weeks. Patients had received no more than two prior platinum-based treatment regimens and had intervals of at least six months between the most recent platinum therapy regimen and study entry. Dose level modifications allowed for dose reduction to 1.0 mg/m2 when significant hematologic toxicity was unresponsive to granulocyte colony stimulating factor or G-CSF (white blood cell growth factor), and dose increase to 2.0 mg/m2 for grade 0 or 1 hematologic toxicity in the prior course of therapy. Of the patients enrolled in the study, 46 were evaluable for response and 47 for safety. Among the patients responding to treatment with Hycamtin, there were two complete responses and 13 partial responses. The median time to response was 2.5 months, or three courses, and the median progression-free interval in all patients was 9.6 months. Severe neutropenia (decreased white blood cell counts) occurred in 91 percent of patients and it was associated with fever in 15 percent of patients. Forty-five percent of patients were administered G-CSF during subsequent courses of therapy. Severe thrombocytopenia (decreased blood platelet counts) was seen in 23 percent of patients. Ninety-one percent of patients reported some degree of anemia with 44 percent of patients requiring red blood cell transfusions during therapy. Fatigue was reported in 32 percent of patients and resulted in a number of patients deciding to discontinue therapy prior to clinical progression. The rate of therapy discontinuation due to fatigue is unique to this study and is unlike that seen in previous studies with Hycamtin. "Currently, patients with recurrent ovarian cancer are often retreated with platinum-based therapies, sometimes resulting in cumulative toxicities," said Dr. McGuire. "These promising study results indicate that using Hycamtin after patients relapse from their initial ovarian cancer treatment may generate responses comparable to those seen with platinum-based retreatment." Ovarian cancer is one of the most common gynecologic cancers and the fifth most common cancer among women in the United States. 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. Ovarian cancer starts in the ovary, the female reproductive organ that is the main source of the estrogen and progesterone hormones. Most ovarian cancer originates in the epithelial cells (known as epithelial ovarian cancer), which are the cells that cover the surface of the ovary. 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, uterine, 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. Hycamtin is indicated for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. The main side effects experienced with Hycamtin are low blood counts, which can make patients more susceptible to infection and bleeding. In some cases, these complications can be life-threatening. The most commonly observed side effects are low-grade nausea, vomiting, hair loss and diarrhea. Hycamtin should not be used in patients who have a history of allergic reactions to Hycamtin or any of its ingredients and should not be used in patients who are pregnant or breast-feeding, or those with low blood counts. Side effects may be more severe if Hycamtin is given with other chemotherapies. SmithKline Beecham Oncology is committed to the research, development, manufacture and marketing of therapeutic and supportive care products in oncology. Currently, SmithKline Beecham Oncology markets Hycamtin(R) (topotecan hydrochloride), Kytril(R) (granisetron hydrochloride), and Compazine(R) (prochlorperazine) and has novel agents in development. Related Links: Hycamtin (topotecan hydrochloride for injection) and SmithKline Beecham. E-mail this page to a friend or colleague! To print, use this version