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| |  ASCO: Hycamtin (Topotecan Hydrochloride) Plus Cisplatin Promising Against Ovarian Cancer NEW ORLEANS, LA -- May 23, 2000 -- A new study demonstrates that treatment with Hycamtin® (topotecan hydrochloride for injection) in combination with cisplatin is an active first-line therapy in patients with ovarian cancer. The study was coordinated at New York University Medical Center by Howard Hochster, M.D., F.A.C.P., associate professor of clinical medicine, and James Speyer, M.D., professor of clinical medicine, in conjunction with New York Gynecologic Oncology Group (NYGOG) and the Eastern Cooperative Oncology Group (ECOG). The results, presented at the 36th annual meeting of the American Society for Clinical Oncology (ASCO), showed a 93 percent response rate in previously untreated patients with ovarian cancer who were given continuous infusion Hycamtin together with full doses of cisplatin. The study evaluated the efficacy and safety of the combination of Hycamtin and cisplatin in a population of patients with varying stages of ovarian cancer who had not received any prior treatment. The Hycamtin and cisplatin regimen was shown to be as effective as paclitaxel in combination with cisplatin, the current standard of care for first-line ovarian cancer treatment. The study showed that among the 43 patients with stage III/IV disease who were evaluable for response in the Hycamtin study, the overall response was 93 percent, including a 47 percent complete response rate and a 47 percent partial response rate. The median time to progression was 20 months. Median survival has not been reached, but at this point it is greater than 22 months of follow-up. Hycamtin is indicated for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. The drug is not indicated currently for first-line ovarian cancer therapy. "Clinical trials have shown that Hycamtin is an effective treatment for patients with recurrent ovarian cancer. In combination with cisplatin, Hycamtin can kill more cancer cells, but tends to depress blood counts. Our research has looked at novel schedules of Hycamtin for a number of years. This is the first which is feasible for combining Hycamtin with standard doses of cisplatin," said Dr. Hochster, the study's lead investigator. Sixty patients entered the study, but after four patients were treated with 0.4 mg/m2/day dose of Hycamtin as a continuous 21-day infusion and myelosuppression occurred, the protocol was amended. The remaining 56 patients were treated with a 0.3mg/m2/day dose of Hycamtin per day for 14 days continuously with a 75 mg/m2 dose of cisplatin on day one. The median number of courses was five. One patient had stage I disease, four had stage II, 41 had stage III and 10 had stage IV disease. Of the five patients with stage I/II, none had evidence of disease at completion of treatment. Of the 51 patients with stage III/IV disease, 47 percent had a complete response to treatment, another 47 percent had a partial response to treatment and eight were inevaluable after one treatment cycle. The median time to progression was 20 months. Median survival has not been reached, but at this point it is 20-plus months. As with many chemotherapeutic agents, the most common side effects were grade 3/4 neutropenia (decreased white blood cell counts), grade 3/4 thrombocytopenia (decreased blood platelet counts) and grade 2/3 anemia. The non-hematologic toxicity was primarily grade 2/3 gastrointestinal (i.e., nausea, loss of appetite, constipation). Ovarian cancer is one of the most common gynecological 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 estrogen and progesterone. There are three main types of ovarian tumors, each named for the type of cells they start from. 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, 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 is 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 non-small cell lung cancer and colorectal cancer. Related Link: Hycamtin (topotecan hydrochloride).
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