To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ECCO: Hycamtin Effective In Combination Therapy For Ovarian Cancer URL: http://www.pslgroup.com/dg/12EA6E.htm Doctor's Guide September 21, 1999
VIENNA, AUSTRIA -- September 21, 1999 -- SmithKline Beecham's Hycamtin (topotecan hydrochloride for injection) and carboplatin alternated with paclitaxel and carboplatin are safe as first-line therapy in patients with advanced epithelial ovarian cancer, according to study results presented at the 10th annual meeting of the European Conference on Clinical Oncology (ECCO).
Hycamtin is indicated for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. The drug is not indicated presently for first-line ovarian cancer therapy.
This phase I study was presented by Alan Gordon, M.D., the Director for Research in Gynecology, US Oncology, a large network of cancer-care professionals.
The study was designed to assess the maximum tolerated dose of Hycamtin in combination with carboplatin alternating with paclitaxel and carboplatin as first-line treatment in patients with newly diagnosed advanced epithelial ovarian cancer, a disease that is rarely curable.
The results showed the maximum tolerated dose of Hycamtin for this combination regimen to be 1.0 mg/m2 given in 30-minute infusions over three days. Phase II trials to determine the efficacy of Hycamtin in combination at this dose are scheduled to begin this year.
"Historic trends in the treatment of ovarian cancer have shown that when an active agent is introduced early in the patient's therapy, there have been improvements in survival," said Dr. Gordon.
"Comparative clinical trials have shown that Hycamtin is as effective as paclitaxel as a single agent in patients with recurrent ovarian cancer. By adding the active agent Hycamtin as a part of the standard first-line combination regimen of carboplatin and paclitaxel, we hope to continue to improve survival in these patients."
In this Phase I study, patients received the following treatment: on Day 1, intravenous carboplatin at a dose of area under the curve (AUC) 4 or 5; intravenous Hycamtin 0.6 mg/m2 over 30 minutes daily on Days 1 through 3 for four 21-day cycles, alternating with paclitaxel 175 mg/m2 over three hours and carboplatin at an AUC 4 or 5 for four cycles. The dose of Hycamtin was gradually increased up to 1.0 mg/m2 30 minutes daily for three days, the highest dose tolerated without G-CSF support.
Results show 1.0 mg/m2 for three days was the maximum tolerated dose of Hycamtin in this combination regimen. In addition, of the evaluable patients who completed treatment (n=30), 26 patients had CA 125 normalization (a common ovarian cancer marker), indicating positive responses to the treatment. Dose delays were seen in 40 percent of courses but were usually less than seven days.
Myelosuppression was observed frequently; however, recovery was rapid and the effects were non-cumulative.
"The establishment of a maximum tolerated dose of Hycamtin in first-line combination is an important first step to developing a new regimen to try and improve outcomes for patients with ovarian cancer," added Dr. Gordon.
Ovarian Cancer
Ovarian cancer is one of the most common gynecological cancers and the fifth most common cancer among women in the United States. 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 tumors, each named for the type of cells they start from. Epithelial ovarian cancer starts in the epithelial cells, which are the cells that cover the surface of the ovary. Eighty-five to 90 percent of 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.
A Novel Mechanism of Action
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 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.
Born of a 1999 merger between the nation's top oncology care companies-American Oncology Resources and Physician Reliance Network-US Oncology is the country's largest network of community physicians, clinicians, nurses and administrators focused exclusively on cancer care and research. With an expanding network of over 750 oncologists and more than 50 cancer centers spanning 25 states, US Oncology is advancing the delivery of cancer care faster than anyone.
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