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In this study, patients with relapsed and resistant myeloma who received Hycamtin as a single-agent therapy demonstrated a 16 percent response rate and a median survival time of 28 months. These results are comparable to those seen with other effective drugs used as single-agent therapies in refractory and relapsed disease. Hycamtin is available for the treatment of recurrent, metastatic ovarian cancer and is not currently indicated for use in the treatment of multiple myeloma.
"There is a great need to identify new agents that can be used to treat patients with relapsed and refractory multiple myeloma, since second-line treatment is very challenging and the prognosis is poor for most patients. The activity we observed with Hycamtin as a single-agent therapy is encouraging, and we plan to study this drug in combination with other agents in the treatment of multiple myeloma patients," said Eric H. Kraut, M.D., Ohio State University, and lead study investigator.
In this phase II clinical trial, patients (n=46) with refractory or relapsed multiple myeloma who had received one prior chemotherapy treatment were administered Hycamtin 1.25 mg/m(2) as a 30 minute infusion for five consecutive days every three weeks. Patients received a median of four cycles of Hycamtin. Some patients also received granulocyte-colony stimulating factor (G-CSF) if they developed grade three or four neutropenia following the first course of chemotherapy. The median time from first treatment for multiple myeloma to the initiation of treatment with Hycamtin was 13 months.
Forty-three patients were evaluable for response; the overall response rate was 16 percent (response was defined as at least a 50 percent reduction in monoclonal protein levels in the blood). Patient responses were sustained at least 70 days, with some patients responding for more than 477 days. The median progression-free survival time was 13 months, and the median survival time was 28 months.
"This study is significant because most agents demonstrate little activity as a single-agent for relapsed myeloma in clinical studies. Response rates are usually higher when combination treatments are used, so we look forward to seeing results from combination studies involving Hycamtin," said Kraut.
As with most chemotherapeutic agents, the most commonly reported side effect was myelosuppression which was dose-limiting. Thrombocytopenia and anemia were also frequent complications. More than half the patients experienced mild vomiting or diarrhea.
Multiple myeloma is a cancer of the bone marrow that is related to leukemia or lymphoma and is characterized by an uncontrolled growth of plasma cells. In otherwise healthy adults, plasma cells comprise less than 5 percent of bone marrow cells. People with multiple myeloma, however, have large numbers of plasma cells in their bone marrow (usually >10 percent and often >90 percent of bone marrow cells).
Multiple myeloma accounts for about 10 percent of all hematologic cancers. An estimated 12,000 new cases occur each year. The disease is most common among individuals ages 50-70, with peak incidence occurring between ages 60-65. Median survival time with currently used single-agent therapies is 6 to 25 months.
Recent studies have demonstrated that Hycamtin is active in other malignancies including lung cancer, myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). In 1997, SmithKline Beecham filed a supplemental new drug indication for the use of Hycamtin in the second-line treatment of small cell lung cancer. Hycamtin has been studied in over 200 clinical trials and is also being investigated for a number of other cancers including breast, colorectal and pediatric cancer, acute and chronic leukemia, as well as first-line combination chemotherapy in patients with ovarian cancer.
Hycamtin, which is available for use in the United States in the treatment of recurrent, metastatic ovarian cancer, is also cleared for second-line treatment of ovarian cancer in 15 European Union (EU) member countries and is under review with regulatory authorities in other major markets around the world. This class of drugs kills cancer cells by inhibiting the enzyme topoisomerase I, an enzyme which is essential in the replication of DNA in human cells.
Hycamtin (generic name: topotecan) and CPT-11 are both topoisomerase inhibitors...a fairly 'new' (in terms of being available clinically) drug. As described in this article, topotecan is approved for use with ovarian cancer and CPT-11 is approved for use with colon cancer. Physicians may explore the use of these agents with other cancers, but data is still being collected.
Hycamtin Single Therapy Effective In
Multiple Myeloma http://www.pslgroup.com/dg/5bfee.htm