Drugs Xagena
The FDA ( Food and Drug Administration ) has approved a combination of Hycamtin ( Topotecan ) and Cisplatin for use as the first drug treatment for women with late-stage ( stage IVB ) cancer of the cervix when surgery or radiation therapy are unlikely to be effective.
Hycamtin was approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.
In clinical trials, a total of 293 patients were randomized to Hycamtin plus Cisplatin or to Cisplatin alone.
Most of the participants had received prior radiation therapy as the standard treatment, while some may have undergone prior surgery.
The combination therapy significantly improved survival compared to the use of Cisplatin alone. Patients on combined therapy survived ( 9.4 months ), about three months longer than patients on Cisplatin alone ( 6.5 months ).
Hycamtin is associated with a significant risk of neutropenia, a condition which makes it more difficult for the body to fight infections. Serious side effects also include thrombocytopenia, a decrease in blood platelets that can lead to excessive bleeding and anemia.
Less serious side effects include nausea and vomiting.
The incidences of neutropenia, anemia, and thrombocytopenia were significantly increased among patients receiving the combination treatment compared to those receiving Cisplatin alone, as were nausea and vomiting, mucositis, rash, and liver toxicity.
In the United States there are an estimated 10,000 new cases of cervical cancer and about 3,700 related deaths each year.
Source: FDA, 2006
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