Sharyn N. Lewin, MD

For women with a gynecologic cancer, reproductive concerns may vary not only by site of disease but also by the presentation and manifestation of the disease. Gynecologic cancer can present before childbearing has been started or completed, during pregnancy, or can even arise out of pregnancy.

Topotecan, a camptothecin analog previously approved for the treatment of ovarian cancer and small-cell lung cancer, was granted regular approval by the US Food and Drug Administration (FDA) on June 14, 2006, for use in combination with cisplatin to treat women with stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The purpose of this summary is to review the database supporting this approval.