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.
As an advocate in the war against all cancers and a person who has focused on cancer issues related to cervical cancer for the past decade, I am excited by the addition of another treatment option in the fight against late-stage cervical cancer.
Often, when a cancer is found to be in a later stage, too little is done to help provide "opportunities of hope" in the battle against that patient's disease. With the recent (June 14, 2006) FDA approval of topotecan (Hycamtin) in combination with cisplatin (TC) for the treatment of stage IVB recurrent or persistent cervical cancer, patients and their family members can now discuss with their clinician whether this additional treatment option might benefit them in their personal cancer battle.
Patients who are members of the National Cervical Cancer Coalition (NCCC) and others undergoing treatment for stage IVB recurrent or persistent cervical cancer will be glad to know of the study that provided the basis for the FDA's approval. The results of this randomized, multicenter Gynecologic Oncology Group-sponsored study (GOG-0179) indicated that there were clinically relevant and statistically significant improvements in overall survival for the patients who received topotecan plus cisplatin, compared to cisplatin monotherapy.
Cervical cancer is the third most common gynecologic cancer among American women. The prognosis for patients diagnosed with cervical cancer is often positive when the disease is caught early. With some exceptions, however, positive outcomes drop dramatically for patients with late-stage disease. It is for these women that we are encouraged about the existence of this new treatment option in the war on cancer.
Alan M. Kaye
The author has no significant financial interest or other relationship with the manufacturers of any products or providers of any service mentioned in this article.