Prevalence of Cervical Cancer

3rd most common gynecologic malignancy
Typically affects women between the ages of 35 and 55
About 20% of women with cervical cancer are diagnosed after age 65
Occurs most often in Hispanic women
African American women develop this cancer about 50% more often than non-Hispanic white women

Estimates for 2006

The American Cancer Society estimated new cases and deaths from cervical cancer in the United States:

9,710 new cases
3,700 deaths

Survival

45% of patients survive longer than 5 years after diagnosis
5-year survival rate is approximately 73%; the survival rate is 92% if found at the earliest stage
The death rate continues to decline by nearly 4% a year

Important Safety Information

Contraindications

Hycamtin is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or to any of its ingredients. Hycamtin should not be used in patients who are pregnant or breast-feeding, or those with severe bone marrow depression.

Warnings

Hycamtin should be used only in patients with adequate bone marrow reserves, including baseline neutrophil counts of at least 1,500 cells/mm³ and platelet counts of at least 100,000/mm³. Frequent monitoring of blood counts should be instituted during treatment with Hycamtin.

Patients should not be treated with subsequent courses of Hycamtin until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary).

Hycamtin may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Hycamtin.

Drug Interactions

Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until day 6 of the course of therapy, 24 hours after completion of treatment with Hycamtin.

Myelosuppression was more severe when Hycamtin was given in combination with cisplatin in phase I studies. In a reported study on concomitant administration of cisplatin 50 mg/m² and Hycamtin at a dose of 1.25 mg/m²/day x 5 days, 1 of 3 patients had severe neutropenia for 12 days, and a second patient died with neutropenic sepsis. There are no adequate data to define a safe and effective regimen for Hycamtin and cisplatin in combination.

Adverse Events

Frequently reported nonhematologic adverse events associated with use of Hycamtin included nausea (64%), vomiting (45%), diarrhea (32%), alopecia (49%), fatigue (29%), and dyspnea (22%). Most nonhematologic toxicities were grade 1 or 2.

Home | Prescribing Information for Hycamtin

This site is intended for US healthcare professionals only.
© 1997-2008 GlaxoSmithKline. All Rights Reserved.
Legal Notices | Privacy Statement | Medicine Savings | Contact Us