Key Facts & Statistics

Prevalence of Ovarian Cancer

  • 7th most common cancer among women, excluding non-melanoma
    skin cancers
  • Accounts for 3% of all cancers in women
  • About 1 in 58 women will develop ovarian cancer (1.7%)
  • About 1 in 98 women will die from ovarian cancer (1.0%)
  • Slightly more common in white women than black women
  • About two thirds of women who develop the disease are 55 or older

Estimates for 2006

The American Cancer Society estimated new cases and deaths from ovarian cancer in the United States:
  • 20,180 new cases
  • 15,310 deaths

Survival

  • 76% survive 1 year after diagnosis
  • 45% survive longer than 5 years after diagnosis
  • Survival rates are better in women younger than age 65
  • 5-year survival rate is 94% if the cancer is diagnosed and treated prior to spreading outside the ovary. Unfortunately, only 19% of ovarian cancers are found at this early stage

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.


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