Detection & Diagnosis
Diagnosing ovarian cancer is critical to patient survival. When found at a localized stage, approximately 90% of women will live longer than 5 years after diagnosis. [22] Unfortunately, only about 25% present with localized disease at diagnosis. [22]

There is currently no established and effective screening for ovarian cancer. There is also a concern that false-positive test results from screening with serum markers such as CA 125 levels, transvaginal ultrasound, or pelvic examinations would result in more diagnostic laparoscopies and laparotomies than new ovarian cancers found. Unnecessary oophorectomies and greater patient anxiety may also result. [25]

Potential screening tests include
  • Pelvic examination
  • Vaginal ultrasound
  • CA 125 antigen

Pelvic examination

The sensitivity and specificity of a pelvic examination for the detection of ovarian cancer is unknown. Typically, this detection method reveals advanced disease. [25]

Vaginal ultrasound

This screening method has been proposed because of its ability to reliably measure ovarian size and detect small masses. [25] The benefit of ultrasonography for early detection of ovarian cancer has not been evaluated in controlled studies.

CA 125 levels

Measuring levels of CA 125, a tumor-associated antigen, has been proposed as a method for the early detection of ovarian cancer. However, current evidence suggests that using CA 125 alone does not have a sufficiently high sensitivity to be recommended for routine screening of ovarian cancer. In addition, elevated CA 125 levels are not specific to ovarian cancer and have been observed in patients with nongynecologic cancers, as well as patients in the first trimester of pregnancy or with endometriosis. [25]

A National Cancer Institute multicenter trial is ongoing to test the utility of transvaginal ultrasound and CA 125 measurement in reducing the mortality from ovarian cancer.

For more information on that current diagnosis and detection methods for ovarian cancer, visit the National Cancer Institute’s Web site.

Disclaimer

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Some of these third-party Web sites may refer to uses of our products that are not recommended by GlaxoSmithKline. You should always consult with your physician or health care professional before using any GlaxoSmithKline prescription product.

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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