Detection & Diagnosis
There are typically no noticeable signs of early cervical cancer. Symptoms such as vaginal bleeding, unusual vaginal discharge, pelvic pain, or pain during sexual intercourse may be caused by cervical cancer or other conditions.

Pap test

Regular screening with a Pap test has been proven to reduce mortality from cervical cancer. [38]

Screening is effective when started within 3 years after beginning vaginal intercourse. It becomes less effective in women 65 years of age and older who have had recent negative Pap tests.

The potential of false positives in this regular screening has its downsides, especially in younger women. Results of the Pap test may lead to unnecessary diagnostic procedures, such as a colposcopy, and treatment for low-grade squamous intraepithelial lesions (LSIL). Younger women have a higher prevalence of LSIL that will often regress without treatment. There is also not enough information regarding any long-term consequences on fertility and pregnancy from these procedures.

New screening technologies

Newer methods employing liquid-based cytology have been developed to improve the sensitivity of screening. Optimal studies need to be performed to determine the sensitivity and specificity of these new technologies. These new technologies are also more expensive than the traditional Pap test.

HPV testing

Since almost all cervical cancers result from infection with HPV, screening with an HPV DNA test is an option. Currently, the HPV DNA test can be used in two situations:
  • The FDA has approved it for use as a screening test in combination with the Pap test in women over 30 years of age. Women younger than 30 have the highest prevalence of transient HPV infection that is asymptomatic and inconsequential. The low specificity of the DNA test makes it of limited value to this population
  • The test is also used to triage women with the ambiguous atypical squamous cells of undetermined significance (ASCUS) findings on cytologic screening. One study found that performing the HPV DNA test on women with ASCUS findings for triage to colposcopy is a more efficient strategy than immediate colposcopy. It was also more efficient than repeating the cytologic testing [38]

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

Disclaimer

These sites are not part of Hycamtin.com, a GlaxoSmithKline Web site. The content and materials in these third-party Web sites are not produced or endorsed by GlaxoSmithKline.

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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