|
| |
 The treatment of cervical cancer is rapidly evolving. Current treatment of cervical cancer depends on a number of factors, including the stage of the disease, the size of the tumor, as well as the patient's age and desire to reproduce. 
Cervical cancer is initially treated with surgery and/or chemoradiotherapy and combination chemotherapy. While most patients respond to primary treatment, recurrent and/or advanced disease is common. In patients with recurrent or persistent disease, response rates and overall survival rates remain low. [33]Treatment of recurrent or advanced stage cervical cancerSingle-agent cisplatin has been the standard cytotoxic chemotherapeutic agent for the treatment of advanced/recurrent cervical cancer, with initial response rates as high as 50%. More recent trials with larger numbers of patients have reported response rates in the 20% to 30% range. [32] New trials are continually underway to find chemotherapy agents, used either alone or in combination, which will prove more effective in increasing overall survival. [32]For more information, please visit the following pages on this site:
Or visit the National Cancer Institute’s Web site for more treatment information. DisclaimerThese 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 InformationIndicationsHycamtin in combination with cisplatin is indicated for the treatment of histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.ContraindicationsHycamtin 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.WarningsHycamtin 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 InteractionsConcomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until 24 hours after completion of treatment with Hycamtin.DosingPrior to administration of the first course of Hycamtin, patients must have a baseline absolute neutrophil count of >1,500 cells/mm³ and a platelet count of >100,000 cells/mm³. The recommended dose of Hycamtin is 0.75 mg/m² by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m² by intravenous infusion on day 1 repeated every 21 days (a 21-day course).Dosage adjustments for subsequent courses of a regimen of Hycamtin in combination with cisplatin are specific for each drug. In the event of severe febrile neutropenia (defined as <1,000 cells/mm³ with temperature of 38.0°C or 100.4°F), the dose of Hycamtin should be reduced by 20% to 0.60 mg/m² for subsequent courses. Doses of Hycamtin should be similarly reduced (by 20% to 0.60 mg/m²) if the platelet count falls below 10,000 cells/mm³. Alternatively, in the event of severe febrile neutropenia, G-CSF may be administered following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of topotecan administration). If febrile neutropenia occurs despite the use of G-CSF, the dose of Hycamtin should be reduced by another 20% to 0.45 mg/m² for subsequent courses. Adverse EventsFrequently reported grade 3/4 adverse events associated with use of Hycamtin/cisplatin included neutropenia (74%), leukopenia (66%), anemia (40%), thrombocytopenia (33%), pain (22%), vomiting (15%), nausea (14%), other GI (14%), metabolic/laboratory (14%), and genitourinary (12%).See manufacturer’s Prescribing Information for cisplatin administration and hydration guidelines, and for cisplatin dosage adjustment in the event of hematologic toxicity. |
|
Education Material | Site Map | References
Home | Prescribing Information for Hycamtin
This site is intended for US healthcare professionals only.
© 1997-2008 GlaxoSmithKline. All Rights Reserved.