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 The efficacy of Hycamtin in the treatment of relapsed ovarian cancer has been extensively studied over the last decade. This section discusses the proven efficacy of Hycamtin in patients with platinum-resistant/refractory and platinum-sensitive ovarian cancer.
Hycamtin and Platinum-Resistant/Refractory* Ovarian CancerOverview of Clinical Trials [2-4,6,7] *Platinum-resistant/refractory disease is defined as disease that has progressed on primary therapy or after a treatment-free interval of <6 months. †Response rates (partial response, complete response, and stable disease) independently confirmed. ‡Stable disease was defined as any measurement that did not fulfill the criteria of response or progression and lasted at least 8 weeks. (NOTE: Kudelka study defined stable disease as “a steady state or <partial response with no disease progression for at least 3 weeks.”) §Clinical benefit=response rate + stable disease. || Intent-to-treat population. N/A=not assessed. Hycamtin Demonstrated Consistent Response Rates in Relapsed Platinum-Resistant/Refractory Ovarian Cancer Across Multiple Clinical Trials [2-4,6,7]  A minimum of 4 courses (approximately 3 months of therapy) is recommended before evaluating tumor response. Hycamtin and Platinum-Sensitive* Ovarian CancerOverview of Clinical Trials [2-6] *Platinum-sensitive disease is defined as disease that has relapsed or progressed after a treatment-free interval of >6 months. †Subset consisting of patients with platinum-sensitive disease. N/A=not assessed. ‡+=median survival not reached in published study. Hycamtin Demonstrated Consistent Response Rates in Relapsed Platinum-Sensitive Ovarian Cancer Across Multiple Clinical Trials [2-6]  The majority of patients achieve clinical benefit (responses and stable disease) with Hycamtin. Learn more about the value of stable disease. Important Safety InformationIndicationsHycamtin is indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.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). Severe myelotoxicity has been reported when 5-day dosing of Hycamtin is used in combination with cisplatin. 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.Myelosuppression was more severe when Hycamtin, at a dose of 1.25 mg/m²/day x 5 days, was given in combination with cisplatin at a dose of 50 mg/m² in phase I studies. In one study, 1 of 3 patients had severe neutropenia for 12 days, and a second patient died with neutropenic sepsis. Adverse EventsThe most common serious adverse event is myelosuppression.Severe neutropenia, the dose-limiting toxicity for Hycamtin, occurred in 78% of 879 ovarian and small cell lung cancer patients treated. Other hematologic adverse events reported include severe leukopenia (32%), severe thrombocytopenia (27%), and severe anemia (37%). 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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