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 In a retrospective study by Cesano et al [8] in patients with either relapsed SCLC or relapsed ovarian cancer who were treated with Hycamtin, both stable disease (lasting >8 weeks) and partial response were found to have similar prognostic value for patient survival following chemotherapy. Stable disease and partial response were associated with a survival benefit vs progressive disease. In patients with relapsed small cell lung cancer
In patients with relapsed ovarian cancer
Stable disease may be a meaningful clinical endpoint that may indicate a survival benefit for patients with SCLC. Compared with progressive disease, stable disease and partial response were associated with improved survival. [8]   Adapted from Cesano et al. Int J Oncol. 1999;15:1236. CR=complete response; PR=partial response; SD=stable disease; NR=no response (progressive disease or not evaluated). Kaplan-Meier plots for 426 patients with SCLC from 4 multicenter clinical trials. Kaplan-Meier plots for 392 patients with relapsed ovarian cancer from 4 multicenter clinical trials. Important Safety InformationIndicationsHycamtin is indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.Hycamtin is indicated for the treatment of small cell lung cancer sensitive disease after failure of first-line 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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