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 Hycamtin vs paclitaxel in later lines of therapyA 2001 study by Gore et al [17] compared the safety and efficacy of Hycamtin vs paclitaxel in patients with relapsed ovarian cancer, and assessed the degree of non–cross-resistance between the 2 compounds in third-line crossover therapy. Of the 61 patients crossing over to Hycamtin who had platinum as first-line therapy and paclitaxel as second, 13% (8/61) responded to Hycamtin in the third line. [17] The study concluded that the two drugs have a degree of non–cross-resistance.  Note: All patients who responded to Hycamtin in the third line were initially platinum sensitive. Stable disease response was not broken out into platinum-sensitive/platinum-resistant/refractory. [17] The results show that Hycamtin is at least as active as paclitaxel as a second-line treatment of epithelial ovarian cancer after platinum-based therapy. [17] Toxicity to Cross-Over TherapyIn the Gore study, the toxicity seen in patients who received the cross-over therapy was similar to that recorded in the randomized study. The principal hematologic side effect was myelosuppression; grade 4 neutropenia occurred in a higher percentage of patients who received Hycamtin (81% of patients, 39% of courses) than paclitaxel (23% of patients, 14% of courses). [17] See chart below.Nonhematologic toxicity in patients treated with Hycamtin was generally mild or moderate (grade 1/2) and consisted mainly of gastrointestinal disturbances. [17]  Adapted from Gore et al. J Clin Oncol. 2001;19:1897. *Note: Partial listing of study toxicity data. 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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