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 Hycamtin vs CAVCyclophosphamide, doxorubicin, and vincristine (CAV) is a standard first-line chemotherapy regimen along with etoposide and cisplatin (EP). There is currently no standard second-line therapy for small cell lung cancer (SCLC), although CAV is often used after first-line treatment with EP. [12] The toxicity profile of CAV is well established and acceptable. In two studies that included sensitive and refractory patients, CAV produced second-line response rates of 13% and 28%. [12]A phase III, randomized, multicenter study by von Pawel et al [12] in patients with relapsed sensitive SCLC compared the efficacy of treatment with Hycamtin (n=107) vs CAV (n=104). Single-agent Hycamtin demonstrated efficacy similar to that of the   Adapted from von Pawel et al. J Clin Oncol. 1999;17:662.
 Adapted from von Pawel et al. J Clin Oncol. 1999;17:662. Symptom improvementHycamtin is the first single-agent therapy to demonstrate symptom palliation in patients with relapsed SCLC. In the von Pawel study comparing Hycamtin with CAV, Hycamtin demonstrated symptom improvement. [12] Adapted from von Pawel et al. J Clin Oncol. 1999;17:663. Not all patients had all symptoms, nor did all patients respond to all questions. Limitations in interpretation of the rating scale and responses preclude formal statistical analysis. CAV=cyclophosphamide, doxorubicin, and vincristine. ‡Symptom terminology used in patient questionnaire: dyspnea=“shortness of breath”; hemoptysis=“coughing up blood”; anorexia=“loss of appetite”; insomnia=“interference with sleep.” §Number of patients with baseline and at least 1 postbaseline assessment. ||Improvement defined as 2 consecutive improvements over the baseline assessment. Important Safety InformationIndicationsHycamtin 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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