Hycamtin has proven efficacy in patients with relapsed sensitive SCLC

Response rate is 24% with a range of 15% to 38% [10-13]
Stable disease rates ranging from 20% to 36% [10-13]
Single-agent efficacy similar to CAV in a randomized, phase III trial [12]

Overview of Clinical Trials With Hycamtin
in Relapsed Sensitive* SCLC [10-13]

*Sensitive disease was defined as disease that had progressed ≥3 months after prior chemotherapy. (NOTE: von Pawel [JCO, 1999] defined sensitive disease as disease that had progressed at least 60 days after first-line chemotherapy.)
†Response rates (partial response, complete response, and stable disease) independently confirmed.
‡Stable disease was defined as any tumor whose measurement did not fulfill the criteria of response or progression.
§Clinical benefit=response rate + stable disease.
|| Intent-to-treat population.
N/A=not assessed.

Hycamtin Demonstrated Consistent Response Rates
in Relapsed Sensitive SCLC Across Multiple Clinical Trials [10-13]

Learn more about the value of stable disease in patient survival. Click here.

Important Safety Information

Indications

Hycamtin is indicated for the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.*

*In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing ≥60 days (in the phase III study) or ≥90 days (in the phase II studies) after chemotherapy.

Contraindications

Hycamtin 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.

Warnings

Hycamtin 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 Interactions

Concomitant 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 Events

The 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.

Home | Prescribing Information for Hycamtin

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