PHILADELPHIASmithKline Beechams topoisomerase I inhibitor Hycamtin (topotecan HCl for injection) has received FDA approval for the treatment of small-cell lung cancer (SCLC) after failure of first-line chemotherapy. The agent was previously approved for use in ovarian cancer after failure of initial or subsequent chemotherapy.
The randomized phase III trial, conducted at 44 centers in North America, Europe, and South Africa, involved 211 patients who had relapsed at least 60 days after their initial treatment. Patients received either an IV infusion of Hycamtin, 1.5 mg/m² as single-agent therapy for 5 consecutive days every 3 weeks, or CAV (cyclophosphamide, doxorubicin(Drug information on doxorubicin), vin-cristine) IV on day 1 every 3 weeks.
Improvement in Symptoms
The response rate was higher with Hycamtin (24% vs 18% for CAV), but not statistically significant. Median survival and time to progression were comparable for both treatment groups.
More patients treated with Hycamtin reported improvement in disease-related symptoms (eight of nine measured) than patients treated with CAV. Improvement was defined as improvement over baseline sustained for at least two consecutive courses. In a measurement of patients well-being, fewer patients treated with Hycamtin experienced interference with daily activities.