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, 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.