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GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer
Date:10/15/2007

pared to BSC alone. Study results were published in the December 1, 2006 issue of the Journal of Clinical Oncology.(1)

"In clinical trials, HYCAMTIN capsules have shown the potential to benefit patients with SCLC, many of whom are prone to relapse," said John Eckardt, M.D., Director of Clinical Research for the Center for Cancer Care and Research, St. Louis, MO. "The approval of HYCAMTIN capsules opens up new possibilities for patients battling this disease and provides a convenient alternative to IV therapy."

HYCAMTIN Capsules Clinical Trial Results(1,2)

In the Phase III multicenter trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomized to receive BSC alone (n = 70) or HYCAMTIN capsules (2.3 mg/m2/day, days 1 through 5, every 21 days) plus BSC (HYCAMTIN capsules; n = 71). The primary objective was to compare overall survival between the two treatment arms. Patients who received HYCAMTIN capsules plus BSC showed a statistically significant improvement in overall survival compared with the patients who received BSC alone (Log-rank p = 0.0104). Median survival with HYCAMTIN capsules plus BSC was 25.9 weeks (95% CI, 18.3 to 31.6) and was 13.9 weeks (95% CI, 11.1 to 18.6) with BSC alone. The hazard ratio was 0.64 (95% C.I: 0.45, 0.90), indicating a 36% reduction in the risk of death for patients who received HYCAMTIN capsules plus BSC compared with the patients who received BSC alone.(1)

The most common Grade 3 or 4 hematologic adverse reactions with HYCAMTIN capsules were neutropenia (61%), anemia (25%) and thrombocytopenia (37%). The most common (>10%) non-hematologic adverse reactions (all grades) were nausea (27%), diarrhea (14%), vomiting (19%), fatigue (11%) and alopecia (10%).(2)

About Small Cell Lung Cancer (SCLC)(3)

SCLC is caused by an uncontrolled growth of cells beginning on the surface of the lung's breathing tubes (called bronchi) and tends to spread widely through the
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SOURCE GlaxoSmithKline
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