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Specifically, HYCAMTIN capsules are indicated for patients who had acomplete or partial response to first-line chemotherapy and who are at least45 days from the end of that treatment. HYCAMTIN capsules are the only oralsingle-agent chemotherapy approved for the treatment of SCLC after failure offirst-line therapy. The product will be available in 2008.
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"The approval of HYCAMTIN capsules is particularly important for patientswith relapsed small cell lung cancer as they now have an effective treatmentoption that has been shown to provide a survival benefit and can beconveniently taken at home," said Debasish Roychowdhury, M.D., Vice President,Global Clinical Development, Oncology Medicine Development Center, GSK."Additionally, this milestone underscores GSK Oncology's commitment to helpingimprove cancer patients' quality of life."
This approval was based on positive results from a Phase III studycomparing HYCAMTIN capsules plus best supportive care (BSC) to BSC alone inpatients with relapsed SCLC, in addition to Phase II and Phase III supportingstudies. Best supportive care refers to treatments intended to control,prevent and relieve disease complications to improve comfort and quality oflife for the patient, but are not intended to have any anti-tumor effects. Inthe pivotal Phase III clinical trial, HYCAMTIN capsules added to BSC wereassociated with prolonged survival in patients with relapsed SCLC. This wasthe first randomized study ever to demonstrate that patients with relapsedSCLC live longer when they are treated with BSC and chemotherapy compared toBSC alone. Study results were published in the December 1, 2006 issue of theJournal of Clinical Oncology.(1)
"In clinical trials, HYCAMTIN capsules have shown the potential to benefitpatients with SCLC, many of whom are prone to relapse," said John Eckardt,M.D., Director of Clinical Research for the Center for Cancer Care andResearch, St. Louis, MO. "The approval of HYCAMTIN capsules opens up newpossibilities for patients battling this disease and provides a convenientalternative to IV therapy."
HYCAMTIN Capsules Clinical Trial Results(1,2)
In the Phase III multicenter trial, 141 patients with relapsed SCLC notconsidered as candidates for standard IV therapy were randomized to receiveBSC 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 objectivewas to compare overall survival between the two treatment arms. Patients whoreceived HYCAMTIN capsules plus BSC showed a statistically significantimprovement in overall survival compared with the patients who received BSCalone (Log-rank p = 0.0104). Median survival with HYCAMTIN capsules plus BSCwas 25.9 weeks (95% CI, 18.3 to 31.6) and was 13.9 weeks (95% CI, 11.1 to18.6) 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 receivedHYCAMTIN capsules plus BSC compared with the patients who received BSCalone.(1)
The most common Grade 3 or 4 hematologic adverse reactions with HYCAMTINcapsules were neutropenia (61%), anemia (25%) and thrombocytopenia (37%). Themost 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 surfaceof the lung's breathing tubes (called bronchi) and tends to spread widelythrough the body. This is important because it means that surgery is rarelyused as a treatment option. Chemotherapy is the mo
