Results from two new investigational phase III clinical trials showed that oral Hycamtin (topotecan hydrochloride) was clinically active in both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).
At this time, oral Hycamtin does not have regulatory approval in any country for use in any indication.
Data from one trial showed Hycamtin to be one of the first oral chemotherapeutic agents to demonstrate clinical activity in a phase III study of patients with relapsed stage III/IV NSCLC. Additionally, results from one of the largest studies conducted in extensive SCLC disease showed that oral Hycamtin, combined with cisplatin, demonstrated clinical activity and tolerability similar to IV etoposide/cisplatin, the standard of care.
The first open-label, phase III trial studied the risk/benefit profile of oral Hycamtin compared with IV docetaxel. A total of 829 previously-treated patients were recruited from 140 centers worldwide. Results for one-year survival rate, the study’s primary endpoint, were similar between groups (25.1% for oral Hycamtin versus 28.7% for IV docetaxel). With regard to differences in one-year survival between groups, Hycamtin was shown to be non-inferior to docetaxel based on the study’s pre-specified non-inferiority margin.
Results from a separate study of oral Hycamtin, one of the largest ever conducted in patients with extensive SCLC, showed that oral Hycamtin administered with IV cisplatin (TC) was similar with regard to activity and tolerability to IV etoposide/cisplatin (PE), the standard of care for first-line extensive disease SCLC.
“Oral Hycamtin may be a convenient therapy for patients who might otherwise choose best supportive care over intravenous chemotherapy – either because they reside a long distance from the hospital or because they prefer to live their remaining few weeks of life at home,” said study investigator, John Eckardt, director of the clinical research program at the Center for Cancer Care and Research, St. Louis, Missouri. “Results from these two investigational studies suggest that oral Hycamtin may one day be an important alternative for these patients.”