NEW YORK (Reuters Health) - As a second line therapy for ovarian cancer, the investigational drug 9-aminocamptothecin (9-AC) seems to induce responses on a par with other approved agents and with a toxicity profile less than that of other agents, according to the findings of a phase II trial.
A water-insoluble camptothecin, 9-AC is an inhibitor of topoisomerase I, Dr. Howard Hochster, at the New York University School of Medicine, and colleagues note in their report in the Journal of Clinical Oncology for January 1st. Although the results of preclinical studies were “excellent,” only minimal efficacy was observed in phase II studies of colorectal and lung cancer and cutaneous T-cell lymphoma.
In the current study, supported in part by the National Cancer Institute, 9-AC was administered in 72-hour continuous i.v. infusions every 2 weeks to women who had recurrent ovarian cancer after an initial platinum-containing regimen. Three cycles or more were administered to 42 patients.
Ten of 60 patients (16.7%) responded to treatment, with complete responses in four. Disease stabilized in an additional 18 patients. Altogether, median progression-free survival was 4 months, and median overall survival was 15.6 months.
Neutropenia occurred in 60% and nausea or vomiting of grade 3 or higher occurred in 27% of the subjects. The authors considered the toxicities to be moderate, and reversible and manageable with dose reductions and supportive care.
“Further studies combining 9-AC with other agents active in ovarian cancer for use as second-line therapy are warranted,” conclude. Dr. Hochster and his team.
Source: J Clin Oncol 2004;22:120-126. [ Google search on this article ]
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