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Lookup NU author(s): Dr Graham Dark,
Professor Alan Calvert
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Purpose: Liposomal lurtotecan (OSI-211) is a liposomal formulation of the water-soluble topoisomerase I inhibitor lurtotecan (GI147211), which demonstrated superior levels of activity compared with topotecan in preclinical models. We studied two schedules of OSI-211 in a randomized design in relapsed ovarian cancer to identify the more promising of the two schedules for further study. Patients and Methods: Eligible patients had measurable epithelial ovarian, fallopian, or primary peritoneal cancer that was recurrent after one or two prior regimens of chemotherapy. Patients were randomly assigned to receive either arm A (OSI-211 1.8 mg/m2/d administered by 30-minute intravenous infusion on days 1, 2, and 3 every 3 weeks) or arm B (OSI-211 2.4 mg/m2/d administered by 30-minute intravenous infusion on days 1 and 8 every 3 weeks). The primary outcome measure was objective response, which was confirmed by independent radiologic review, and a pick the winner statistical design was used to identify the schedule most likely to be superior. Results: Eighty-one patients were randomized between October 2000 and September 2001. The hematologic toxic effects were greater on arm A than on arm B (grade 4 neutropenia, 51% v 22%, respectively), as was febrile neutropenia (26% v 2.4%, respectively). Of the 80 eligible patients, eight patients (10%) had objective responses; six responders (15.4%; 95% CI, 6% to 30%) were in arm A and two responders (4.9%; 95% CI, 1% to 17%) were in arm B. Conclusion: The OSI-211 daily for 3 days intravenous schedule met the statistical criteria to be declared the winner in terms of objective response. This schedule was also associated with more myelosuppression than the schedule of OSI-211 administered in arm B. © 2005 by American Society of Clinical Oncology.
Author(s): Dark, G., Calvert, A. H., Grimshaw, R., Poole, C., Swenerton, K., Kaye, S., Coleman, R., Jayson, G., Le, T., Ellard, S., Trudeau, M., Vasey, P., Hamilton, M., Cameron, T., Barrett, E., Walsh, W., McIntosh, L., Eisenhauer, E.
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Oncology
Print publication date: 20/03/2005
ISSN (print): 0732-183X
ISSN (electronic): 1527-7755
PubMed id: 15699482
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