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Topotecan in colorectal cancer: A phase II study of the EORTC early clinical trials group |
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| Authors: | Creemers, G. J. Wanders, J. Gamucci,, T. Vallentin, S. Dirix, L. Y. Schoffski, P. Hudson, I. Verweij, J. |
| Affiliation: | 1Department of Medical Oncology, Rotterdam Cancer Institute, Rotterdam 2EORTC - New Drug Development Office, Amsterdam, The Netherlands 3Divisione Oncologia Medica, Istituto Regina Elena Roma, Italy 4Department of Medical Oncology, Copenhagen University Hospital Herlev, Denmark 5Department of Medical Oncology, University Hospital Antwerpen Antwerpen, Belgium 6Abteilung Hämatologie und Onkologie, Medizinische Hochschule Hannover Hannover, Germany 7SmithKline Beecham Pharmaceuticals Harlow Essex, U.K. |
| Abstract: | Background: This phase II study with the topoisomerase I inhibitortopotecan was performed to determine its clinical activity andtoxicity in patients with metastatic or locally unresectablecolorectal cancer Patients and methods: Topotecan 1.5 mg/m2 was administered intravenouslyby 30-minute infusion for 5 days. Fifty-nine patients enteredthe study, 2 were considered ineligible and 57 were evaluablefor response and toxicity Results: Partial response was obtained in 4 of 57 evaluablepatients (7%). The median duration of the response was 11 months(range 9.3 to 12.2). This topotecan regimen was very well tolerated.A total of 290 courses were given, with a median of 4 coursesper patient (range, 1 to 18). The major toxic effects were leuko-and neutropenia (91%), grade 34 in 48% and 79% of courses,respectively, but with only 2 infectious complications. Otherside effects were grade 1 alopecia (77%) in 46%, nausea (35%),vomiting (10%), and maculo-papular rash (6%) Conclusions: Topotecan administered as a daily-times-five regimenhas only minor activity as a single-agent therapy in colorectalcancer phase II, topotecan, colorectal cancer |
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