Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study
| Autor: | Giovanna Scarfone, Jaap Verweij, W W ten Bokkel Huinink, G Favalli, Giorgio Bolis, I. Hudson, S Van Belle, R Kreinberg, R. Despax, M Gore, J P Guastalla, A J Lacave, G. J. Creemers |
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| Rok vydání: | 1996 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty medicine.medical_treatment Phases of clinical research Antineoplastic Agents Neutropenia Gastroenterology Drug Administration Schedule Epithelium Leukocytopenia Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Aged Cisplatin Ovarian Neoplasms Chemotherapy business.industry Middle Aged medicine.disease Surgery Oncology Drug Resistance Neoplasm Topotecan Camptothecin Female business Ovarian cancer medicine.drug |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 0732-183X |
| Popis: | PURPOSE Topotecan is a topoisomerase I inhibitor with preclinical activity against various tumor types. We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who had failed to respond to one prior cisplatin-based chemotherapeutic regimen. PATIENTS AND METHODS Topotecan 1.5 mg/m2/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks. As the cisplatin-free interval relates to response in subsequent treatment, patients were stratified in subgroups, ie, cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive. RESULTS One-hundred eleven patients entered the study. Nineteen patients were considered to be ineligible; 92 patients were assessable for response. A total of 552 courses were given (median, four per patient; range, one to 17). The major toxicities were leukocytopenia and neutropenia, which were grade 3 to 4 in 54.2% and 69.1% of courses, respectively, but with only 4.3% of these being grade 4 neutropenia plus fever or infectious complications. Prophylactic granulocyte colony-stimulating factor (G-CSF) was given in 20.5% of courses to maintain dose-intensity. Other relatively frequent side effects were alopecia (82%), nausea (36.4%), and vomiting (17.5%). The overall response rate was 16.3%, with one complete response (CR) and 14 partial responses (PRs). In the cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive strata, the response rates were 5.9%, 17.8%, and 26.7%, respectively. The median duration of time of documented response was 21.7 weeks (range, 4.6 to 41.9). CONCLUSION Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer. Further investigations of topotecan in ovarian cancer, including first-line use and combination with other active agents, are indicated. |
| Databáze: | OpenAIRE |
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