Combination of weekly topotecan and gemcitabine as a salvage treatment in patients with recurrent ovarian cancer: a phase I study
| Autor: | Kostas Kalbakis, Dora Hatzidaki, Vassilis Georgoulias, Nikolaos Vardakis, Aris Polyzos, Nikolaos Kentepozidis, Athanasios Kotsakis, John Syrios, Charalambos Kouroussis, Emmanouil Kontopodis |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty Antimetabolites Antineoplastic medicine.medical_treatment Neutropenia Gastroenterology Deoxycytidine Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans Aged Ovarian Neoplasms Salvage Therapy Chemotherapy 030219 obstetrics & reproductive medicine Performance status business.industry Obstetrics and Gynecology Middle Aged medicine.disease Gemcitabine Regimen Drug Combinations 030220 oncology & carcinogenesis Topotecan Female Neoplasm Recurrence Local business Ovarian cancer Febrile neutropenia medicine.drug |
| Zdroj: | Minerva ginecologica. 71(3) |
| ISSN: | 1827-1650 |
| Popis: | Background Evaluation of safety of the weekly intravenous gemcitabine/topotecan combination as salvage treatment in patients with recurrent epithelial ovarian cancer. Methods Twenty-four women with histologically-proven relapsed ovarian cancer (ROC) were enrolled in the study. Topotecan (1.75 mg/m2 IV) along with escalated doses of gemcitabine (starting dose 700 mg/m2 with increments of 100 mg/m2) were administered on days 1, 8, and 15 every 28 days. The maximum tolerated dose (MTD) and the dose-limiting toxicity of the combination were evaluated at the first cycle. Results Twenty-four ROC patients were enrolled in six dose-levels. Most patients had high-grade serous metastatic ovarian cancer (41.7%) and performance status score of 0-1 (95.8%). For 12 patients (50%) treatment was 2nd line and for 12 >2nd line. Eighty-eight cycles were administered with a median of three cycles per patient. The MTD was not reached and grade 3-4 (3.4% and 2.3% of cycles, respectively) neutropenia and grade 4 (3.4% of cycles) thrombocytopenia were the main adverse events. There was no case of febrile neutropenia. Non-hematologic toxicity was mild with grade 2 fatigue being the most frequent complain. The recommended MTD doses of the combination were topotecan 1.75 mg/m2 and gemcitabine 1200 mg/m2 on days 1, 8, and 15 every 28 days. Two complete (8.3%) and three (12.5%) partial responses were achieved (ORR: 20.8%). Conclusions The weekly administration of gemcitabine/topotecan regimen in patients with pretreated metastatic ovarian cancer is an active chemotherapy combination, even in heavily pretreated patients, with a manageable toxicity profile which merits further investigation. |
| Databáze: | OpenAIRE |
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