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Minerva Ginecologica 2019 June;71(3):182-90

DOI: 10.23736/S0026-4784.19.04249-7


lingua: Inglese

Combination of weekly topotecan and gemcitabine as a salvage treatment in patients with recurrent ovarian cancer: a phase I study

John SYRIOS, Charalambos KOUROUSSIS, Athanasios KOTSAKIS, Nikolaos KENTEPOZIDIS, Emmanouil KONTOPODIS, Kostas KALBAKIS, Nikolaos VARDAKIS, Dora HATZIDAKI, Aris POLYZOS, Vassilis GEORGOULIAS on behalf of the GU Working Group of the Hellenic Oncology Research Group (HORG)

Hellenic Oncology Research Group (HORG), Athens, Greece

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.

KEY WORDS: Topotecan; Gemcitabine; Ovarian neoplasms; Local cancer recurrence

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