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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/6452

Title: Gemcitabine combined with cisplatin as first-line treatment in patients with epithelial ovarian cancer: a phase II study
Authors: Belpomme, D.
Krakowski, I.
Beaudin, M.
Petit, T.
Canon, J.L.
JANSSENS, Jaak
Gauthier, S.
de Pauw, A.
Moreau, V.
Kayitalire, I.
Issue Date: 2003
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Citation: Gynecologic oncology, 91(1). p. 32-38
Abstract: Objective. This phase II study was performed to evaluate the activity and toxicity of gemcitabine plus cisplatin as first-line treatment of advanced epithelial ovarian cancer. Methods. Chemonaive patients with histologically or cytologically confirmed FIGO stage III or IV epithelial ovarian carcinoma were enrolled. Patients received cisplatin 75 mg/m(2) on Day 1 and gemcitabine 1250 mg/m(2) on Days 1 (after cisplatin) and 8 of a 21-day cycle. Results. Of the 42 female patients (median age 60 years) enrolled, 81% had a Zubrod performance status of 0 or 1. Among the 37 response-evaluable patients, there were 5 (13.5%) pathological complete responses (CRs), 16 (43.2%) pathological partial responses (PRs), and 3 (8.1%) clinical PRs, for an overall response rate of 64.9% (95% CI: 47.4-79.8%) and a pathological response rate of 56.8%. Per an intent-to-treat analysis, the overall response rate was 57.1% (95% CI: 41.0-72.3%). After a median follow-up time of 15.8 months, the median survival was 24.0 months and median progression-free survival was 13.4 months. Grade 3/4 neutropenia and thrombocytopenia occurred in 69.0 and 33.3% of patients, respectively, with no febrile neutropenia or hemorrhage. Grade 3/4 nausea and vomiting occurred in 35.7% and grade 3 alopecia in 21.4% of the patients. One patient died due to a toxicity-related death (dyspnea). Conclusions. Gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer. Further clinical trials adding gemcitabine to first-line treatment seem warranted. (C) 2003 Elsevier Inc. All rights reserved.
URI: http://hdl.handle.net/1942/6452
DOI: 10.1016/S0090-8258(03)00413-X
ISI #: 000185731200005
ISSN: 0090-8258
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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