Gemcitabine combined with cisplatin as first-line treatment in patients with epithelial ovarian cancer: a phase II study
| Autor: | L Kayitalire, V Moreau, D Belpomme, M Beauduin, I Krakowski, J Janssens, Thierry Petit, J.L Canon, A De Pauw, S Gauthier |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
medicine.medical_specialty medicine.medical_treatment Phases of clinical research Neutropenia Gastroenterology Deoxycytidine Disease-Free Survival Drug Administration Schedule Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Infusions Intravenous Aged Cisplatin Ovarian Neoplasms Chemotherapy business.industry Obstetrics and Gynecology Middle Aged medicine.disease Gemcitabine Surgery Survival Rate Oncology Female Ovarian cancer business Febrile neutropenia medicine.drug |
| Zdroj: | Gynecologic oncology. 91(1) |
| ISSN: | 0090-8258 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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