Gemcitabine combined with cisplatin as first-line treatment in patients 60 years or older with epithelial ovarian cancer: a phase II study
| Autor: | G. Morack, K. Mansouri, J. Blatter, A. Hefti, G. P. Breitbach, Thomas Bauknecht, C. Villena-Heinsen, D. Elling, Diethelm Wallwiener, G. V. Minckwitz |
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| Rok vydání: | 2003 |
| Předmět: |
Oncology
medicine.medical_specialty Nausea FIGO Stage IIIC Phases of clinical research Neutropenia Deoxycytidine Gastroenterology Disease-Free Survival Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Stage IIIC Karnofsky Performance Status Aged Neoplasm Staging Aged 80 and over Ovarian Neoplasms Cisplatin business.industry Carcinoma Age Factors Obstetrics and Gynecology Middle Aged medicine.disease Survival Analysis Gemcitabine Treatment Outcome Female medicine.symptom Ovarian cancer business medicine.drug |
| Zdroj: | International Journal of Gynecological Cancer. 13:130-137 |
| ISSN: | 1525-1438 1048-891X |
| DOI: | 10.1046/j.1525-1438.2003.13039.x |
| Popis: | This phase II study evaluated the activity and toxicity of gemcitabine plus cisplatin as first-line treatment of patients with advanced ovarian cancer. Chemonaive patients ≥60-year-old with FIGO stage IIIC or IV epithelial ovarian carcinoma were enrolled. Patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1250 mg/m2 on day 1 (before cisplatin) and day 8 of a 21-day cycle. Of 44 female patients (median age, 70 years), 72.7% had stage IIIC disease and 67.4% had a Karnofsky performance status ≥80. Of the 37 response-evaluable patients (35 with measurable lesion[s] ≥2 cm), there were seven (18.9%) pathologic complete responses, two (5.4%) pathologic partial responses, two (5.4%) clinical complete responses, and 12 (32.4%) clinical partial responses, for an overall response rate of 62.2% (95% CI, 44.8%–77.5%), and a pathologic response rate of 24.3% (95% CI, 11.8%–41.2%). Median survival was 27.7 months (95% CI, 14.3–40.8 months). Grade 3/4 neutropenia and thrombocytopenia occurred in 59.5% and 30.2% of patients, respectively, with neutropenic fever in one patient. Grade 3 nausea /vomiting and alopecia occurred in 25.6% and 9.5% of patients, respectively. We conclude that gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer in patients ≥60 years. Further clinical trials adding gemcitabine to current standard, first-line treatment seem warranted in younger as well as older patients. |
| Databáze: | OpenAIRE |
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