Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicentric, prospective, randomized phase III trial
| Autor: | M. Welnicka-Jaskiewicz, Thomas Brodowicz, Nicolae Ghilezan, Zrinka Mrsic-Krmpotic, Zsuzsanna Kahán, Ivan Chernozemsky, Jozika Cervek, Damir Vrbanec, Christoph C. Zielinski, Valentina Tzekova, János Szántó, Victoria Soldatenkova, Semir Beslija, Janusz Pawlega, Stanislav Spanik, Maria Wagnerova, Christoph Wiltschke, Moshe Inbar, Mislav Grgic, Dmitry Khamtsov |
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| Jazyk: | angličtina |
| Rok vydání: | 2005 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Adolescent Paclitaxel Cyclophosphamide medicine.medical_treatment Breast Neoplasms Deoxycytidine Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Epirubicin Chemotherapy business.industry Middle Aged medicine.disease chemotherapy breast cancer Metastatic breast cancer Gemcitabine Fluorouracil Female Taxoids business Progressive disease medicine.drug |
| Popis: | Background The objectives of this phase III trial were to compare the time to progressive disease (TtPD), overall response rate (ORR), overall survival, and toxicity of gemcitabine, epirubicin, and paclitaxel (GET) versus fluorouracil (FU), epirubicin, and cyclophosphamide (FEC) as first-line therapy in patients with metastatic breast cancer (MBC). Patients and Methods Female patients aged 18 to 75 years with stage IV and measurable MBC were enrolled and randomly assigned to either gemcitabine (1,000 mg/m2, days 1 and 4), epirubicin (90 mg/m2, day 1), and paclitaxel (175 mg/m2, day 1) or FU (500 mg/m2, day 1), epirubicin (90 mg/m2, day 1), and cyclophosphamide (500 mg/m2, day 1). Both regimens were administered every 21 days for a maximum of eight cycles. Results Between October 1999 and November 2002, 259 patients (GET, n = 124; FEC, n = 135) were enrolled. Baseline characteristics were well balanced across treatment arms. After a median of 20.4 months of follow-up, median TtPD was 9.1 months and 9.0 months in the GET and FEC arms, respectively (P = .557). The ORR was 62.3% in the GET arm (n = 114) and 51.2% in the FEC arm (n = 129; P = .093). Grade 3 and 4 toxicities, including neutropenia, thrombocytopenia, anemia, stomatitis, neurosensory toxicity, and allergy, occurred significantly more often in the GET arm. Conclusion No significant differences in terms of TtPD and ORR were observed between the two treatment arms. Treatment-related toxicity was higher in the GET arm. |
| Databáze: | OpenAIRE |
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