Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: A Central European Cooperative Oncology Group International, Multicenter, Prospective, Randomized Phase III Trial

Christoph Zielinski, Semir Beslija, Zrinka Mrsic-Krmpotic, Marzena Welnicka-Jaskiewicz, Christoph Wiltschke, Zsuzsanna Kahan, Mislav Grgic, Valentina Tzekova, Moshe Inbar, Jozika Cervek, Ivan Chernozemsky, Janos Szanto, Stanislav Spanik, Maria Wagnerova, Nicolae Ghilezan, Janusz Pawlega, Damir Vrbanec, Dmitry Khamtsov, Victoria Soldatenkova, Thomas Brodowicz

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Abstract

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.

Original languageEnglish
Pages (from-to)1401-1408
Number of pages8
JournalJournal of Clinical Oncology
Volume23
Issue number7
DOIs
Publication statusPublished - Dec 1 2005

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Zielinski, C., Beslija, S., Mrsic-Krmpotic, Z., Welnicka-Jaskiewicz, M., Wiltschke, C., Kahan, Z., Grgic, M., Tzekova, V., Inbar, M., Cervek, J., Chernozemsky, I., Szanto, J., Spanik, S., Wagnerova, M., Ghilezan, N., Pawlega, J., Vrbanec, D., Khamtsov, D., Soldatenkova, V., & Brodowicz, T. (2005). Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: A Central European Cooperative Oncology Group International, Multicenter, Prospective, Randomized Phase III Trial. Journal of Clinical Oncology, 23(7), 1401-1408. https://doi.org/10.1200/JCO.2005.12.106