Online citations, reference lists, and bibliographies.
Please confirm you are human
(Sign Up for free to never see this)
← Back to Search

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.

C. Zielinski, S. Bešlija, Z. Mršić-Krmpotić, M. Wełnicka-Jaśkiewicz, C. Wiltschke, Z. Kahán, M. Grgic, V. Tzekova, M. Inbar, J. Cervek, I. Chernozemsky, J. Szántó, S. Špánik, M. Wagnerová, N. Ghilezan, J. Pawlęga, D. Vrbanec, Dmitry Khamtsov, V. Soldatenkova, T. Brodowicz
Published 2005 · Medicine

Save to my Library
Download PDF
Analyze on Scholarcy
Share
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/m(2), days 1 and 4), epirubicin (90 mg/m(2), day 1), and paclitaxel (175 mg/m(2), day 1) or FU (500 mg/m(2), day 1), epirubicin (90 mg/m(2), day 1), and cyclophosphamide (500 mg/m(2), 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.
This paper references
10.1200/JCO.2003.04.040
Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial.
J. Nabholtz (2003)
10.1016/S0093-7754(03)70137-7
Monotherapy options in the management of metastatic breast cancer.
A. Seidman (2003)
10.2307/2529712
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
S. Pocock (1975)
10.1016/S0959-8049(01)00350-1
Estimates of cancer incidence and mortality in Europe in 1995.
F. Bray (2002)
10.1093/ANNONC/MDL498
Estimates of the cancer incidence and mortality in Europe in 2006.
J. Ferlay (2007)
10.1016/0277-5379(91)90261-B
Long-term survival of patients treated with combination chemotherapy for metastatic breast cancer.
G. Falkson (1991)
10.1200/JCO.1988.6.6.976
Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial.
G. Ambrosini (1988)
10.1200/JCO.1998.16.10.3439
Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women.
R. Fossati (1998)
10.1200/JCO.2003.10.086
Sequential single-agent chemotherapy for metastatic breast cancer: therapeutic nihilism or realism?
A. Seidman (2003)
10.1200/JCO.2001.19.6.1707
Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial.
J. Jassem (2001)
10.1200/JCO.2002.11.005
Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial.
L. Biganzoli (2002)
10.1200/JCO.2003.08.013
Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193).
G. Sledge (2003)
10.1200/JCO.2004.10.907
Adjuvant interferon therapy for melanoma: high-dose, low-dose, no dose, which dose?
L. Schuchter (2004)
Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer.
P. Dombernowsky (1996)
10.1200/JCO.1995.13.11.2688
Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study.
L. Gianni (1995)
10.1093/ANNONC/MDF164
Gemcitabine, epirubicin and paclitaxel: pharmacokinetic and pharmacodynamic interactions in advanced breast cancer.
S. Fogli (2002)
10.1200/JCO.2002.09.002
Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results.
J. O'Shaughnessy (2002)
10.3322/canjclin.49.3.138
Global breast cancer mortality statistics
C. Mettlin (1999)
10.1023/A:1011945623464
Gemcitabine plus epirubicin plus taxol (GET) in advanced breast cancer: a phase II study*
P. Conte (2004)
10.1200/JCO.1996.14.8.2197
Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer.
P. A. Greenberg (1996)



This paper is referenced by
10.1186/1471-2407-6-76
Phase II study of gemcitabine, doxorubicin and paclitaxel (GAT) as first-line chemotherapy for metastatic breast cancer: a translational research experience
A. Passardi (2006)
10.1007/s00280-009-0928-6
A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer
V. Bozionelou (2009)
10.1186/2193-1801-3-293
A systematic review of gemcitabine and taxanes combination therapy randomized trials for metastatic breast cancer
Q. Hu (2014)
10.1007/S12254-008-0002-9
memo – New official Journal of CECOG
C. Zielinski (2008)
10.1017/S0266462308080495
Progression-free survival as a surrogate endpoint in advanced breast cancer.
R. Miksad (2008)
10.1053/j.seminoncol.2005.07.028
Role of Gemcitabine in Breast Cancer Management: An Update.
B. Wirk (2006)
10.1016/J.CRITREVONC.2006.12.007
Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial.
G. Romieu (2007)
10.1186/s13058-020-01348-w
Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer—results from the randomized phase III SUCCESS-A trial
A. de Gregorio (2020)
Study of a Molecular Promoter for Enhancing Cisplatin Cancer Chemotherapy
Jenny Nguyen (2010)
10.3816/CBC.2010.n.048
A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer.
D. Yardley (2010)
10.1634/theoncologist.2018-0184
Permanent Chemotherapy‐Induced Alopecia in Patients with Breast Cancer: A 3‐Year Prospective Cohort Study
Danbee Kang (2019)
10.1007/s00280-008-0682-1
Trastuzumab and gemcitabine as salvage therapy in heavily pre-treated patients with metastatic breast cancer
R. Bartsch (2008)
10.1007/S10330-009-0147-Y
The effect and side effects of Gemcitabine plus Vinorelbine in patients with triple-negative metastatic breast cancer
C. Yang (2009)
10.1371/journal.pone.0074872
Increased Risk of High-Grade Hemorrhage in Cancer Patients Treated with Gemcitabine: A Meta-Analysis of 20 Randomized Controlled Trials
Y. Hu (2013)
10.7150/jca.8304
Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature
Pamela Abdayem (2014)
10.1002/14651858.CD003366.pub3
Taxane-containing regimens for metastatic breast cancer.
D. Ghersi (2015)
10.1016/J.EJCA.2006.05.002
EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours.
M. Aapro (2006)
10.1038/sj.bjc.6603832
A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours
V. Bozionelou (2007)
10.1016/j.clbc.2015.09.007
Use of Cytotoxic Chemotherapy in Metastatic Breast Cancer: Putting Taxanes in Perspective.
J. Sachdev (2016)
10.1053/J.SEMINONCOL.2005.12.006
The emergence of a unique population in non-small cell lung cancer: systemic or loco-regional relapse following postoperative adjuvant platinum-based chemotherapy.
M. Socinski (2006)
10.1016/J.BREAST.2007.10.009
Role of gemcitabine in metastatic breast cancer patients: a short review.
N. Silvestris (2008)
10.1007/s10549-015-3453-9
A network meta-analysis of everolimus plus exemestane versus chemotherapy in the first- and second-line treatment of estrogen receptor-positive metastatic breast cancer
D. Generali (2015)
10.3816/CBC.2008.n.029
Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group.
J. Hamm (2008)
10.1053/J.SEMINONCOL.2006.03.020
Overview of gemcitabine activity in advanced breast cancer.
I. Smith (2006)
Establishment of immunocytochemical and molecular methods for characterization of circulating tumor cells in breast cancer patients
K. Pantel (2007)
10.1016/S1043-321X(05)80251-6
Cardiotoxicity of Anthracycline–Taxane Combinations in Metastatic Breast Cancer
B. Hennessy (2006)
10.1634/THEONCOLOGIST.9-6-617
Facts and controversies in systemic treatment of metastatic breast cancer.
C. Bernard-Marty (2004)
10.1093/ANNONC/MDP261
Third consensus on medical treatment of metastatic breast cancer
D. Berthold (2006)
10.4143/crt.2006.38.4.206
Gemcitabine single or combination chemotherapy in post anthracycline and taxane salvage treatment of metastatic breast cancer: retrospective analysis of 124 patients.
M. K. Kim (2006)
10.1038/sj.bjc.6605441
Improving outcome of chemotherapy of metastatic breast cancer by docosahexaenoic acid: a phase II trial
P. Bougnoux (2009)
10.1016/S0305-7372(05)80003-9
Gemcitabine-taxane experience in the treatment of metastatic breast cancer.
A. Barnadas (2005)
10.1093/jnci/djn414
Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancer.
D. Mauri (2008)
See more
Semantic Scholar Logo Some data provided by SemanticScholar