Phase II to III study comparing doxorubicin and docetaxel with fluorouracil, doxorubicin, and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: Results of a Dutch community setting trial for the clinical trial group of the comprehensive cancer centre

Journal of Clinical Oncology

Volumn 23, Issue 28, 2005, Pages 7081-7088

  Bontenbal, Marijke ^a   Creemers, Geert Jan ^a   Braun, Hans J ^a   de Boer, Auke C ^a   Janssen, Jos Th ^a   Leys, Rieneke B ^a   Ruit, Jan B ^a   Goey, Swan Hoo ^a   van der Velden, Paul C ^a   Kerkhofs, Leon G ^a   Schothorst, Kristel L ^a   Schmitz, Paul I ^a   Bokma, Hansje J ^a   Verweij, Jaap ^a   Seynaeve, Caroline ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; ANTINEOPLASTIC AGENT; AT PROTOCOL; CAF PROTOCOL; PACLITAXEL;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CENTER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COMMUNITY CARE; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; MAJOR CLINICAL STUDY; METASTASIS; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; TREATMENT RESPONSE; VOMITING; BREAST TUMOR; COMPARATIVE STUDY; DISEASE COURSE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; SURVIVAL;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; DISEASE PROGRESSION; DOXORUBICIN; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAVENOUS; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL; SURVIVAL ANALYSIS;

EID: 27244438750     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.06.236     Document Type: Article

References (25)

1. Bergh J, Jonsson P-E, Glimelius B, et al: A systematic overview of chemotherapy effects in breast cancer. Acta Oncol 40:253-281, 2001
2. Fossati R, Confalonieri C, Torri V, et al: Cytotoxic and hormonal treatment for metastatic breast cancer: A systematic review of published randomized trials involving 31,510 women. J Clin Oncol 16:3439-3460, 1998
3. Ten Bokkel Huinink W, Prove AM, Piccart M, et al: A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer: A study of the EORTC-ECTG. Ann Oncol 5:527-532, 1994
4. Trudeau ME, Eisenhauer EA, Higgins BP, et al: Docetaxel in patients with metastatic breast cancer: A phase II trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 14:422-428, 1996
5. Hudis CA, Seidman AD, Crown JPA, et al: Phase II pharmacologic study of docetaxel as initial chemotherapy for metastatic breast cancer. J Clin Oncol 14:58-65, 1996
6. Chevallier B, Fumuleau P, Kerbrat P, et al: Docetaxel is a major cytotoxic drug for the treatment of metastatic breast cancer: A phase II trial of the Clinical Screening Cooperative Group of the EORTC. Ann Oncol 7:165-171, 1996
7. Chan S, Friedrichs K, Bnoel D: Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 17:2341-2354, 1999
8. Misset JL, Dieras V, Gruia G, et al: Dose finding study of docetaxel and doxorubicin in first-line treatment of patients with metastatic breast cancer. Ann Oncol 10:553-560, 1999
9. Nabholtz JM, Falkson C, Campos D, et al: 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 Clin Oncol 21:968-975, 2003
10. Mackey JR, Paterson A, Dirix LY, et al: Final results of the phase III randomized trial comparing docetaxel (T), doxorubicin (A) and cyclophosphamide (C) to FAC as first-line chemotherapy (CT) for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 21:35a, 2002 (abstr 137)
11. Tubiana-Hulin M, Bonneterre J, Bougnoux P, et al: Better survival with epirubicin-docetaxel (ET) combination as first-line chemotherapy in patients with metastatic breast cancer (MBC): Final results of a phase II randomized study. Proc Am Soc Clin Oncol 22:46, 2003 (abstr 182)
12. Machin D, Campbell MJ: Statistical Tables for the Design of Clinical Trials. Oxford, United Kingdom, Blackwell Scientific Publications, 1987
13. Jassem J, Pienkowski T, Pluzanska A, et al: 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 Clin Oncol 19:1707-1715, 2001
14. Biganzoli L, Cufer T, Bruning P, et al: 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. J Clin Oncol 20:3114-3121, 2002
15. Carmichel J: UKCCR trial of epirubicin and cyclophosphamide (EC) vs. epirubicin and Taxol (ET) in the first line treatment of women with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 20:22a, 2001 (abstr 84)
16. Lück HJ, Thomssen C, Untch M, et al: Multicentric phase III study in first line treatment of advanced metastatic breast cancer (ABC): Epirubicin/paclitaxel (ET) vs epirubicin/cyclophosphamide (EC)-A study of the AGO Breast Cancer Group. Proc Am Soc Clin Oncol 19:73a, 2000 (abstr 280)
17. Friedrichs K, Hölzel F, Jänicke F: Combinations of taxanes and anthracyclines in first-line chemotherapy of metastatic breast cancer: An interim report. Eur J Cancer 38:1730-1738, 2002
18. Valero V, Hortobagyi GN: Are anthracycline-taxane regimens the new standard of care in the treatment of metastatic breast cancer? J Clin Oncol 21:959-962, 2003
19. Miles D, von Minckwitz G, Seidman AD: Combination versus sequential single-agent therapy in metastatic breast cancer. Oncologist 7:13-19, 2002 (suppl 6)
20. Alonso MC, Taberno JM, Ojeda B, et al: A phase III randomized trial of cyclophosphamide, mitoxantrone, and 5-fluorouracil (CNF) versus cyclophosphamide, Adriamycin, and 5-fluorouracil (CAF) in patients with metastatic breast cancer. Breast Cancer Res Treat 34:15-24, 1995
21. French Epirubicin Study Group: A prospective randomized phase III trial comparing combination chemotherapy with cyclophosphamide, fluorouracil, and either doxorubicin or epirubicin. J Clin Oncol 6:679-688, 1988
22. Italian Multicenter Breast Study With Epirubicin: Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide, v fluorouracil, doxorubicin and cyclophosphamide in advanced breast cancer: An Italian Multicenter Trial. J Clin Oncol 6:976-982, 1988
23. Bennett JM, Muss HB, Doroshow JH, et al: A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast cancer. J Clin Oncol 6:1611-1620, 1988
24. Marin M, Pienkowski T, Mackey J, et al: TAC improves DFS and OS over FAC in node-positive early breast cancer patients, BCIRG001. San Antonio Breast Cancer Conference, San Antonio, TX, December 3-6, 2003 (abstr 35)
25. Martin M, Lluch A, Sequi MA, et al: Prophylactic growth factor (GF) support with adjuvant docetaxel, doxorubicin and cyclophosphamide (TAC) for node-negative breast cancer (BC): An interim safety analysis of GEICAM9805 study. J Clin Oncol 22:32, 2004 (suppl, abstr 620)