Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: The FNCLCC PACS 01 trial

Journal of Clinical Oncology

Volumn 24, Issue 36, 2006, Pages 5664-5671

  Roché, Henri ^a   Fumoleau, Pierre ^b   Spielmann, Marc ^b   Canon, Jean Luc ^b   Delozier, Thierry ^b   Serin, Daniel ^b   Symann, Michel ^b   Kerbrat, Pierre ^b   Soulié, Patrick ^b   Eichler, Françoise ^b   Viens, Patrice ^b   Monnier, Alain ^b   Vindevoghel, Anita ^b   Campone, Mario ^b   Goudier, Marie Josèphe ^b   Bonneterre, Jacques ^b   Ferrero, Jean Marc ^b   Martin, Anne Laure ^b   Genève, Jean ^b   Asselain, Bernard ^b  

^a INSTITUT CLAUDIUS REGAUD   (France)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; FLUOROURACIL; PREDNISOLONE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TAMOXIFEN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; FEC PROTOCOL; TAXOID;

ADJUVANT THERAPY; ADULT; ALOPECIA; AMENORRHEA; ANEMIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER CHEMOTHERAPY; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE SEQUENCE; EDEMA; FEBRILE NEUTROPENIA; FLUID RETENTION; FOLLOW UP; HEART DEATH; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERSENSITIVITY; INCIDENCE; INFECTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING; ADJUVANT CHEMOTHERAPY; AGED; BREAST TUMOR; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; FEMALE; LYMPH NODE METASTASIS; MIDDLE AGED; PATHOLOGY;

ADULT; AGED; ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EPIRUBICIN; FEMALE; FLUOROURACIL; HUMANS; LYMPHATIC METASTASIS; MIDDLE AGED; TAMOXIFEN; TAXOIDS; TREATMENT OUTCOME;

EID: 34247329446     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.07.3916     Document Type: Article

References (37)

1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 365:1687-1717, 2005
2. Chevallier B, Fumoleau P, Kerbrat P, et al: Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: A phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer. J Clin Oncol 13:314-322, 1995
3. Valero V, Holmes FA, Walters RS, et al: Phase II trial of docetaxel: A new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol 13:2886-2894, 1995
4. Ravdin PM, Burris HA 3rd, Cook G, et al: Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol 13:2879-2885, 1995
5. Jones SE, Erban J, Overmoyer B, et al: Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542-5551, 2005
6. Gianni L, Munzone E, Capri G, et al: 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. J Clin Oncol 13:2688-2699, 1995
7. Dombernowsky P, Boesgaard M, Andersen E, et al: Doxorubicin plus paclitaxel in advanced breast cancer. Semin Oncol 24:S17-S18, 1997 (suppl 17)
8. Luck HJ, Thomssen C, Du Bois A, et al: Metastatic breast cancer: Experience with the combination paclitaxel plus epirubicin. Oncology (Williston Park) 12:36-39, 1998 (suppl 1)
9. Conte PF, Gennari A, Salvadori B, et al: Paclitaxel plus epirubicin in advanced breast cancer. Oncology (Williston Park) 12:40-44, 1998 (suppl 1)
10. 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
11. Nabholtz JM, Mackey JR, Smylie M, et al: Phase II study of docetaxel, doxorubicin, and cyclophosphamide as first-line chemotherapy for metastatic breast cancer. J Clin Oncol 19:314-321, 2001
12. Sparano JA, O'Neill A, Schaefer PL, et al: Phase II trial of doxorubicin and docetaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: Eastern Cooperative Oncology Group Study E1196. J Clin Oncol 18:2369-2377, 2000
13. Viens P, Roche H, Kerbrat P, et al: Epirubicin-docetaxel combination in first-line chemotherapy for patients with metastatic breast cancer: Final results of a dose-finding and efficacy study. Am J Clin Oncol 24:328-335, 2001
14. Pagani O, Sessa C, Nole F, et al: Epidoxorubicin and docetaxel as first-line chemotherapy in patients with advanced breast cancer: A multicentric phase I-II study. Ann Oncol 11:985-991, 2000
15. Mavroudis D, Alexopoulos A, Ziras N, et al: Front-line treatment of advanced breast cancer with docetaxel and epirubicin: A multicenter phase II study. Ann Oncol 11:1249-1254, 2000
16. Venturini M, Michelotti A, Papaldo P, et al: Identification of the highest dose of docetaxel associate with active doses of epirubicin: Results from a dose-finding study in advanced breast cancer patients. Ann Oncol 12:1097-1106, 2001
17. Milla-Santos A, Milla L, Rallo L, et al: High-dose epirubicin plus docetaxel at standard dose with lenograstim support as first-line therapy in advanced breast cancer. Am J Clin Oncol 24:138-142, 2001
18. Morales S, Lorenzo A, Ramos M, et al: Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer. Results of a large, multicentre phase II study. Cancer Chemother Pharmacol 53:75-81, 2004
19. 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
20. 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 Organisation for Research and Treatment of Cancer Multicenter Phase III Trial 10961. J Clin Oncol 20:3114-3121, 2002
21. Luck H, Thomssen C, Untch M, et al: Multicentric phase III study in first line treatment of advanced metastatic breast cancer: Epirubicin/paclitaxel vs epirubicin/cyclophosphamide - A study of the AGO Breast Cancer Group. Proc Am Soc Clin Oncol 19: 73a, 2000 (abstr 280)
22. Langley RE, Carmichael J, Jones AL, et al: Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Res Institute trial AB01. J Clin Oncol 23:8322-8330, 2005
23. 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
24. Mackey JR, Paterson A, Dirix LY, et al: Final results of the phase III randomized trial comparing docetaxel, doxorubicin, and cyclophosphamide to FAC as first line chemotherapy for patients with metastatic breast cancer. Proc Am Soc Clin Oncol 21: 35a, 2002 (abstr 137)
25. Bontenbal M, Creemers GJ, Braun HJ, et al: 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. J Clin Oncol 23:7081-7088, 2005
26. Bonneterre J, Dieras V, Tubiana-Hulin M, et al: Phase II multicentre randomised study of docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide in metastatic breast cancer. Br J Cancer 91:1466-1471, 2004
27. Henderson IC, Berry DA, Demetri GD, et al: Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 21:976-983, 2003
28. Mamounas EP, Bryant J, Lembersky B, et al: Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: Results from NSABP B-28. J Clin Oncol 23:3686-3696, 2005
29. Martin M, Pienkowski T, Mackey J, et al: Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352:2302-2313, 2005
30. Bonneterre J, Roche H, Kerbrat P, et al: Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial. J Clin Oncol 23:2686-2693, 2005
31. Fumoleau P, Kerbrat P, Romestaing P, et al: Randomized trial comparing six versus three cycles of epirubicin-based adjuvant chemotherapy in premenopausal, node-positive breast cancer patients: 10-year follow-up results of the French Adjuvant Study Group 01 trial. J Clin Oncol 21:298-305, 2003
32. Peto R, Pike MC, Armitage P, et al: Design and analysis of randomized clinical trials requiring prolonged observation of each patient, I: Introduction and design. Br J Cancer 34:585-612, 1976
33. Fumoleau P, Bonneterre J, Luporsi E: Adjuvant chemotherapy for node-positive breast cancer patients: Which is the reference today? J Clin Oncol 21:1190-1192, 2003
34. National Institutes of Health Consensus Development Panel: National Institutes of Health consensus development conference statement: Adjuvant therapy for breast cancer, November 1-3, 2000. J Natl Cancer Inst 93:979-989, 2001
35. Bonneterre J, Roche H, Kerbrat P, et al: Long-term cardiac follow-up in relapse-free patients after six courses of fluorouracil, epirubicin, and cyclophosphamide, with either 50 or 100 mg of epirubicin, as adjuvant therapy for node-positive breast cancer: French adjuvant study group. J Clin Oncol 22:3070-3079, 2004
36. Fumoleau P, Roche H, Kerbrat P, et al: Long-term cardiac toxicity after adjuvant epirubicin-based chemotherapy in early breast cancer. French Adjuvant Study Group Results. Ann Oncol 17:85-92, 2006
37. Campone M, Roche H, Kerbrat P, et al: Secondary leukemia after epirubicin-based adjuvant chemotherapy in operable breast cancer patients: 16 years experience of the French Adjuvant Study Group. Ann Oncol 16:1343-1351, 2005