Phase II trial of dose dense docetaxel followed by FEC100 as neoadjuvant chemotherapy in patients with operable breast cancer

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 33, Issue 6, 2010, Pages 544-549

  Jacot, William ^a   Bibeau, Frédéric ^a   Gourgou Bourgade, Sophie ^a   Gutowski, Marian ^a   Colombo, Pierre Emmanuel ^a   Bleuse, Jean Pierre ^a   Kramar, Andrew ^a   Romieu, Gilles ^a  

^a CENTRE VAL D AURELLE   (France)

Author keywords

Breast cancer; Docetaxel; Dose dense; Neoadjuvant; Phase II trial

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; FLUOROURACIL; PREDNISOLONE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADJUVANT THERAPY; ADULT; ANEMIA; ARTHRALGIA; ARTICLE; BREAST CANCER; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLUID RETENTION SYNDROME; HUMAN; HUMAN TISSUE; IDIOPATHIC EDEMA; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PATIENT COMPLIANCE; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR VOLUME; VOMITING;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MASTECTOMY; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM INVASIVENESS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; RISK ASSESSMENT; SURVIVAL ANALYSIS; TAXOIDS; TIME FACTORS; TREATMENT OUTCOME;

EID: 78650034762     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e3181bead47     Document Type: Article

References (30)

1. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol. 2007;18:581-592.
2. Schwartz GF, Birchansky CA, Komarnicky LT, et al. Induction chemotherapy followed by breast conservation for locally advanced carcinoma of the breast. Cancer. 1994;73:362-369.
3. Clarke M. Meta-analyses of adjuvant therapies for women with early breast cancer: the Early Breast Cancer Trialists' Collaborative Group overview. Ann Oncol. 2006;(17 suppl 10):x59-x62.
4. Kaufmann M, von Minckwitz G, Bear HD, et al. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: new perspectives 2006. J Clin Oncol. 2006;24:1940-1949.
5. Fisher B, Bryant J, Wolmark N, et al. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998;16: 2672-2685.
6. Bonadonna G, Veronesi U, Brambilla C, et al. Primary chemotherapy to avoid mastectomy in tumors with diameters of three centimeters or more. J Natl Cancer Inst. 1990;82:1539-1545.
7. Ellis P, Smith I, Ashley S, et al. Clinical prognostic and predictive factors for primary chemotherapy in operable breast cancer. J Clin Oncol. 1998;16:107-114.
8. Burris HA III. Single-agent docetaxel (Taxotere) in randomized phase III trials. Semin Oncol. 1999;26(3 suppl 9):1-6.
9. Amat S, Bougnoux P, Penault-Llorca F, et al. Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breastconservation rate. Br J Cancer. 2003;88:1339-1345.
10. Smith IC, Heys SD, Hutcheon AW, et al. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol. 2002;20:1456-1466.
11. Hutcheon AW, Heys SD, Sarkar TK. Neoadjuvant docetaxel in locally advanced breast cancer. Breast Cancer Res Treat. 2003;(79 suppl 1):S19-S24.
12. Culine S, Romieu G, Fabbro M, et al. Reducing the time interval between cycles using standard doses of docetaxel and lenogastrim support: A feasibility study. Cancer. 2004;101:178-182.
13. Mitchell PL, Basser R, Chipman M, et al. A phase II study of escalated-dose docetaxel with granulocyte colony-stimulating factor support in patients with advanced breast cancer. Ann Oncol. 2004;15:585-589.
14. Paciucci PA, Raptis G, Bleiweiss I, et al. Neo-adjuvant therapy with dosedense docetaxel plus short-term filgrastim rescue for locally advanced breast cancer. Anticancer Drugs. 2002;13:791-795.
15. Chevallier B, Roche H, Olivier JP, et al. Inflammatory breast cancer. Pilot study of intensive induction chemotherapy (FEC-HD) results in a high histologic response rate. Am J Clin Oncol. 1993;16:223-228.
16. Sataloff DM, Mason BA, Prestipino AJ, et al. Pathologic response to induction chemotherapy in locally advanced carcinoma of the breast: A determinant of outcome. J Am Coll Surg. 1995;180:297-306.
17. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1-10.
18. Nabholtz JM, Thuerlimann B, Bezwoda WR, et al. Docetaxel vs mitomycin plus vinblastine in anthracycline-resistant metastatic breast cancer. Oncology (Williston Park). 1997;11(8 suppl 8):25-30.
19. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17:2341-2354.
20. Bonneterre J, Roche H, Monnier A, et al. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure. Br J Cancer. 2002;87:1210-1215.
21. Ganem G, Tubiana-Hulin M, Fumoleau P, et al. Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer. Ann Oncol. 2003;14:1623-1628.
22. Roche H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubicinbased and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol. 2006;24:5664-5671.
23. Amat S, Mouret-Reynier MA, Penault-Llorca F, et al. Sequential addition of an anthracycline-based regimen to docetaxel as neoadjuvant chemotherapy in patients with operable breast cancer. Clin Breast Cancer. 2006;7:262-269.
24. Miller KD, McCaskill-Stevens W, Sisk J, et al. Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer: A randomized pilot trial of the Hoosier Oncology Group. J Clin Oncol. 1999;17:3033-3037.
25. von Minckwitz G, Costa SD, Raab G, et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. J Clin Oncol. 2001;19:3506-3515.
26. von Minckwitz G, Raab G, Caputo A, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005;23: 2676-2685.
27. Toi M, Nakamura S, Kuroi K, et al. Phase II study of preoperative sequential FEC and docetaxel predicts of pathological response and disease free survival. Breast Cancer Res Treat. 2008;110:531-539.
28. Natoli C, Cianchetti E, Tinari N, et al. A phase II study of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine and pegfilgrastim support as preoperative therapy for patients with stage II, IIIA breast cancer. Ann Oncol. 2007;18:1015-1020.
29. Ramaswamy B, Povoski SP, Rhoades C, et al. Phase II trial of neoadjuvant chemotherapy with docetaxel followed by epirubicin in stage II/III breast cancer. Breast Cancer Res Treat. 2005;93:67-74.
30. Steger GG, Galid A, Gnant M, et al. Pathologic complete response with six compared with three cycles of neoadjuvant epirubicin plus docetaxel and granulocyte colony-stimulating factor in operable breast cancer: results of ABCSG-14. J Clin Oncol. 2007;25:2012-2018.