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Docetaxel

In the treatment of operable breast cancer

  • Adis Drug Profile
  • Published:
American Journal of Cancer

Abstract

▴ Docetaxel is an antimicrotubule agent established as a first- and/or second-line intravenous therapy in a variety of cancers, including locally advanced or metastatic breast cancer. It also is approved in the US as adjuvant therapy in early breast cancer, and continues to be investigated in this setting in combination with other agents and in various dosing schedules.

▴ The efficacy of docetaxel-containing adjuvant therapy has been evaluated in two large (n >1000 per trial), randomized clinical trials. One trial compared intravenous docetaxel plus doxorubicin and cyclophosphamide (TAC) every 3 weeks with standard fluorouracil plus doxorubicin and cyclophosphamide (FAC) chemotherapy. Another trial compared intravenous docetaxel plus cyclophosphamide (TC) every 3 weeks with doxorubicin plus cyclophosphamide (AC).

▴ Treatment with TAC improved disease-free survival (75% vs 68%; p = 0.001) and overall survival (87% vs 81%; p = 0.008) at 55 months to a greater extent than FAC.

▴ There were no significant differences in disease-free survival and overall survival between TC and AC. Nevertheless, a nonsignificant trend in disease-free survival favors TC and follow-up data were for a period of only 43 months.

▴ Tolerability in docetaxel-containing adjuvant chemotherapy regimens was manageable. The most frequently reported severe adverse events with TAC were predominantly hematologic, including neutropenia, febrile neutropenia, and neutropenic infection.

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References

  1. Figgitt D, Wiseman LR. Docetaxel: an update of its use in advanced breast cancer. Drags 2000; 59(3): 621–51

    Article  CAS  Google Scholar 

  2. Aventis Pharma SA. Taxotere summary of product characteristics [online]. Available from URL: http://www.emea.eu.int/humandocs/Humans/EPAR/Taxotere/Taxotere.htm [Accessed 2004 Jul 20]

  3. Aventis Pharmaceuticals Inc. Taxotere (docetaxel): US prescribing information [online]. Available from URL: http://www.fda.gov/cder/foi/label/2004/020449s0291bl.pdf [Accessed 2004 Aug 23]

  4. Nabholtz J-M, Tonkin K, Smylie M, et al. Review of docetaxel and doxorubicin-based combinations in the management of breast cancer: from metastatic to adjuvant setting. Semin Oncol 1999 Feb; 26(1 Suppl. 3): 10–6

    PubMed  CAS  Google Scholar 

  5. Piccart M. The role of taxanes in the adjuvant treatment of early stage breast cancer. Breast Cancer Res Treat 2003; 79Suppl. 1: S25–34

    Article  PubMed  CAS  Google Scholar 

  6. Early Breast Cancer Trialists’ Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998; 352: 930–42

    Article  Google Scholar 

  7. Blum JL, Jones SE, Fay JW, et al. Guidelines for systemic therapy of early stage breast cancer. Breast Cancer Res Treat 1997 May; 43(3): 259–76

    Article  PubMed  CAS  Google Scholar 

  8. Goldhirsch A, Wood WC, Gelber RD, et al. Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003 Sep 1; 21(17): 3357–65

    Article  PubMed  Google Scholar 

  9. Fulton B, Spencer CM. Docetaxel: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the management of metastatic breast cancer. Drags 1996; 51(6): 1075–92

    Article  CAS  Google Scholar 

  10. Martin M, Pienkowski T, Mackey J, et al. TAC improves disease free survival and overall survival over FAC in node positive breast cancer patients, BCIRG 001: 55 months follow-up [abstract no. 43]. Breast Cancer Res Treat 2004 May; 85(2): 173–195. Plus oral presentation available at http://www.bcirg.org/Internet/Studies/BCIRG+001.htm

    Article  Google Scholar 

  11. Martin M, Pienkowski T, Mackey J, et al. Docetaxel-based regimen (TAC) improves DFS and OS over FAC in node positive early breast cancer patients: efficacy, safety and quality of life at 55 month follow-up [abstract no. 50]. Eur J Cancer 2004; 2(3 Suppl.): 70

    Google Scholar 

  12. Vogel CL, Mackey JR, Martin M, on behalf of the BCIRG 001 Investigators. The role of growth factor support following neutropenic events in early stage breast cancer (BC) patients treated with adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC): a subanalysis of BCIRG 001 [abstract no. 677]. J Clin Oncol 2004; 22(14 Suppl.): 46s. Plus poster presented at the 40th Annual Meeting of the American Society of Clinical Oncology, 2004 June 5–8; New Orleans

  13. Jones SE, Savin MA, Asmar L, et al. Three year results of a prospective randomized trial of adjuvant chemotherapy for patients (pts) with stage I–III operable, invasive breast cancer comparing 4 courses of doxorabicin/cyclophosphamide (AC) to 4 courses of docetaxel/cyclophosphamide (TC) [abstract 59]. Proc Am Soc Clin Oncol 2003; 22: 15. Plus oral presentation given at the 39th Annual Meeting of the American Society of Clinical Oncology, 2003 May 31–June 3; Chicago

    Article  Google Scholar 

  14. Smith IC, Heys SD, Hutcheon AW, et al. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol 2002 Mar 15; 20: 1456–66

    Article  PubMed  CAS  Google Scholar 

  15. Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project protocol B-27. J Clin Oncol 2003; 21(22): 4165–74

    Article  PubMed  CAS  Google Scholar 

  16. Jackisch C, von Minckwitz G, Eidtmann H, et al. Dose-dense biweekly doxorubicin/docetaxel versus sequential neoadjuvant chemotherapy with doxorubicin/cyclophosphamide/docetaxel in operable breast cancer: second interim analysis. Clin Breast Cancer 2002; 3(4): 276–80

    Article  PubMed  CAS  Google Scholar 

  17. Hutcheon AW, Heys SD, Sarkar TK, et al. Docetaxel primary chemotherapy in breast cancer: a five year update of the Aberdeen trial [abstract no. 11]. 26th Annual San Antonio Breast Cancer Symposium; 2003 Dec 3–6; San Antonio

  18. von Minckwitz G, Raab G, Schuette M, et al. Dose-dense versus sequential adriamycin/docetaxel combination as preoperative chemotherapy (pCHT) in operable breast cancer (T2-3, NO-2, M0): primary endpoint analysis of the GEPAR-DUO study [abstract no. 168]. Proc Am Soc Clin Oncol 2002; 21 Pt 1: 43a. Plus poster presented at the 38th Annual Meeting of the American Society of Clinical Oncology; 2002 May 18–21; Orlando

    Google Scholar 

  19. Jones SE, Savin M, Holmes FA, et al. Preliminary results of a prospective randomized trial of adjuvant chemotherapy for patients (pts) with stage I–III operable, invasive breast cancer comparing 4 courses of adriamycin/cyclophosphamide (AC) to 4 courses of Taxotere/cyclophosphamide (TC) [abstract no. 128]. Proc Am Soc Clin Oncol 2001; 20 Pt 1: 33a

    Google Scholar 

  20. Martin M, Lluch A, Seguí 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 the GEICAM 9805 study [abstract no. 620]. J Clin Oncol 2004; 22(14 Suppl.): 32s. Plus poster presented at the 40th Annual Meeting of the American Society of Clinical Oncology; 2004 June 5–8; New Orleans

    Google Scholar 

  21. Brain EGC, Bachelot T, Serin D, et al. Phase III trial comparing doxorubicin docetaxel (AT) with doxorubicin cyclophosphamide (AC) in the adjuvant treatment of high-risk node negative (pN0) and limited node positive (pN+≤3) breast cancer (BC) patients (pts): first analysis of toxicity [abstract no. 617]. J Clin Oncol 2004; 22(14 Suppl.): 31s

    Google Scholar 

  22. Goldstein LJ, O’Neill A, Sparano JA, et al. LVEF assessment of adjuvant doxorubicin/cyclophosphamide (AC) vs. doxorabicin/docetaxel (AT) in early stage breast cancer: cardiac safety results of ECOG 2197 [abstract no. 73]. Proc Am Soc Clin Oncol 2003; 22: 19

    Article  Google Scholar 

  23. Roche H, Spielmann M, Fumoleau P, et al. Safety analysis of the PACS 01 adjuvant trial comparing 6 cycles of FEC 100 to 3 cycles of FEC 100 followed by 3 cycles of docetaxel (Taxotere®) or node positive breast cancer [abstract no. 144]. 26th Annual San Antonio Breast Cancer Symposium; 2003 Dec 3—6; San Antonio

  24. Aventis Pharmaceuticals Inc. FDA approves Taxotere® for the treatment of women with early stage breast cancer [media release]. 2004 Aug 19

  25. De Laurentiis M. Sequential epirubicin-docetaxel-CMF regimen as adjuvant therapy of early breast cancer: preliminary results of the Taxit-216 multicenter phase III trial [abstract no. 115]. Proc Am Soc Clin Oncol 2003; 22: 29

    Google Scholar 

  26. Breast International Group. B.I.G.-aisbl Newsletter 2004; 6 (2) [online]. Available from URL: http://www.breastinternationalgroup.org [Accessed 2004 Jul 19]

  27. Breast Cancer International Research Group. Study: BCIRG 005 (GMA TAX301) [online]. Available from URL: http://www.bcirg.org [Accessed 2004 Jul 19]

  28. Breast Cancer International Research Group. BCIRG 006 (GMA TAX302) [online]. Available from URL: http://www.bcirg.org [Accessed 2004 Jul 19]

  29. Participating Institutions of Goim 9902 Trial, Italian Cooperative Group. Epirubicin and cyclophosphamide (EC) vs docetaxel (D) followed by EC in adjuvant (ADJ) treatment of node positive (pN1) breast cancer (BC): a multi-center randomized phase III study [abstract no. 1836]. Proc Am Soc Clin Oncol 2001; 20 Pt 2: 22b

  30. Rack B, Janni W, Harbeck N, et al. Phase III study evaluating the role of docetaxel in the adjuvant therapy of breast cancer patients with extensive lymph node involvement (4 nodes +): ADEBAR study [abstract no. P78]. Breast 2003 Feb; 12Suppl. 1: S37

    Article  Google Scholar 

  31. Phase III randomized study of adjuvant doxorubicin and cyclophosphamide followed by docetaxel versus doxorubicin and docetaxel versus doxorubicin, docetaxel, and cyclophosphamide in women with breast cancer and positive axillary lymph nodes (NSABP-B-30) [online]. Available from URL: http://www.cancer.gov [Accessed 2004 Jul 19]

  32. Phase III randomized study of doxorubicin and cyclophosphamide followed by paclitaxel or docetaxel in women with node-positive or high-risk node-negative stage II or IIIA breast cancer (E-1199) [online]. Available from URL: http://www.cancer.gov URL [Accessed 2004 Jul 19]

  33. Phase III study of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen in postmenopausal women with node-positive breast cancer (ICCG-C/14/96) [online]. Available from URL: http://www.cancer.gov [Accessed 2004 Jul 19]

  34. Phase III randomized study of adjuvant docetaxel and epirubicin versus adjuvant cyclophosphamide, epirubicin, and fluorouracil with or without trastuzumab (herceptin) in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion (PACS-004) [online]. Available from URL: http://www.cancer.gov [Accessed 2004 Jul 19]

  35. Phase III randomized adjuvant study of fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF versus FEC followed by sequential docetaxel in women with resected stage I or II breast cancer (ICR-TACT) [online]. Available from URL: http://www.cancer.gov [Accessed 2004 Jul 19]

  36. Scottish Cancer Therapy Network. Recruitment update: Anglo Celtic II — primary medical therapy; Scottish Cancer Therapy Network newsletter No.30 Spring 2001 [online]. Available from URL: http://www.show.scot.nhs.uk/isdonline/cancer/research/SCTN30.pdf [Accessed 2004 Jul 19]

  37. von Minckwitz G, Raab G, Blohmer JU, et al. In vivo chemosensitivity-adapted neoadjuvant chemotherapy (docetaxel-doxorubicin-cyclophosphamide followed by vinorelbine-capecitabine salvage therapy) in patients with primary breast cancer: results of the GEPAR-TRIO randomized pilot study [abstract no. 236]. 26th Annual San Antonio Breast Cancer Symposium; 2003 Dec 3–6; San Antonio

  38. Costa S, von Minckwitz G, Jackisch C, et al. TAC as neoadjuvant chemotherapy in patients with primary breast cancer: interim progress report on 907 cases of the randomized prospective Gepartrio-trial [abstract no. 825]. Proc Am Soc Clin Oncol 2004; 23: 82

    Google Scholar 

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  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, PA, 19067, USA

    Susan J. Keam & Lesley J. Scott

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  1. Susan J. Keam
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  2. Lesley J. Scott
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Correspondence to Susan J. Keam.

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Keam, S.J., Scott, L.J. Docetaxel. Am J Cancer 3, 325–332 (2004). https://doi.org/10.2165/00024669-200403050-00006

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