European Journal of Surgical Oncology
Volume 35, Issue 10 , Pages 1048-1054 , October 2009

Neoadjuvant bevacizumab, docetaxel and capecitabine combination therapy for HER2/neu-negative invasive breast cancer: Efficacy and safety in a phase II pilot study

  • R. Greil

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria
    • Corresponding Author InformationCorresponding author. Tel.: +43 662 4482 2879; fax: +43 662 4482 2898.
  • ,
  • M. Moik

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria
  • ,
  • R. Reitsamer

      Affiliations

    • Special Gynecology, Private Medical University Hospital, Salzburg, Austria
  • ,
  • S. Ressler

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria
  • ,
  • M. Stoll

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria
  • ,
  • K. Namberger

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria
  • ,
  • C. Menzel

      Affiliations

    • Special Gynecology, Private Medical University Hospital, Salzburg, Austria
  • ,
  • B. Mlineritsch

      Affiliations

    • IIIrd Medical Department with Hematology and Medical Oncology, Private Medical University Hospital Salzburg, Muellner Hauptstrasse 48, Salzburg A-5020, Austria

,Accepted 28 January 2009.

References 

  1. Bear HD, Anderson S, Smith RE, et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006;24:2019–2027
  2. Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thürlimann B, Senn HJ, et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol. 2007;18:1133–1144
  3. O'Shaughnessy JA, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20:2812–2823
  4. Cameron D. Bevacizumab in the first-line treatment of metastatic breast cancer. Eur J Cancer Suppl. 2008;6:21–28
  5. Miles D, Chan A, Romieu G, et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol. 2008;26(18S):1088s;[LBA1011]
  6. Miller KD, Chap LI, Holmes FA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005;23:792–799
  7. Sledge G, Miller K, Moisa C, Gradishar W. Safety and efficacy of capecitabine (C) plus bevacizumab (B) as first-line in metastatic breast cancer. J Clin Oncol. 2007;25(18S):1013
  8. Perez EA, Hillman DW, Kugler JW, Steen PD, Fitch RT, Rowland KM. North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first line chemotherapy for patients with metastatic breast cancer. Breast Cancer Res Treat. 2006;100(Suppl. 1):S104;[Abst. 2069]
  9. Lee KS, Ro J, Nam BH, et al. A randomized phase-III trial of docetaxel/capecitabine versus doxorubicin/cyclophosphamide as primary chemotherapy for patients with stage II/III breast cancer. Breast Cancer Res Treat. 2008;109:481–489
  10. Joensuu H, Kellokumpu-Lehtinen P, Huovinen R, et al. Significant improvement in recurrence-free survival (RFS) when capecitabine (X) is integrated into docetaxel (T) 5→FU+epirubicin+cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer (BC): interim analysis of the FinXX-trial. Cancer Res. 2009;69(Suppl):[Abst. 82]
  11. Wedam SB, Low JA, Yang SX, et al. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol. 2006;24:769–777
  12. Makhoul I, Vicki KS, Korourian S, et al. Bevacizumab combined with chemotherapy significantly improves pathologic complete response in patients with operable or locally advanced breast cancer. Cancer Res. 2009;69(Suppl):343s;[Abst. 5114]
  13. Raefsky E, Castillo R, Lahiry A, et al. Phase II study of neoadjuvant bevacizumab and trastuzumab administered with albumin-bound paclitaxel (nab paclitaxel) and carboplatin in HER2+ locally advanced breast cancer. J Clin Oncol. 2008;26(15S):37S;[Abst. 627]
  14. Miller KD, O'Neill A, Perez EA, Seidman AD, Sledge GW. Phase II feasibility trial incorporating bevacizumab into dose-dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node-positive breast cancer: a trial of the Eastern Cooperative Oncology Group (E2104). J Clin Oncol. 2008;26(15S):11S;[Abst. 520]
  15. McArthur HL, Rugo H, Nulsen B, et al. Cardiac safety of adjuvant bevacizumab (B) plus dose-dense doxorubicin/cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel (nab-P) in patients with early stage breast cancer. Cancer Res. 2009;69(Suppl):288s;[Abst. 4104]
  16. Yardley DA, Hart L, Waterhouse DM, et al. Preliminary safety results: addition of bevacizumab to 3 docetaxel regimens as adjuvant therapy for early stage breast cancer. Cancer Res. 2009;69(Suppl):289s;[Abst. 4107]
  17. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357:2666–2676
  18. Haller DG, Cassidy J, Clarke SJ, et al. Potential regional differences for the tolerability profiles of fluoropyrimidines. J Clin Oncol. 2008;26:2118–2123
  19. Colleoni M, Viale G, Zahrieh D, et al. Expression of ER, PgR, HER1, HER2, and response: a study of preoperative chemotherapy. Ann Oncol. 2008;19:465–472
  20. Mehta RS, Schubbert T, Kong K, Hsiang D, Butler J, Baick C. Pathologic complete response (pCR) following weekly (wkly) paclitaxel (cremophor or albumin-bound) and carboplatin (TC) ± trastuzumab (H), ± bevacizumab (B) in patients (pts) with doxorubicin/cyclophosphamide-resistant (AC-Res) and AC-sensitive (AC-S) large and inflammatory breast cancer. J Clin Oncol. 2007;25(18S):591
  21. Fernández-Morales LA, Seguí MA, Andreu X, et al. Analysis of the pathologic response to primary chemotherapy in patients with locally advanced breast cancer grouped according to estrogen receptor, progesterone receptor, and HER2 status. Clin Breast Cancer. 2007;7:559–564
  22. Guarneri V, Broglio K, Kau SW, et al. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol. 2006;24:1037–1044
  23. Heys SD, Hutcheon AW, Sarkar TK, et al. Aberdeen Breast Group. Neoadjuvant docetaxel in breast cancer: 3-year survival results from the Aberdeen trial. Clin Breast Cancer. 2002;3(Suppl. 2):S69–S74
  24. Evans TR, Yellowlees A, Foster E, et al. Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: an Anglo-Celtic Cooperative Oncology Group study. J Clin Oncol. 2005;23:2988–2995
  25. 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
  26. Lebowitz PF, Eng-Wong J, Swain SM, et al. A phase II trial of neoadjuvant docetaxel and capecitabine for locally advanced breast cancer. Clin Cancer Res. 2004;10:6764–6769
  27. Wildiers H, Neven P, Christaens M-R, et al. Multicenter phase II study of neoadjuvant capecitabine (X), docetaxel (T) ± trastuzumab (H) for patients (pts) with locally advanced breast cancer (LABC): preliminary safety and efficacy data. Cancer Res. 2009;69(Suppl):S147;[Abst. 5115]
  28. Tripathy D, Moisa C, Gluck S. Neoadjuvant capecitabine plus docetaxel±trastuzumab therapy for recently diagnosed breast cancer: phase II results. Breast Cancer Res Treat. 2007;106(Suppl. 1):S226;[Abst. 5059]
  29. Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008;26:1275–1281
  30. Keam B, Im SA, Kim HJ, et al. Prognostic impact of clinicopathologic parameters in stage II/III breast cancer treated with neoadjuvant docetaxel and doxorubicin chemotherapy: paradoxical features of the triple negative breast cancer. BMC Cancer. 2007 Nov;1(7):203
  31. Rouzier R, Perou CM, Symmans WF, et al. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005;11:5678–5685

 Previously presented at the 30th San Antonio Breast Cancer Symposium, December 13–16, 2007 (abstract 4064).

☆☆ Sources of support: Roche Austria was sole sponsor of this trial, provided study medication (Taxotere in co-operation with Sanofi–Aventis) and was responsible for monitoring. Data management and statistical analysis were performed by Dr. Anton Klingler (Assign Data Management and Biostatistics GmbH; Feldstrasse 1, A-6020 Innsbruck, Austria).

PII: S0748-7983(09)00033-X

doi: 10.1016/j.ejso.2009.01.014

European Journal of Surgical Oncology
Volume 35, Issue 10 , Pages 1048-1054 , October 2009