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A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: results of the ERASME 3 study

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Abstract

Purpose In first-line metastatic breast cancer, both paclitaxel (P)-doxorubicin (A) and docetaxel (D)-doxorubicin (A) combinations have shown superiority over treatments without taxane. The aim of this study was to compare the two combinations. Patients and methods Chemotherapy-naive (except for adjuvant therapy) metastatic breast cancer patients were randomly assigned to intravenous AD (arm D) or AP (arm P) every 3 weeks for a maximum of four cycles, then four cycles of single agent docetaxel (arm D) or paclitaxel (arm P). Primary endpoint was overall quality of life (QoL) measured by EORTC QLQ-C30 after four courses of doxorubicin–taxane combination. Secondary endpoints were toxicity, overall survival (OS), progression-free survival (PFS), and QoL sub-scores. Results Between March 2000 and April 2004, 210 patients were randomized: 103 to arm P and 107 to arm D. Patient characteristics were well balanced between arms. After four courses, QoL score differences between groups or compared to baseline scores were not significant. Response rate was 39.6% for AD and 41.8% for AP. After a median follow-up of 50.2 months, median PFS and median OS were 8.7 and 21.4 months in arm D and 8.0 and 27.3 months in arm P (p = 0.977 and 0.081, respectively). Hematological toxicity was significantly more frequent in arm D than in arm P (p < 10−6), as well as grades 3–4 asthenia (p = 0.03). Neuropathy occurred more frequently in arm P (p = 0.03). Conclusion In this study, paclitaxel or docetaxel combined with doxorubicin were not significantly different in terms of QoL scores and efficacy, but had different toxicity profiles.

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References

  1. Boyle P, Ferlay J (2005) Cancer incidence and mortality in Europe, 2004. Ann Oncol 16(3):481–488

    Article  PubMed  CAS  Google Scholar 

  2. Jemal A, Murray T, Ward E, et al (2005) Cancer statistics, 2005. CA Cancer J Clin 55(1):10–30

    Article  PubMed  Google Scholar 

  3. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365(9472):1687–1717

    Article  CAS  Google Scholar 

  4. Nabholtz JM, Falkson C, Campos D, et al (2003) 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(6):968–975

    Article  PubMed  CAS  Google Scholar 

  5. Paridaens R, Biganzoli L, Bruning P, et al (2000) Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European organization for research and treatment of cancer randomized study with cross-over. J Clin Oncol 18(4):724–733

    PubMed  CAS  Google Scholar 

  6. Sledge GW, Neuberg D, Bernardo P, et al (2003) Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 21(4):588–592

    Article  PubMed  Google Scholar 

  7. Mouridsen H, Gershanovich M, Sun Y, et al (2003) Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 21(11):2101–2109

    Article  PubMed  CAS  Google Scholar 

  8. Jassem J, Pienkowski T, Pluzanska A, et al (2001) 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(6):1707–1715

    PubMed  CAS  Google Scholar 

  9. Bontenbal M, Creemers GJ, Braun HJ, et al (2005) 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(28):l7081–7088

    Article  CAS  Google Scholar 

  10. Biganzoli L, Cufer T, Bruning P, et al (2002) 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(14):3114–3121

    Article  PubMed  CAS  Google Scholar 

  11. Cassier PA, Chabaud S, Freyer G, et al (2005) A phase III randomized trial of doxorubicin (A) and docetaxel (D) versus doxorubicin and paclitaxel (P) in metastatic breast cancer—preliminary results of the Erasme 3 study. Breast Cancer Treat Res 94(Suppl 1):S279

    Google Scholar 

  12. Aaronson NK, Ahmedzai S, Bergman B, et al (1993) The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):65–376

    Article  Google Scholar 

  13. Fayers P, Aaronson NK, Bjordal K, Urran D, Roenvold M (1999) On behalf of the EORTC quality of life group EORTC QLQ-C30 scoring manual, 2nd edn. EORTC, Brussels

    Google Scholar 

  14. Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16(1):139–144

    PubMed  CAS  Google Scholar 

  15. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457–481

    Article  Google Scholar 

  16. Peto R, Pike MC, Armitage P, et al (1977) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer 35(1):1–39

    PubMed  CAS  Google Scholar 

  17. Bottomley A, Biganzoli L, Cufer T, et al (2004) Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: European organization for research and treatment of cancer breast cancer group, investigational drug branch for breast cancer and the new drug development group study. J Clin Oncol 22(13):2576–2586

    Article  PubMed  CAS  Google Scholar 

  18. Kramer JA, Curran D, Piccart M, et al (2000) Randomised trial of paclitaxel versus doxorubicin as first-line chemotherapy for advanced breast cancer: quality of life evaluation using the EORTC QLQ-C30 and the Rotterdam symptom checklist. Eur J Cancer 36(12):1488–1497

    Article  PubMed  CAS  Google Scholar 

  19. van Steen K, Curran D, Molenberghs G (2001) Sensitivity analysis of longitudinal binary quality of life data with drop-out: an example using the EORTC QLQ-C30. Stat Med 20(24):3901–3920

    Article  PubMed  Google Scholar 

  20. Goodwin PJ, Black JT, Bordeleau LJ, Ganz PA (2003) Health-related quality-of-life measurement in randomized clinical trials in breast cancer—taking stock. J Natl Cancer Inst 95(4):263–281

    Article  PubMed  Google Scholar 

  21. Efficace F, Therasse P, Piccart MJ, et al (2004) Health-related quality of life parameters as prognostic factors in a nonmetastatic breast cancer population: an international multicenter study. J Clin Oncol 22(16):3381–3388

    Article  PubMed  Google Scholar 

  22. Brain EG, Bachelot T, Serin D, et al (2005) Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer. JAMA 293(19):2367–2371

    Article  PubMed  CAS  Google Scholar 

  23. Smith TJ, Khatcheressian J, Lyman GH, et al (2006) Update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 24(19):3187–3205

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Medical Oncology, Hopital Edouard Herriot, Université de Lyon et Hospices Civils de Lyon, Lyon, France

    Philippe A. Cassier & Jean-Dominique Tigaud

  2. Medical Oncology and Biostatistics Unit, Centre Leon Berard, 28 rue Laennec, Lyon cedex 08, 69673, France

    Sylvie Chabaud, Jean-Paul Guastalla, David Pérol & Thomas Bachelot

  3. Medical Oncology, Centre Hospitalier Lyon Sud, Université de Lyon et Hospices Civils de Lyon, Lyon, France

    Véronique Trillet-Lenoir

  4. Medical Oncology, Centre Hospitalier de Valence, Valence, France

    Pierre-Yves Peaud

  5. Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France

    Hervé Cure

  6. Medical Oncology, Centre Hospitalier de Bourg-en-Bresse, Bourg-en-Bresse, France

    Hubert Orfeuvre

  7. Medical Oncology, Centre Hospitalier de Chalon-sur-Saone, Chalon-sur-Saone, France

    Bruno Salles

  8. Medical Oncology, Centre Hospitalier d’Annecy, Annecy, France

    Claude Martin

  9. Medical Oncology, Clinique de la Digonniere, St. Etienne, France

    Jean-Philippe Jacquin

  10. Medical Oncology, Centre Hospitalier de Chambery, Chambery, France

    Cecile Agostini

Authors
  1. Philippe A. Cassier
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  2. Sylvie Chabaud
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  9. Claude Martin
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  14. Thomas Bachelot
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Corresponding author

Correspondence to Thomas Bachelot.

Appendix

Appendix

The following persons also participated in the ERASME 3 study: Investigators: B. Anglaret, P. Biron, J. Y. Blay, D. Dramais, A. Fontana, G. Freyer, X. Froger, M. F. Mazen-Scherrer, J. Provencal, I. Ray-Coquard, and P. Rebattu. Coordinating center and statistics: V. Fouillat, M. Garnier, S. Laurent. The authors wish to thank Mrs. Dominique Reynaud for her assistance in the preparation of the manuscript.

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Cassier, P.A., Chabaud, S., Trillet-Lenoir, V. et al. A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: results of the ERASME 3 study. Breast Cancer Res Treat 109, 343–350 (2008). https://doi.org/10.1007/s10549-007-9651-3

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  • DOI: https://doi.org/10.1007/s10549-007-9651-3

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