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Breast Cancer Research and Treatment

, Volume 113, Issue 1, pp 137–144 | Cite as

Is chemotherapy necessary for premenopausal women with lower-risk node-positive, endocrine responsive breast cancer? 10-year update of International Breast Cancer Study Group Trial 11-93

  • Beat ThürlimannEmail author
  • Karen N. Price
  • Richard D. Gelber
  • Stig B. Holmberg
  • Diana Crivellari
  • Marco Colleoni
  • John Collins
  • John F. Forbes
  • Monica Castiglione-Gertsch
  • Alan S. Coates
  • Aron Goldhirsch
Clinical Trial

Abstract

Introduction International Breast Cancer Study Group (IBCSG) Trial 11-93 is the largest trial evaluating the role of the addition of chemotherapy to ovarian function suppression/ablation (OFS) and tamoxifen in premenopausal patients with endocrine-responsive early breast cancer. Methods IBCSG Trial 11-93 is a randomized trial comparing four cycles of adjuvant chemotherapy (AC: doxorubicin or epirubicin, plus cyclophosphamide) added to OFS and 5 years of tamoxifen versus OFS and tamoxifen without chemotherapy in premenopausal patients with node-positive, endocrine-responsive early breast cancer. There were 174 patients randomized from May 1993 to November 1998. The trial was closed before the target accrual was reached due to low accrual rate. Results Patients randomized tended to have lower risk node-positive disease and the median age was 45. After 10 years median follow up, there remains no difference between the two randomized treatment groups for disease-free (hazard ratio = 1.02 (0.57–1.83); P = 0.94) or overall survival (hazard ratio = 0.97 (0.44–2.16); P = 0.94). Conclusion This trial, although small, offers no evidence that AC chemotherapy provides additional disease control for premenopausal patients with lower-risk node-positive endocrine-responsive breast cancer who receive adequate adjuvant endocrine therapy. A large trial is needed to determine whether chemotherapy adds benefit to endocrine therapy for this population.

Keywords

Breast cancer Estrogen receptor Goserelin Ovarian ablation Ovarian function suppression Tamoxifen 

Notes

Acknowledgments

We thank the patients, physicians, nurses, and data managers who participated in this International Breast Cancer Study Group (IBCSG) trial. The IBCSG is funded by the Swedish Cancer Society, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group (NHMRC grant number 940892), the Frontier Science and Technology Research Foundation, the Swiss Group for Clinical Cancer Research (SAKK), Cancer Research Switzerland/Oncosuisse, the Foundation for Clinical Research of Eastern Switzerland (OSKK), and the United States National Cancer Institute (CA-75362).

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Copyright information

© Springer Science+Business Media, LLC. 2008

Authors and Affiliations

  • Beat Thürlimann
    • 1
    • 2
    Email author
  • Karen N. Price
    • 3
  • Richard D. Gelber
    • 3
    • 4
    • 5
  • Stig B. Holmberg
    • 6
  • Diana Crivellari
    • 7
  • Marco Colleoni
    • 8
  • John Collins
    • 9
  • John F. Forbes
    • 10
  • Monica Castiglione-Gertsch
    • 11
  • Alan S. Coates
    • 12
    • 13
  • Aron Goldhirsch
    • 14
    • 15
  1. 1.Senology Center of Eastern SwitzerlandSt. GallenSwitzerland
  2. 2.Swiss Group for Clinical Cancer Research (SAKK)BernSwitzerland
  3. 3.IBCSG Statistical CenterFrontier Science and Technology Research FoundationBostonUSA
  4. 4.IBCSG Statistical CenterDana-Farber Cancer InstituteBostonUSA
  5. 5.Harvard School of Public HealthBostonUSA
  6. 6.Department of SurgerySahlgrenska University HospitalGoteborgSweden
  7. 7.Centro di Riferimento OncologicoAvianoItaly
  8. 8.Department of MedicineEuropean Institute of OncologyMilanItaly
  9. 9.Department of SurgeryRoyal Melbourne HospitalParkvilleAustralia
  10. 10.Australian New Zealand Breast Cancer Trials GroupUniversity of NewcastleNewcastleAustralia
  11. 11.IBCSG Coordinating CenterBernSwitzerland
  12. 12.International Breast Cancer Study GroupBernSwitzerland
  13. 13.University of SydneySydneyAustralia
  14. 14.Department of MedicineEuropean Institute of OncologyMilanItaly
  15. 15.Oncology Institute of Southern SwitzerlandBellinzonaSwitzerland

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