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
- 257 Downloads
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.
KeywordsBreast cancer Estrogen receptor Goserelin Ovarian ablation Ovarian function suppression Tamoxifen
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).
- 3.Klijn JGM, Blamey RW, Boccardo R et al, for the Combined Hormone Agents Trialists’ Group and the European Organization for Research and Treatment of Cancer (2001) Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol 19:343–353PubMedGoogle Scholar
- 7.The [T1]Adjuvant Breast Cancer Trials Collaborative Group (2007) Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst 99:516–525Google Scholar
- 8.International Breast Cancer Study Group (2001) Randomized controlled trial of ovarian function suppression plus tamoxifen versus the same endocrine therapy plus chemotherapy: is chemotherapy necessary for premenopausal women with node-positive, endocrine responsive breast cancer? First results of International Breast Cancer Study Group Trial 11-93. Breast 10 (Suppl 3):130–138Google Scholar
- 12.Greenwood M (1926) The natural duration of cancer. HM Stationary Office, LondonGoogle Scholar
- 13.Cox DR (1972) Regression models and life-tables (with discussion). J R Stat Soc 34:187–220Google Scholar
- 16.International Breast Cancer Study Group (2003) Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst 95:1833–1846Google Scholar
- 18.National Cancer Institute. US National Institutes of Health. The TAILORx breast cancer trial. http://www.cancer.gov/clinicaltrials/digestpage/TAILORx
- 19.Breast International Group. MINDACT (microarray in node negative disease may avoid chemotherapy). http://www.breastinternationalgroup.org/TransBIG/Mindact.aspx