Author/Editor     Thurlimann, Beat; Price, Karen N; Gelber, Richard D; Holmberg, Stig B; Crivellari, Diana; Colleoni, Marco; Collins, John; Forbes, John F; Castiglione-Gertsch, Monica; Lindtner, J; Eržen, D; Čufer, T; Červek, J; Cerar, O; Zakotnik, B; Majdič, E; Golouh, R; Lamovec, J; Jančar, J; Vrhovec, I; Kramberger, M
Title     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
Type     članek
Source     Breast Cancer Res Treat
Vol. and No.     Letnik 113, št. 1
Publication year     2009
Volume     str. 137-44
Language     eng
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.
Descriptors     BREAST NEOPLASMS
CHEMOTHERAPY, ADJUVANT
CYCLOPHOSPHAMIDE
DOXORUBICIN
EPIRUBICIN
FOLLOW-UP STUDIES
LYMPH NODES
LYMPHATIC METASTASIS
PREMENOPAUSE
RECEPTORS, ESTROGEN
RECEPTORS, PROGESTERONE
RISK ASSESSMENT
SURVIVAL ANALYSIS
SURVIVORS
TAMOXIFEN