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Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93.
J Clin Oncol. 2006 Mar 20; 24(9):1332-41.JC

Abstract

PURPOSE

The value of adjuvant tamoxifen after chemotherapy for premenopausal women with breast cancer has not been adequately assessed.

PATIENTS AND METHODS

Between 1993 and 1999, International Breast Cancer Study Group Trial 13-93 enrolled 1,246 assessable premenopausal women with axillary node-positive, operable breast cancer. All patients received chemotherapy (cyclophosphamide plus either doxorubicin or epirubicin for four courses followed by immediate or delayed classical cyclophosphamide, methotrexate, and fluorouracil for three courses), which was followed by either tamoxifen (20 mg daily) for 5 years or no further treatment. The primary end point was disease-free survival (DFS). Tumors were classified as estrogen receptor (ER) -positive (n = 735, 59%) if immunohistochemical (IHC) or ligand-binding assays (LBA) were clearly positive. The ER-negative group included all other tumors (n = 511, 41%). A subset of the ER-negative group was defined as ER absent (n = 108, 9%) if IHC staining was none or if the LBA result was 0 fmol/mg cytosol protein. The median follow-up time was 7 years.

RESULTS

Tamoxifen improved DFS in the ER-positive cohort (hazard ratio [HR] for tamoxifen v no tamoxifen = 0.59; 95% CI, 0.46 to 0.75; P < .0001) but not in the ER-negative cohort (HR = 1.02; 95% CI, 0.77 to 1.35; P = .89). Tamoxifen had a detrimental effect on patients with ER-absent tumors compared with no tamoxifen in an unplanned exploratory analysis (HR = 2.10; 95% CI, 1.03 to 4.29; P = .04). Patients with ER-positive tumors who achieved chemotherapy-induced amenorrhea had a significantly improved outcome (HR for amenorrhea v no amenorrhea = 0.61; 95% CI, 0.44 to 0.86; P = .004), whether or not they received tamoxifen.

CONCLUSION

Tamoxifen after adjuvant chemotherapy significantly improved treatment outcome in premenopausal patients with endocrine-responsive disease, but its use as adjuvant therapy for patients with ER-negative tumors is not recommended.

Authors+Show Affiliations

Division of Medical Oncology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy. marco.colleoni@ieo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16505417

Citation

International Breast Cancer Study Group, et al. "Tamoxifen After Adjuvant Chemotherapy for Premenopausal Women With Lymph Node-positive Breast Cancer: International Breast Cancer Study Group Trial 13-93." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 24, no. 9, 2006, pp. 1332-41.
International Breast Cancer Study Group, Colleoni M, Gelber S, et al. Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. J Clin Oncol. 2006;24(9):1332-41.
Colleoni, M., Gelber, S., Goldhirsch, A., Aebi, S., Castiglione-Gertsch, M., Price, K. N., Coates, A. S., & Gelber, R. D. (2006). Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 24(9), 1332-41.
International Breast Cancer Study Group, et al. Tamoxifen After Adjuvant Chemotherapy for Premenopausal Women With Lymph Node-positive Breast Cancer: International Breast Cancer Study Group Trial 13-93. J Clin Oncol. 2006 Mar 20;24(9):1332-41. PubMed PMID: 16505417.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. AU - ,, AU - Colleoni,Marco, AU - Gelber,Shari, AU - Goldhirsch,Aron, AU - Aebi,Stefan, AU - Castiglione-Gertsch,Monica, AU - Price,Karen N, AU - Coates,Alan S, AU - Gelber,Richard D, Y1 - 2006/02/27/ PY - 2006/3/1/pubmed PY - 2006/4/6/medline PY - 2006/3/1/entrez SP - 1332 EP - 41 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 24 IS - 9 N2 - PURPOSE: The value of adjuvant tamoxifen after chemotherapy for premenopausal women with breast cancer has not been adequately assessed. PATIENTS AND METHODS: Between 1993 and 1999, International Breast Cancer Study Group Trial 13-93 enrolled 1,246 assessable premenopausal women with axillary node-positive, operable breast cancer. All patients received chemotherapy (cyclophosphamide plus either doxorubicin or epirubicin for four courses followed by immediate or delayed classical cyclophosphamide, methotrexate, and fluorouracil for three courses), which was followed by either tamoxifen (20 mg daily) for 5 years or no further treatment. The primary end point was disease-free survival (DFS). Tumors were classified as estrogen receptor (ER) -positive (n = 735, 59%) if immunohistochemical (IHC) or ligand-binding assays (LBA) were clearly positive. The ER-negative group included all other tumors (n = 511, 41%). A subset of the ER-negative group was defined as ER absent (n = 108, 9%) if IHC staining was none or if the LBA result was 0 fmol/mg cytosol protein. The median follow-up time was 7 years. RESULTS: Tamoxifen improved DFS in the ER-positive cohort (hazard ratio [HR] for tamoxifen v no tamoxifen = 0.59; 95% CI, 0.46 to 0.75; P < .0001) but not in the ER-negative cohort (HR = 1.02; 95% CI, 0.77 to 1.35; P = .89). Tamoxifen had a detrimental effect on patients with ER-absent tumors compared with no tamoxifen in an unplanned exploratory analysis (HR = 2.10; 95% CI, 1.03 to 4.29; P = .04). Patients with ER-positive tumors who achieved chemotherapy-induced amenorrhea had a significantly improved outcome (HR for amenorrhea v no amenorrhea = 0.61; 95% CI, 0.44 to 0.86; P = .004), whether or not they received tamoxifen. CONCLUSION: Tamoxifen after adjuvant chemotherapy significantly improved treatment outcome in premenopausal patients with endocrine-responsive disease, but its use as adjuvant therapy for patients with ER-negative tumors is not recommended. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/16505417/Tamoxifen_after_adjuvant_chemotherapy_for_premenopausal_women_with_lymph_node_positive_breast_cancer:_International_Breast_Cancer_Study_Group_Trial_13_93_ L2 - https://ascopubs.org/doi/10.1200/JCO.2005.03.0783?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -