© 2003 by Oxford University Press
© 2003 Oxford University Press
ARTICLE |
Adjuvant Chemotherapy Followed by Goserelin Versus Either Modality Alone for Premenopausal Lymph Node–Negative Breast Cancer: A Randomized Trial
International Breast Cancer Study Group (IBCSG)1,
Affiliations of Writing Committee members: International Breast Cancer Study Group (IBCSG) Coordinating Center and Inselspital, Bern, Switzerland (MCG); IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA (AO, KNP, MB, RDG); IBCSG Scientific Committee, European Institute of Oncology, Milan, Italy, and Oncology Institute of Southern Switzerland, Bellinzona, Switzerland (AG); IBCSG Scientific Committee, University of Sydney and The Cancer Council Australia, Sydney, Australia (ASC); European Institute of Oncology, Milan (MC); IBCSG Coordinating Center, Bern (MLN).
Correspondence to: Monica Castiglione-Gertsch, MD, IBCSG Coordinating Center, Effingerstrasse 40, CH-3008 Bern, Switzerland (e-mail: mcastiglione{at}sakk.ch)
Background: Although chemotherapy and ovarian function suppression are both effective adjuvant therapies for patients with early-stage breast cancer, little is known of the efficacy of their sequential combination. In an International Breast Cancer Study Group (IBCSG) randomized clinical trial (Trial VIII) for pre- and perimenopausal women with lymph node–negative breast cancer, we compared sequential chemotherapy followed by the gonadotropin-releasing hormone agonist goserelin with each modality alone. Methods: From March 1990 through October 1999, 1063 patients stratified by estrogen receptor (ER) status and radiotherapy plan were randomly assigned to receive goserelin for 24 months (n = 346), six courses of "classical" CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or six courses of classical CMF followed by 18 months of goserelin (CMF 
goserelin; n = 357). A fourth arm (no adjuvant treatment) with 46 patients was discontinued in 1992. Tumors were classified as ER-negative (30%), ER-positive (68%), or ER status unknown (3%). Twenty percent of patients were aged 39 years or younger. The median follow-up was 7 years. The primary outcome was disease-free survival (DFS). Results: Patients with ER-negative tumors achieved better disease-free survival if they received CMF (5-year DFS for CMF = 84%, 95% confidence interval [CI] = 77% to 91%; 5-year DFS for CMF goserelin = 88%, 95% CI = 82% to 94%) than if they received goserelin alone (5-year DFS = 73%, 95% CI = 64% to 81%). By contrast, for patients with ER-positive disease, chemotherapy alone and goserelin alone provided similar outcomes (5-year DFS for both treatment groups = 81%, 95% CI = 76% to 87%), whereas sequential therapy (5-year DFS = 86%, 95% CI = 82% to 91%) provided a statistically nonsignificant improvement compared with either modality alone, primarily because of the results among younger women. Conclusions: Premenopausal women with ER-negative (i.e., endocrine nonresponsive), lymph node–negative breast cancer should receive adjuvant chemotherapy. For patients with ER-positive (i.e., endocrine responsive) disease, the combination of chemotherapy with ovarian function suppression or other endocrine agents, and the use of endocrine therapy alone should be studied.
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- Ovarian Ablation as Adjuvant Therapy for Premenopausal Women With Breast Cancer—Another Step Forward
- Joseph L. Pater and Wendy R. Parulekar
J Natl Cancer Inst 2003 95: 1811-1812.[Extract] [Full Text] [PDF]
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