Author/Editor		Goldhirsch, A; Lindtner, J; Eržen, D; Majdič, E; Štabuc, B; Plesničar, A; Golouh, R; Lamovec, J; Jančar, J; Vrhovec, I; Kramberger, M
Title		Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial
Type		članek
Source		J Natl Cancer Inst
Vol. and No.		Letnik 95, št. 24
Publication year		2003
Volume		str. 1833-46
Language		eng
Abstract		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 diseasefree 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. (Abstract truncated at 2000 characters).
Descriptors		BREAST NEOPLASMS ANTINEOPLASTIC AGENTS, HORMONAL ANTINEOPLASTIC AGENTS, COMBINED GOSERELIN METHOTREXATE ADULT MIDDLE AGE TREATMENT OUTCOME INCIDENCE SURVIVAL ANALYSIS RECEPTORS, ESTROGEN AMENORRHEA LYMPHATIC METASTASIS CHEMOTHERAPY, ADJUVANT CONFIDENCE INTERVALS PREMENOPAUSE FLUOROURACIL