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  • Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer : a randomized trial
    International Breast Cancer Study Group
    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 breastcancer, 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 wasdiscontinued 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 šCIđ = 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 astatistically nonsignificant improvement compared with either modality alone,primarily because of the results among younger women. (Abstract truncated at 2000 characters).
    Source: Journal of the National Cancer Institute. - ISSN 0027-8874 (Letn. 95, št. 24, 2003, str. 1833-1846)
    Type of material - article, component part
    Publish date - 2003
    Language - english
    COBISS.SI-ID - 17848793

source: Journal of the National Cancer Institute. - ISSN 0027-8874 (Letn. 95, št. 24, 2003, str. 1833-1846)

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