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Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Castiglione-Gertsch, Monica O'Neill, Anne Price, Karen N. Goldhirsch, Aron Coates, Alan S. Colleoni, Marco Nasi, Magdalena Bonetti, Marco Gelber, Richard D. |
| Copyright Year | 2003 |
| 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 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. |
| Starting Page | 1 |
| Ending Page | 3 |
| Page Count | 3 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://bcb.dfci.harvard.edu/ibcsg/Publications/141_IBCSG_adjuvant_chemotherapy.pdf |
| Alternate Webpage(s) | http://www.rima.org/web/medline_pdf/JNatCancerInst_1833.pdf |
| PubMed reference number | 14679153v1 |
| Volume Number | 95 |
| Issue Number | 24 |
| Journal | Journal of the National Cancer Institute |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Anatomic Node Chemotherapy, Adjuvant Classification Confidence Intervals Cyclophosphamide Early-Stage Breast Carcinoma Endocrine System Diseases Estrogen Receptors Estrogens Fluorouracil Freund's Adjuvant Gonadorelin Goserelin Hormone Therapy International Breast Cancer Study Group Lymph Node Tissue Mammary Neoplasms Methotrexate Multiple Endocrine Neoplasia Type 1 Patients PersonNameUse - assigned Pharmaceutical Adjuvants Status Epilepticus Therapeutic procedure cyclophosphamide/fluorouracil/methotrexate protocol estrogen receptor alpha, human lymph nodes ovarian neoplasm |
| Content Type | Text |
| Resource Type | Article |
