Author/Editor		Crivellari, Diana; Bonetti, Marco; Castiglione-Gertsch, Monica; Gelber, Richard D; Rudenstam, Carl-Magnus; Thuerlimann, Beat; Price, Karen N; Coates, Alan S; Huerny, Christoph; Lindtner, Jurij
Title		Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer: the International breast cancer study group Trial VII
Type		članek
Source		J Clin Oncol
Vol. and No.		Letnik 18, št. 7
Publication year		2000
Volume		str. 1412-22
Abstract		Purpose: Information on the tolerability and efficacy of adjuvant chemoendocrine therapy for older women is limited. We studied these issues using the data collected as part of the International Breast Cancer Study Group Trial VII. Patients and methods: Postmenopausal women with operable, node-positive breast cancer were randomized to receive either tamoxifen alone for 5 years (306 patients) or tamoxifen plus three consecutive cycles of classical cyclophosphamide (100 mg/m(2) orally days 1 to 14), methotrexate (40 mg/m(2) intravenous days 1 and 8), and fluorouracil (600 mg/m(2) intravenous days 1 and 8) every 28 days (CMF; 302 patients). The median follow-up was 8.0 years. RESULTS: Among the 299 patients who received at least one dose of CMF, women 65 years of age or older (n = 76) had higher grades of toxicity compared with women less than 65 years old (n = 223) (P =.004). More women in the older age group compared with the younger women experienced grade 3 toxicity of any type (17% v 7%, respectively), grade 3 hematologic toxicity (9% v 5%, respectively), and grade 3 mucosal toxicity (4% v 1%, respectively). Older patients also received less than their expected CMF dose compared with younger postmenopausal women (P =.0008). The subjective burdens of treatment, however, were similar for younger and older patients based on quality-of-life measures (performance status, coping, physical well-being, mood, and appetite). For older patients, the 5-year disease-free survival (DFS) rates were 63% for CMF plus tamoxifen and 61% for tamoxifen alone (hazards ratio (HR), 1.00; 95% confidence interval (CI), 0.65 to 1.52; P=.99). For younger patients, the corresponding 5-year DFS rates were 61% and 53% (HR, 0.70; 95% CI, 0.53 to 0.91; P =.008), but the test for heterogeneity of CMF effect according to age group was not statistically significant. (Abstract truncated at 2000 characters).
Descriptors		BREAST NEOPLASMS CYCLOPHOSPHAMIDE METHOTREXATE FLUOROURACIL TAMOXIFEN AGED SURVIVAL ANALYSIS