TY - JOUR
T1 - Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer
T2 - The International Breast Cancer Study Group Trial VII
AU - Crivellari, Diana
AU - Bonetti, Marco
AU - Castiglione-Gertsch, Monica
AU - Gelber, Richard D.
AU - Rudenstam, Carl Magnus
AU - Thürlimann, Beat
AU - Price, Karen N.
AU - Coates, Alan S.
AU - Hürny, Christoph
AU - Bernhard, Jürg
AU - Lindtner, Jurij
AU - Collins, John
AU - Senn, Hans Jörg
AU - Cavalli, Franco
AU - Forbes, John
AU - Gudgeon, Anne
AU - Simoncini, Edda
AU - Cortes-Funes, Hernan
AU - Veronesi, Andrea
AU - Fey, Martin
AU - Goldhirsch, Aron
PY - 2000/4
Y1 - 2000/4
N2 - 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/m2 orally days 1 to 14), methotrexate (40 mg/m2 intravenous days 1 and 8), and fluorouracil (600 mg/m2 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. The reduced effectiveness of CMF among older women could not be attributed to dose reductions according to dose received. Conclusion: CMF tolerability and effectiveness were both reduced for older patients compared with younger postmenopausal node-positive breast cancer patients who received tamoxifen for 5 years. The development and evaluation of less toxic and more effective chemotherapy regimens are required for high-risk elderly patients. (C) 2000 by American Society of Clinical Oncology.
AB - 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/m2 orally days 1 to 14), methotrexate (40 mg/m2 intravenous days 1 and 8), and fluorouracil (600 mg/m2 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. The reduced effectiveness of CMF among older women could not be attributed to dose reductions according to dose received. Conclusion: CMF tolerability and effectiveness were both reduced for older patients compared with younger postmenopausal node-positive breast cancer patients who received tamoxifen for 5 years. The development and evaluation of less toxic and more effective chemotherapy regimens are required for high-risk elderly patients. (C) 2000 by American Society of Clinical Oncology.
UR - http://www.scopus.com/inward/record.url?scp=17044460539&partnerID=8YFLogxK
U2 - 10.1200/JCO.2000.18.7.1412
DO - 10.1200/JCO.2000.18.7.1412
M3 - Article
C2 - 10735888
AN - SCOPUS:17044460539
SN - 0732-183X
VL - 18
SP - 1412
EP - 1422
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -