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
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. 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.
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In colorectal or lung cancer, adjuvant systemic therapy may be safely delayed by as much as 8 weeks.
“For example, for patients with colorectal or lung cancer, it can be safely postponed for up to 8 weeks [89,90], and for those with breast cancer for up to 12 weeks after surgery [91].”
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- Authors
- Crivellari, D., Bonetti, M., Castiglione-Gertsch, M., Gelber, R. D., Rudenstam, C.-M., Thürlimann, B., Price, K. N., Coates, A. S., Hürny, C., Bernhard, J., Lindtner, J., Collins, J., Senn, H.-J., Cavalli, F., Forbes, J., Gudgeon, A., Simoncini, E., Cortes-Funes, H., Veronesi, A., Fey, M., Goldhirsch, A., & for the International Breast Cancer Study Group
- Affiliations
- University Hospital of Bern (CH)
- From the Centro di Riferimento OncologicoAviano; Ospedali Civili and Fondazione Beretta, Brescia; and European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute and Frontier Science and Technology Research Foundation; and Harvard School of Public Health, Boston, MA; International Breast Cancer Study Group Coordinating Center; and Swiss Group for Clinical Cancer Research, Inselspital, Bern; Kantonsspital; Bürgerspital; and Center...
- Venue
- Journal of Clinical Oncology
- Published
- 2000-04-07
- Volume
- 18
- Issue
- 7
- Pages
- 1412-1422
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2167527499
- Cited by
- 291
- References
- 25
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 6 · 2020: 1 · 2019: 3 · 2018: 5 · 2017: 7 · 2016: 7 · 2015: 12 · 2014: 10 · 2013: 12 · 2012: 9
- FWCI
- 6.37
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Archivio istituzionale della Ricerca - Bocconi (submittedVersion)
- Funders
- National Cancer Institute (CA06516, CA-75362, U24CA075362, P30CA006516)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
- Keywords
- adjuvant chemotherapy, adjuvant endocrine therapy, tamoxifen, CMF, elderly patients, older women, postmenopausal women, node-positive breast cancer, treatment toxicity, quality of life, disease-free survival, age differences in treatment response
- MeSH terms
- Age Factors, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Cisplatin, Combined Modality Therapy, Female, Fluorouracil, Humans, Infusions, Intravenous, Methotrexate, Middle Aged, Tamoxifen, Chemotherapy, Adjuvant, Postmenopause, Antineoplastic Agents, Hormonal
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