© 1997 by Oxford University Press
Journal Of The National Cancer Institute, Vol 89, 1673-1682, Copyright © 1997 by Oxford University Press
B Fisher, J Dignam, N Wolmark, A DeCillis, B Emir, DL Wickerham, J Bryant, NV Dimitrov, N Abramson, JN Atkins, H Shibata, L Deschenes and RG Margolese
BACKGROUND: The B-20 study of the National Surgical Adjuvant Breast and
Bowel Project (NSABP) was conducted to determine whether chemotherapy plus
tamoxifen would be of greater benefit than tamoxifen alone in the treatment
of patients with axillary lymph node-negative, estrogen receptor-positive
breast cancer. METHODS: Eligible patients (n = 2306) were randomly assigned
to one of three treatment groups following surgery. A total of 771 patients
with follow-up data received tamoxifen alone; 767 received methotrexate,
fluorouracil, and tamoxifen (MFT); and 768 received cyclophosphamide,
methotrexate, fluorouracil, and tamoxifen (CMFT). The Kaplan-Meier method
was used to estimate disease- free survival, distant disease-free survival,
and survival. Reported P values are two-sided. RESULTS: Through 5 years of
follow-up, chemotherapy plus tamoxifen resulted in significantly better
disease- free survival than tamoxifen alone (90% for MFT versus 85% for
tamoxifen [P = .01]; 89% for CMFT versus 85% for tamoxifen [P = .001]). A
similar benefit was observed in both distant disease-free survival (92% for
MFT versus 87% for tamoxifen [P = .008]; 91% for CMFT versus 87% for
tamoxifen [P = .006]) and survival (97% for MFT versus 94% for tamoxifen [P
= .05]; 96% for CMFT versus 94% for tamoxifen [P = .03]). Compared with
tamoxifen alone, MFT and CMFT reduced the risk of ipsilateral breast tumor
recurrence after lumpectomy and the risk of recurrence at other local,
regional, and distant sites. Risk of treatment failure was reduced after
both types of chemotherapy, regardless of tumor size, tumor estrogen or
progesterone receptor level, or patient age; however, the reduction was
greatest in patients aged 49 years or less. No subgroup of patients
evaluated in this study failed to benefit from chemotherapy. CONCLUSIONS:
Findings from this and other NSABP studies indicate that patients with
breast cancer who meet NSABP protocol criteria, regardless of age, lymph
node status, tumor size, or estrogen receptor status, are candidates for
chemotherapy.
ARTICLES
Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor- positive breast cancer
National Surgical Adjuvant Breast and Bowel Project, University of Pittsburgh, PA, USA.
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