Journal of Clinical Oncology, Vol 16, 441-452, Copyright © 1998 by American Society of Clinical Oncology
Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17
B Fisher, J Dignam, N Wolmark, E Mamounas, J Costantino, W Poller, ER Fisher, DL Wickerham, M Deutsch, R Margolese, N Dimitrov and M Kavanah
National Surgical Adjuvant Breast and Bowel Project Operations and Statistical Centers, USA.
PURPOSE: In 1993, findings from a National Surgical Adjuvant Breast and
Bowel Project (NSABP) trial to evaluate the worth of radiation therapy
after lumpectomy concluded that the combination was more beneficial than
lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This
report extends those findings. PATIENTS AND METHODS: Women (N = 818) with
localized DCIS were randomly assigned to lumpectomy or lumpectomy plus
radiation (50 Gy). Tissue was removed so that resected specimen margins
were histologically tumor-free. Mean follow-up time was 90 months (range,
67 to 130). Size and method of tumor detection were determined by central
clinical, mammographic, and pathologic assessment. Life-table estimates of
event-free survival and survival, average annual rates of occurrence for
specific events, relative risks for event-specific end points, and
cumulative probability of specific events comprising event-free survival
are presented. RESULTS: The benefit of lumpectomy plus radiation was
virtually unchanged between 5 and 8 years of follow-up and was due to a
reduction in invasive and noninvasive ipsilateral breast tumors (IBTs).
Incidence of locoregional and distant events remained similar in both
treatment groups; deaths were only infrequently related to breast cancer.
Incidence of noninvasive IBT was reduced from 13.4% to 8.2% (P = .007), and
of invasive IBT, from 13.4% to 3.9% (P < .0001). All cohorts benefited
from radiation regardless of clinical or mammographic tumor
characteristics. CONCLUSION: Through 8 years of follow-up, our findings
continue to indicate that lumpectomy plus radiation is more beneficial than
lumpectomy alone for women with localized, mammographically detected DCIS.
When evaluated according to the mammographic characteristics of their DCIS,
all groups benefited from radiation.
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