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Pathologic Findings from the National
Surgical Adjuvant Breast Project (NSABP)
Eight-Year Update of Protocol B-17
Intraductal Carcinoma
e read with much interest the latest report by Fisher et al.1 on the
updated results in a large subgroup of patients with ductal
carcinoma in situ (DCIS) included in the NSABP B-17 trial.2 Indeed,
among the 623 patients analyzed, representing 77% of the entire
group with an acceptable balance between the 2 arms (303 patients
vs. 320 patients treated without and with radiotherapy, respectively),
the frequency of subsequent local recurrence (LR) decreased from
31% to 13% (P ⫽ 0.0001) by irradiation (XRT) after lumpectomy.
In a retrospective study conducted in 772 women in 7 French
cancer institutes between 1985 and 1992 to analyze the “current
practice” in DCIS, 592 women underwent conservative treatment.
The median age at the time of diagnosis was 53 years. In 22.4% and
14.1% of women, respectively, a family history of breast carcinoma
and a previous surgery for benign lesion of the breast were found. One
hundred forty-four women (24.3%) underwent conservative surgery
(CS) alone and 448 women (75.7%) underwent CS ⫹ XRT. With a
median follow-up of 84 months, the LR rates were 29.2% (42 of 144)
and 12.9% (58 of 448) in patients treated without and with XRT,
respectively (P ⫽ 0.0001).
In our study, the benefit of XRT was confirmed in the 403 (68%)
mammographically detected tumors (To) with 8-year LR rates of
37.6% and 11.8%, respectively, in patients treated without and with
XRT (P ⫽ 0.001). Moreover, although age did not appear to influence
the LR rate in women treated with CS alone, this parameter was
important in those patients treated by CS ⫹ XRT. Indeed, the 8-year
LR rates were reported to be 26.8%, 14.9%, and 8.6%, respectively,
(P ⫽ 0.02) in women age ⬍ 40 years, 40 –59 years, and ⬎ 60 years. As
outlined by others, the extent of excision is important.3 In our study,
the 8-year LR rates in the CS group were 40.7%, 61.9%, and 22.7%,respectively, for patients with a complete, incomplete, and not specified
excision; in the CS ⫹ XTR group the rates were 10%, 30.1%, and 12.7%,
The analysis of histologic features in the DCIS series is extremely
complicated for several reasons. The lesions are heterogeneous with
2–3 architectural components present in approximately 33% of cases;
it often is difficult to quantify the presence of necrosis and to determine the grade of the lesion because both parameters are not easily
reproducible.4 This point is confirmed by the existence of numerous
pathologic classifications currently in use.5
The size of the lesion also is difficult to assess, especially in small
lesions with only few foci of involved cells. Moreover, many of these
pathologic features are interrelated. From the literature, the extent of
© 2000 American Cancer Society
excision is considered to be an important parameter
correlated with the LR risk. The NSABP B-17 trial required tumor free margins, but the central review
revealed approximately 20% of cases in which the
tumor margin was violated. This fact may be due in
part to the very large number of institutes taking part
into the trial, with only a few cases included in several
institutes over the course of 6 years with a quite heterogeneous pathologic analysis.
In our study, we had a similar problem with a high
rate of “not specified” margins, especially in the CS
group. Therefore, our results, despite the lack of randomization and the different balance among the
treated groups, are very similar to those of the NSABP
B-17 trial. However, with regard to the effect of histologic features on LR, we observed a higher rate of
infiltrating carcinoma (including microinvasive carcinoma): 57% and 62%, after CS and CS ⫹ XRT, respectively. If we consider the recent meta-analysis by Boyages et al.,6 we again find a clear benefit in favor of
complementary irradiation after lumpectomy for
DCIS. In this study, the LR rates were 22.5% (95%
confidence interval [95% CI],16.9 –28.2) and 8.9% (95%
CI, 6.8 –11) for the CS and CS ⫹ XRT groups, respectively, but with a relatively short follow-up for each
group (68 months and 62 months, respectively).
Conversely, Silverstein et al. attempted to identify
a subgroup of women with DCIS who do not require
postoperative radiation therapy. In his latest retrospective report,3 469 cases were analyzed, but the
characteristics of the groups treated without (CS) and
with radiotherapy (CS ⫹ XRT) were not comparable.
First, the CS group included the 79 patients from
the previous series by Lagios et al., with very selective
inclusion criteria and a 19% 10-year LR rate.7 Second,
the median tumor size was significantly smaller in
83.7% of cases in the CS group, whereas comedonecrosis was more frequent in the CS ⫹ XRT group.
Finally, the median follow-up was different between
both groups (92 months in the CS ⫹ XRT group vs.
only 72 months in the CS group, including the 79
above-mentioned patients treated between 1972–1987
in the study by Lagios et al.).
For these reasons, we believe that at the moment
it is not possible to identify clearly a subset of patients
with such a low risk of LR that postoperative irradiation therapy is not needed. Our daily practice confirms
this fact and the results of the study by Fisher et al.1,
and constitutes supplementary support for clinicians
to treat women with DCIS with optimal chances for
Fisher ER, Dignam J, Tan-Chiu E, Costantino J, Fisher B,
Paik S, et al. Pathologic findings from the National Surgical
Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer 1999;86:429 –38.
Fisher B, Dignam J, Wolkmar N, Mamounas E, Costantino J,
Poller W, et al. Lumpectomy and radiation therapy for the
treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17.
J Clin Oncol 1998;16:441–52.
Silverstein MJ, Lagios MD, Groshen S, Waisman JR, Lewinsky BS, Martino S, et al. The influence of margin width on
local control of ductal carcinoma in situ of the breast. N Engl
J Med 1999;340:1455– 61.
Vicini FA, Goldstein NS, Kestin LL. Pathologic and technical
considerations in the treatment of ductal carcinoma in situ
of the breast with lumpectomy and radiation therapy. Ann
Oncol 1999;10:883–90.
The Consensus Conference Committee. Consensus Conference on the classification of ductal carcinoma in situ. Cancer 1997;80:1798 – 802.
Boyages J, Delaney G, Taylor R. Predictors of local recurrence after treatment of ductal carcinoma in situ: a metaanalysis. Cancer 1999;85:616 –28.
Lagios MD. Lagios experience. In: Ductal carcinoma in situ
of the breast. Silverstein MJ, ed. Baltimore: Williams and
Wilkins, 1997;361–5.
Bruno Cutuli, M.D.
On behalf of the Breast Cancer Group
of the French Cancer Centers
Polyclinique Courlancy
Reims, France
Author Reply
e appreciate the opportunity to review Dr. Cutuli’s
letter concerning our article “Pathologic Findings
from the National Surgical Adjuvant Breast Project
(NSABP) Eight-Year Update of Protocol B-17.” We were
pleased to learn that Dr. Cutuli and his group also failed
to identify unequivocally a subset of patients with ductal
carcinoma in situ who might not benefit from or require
postoperative local breast irradiation.
Edwin R. Fisher, M.D.
National Surgical Adjuvant Breast
and Bowel Project Pathology Center;
Department of Surgical Oncology
Continuing Care Center
Allegheny General Hospital
Allegheny University
Pittsburgh, Pennsylvania
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