Early Breast Cancer Trialists' Collaborative Group, "Effects of
Radiotherapy and Surgery in Early Breast Cancer - An Overview of the
Randomized Trials", New England Journal of Medicine, November 30, 1995,
Vol. 333, Num. 22, pp. 1444-1456
"Background. Randomized trials of radiotherapy and surgery for early
breast cancer may have been too small to detect differences in
long-term survival and recurrence reliably. We therefore performed a
systematic overview (meta-analysis) of the results of such trials."
"Methods. Information was sought on each subject from investigators
who conducted trials that began before 1985 and that compared local
therapies for early breast cancer. Data on mortality were available
from 36 trials comparing radiotherapy plus surgery with the same type
of surgery alone, 10 comparing more-extensive surgery with
less-extensive surgery, and 18 comparing more-extensive surgery with
less-extensive surgery plus radiotherapy. Information on mortality was
available for 28,405 women (97.4 percent of the 29,175 women in the
trials)."
"Results. The addition of radiotherapy to surgery resulted in a rate
of local recurrence that was three times lower than the rate with
surgery alone, but there was no significant difference in 10-year
survival; among a total of 17,273 women enrolled in such trials,
mortality was 40.3 percent with radiotherapy and 41.4 percent without
radiotherapy (P = 0.3). Radiotherapy was associated with a reduced risk
of death due to breast cancer (odds ratio, 0.94; 95 percent confidence
interval, 0.88 to 1.00; P = 0.03), which indicates that, after 10
years, there would be about 0 to 5 fewer deaths due to breast cancer
per 100 women. However, there was an increased risk of death from other
causes (odds ratio, 1.24; 95 percent confidence interval, 1.09 to 1.42;
P = 0.002). This, together with the age-specific death rates, implies,
after 10 years, a few extra deaths not due to breast cancer per 100
older women or per 1000 younger women. During the first decade or two
after diagnosis, the excess in the rate of such deaths that was
associated with radiotherapy was much greater among women who were over
60 years of age at randomization (15.3 percent vs. 11.1 percent [339
vs. 249 deaths]) than among those under 50 (2.5 percent vs. 2.0 percent
[62 vs. 49 deaths]). Breast-conserving surgery involved some risk of
recurrence in the remaining tissue, but no significant differences in
overall survival at 10 years were found in the studies of mastectomy
versus breast-conserving surgery plus radiotherapy (4891 women),
more-extensive surgery versus less-extensive surgery (4818 women), or
axillary clearance versus radiotherapy as adjuncts to mastectomy (4370
women)."
"Conclusions. Some of the local therapies for breast cancer had
substantially different effects on the rates of local recurrence - such
as the reduced recurrence with the addition of radiotherapy to surgery
- but there were no definite differences in overall survival at 10
years."
"Trials of Radiotherapy"
"Figure 2 shows survival among the approximately 16,000 women in the
35 trials of radiotherapy from whom individual data on survival were
collected, categorized according to nodal status. There was no
statistically significant effect of radiotherapy in women with
node-positive or node-negative cancer."
"Overall, about one third more women in the radiotherapy groups than
in the non-radiotherapy groups died of "non-breast-cancer" causes (7.7
percent vs. 5.7 percent [527 vs. 391]), but this difference occurred
partly because those assigned to radiotherapy had slightly longer
recurrence-free survival and were therefore at risk for death without
recurrence for slightly longer. After we allowed for this, there was an
increase of only about one quarter in such deaths (odds ratio, 1.24 +/-
0.08; 95 percent confidence interval, 1.09 to 1.42; P=0.002). This
increase of about one quarter was found among women in all age groups:
under 50, 50 through 59, and 60 or older, at randomization. But, at
least during the first decade or two after diagnosis, that absolute
excess was much greater among those who were 60 or older at
randomization (15.3 percent vs. 11.1 percent [339 vs. 249 deaths] that
among those under 50 (2.5 percent vs. 2.0 percent [62 vs 49])."
"Trials Comparing More Extensive with Less Extensive Surgery"
"Overall, 48.0 percent of the women assigned to more extensive
surgery and 50.1 percent of those assigned to less extensive surgery
died; this corresponds to a nonsignificant reduction of 3 percent in
the odds of death. ... Data on causes of death were available for only
53 percent of the women who died without a recurrence of breast cancer;
these data also showed no significant differences."
"Figure 4 shows survival according to nodal status for approximately
3400 women in trials comparing more extensive with less extensive
surgery. The less extensive surgery was total or radical mastectomy in
some of these trials and simple mastectomy in all the others, since
data on individual patients were not available from the trial of
breast-conserving surgery. No difference in survival was apparent among
either women with node-positive cancer or those with node-negative
disease."
"Among the women whose outcomes are summarized in Figure 4,
more-extensive surgery involved a nonsignificant reduction in the rate
of recurrence; 48.8 percent of those treated with more-extensive
surgery and 50.3 percent of those with less-extensive surgery had a
reported recurrence (odds ratio, 0.98 +/- 0.05 with no significant
heterogeneity among different trials or among different types of
surgery)."
"Some of the local therapies for breast cancer had substantially
different effects on the rates of local recurrence, but there were no
definite differences in overall 10-year survival. It has long been
accepted that radiotherapy can delay or prevent local or regional
recurrence in women with early breast cancer, as may more extensive
surgery. More recently, it has appeared that radiotherapy can also
produce a small increase in the rate of death from causes other than
breast cancer. In this extensive overview, we confirmed these findings,
but we could not assess separately the effects of treatment on deaths
from cardiovascular or other specific causes or the relevance of
particular details of radiologic or surgical technique. Our findings
indicate, however, that the absolute excess rate of non-breast-cancer
mortality during the first decade or so after radiotherapy is strongly
related to age. Among women who were under 50 when they underwent
irradiation, the apparent excess is just a few deaths not due to breast
cancer per 1000 women, whereas among women who we 60 or older at the
time of radiotherapy, it is a few per 100. As Table 2 suggests, the
excess may persist for more than 10 years. If such a proportional
excess persists indefinitely, the absolute excess might become
appreciable even among women who were under 50 when they received
radiotherapy. Although the radiotherapy techniques differed
substantially among the studies, the overall result still provides a
valid measure of the value of such treatment."
Authors Note:
Despite the commonly held belief that radiation therapy after breast
cancer surgery is life saving, this research shows that there was no
definite overall difference in survival rate after 10 years. Also,
there was no definite difference in survival rate for less drastic
surgery, such as lumpectomy, as opposed more extensive surgery, such as
mastectomy. What is also alarming is that excess deaths due to
radiation for women under 50 amounted to a few per 1,000, whereas women
over 60 that were subject to radiation therapy resulted in a few deaths
per 100. Women should consider this important study before making a
decision to receive radiation therapy or a drastic mastectomy.
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