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"Tamoxifen for prevention of breast
cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1
study," by Bernard Fisher and 14
others, with the National Surgical Adjuvant Breast and Bowel Project
Investigators, Journal of the National Cancer Institute,
90(18):1371-88, 16 September 1998.
[Authors' affiliations: 10 U.S. and Canadian
institutions]
Abstract: "Background: The
finding of a decrease in contralateral breast cancer incidence following
tamoxifen administration for adjuvant therapy led to the concept that the drug
might play a role in breast cancer prevention. To test this hypothesis, the
National Surgical Adjuvant Breast and Bowel Project initiated the Breast
Cancer Prevention Trial (P-1) in 1992. Methods: Women (N = 13 388) at
increased risk for breast cancer because they 1) were 60 years of age or
older, 2) were 35-59 years of age with a 5-year predicted risk for breast
cancer of at least 1.66%, or 3) had a history of lobular carcinoma in situ
were randomly assigned to receive placebo (n = 6707) or 20 mg/day tamoxifen (n
= 6681) for 5 years. Gail's algorithm, based on a multivariate logistic
regression model using combinations of risk factors, was used to estimate the
probability (risk) of occurrence of breast cancer over time. Results:
Tamoxifen reduced the risk of invasive breast cancer by 49% (two-sided
P<.00001), with cumulative incidence through 69 months of follow-up of 43.4
versus 22.0 per 1000 women in the placebo and tamoxifen groups, respectively.
The decreased risk occurred in women aged 49 years or younger (44%), 50-59
years (51%), and 60 years or older (55%); risk was also reduced in women with
a history of lobular carcinoma in situ (56%) or atypical hyperplasia (86%) and
in those with any category of predicted 5-year risk. Tamoxifen reduced the
risk of noninvasive breast cancer by 50% (two-sided P<.002). Tamoxifen
reduced the occurrence of estrogen receptor-positive tumors by 69%, but no
difference in the occurrence of estrogen receptor-negative tumors was seen.
Tamoxifen administration did not alter the average annual rate of ischemic
heart disease; however, a reduction in hip, radius (Colles'), and spine
fractures was observed. The rate of endometrial cancer was increased in the
tamoxifen group (risk ratio = 2.53; 95% confidence interval = 1.35-4.97); this
increased risk occurred predominantly in women aged 50 years or older. All
endometrial cancers in the tamoxifen group were stage 1 (localized disease);
no endometrial cancer deaths have occurred in this group. No liver cancers or
increase in colon, rectal, ovarian, or other tumors was observed in the
tamoxifen group. The rates of stroke, pulmonary embolism, and deep-vein
thrombosis were elevated in the tamoxifen group; these events occurred more
frequently in the women aged 50 years or older. Conclusions: Tamoxifen
decreases the incidence of invasive and noninvasive breast cancer. Despite
side effects resulting from administration of tamoxifen, its use as a breast
cancer preventive agent is appropriate in many women at increased risk for the
disease."
This 1998 report from the Journal of the
National Cancer Institute was cited 40 times in current
journal articles indexed in the ISI database during September-October 2000.
During that two-month period, this was the second-most-cited paper in all of
medicine (aside from reviews) published in the last two years. Prior to the
most recent bimonthly count, citations to the paper have accrued as follows:
July-August: 36 citations
May-June 2000: 41
March-April 2000: 48
January-February 2000: 33
November-December 1999: 40
September-October 1999: 31
July-August 1999: 36
May-June 1999: 23
March-April 1999: 10
January-February 1999: 6
November-December 1998: 4
Total citations to date: 348
SOURCE: Hot
Papers Database (Available from the ISI
Research Services Group in a CD-ROM version containing data on
hundreds of highly cited papers published during the last two years.
User interface permits searching by author, organization, journal,
field, and more. Total citations, as well as citations accrued during
successive bimonthly periods, can be assessed and graphed. Database is
combined with subscription to the ISI newsletter Science
Watch®; updated discs containing the
most recent bimonthly data are mailed with each new issue, six times a
year.)
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