Early release for Breast Cancer
We received from the New
England Journal of Medicine (NEJM) the results of this important trial. (Paul E. Goss, M.D.,
Ph.D., James N. Ingle, M.D., Silvana Martino, D.O., Nicholas J. Robert, M.D.,
Hyman B. Muss, M.D., Martine J. Piccart, M.D., Ph.D., Monica Castiglione, M.D.,
Dongsheng Tu, Ph.D., Lois E. Shepherd, M.D., Kathleen I. Pritchard, M.D.,
Robert B. Livingston, M.D., Nancy E. Davidson, M.D., Larry Norton, M.D., Edith
A. Perez, M.D., Jeffrey S. Abrams, M.D., Patrick Therasse, M.D., Michael J.
Palmer, M.Sc., and Joseph L. Pater, M.D. A
Randomized Trial of letrozole in
Postmenopausal Women after Five Years of Tamoxifen Therapy for Early-Stage
Breast Cancer) Because of its potential therapeutic
implications, we have published the abstract of this article today. It will appear in the November 6
issue of the NEJM.
ABSTRACT
Background In hormone-dependent
breast cancer, five years of postoperative tamoxifen therapy -- but
not tamoxifen therapy of longer duration -- prolongs disease-free
and overall survival. The aromatase inhibitor letrozole, by
suppressing estrogen production, might improve the outcome after the
discontinuation of tamoxifen therapy.
Methods We conducted a
double-blind, placebo-controlled trial to test the effectiveness of
five years of letrozole therapy in postmenopausal women with breast
cancer who have completed five years of tamoxifen therapy. The
primary end point was disease-free survival.
Results A total of 5187 women were enrolled
(median follow-up, 2.4 years). At the first interim analysis, there
were 207 local or metastatic recurrences of breast cancer or new
primary cancers in the contralateral breast -- 75 in the letrozole
group and 132 in the placebo group -- with estimated four-year
disease-free survival rates of 93 percent and 87 percent, respectively,
in the two groups (P
0.001 for the comparison
of disease-free survival). A total of 42 women in the placebo group
and 31 women in the letrozole group died (P=0.25 for the comparison of
overall survival). Low-grade hot flashes, arthritis, arthralgia, and
myalgia were more frequent in the letrozole group, but vaginal bleeding
was less frequent. There were new diagnoses of osteoporosis in 5.8
percent of the women in the letrozole group and 4.5 percent of the
women in the placebo group (P=0.07); the rates of fracture were
similar. After the first interim analysis, the independent data and
safety monitoring committee recommended termination of the trial and
prompt communication of the results to the participants.
Conclusions As compared with
placebo, letrozole therapy after the completion of standard
tamoxifen treatment significantly improves disease-free survival.
You can
get the full article in PDF at www.nejm.org.
BM&L-October 2003