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Experts Review NCI Recommendation to Limit Tamoxifen Duration to Five Years

Experts Review NCI Recommendation to Limit Tamoxifen Duration to Five Years

An expert panel of seven cancer researchers and a representative
of the National Alliance of Breast Cancer Organizations (NABCO)
came together at the San Antonio Breast Cancer Symposium for a
roundtable discussion of the use of tamoxifen (Nolvadex), sponsored
by PRR, Inc., publisher of Oncology News International and the
journal ONCOLOGY.

Last month, an article based on the roundtable focused on the
possible risks of secondary cancers with tamoxifen use. This report
covers the appropriate duration of tamoxifen therapy. Future articles
in this series will include the panel's discussion of possible
noncancer benefits of tamoxifen and how to deal with side effects.

SAN ANTONIO--The National Cancer Institute, in a clinical announcement,
has recommended that physicians limit tamoxifen (Nolvadex) use
in the treatment of early breast cancer to 5 years in clinical

"But nobody really has done a valid comparison to determine
an optimal duration," said V. Craig Jordan, PhD, DSc, of
Northwestern University, who chaired the tamoxifen roundtable.
He believes that the question of 5 vs 10 years is "almost
a null hypothesis. You won't be able to detect any difference
with clinical trials as they are set up because they are not large

The NCI announcement came on the heels of the decision by the
National Surgical Adjuvant Breast and Bowel Project (NSABP) to
stop a clinical trial (B-14) comparing 5 and 10 years of tamoxifen
use after surgery in women with node-negative, estrogen-receptor
(ER)-positive breast cancer.

In this trial, 1,172 women who had been on tamoxifen for 5 years
and had not relapsed were randomized a second time to either 5
more years of tamoxifen, 20 mg/day, or placebo. After 4 years
of follow-up, 92% of the placebo group were alive and free of
disease, compared with 86% of the group scheduled to receive 10
years of tamoxifen.

C. Kent Osborne, MD, of the University of Texas Health Science
Center, San Antonio, said that ideas on tamoxifen duration have
changed over the last 10 years. Initially, he said, it was felt
that since tamoxifen seemed to be predominantly a cytostatic agent,
it might be best to continue the drug for a longer period of time,
maybe indefinitely.


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