SAN ANTONIOThe aromatase inhibitor letrozole (Femara) should be
considered for first-line hormonal therapy in postmenopausal women with
advanced breast cancer, according to the final analysis of a pivotal phase
III trial comparing the agent with tamoxifen (Nolvadex).
The large multinational trial included 907 women randomized to receive
letrozole 2.5 mg daily or tamoxifen 20 mg daily as first-line therapy for
Martine Piccart, MD, PhD, of Jules Bordet Institute, Brussels, Belgium,
reported the findings at the 24th Annual San Antonio Breast Cancer Symposium
(abstract 9) on behalf of lead author Henning Mouridsen, MD, of
Copenhagen, who could not attend the meeting.
Some of the study results have been previously reported (Mouridsen H et
al: J Clin Oncol 19:2596, 2001). At the San Antonio conference, Dr. Piccart
reported the 32-month follow-up that included the first survival figures for
the randomized comparison.
Letrozole was shown to be significantly superior to tamoxifen in the
primary endpoint of median time to progression: 9.4 months vs 6 months, for
a 28% risk reduction (P = .0001), Dr. Piccart said.
"In addition to being statistically significant, these differences
are also clinically relevant," she commented. "And there is a
consistency of the results across all the subgroups of women in this trial.
The superiority of letrozole is seen whether or not they received adjuvant
tamoxifen or had hormone-receptor-positive tumors, and independently of the
dominant site of disease."