Combination of TYKERB(R) (lapatinib) Plus Letrozole Demonstrated Significant Improvement in Delaying Disease Progression for HER2+/ErbB2+ Post-Menopausal Metastatic Bre...( Findings from one of the largest stud...),Health

Findings from one of the largest studies in hormone receptor positive women with first-line oral treatment regimen

PHILADELPHIA, Dec. 11 /PRNewswire-USNewswire/ -- New results from a study evaluated the combination of TYKERB(R)(lapatinib) plus Femara(R) (letrozole) versus letrozole alone as a first-line treatment regimen in hormone receptor positive (HR+) metastatic breast cancer. In the study, women diagnosed with post-menopausal, hormone receptor positive (HR+) and HER2+/ErbB2+ metastatic breast cancer experienced a 5.2 month increase in median progression-free survival (PFS) compared to women treated with letrozole alone. Results from the intent-to-treat group (ITT; all patients, irrespective of HER2/ErbB2 status) showed that lapatinib plus letrozole provided an additional 1.1 month before disease progression compared to letrozole treatment alone. These data were unveiled at the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium, December 10th-14th, 2008.

This double-blind, placebo-controlled study (EGF30008) included 1,286 post-menopausal women with HR+ breast cancer who were randomized to treatment with lapatinib plus letrozole or to letrozole alone. Letrozole, an aromatase inhibitor (AI), is a recognized therapy in the treatment of HR+ breast cancer. The HER2/ErbB2 status of patients was not required for randomization into the study, however, PFS was the primary endpoint in the HR+ and HER2+/ErbB2+ patient post study analysis.

Independent central testing revealed that 219 patients were HER2+/ErbB2+. In women who were HR+ and HER2+/ErbB2+, combination therapy with lapatinib and letrozole significantly increased median PFS, compared to treatment with letrozole alone (8.2 months versus 3.0 months respectively, HR=0.71, p=0.019).

"The encouraging positive results seen in women who are HR positive and ErbB2 positive shows that the lapatinib and letrozole combina
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