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Lapatinib plus letrozole delayed progression in metastatic HER-2–positive disease

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San Antonio Breast Cancer Symposium

SAN ANTONIO — Results from the EGF30008 trial showed the combination of lapatinib and letrozole nearly tripled PFS compared with letrozole alone in patients with postmenopausal metastatic HER-2–positive disease.

Stephen Johnston, MD, PhD, consultant medical oncologist and director of Clinical Research and Development at the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, presented first results from EGF30008, a phase-3 trial, at the San Antonio Breast Cancer Symposium.

“If we can identify patients who are hormone-receptor–positive who also express ErbB2 growth factor receptor, the 30008 trial shows that the combination of an orally active tyrosine kinase inhibitor against HER-2, lapatinib, with letrozole significantly improved time to progression and the clinical benefit rate over just using letrozole alone,” Johnston said at a press briefing. “It suggests that combined therapy is better than just using endocrine therapy alone.”

Researchers recruited 1,286 postmenopausal women from 212 international centers. The women had hormone-receptor–positive disease, and 219 were HER-2–positive. Patients were randomly assigned to once daily 2.5 mg letrozole (Femara, Novartis) and 1500 mg lapatinib (Tykerb, GlaxoSmithKline) or letrozole alone (n=108).

Women assigned to the combination (n=111) had a median PFS of 8.2 months compared with three months in the letrozole alone arm (HR=0.71; 95% CI, 0.53-0.96).

“There is a statistically significant 29% reduction in risk of progression, which is manifested in the median PFS,” Johnston said.

Median OS was 33.3 months in the combination arm and 32.3 months in the letrozole group (HR=0.74; 95% CI, 0.5-1.1). Overall response rate was 28% in the combination arm compared with 15% in the monotherapy group (P=.021). The clinical benefit rate for the combination was 48% compared with 29% in the letrozole group (P=.003).

“Again, highly statistically significant, showing the benefit from the combination in controlling the disease and controlling it for longer than just using endocrine therapy alone,” Johnston said.

He added that the combination was associated with a higher incidence of low-grade rash and diarrhea, known side effects of lapatinib. Nine percent of patients developed grade-3/4 diarrhea in the combination arm, but the toxicities were manageable and caused only ten patients to leave the study. – by Jason Harris

For more information:

• Johnston S. #46. Presented at: the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 10-14, 2008; San Antonio.