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Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer
Journal of Clinical Oncology, 10/02/09

Johnston S et al. – This trial demonstrated that a combined targeted strategy with letrozole and lapatinib significantly enhances PFS and clinical benefit rates in patients with MBC that coexpresses HR and HER2

Methods

Postmenopausal women with HR-positive MBC randomly assigned to daily letrozole (2.5 mg orally) plus lapatinib (1,500 mg orally) or letrozole and placebo
Primary end point PFS in HER2-positive population

Results

HR-positive, HER2-positive patients (n = 219), addition of lapatinib to letrozole significantly reduced the risk of disease progression versus letrozole-placebo ); median PFS was 8.2 v 3.0 mos
Clinical benefit (responsive or stable disease 6 months) significantly greater for lapatinib-letrozole versus letrozole-placebo
Patients with centrally confirmed HR-positive, HER2-negative tumors had no improvement in PFS
Preplanned Cox regression analysis identified prior antiestrogen therapy as significant factor in HER2-negative population
Nonsignificant trend toward prolonged PFS for lapatinib-letrozole seen in patients who experienced relapse less than 6 months since prior tamoxifen discontinuation
Grade 3 or 4 adverse events more common in lapatinib-letrozole arm versus letrozole-placebo arm (diarrhea, 10% v 1%; rash, 1% v 0%, respectively)

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