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Lapatinib, letrozole increased PFS for HR+, HER2+ metastatic breast cancer
The chemotherapy-free regimen also maintained quality of life.
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Women with metastatic breast cancer assigned to a combinaton of lapatinib — a targeted therapy for HER2-positive breast cancer — and letrozole — an aromastase inhibitor — had superior PFS and equivalent quality of life when compared with women assigned to letrozole alone.
Beth Sherrill, MD, global head of biometrics for RTI Health Solutions in Triangle Park, N.C., presented the results at the 2009 Breast Cancer Symposium.
She said median PFS was 8.2 months for the combination arm compared with three months in the letrozole arm (HR=0.71; 95% CI, 0.53-0.96).
“The significantly longer PFS period in patients taking lapatinib [Tykerb, GlaxoSmithKline] combined with letrozole was achieved without detriment to their quality of life associated with adverse events,” she said.
Sherrill added that quality of life scores improved for about one-third of patients who stayed with the study.
Researchers in the United Kingdom and at multiple sites in the United States enrolled 219 women with HER2–positive, HR–positive metastatic disease and randomly assigned 111 patients 1,500 mg daily lapatinib plus 2.5 mg daily letrozole.
The remaining 108 patients were randomly assigned 2.5 mg daily letrozole alone. Quality of life was assessed at baseline, every 12 weeks and at withdrawal.
As measured by the Functional Assessment of Cancer Therapy–Breast (FACT-B) questionnaire, average quality-of-life scores improved at all scheduled visits. The maximum difference in scores between the arms was 2.6 points (95% CI, –5.8 to 11.0).
Sherrill said quality-adjusted survival scores favored the combination arm but the difference was not significant.
For more information:
- Sherrill B. #212.. Presented at 2009 Breast Cancer Symposium; October 8-10, 2009, San Francisco
The combination of endocrine therapy plus anti-HER2 therapy is a very valid option for these patients — particularly frail patients or patients where the disease is not that aggressive. However, the combination of chemotherapy plus anti-HER2 therapy remains the gold standard, particularly if we want to have a rapid response.
– Christos Sotiriou, MD, PhD
Head of the Functional Genomics and Translational Research Unit, Jules Bordet Institute, Brussels, Belgium