Biomarkers for Lapatinib Therapy in Breast Cancer

Research conducted in the United States analyzed biomarkers in breast cancer tissue to optimize the selection of patients for lapatinib therapy. The study involved patients with HER-2-negative and HER-2-positive metastatic breast cancer who received paclitaxel and capecitabine with or without lapatinib. The researchers found that HER-2 gene amplification was detected in 47% of patients, and immunohistochemistry (IHC) showed HER-2 protein expression in 35% of patients. The study concluded that women with HER-2-positive metastatic breast cancer benefit from lapatinib, while those with HER-2-negative metastatic breast cancer do not derive additional benefit from the therapy.

Key Takeaways:

  • The study analyzed biomarkers in breast cancer tissue from two phase III trials: EGF30001 and EGF100151.
  • The trials involved 579 and 399 patients, respectively, with HER-2-negative and HER-2-positive metastatic breast cancer.
  • HER-2 gene amplification was detected in 47% of patients (344 of 733) using fluorescence in situ hybridization (FISH).
  • Immunohistochemistry (IHC) showed HER-2 protein expression in 35% of patients (279 of 798) with significant correlation (P < 0.001).
  • The study found a significant correlation between HER-2 gene amplification and response to lapatinib therapy.
  • Women with HER-2-positive metastatic breast cancer benefit from lapatinib, while those with HER-2-negative metastatic breast cancer do not derive additional benefit from the therapy.
  • The study highlights the importance of biomarker analysis in optimizing the selection of patients for lapatinib therapy.

Statistics:

  • 47% of patients had HER-2 gene amplification (344 of 733)
  • HER-2 protein expression was detected in 35% of patients (279 of 798)
  • Significant correlation (P < 0.001) was found between HER-2 gene amplification and response to lapatinib therapy
  • 579 patients participated in EGF30001
  • 399 patients participated in EGF100151

Sources:

  • Press, M. F., et al. "HER-2 Gene Amplification, HER-2 and Epidermal Growth Factor Receptor mRNA and Protein Expression, and Lapatinib Efficacy in Women with Metastatic Breast Cancer." Clinical Cancer Research, vol. 14, no. 23, 2008, pp. 7861-7870.