Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers

Table 7

Selected clinical trials of lapatinib. MBC, metastatic breast cancer; PFS, progression free survival; OS, overall survival; TTP, time to progression.

Malignancy	Regimen	Number of patients	Response rate	Comments
MBC	Capecitibine +/− Lapatinib [59]	324 pts HER2-positive MBC that had progressed with chemotherapy (anthracycline, a taxane, and trastuzumab)	Capecitabine, Lapatinib: TTP (6.2 mo) ORR (24%) Capecitabine monotherapy: TTP (4.3 mo) ORR (14%)	Non-significant trend toward improved OS favoring lapatinib Fewer pts in the lapatinib arm developed brain metastases as the first site of progression (13 vs. 4%)
MBC	Lapatinib, Paclitaxel vs. Paclitaxel monotherapy [60]	580 pts 55% received prior chemotherapy or hormonal therapy No pts received prior traztuzumab	Lapatinib, Paclitaxel: ORR (60%) Median TTP (8 mo) Paclitaxel monotherapy: ORR (36%) Median TTP (6 mo)	Improved clinical outcome was seen with the combination without a significant change in side effect profile No difference in OS, but majority of pts were not properly tested for HER2