The Pharmaceutical Journal
Vol 278 No 7435 p68
20 January 2007

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Lapatinib shows survival benefit in breast cancer

Analysis of results from a phase III trial of the oral dual-kinase inhibitor lapatinib (Tykerb; GlaxoSmithKline) in women with HER2-positive advanced or metastatic breast cancer has confirmed a survival benefit for lapatinib plus capecitabine, compared with capecitabine alone (New England Journal of Medicine 2006;355:2733). The trial was stopped early last year due to positive interim results (PJ, 15 April 2006, p436).

The study involved 324 women who had received multiple previous treatments. Data showed that 49 women progressed in the combination therapy group compared with 72 in the monotherapy group (hazard ratio 0.49, 95 per cent confidence interval 0.34–0.71; P<0.001). Median time to progression was 8.4 months and 4.4 months, respectively.

Adverse events leading to discontinuation were similar in the two groups although more women in the lapatinib group experienced asymptomatic cardiac events related to treatment (four versus zero). No symptomatic cardiac events were observed and there were no withdrawals from treatment due to decreases in left ventricular ejection fraction.

“The findings … warrant elevations of the role of lapatinib, which has a mechanism of action distinct from that of trastuzumab, earlier in the treatment of HER2-positive breast cancer,” the researchers conclude.