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Predicting for activity of second-line trastuzumab-based therapy in Her2-positive advanced breast cancer
BMC Cancer, 10/23/09

Bartsch R et al. – Trastuzumab beyond progression showed considerable activity. None of the variables investigated correlated with activity of second-line therapy. In order to predict for activity of second-line trastuzumab, it appears necessary to evaluate factors known to confer trastuzumab-resistance.

Methods

97 patients treated with > 1 line of trastuzumab-containing therapy available for analysis
Her2-status determined by immunohistochemistry and re-analyzed by FISH if score of 2+ gained
Time to progression (TTP) on second-line therapy defined as primary study endpoint
TTP and overall survival (OS) estimated using Kaplan-Meier product limit method
Multivariate analyses (Cox proportional hazards model, multinomial logistic regression) applied in order to identify factors associated with TTP, response, OS, and incidence of brain metastases
p values <0.05 considered to indicate statistical significance

Results

Median TTP on second-line trastuzumab-based therapy 7 months (95% CI 5.74-8.26), and 8 months (95% CI 6.25-9.74) on first-line, respectively (n.s.)
In multivariate models, none of clinical or histopthological features could reliably predict for activity of second-line trastuzumab-based treatment
OS was 43 months suggesting improved survival in patients treated with trastuzumab in multiple-lines
Significant deterioration of cardiac function observed in 3 patients; 40.2% developed brain metastases while on second-line trastuzumab or thereafter