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Significantly higher pathological complete remission (PCR) rate following neoadjuvant therapy with trastuzumab (H), paclitaxel (P), and anthracycline-containing chemotherapy (CT): Initial results of a randomized trial in operable breast cancer (BC) with HER/2 positive disease.

520 Background: In patients (pts) with metastatic BC, trastuzumab [Herceptin (H)] in combination with CT results in higher response rates, longer control of disease, and superior survival. The objective of this study was to determine whether the addition of H to CT in the neoadjuvant setting could increase PCR rate in pts with HER/2 positive disease.


METHODS
42 pts with HER/2-positive disease (IHC 3+ or FISH +) with operable BC were randomized to 4 cycles of P followed by 4 cycles of FEC, or the same CT with simultaneous weekly H at 2 mg/kg for 24 weeks.The primary objective was to demonstrate a 20% improvement in PCR (assumed 21% to 41%) with addition of H to CT. At the end of CT±H, pts had definitive surgery. The planned sample size was 164 pts.


RESULTS
Prognostic factors were similar in the two groups. After 34 pts had completed therapy, the trial's Data Monitoring Committee stopped the trial for superiority of CT + H. PCR rates were 25% and 67%, respectively, for CT alone (n=16) and CT + H (n=18) (P=0.02). Additional results are included in the table. Fever during neutropenia occurred in 9 and 11 pts, respectively, in CT alone and CT + H. Of those, 3 pts in each subgroup were hospitalized. Decrease in cardiac ejection fraction (>10%) was observed in 6 and 4 pts, respectively, in CT and CT + H. No pts had clinical CHF or other clinically relevant cardiac toxicity. Troponin-T levels remained normal in all pts. The trial was stopped by an independent DMC based on a Bayesian predictive probability of 0.95 that the trial would conclude a significant benefit for CT+H if completed to originally planned 164 pts.


CONCLUSIONS
Despite the small sample size, these data indicate that adding H to CT as utilized in this trial significantly increased PCR without clinical CHF. [Figure: see text] [Table: see text].