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A new study done by investigators from MD Anderson Cancer Center in Houston is showing new promising approach to patients with human epidermal growth factor receptor 2 (Her2) positive breast cancer. The study published as an early release by Journal of Clinical Oncology (JCO) shows the women who have over-expression of Her2 gene may benefit from pre-operative chemotherapy in combination with trastuzumab (Herceptin). These investigators wanted to see if addition of trastuzumab (Herceptin) to chemotherapy as the pre-operative treatment would improve rate of elimination of the tumor. The study was looking at the possibility of increased pathological response (pCR) with the combination therapy
The study enrolled forty-two patients with Her2-positive operable breast cancer and these patients were randomly assigned to either four cycles of paclitaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide or to the same chemotherapy with simultaneous weekly trastuzumab (Herceptin) for 24 weeks. The main objective of the study was to a 20% improvement in pCR (assumed 21% to 41%) with the addition of trastuzumab to chemotherapy. The planned sample size was 164 patients. The study was abandoned after enrolling 34 patients because the analysis showed that patients in the chemotherapy plus trastuzumab (Herceptin) achieved much pCR than anticipated and the data monitoring committee has advised to discontinue the trial.
The following are the results of the trial Chemotherapy alone Vs Chemotherapy plus trastuzumab (Herceptin) respectively in 34 evaluable patients:
PCR rates were 25% or (4/16) in the chemotherapy alone arm compared to 66.7% (12/18) in the chemotherapy plus trastuzumab (Herceptin) arm. P value was significant at .02.
Of the 42 randomized patients, 26% in the chemotherapy arm achieved pCR compared with 65.2% in the trastuzumab plus chemotherapy arm (P = .016). It was not possible to establsish the safety of trastuzumab (Herceptin) from this study because of the small sample size, however no clinical congestive heart failure was observed in the study. A more than 10% decrease in the cardiac ejection fraction was observed in five and seven patients in the chemotherapy and trastuzumab plus chemotherapy arms, respectively.
The investigators have concluded that Despite the small sample size, these data indicate that adding trastuzumab (Herceptin) to chemotherapy, as used in this trial, significantly increased pCR without clinical congestive heart failure.
Ref: Journal of clinical oncology early release
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