The Effect of Adding Pertuzumab to Adjuvant Trastuzumab in Early HER2-Positive Breast Cancer

Objectives: In this trial, It has been investigated whether pertuzumab, when added to adjuvant trastuzumab and chemotherapy, improves outcomes among patients with HER2-positive early breast cancer in compares to patients who received only Herceptin Methods: After surgery and central HER2-positive confirmation, about randomly 220 patients assigned with high-risk HER2-positive, operable breast cancer to received Anthracycline based chemotherapy 3 cycles fallowed by Taxotere 3 + either pertuzumab + hercetin 3 or standard adjuvant Herceptin alone, 17 cycles in 1 year. The patients were followed up for 3 years. Results: Results were indicated that about 50% of the patients who were randomly assigned to arm A received pertuzumab+Herceptin 3 cycles every 3 weeks (110 patients) and arm B 50% (110 patients) received Herceptin alone 17 cycles every 3 weeks. Disease recurrence occurred in 12 patients (10.9 %) in the pertuzumab group and 8 patients (7.2%) in the arm B group (hazard ratio, 0.81; 95% confidence interval [CI], 0.66 to 1.00; P=0.045). The estimates of the 3-year rates of invasive-disease-free survival were 89% in the pertuzumab+ herceptin group and 93% in the herceptin group. Heart failure, cardiac death, and cardiac dysfunction were infrequent in both treatment groups. Diarrhea of grade 3 or higher occurred almost exclusively during chemotherapy and it was more frequent with pertuzumab than with group B (7.9% vs. 2.8%). Conclusions: The study showed that pertuzumab + Trastuzumab adjuvant in 3 cycles worse rates of invasive-disease-free survival among patients with HER2-positive, operable breast cancer in compares with classical trastuzumab alone in 17 cycles. Diarrhea was more common with pertuzumab than with classical Trastuzumab therapy.