ABSTRACT
<p><b>OBJECTIVE</b>To assess the efficacy and safety of neoadjuvant 3-weekly paclitaxel plus trastuzumab (TH) in Chinese women with Her-2 overexpressing operable breast cancer.</p><p><b>METHODS</b>This is a single center open-label phase II clinical trial. The included patients underwent 4 cycles of neoadjuvant 3-weekly TH before surgery. The primary endpoint was pathologic complete response rate (pCR rate) and the secondary endpoint was overall response rate (OR rate). Patients were also stratified according to hormone receptor status, and pCR rate and OR rate were compared between subgroups. Adverse events were graded according to CTCAE v3.0.</p><p><b>RESULTS</b>There were 40 eligible patients entering this study with median age of 49 years. All patients completed 4 cycles of neoadjuvant treatment. pCR rate was 52.5% and OR rate was 87.5%. The differences of pCR and OR rates between subgroups were of no statistical significance. No cardiac toxicity event severer than grade 2 was recorded.</p><p><b>CONCLUSION</b>3-weekly TH regimen has satisfactory pCR rate and OR rate in Chinese patients with Her-2 overexpressing operable breast cancer and reliable safety.</p>
Subject(s)
Adult , Female , Humans , Middle Aged , Antibodies, Monoclonal , Antibodies, Monoclonal, Humanized , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Asian People , Breast Neoplasms , Drug Therapy , Metabolism , Pathology , Carcinoma, Ductal, Breast , Drug Therapy , Metabolism , Pathology , Lymphatic Metastasis , Neoadjuvant Therapy , Neutropenia , Paclitaxel , Receptor, ErbB-2 , Metabolism , Remission Induction , TrastuzumabABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of neoadjuvant chemotherapy combined with trastuzumab for HER2 positive breast cancers.</p><p><b>METHODS</b>PubMed online database, ASCO abstract database, SABCS abstract database, ESMO abstract database and CBMdisc database were searched for literatures related to trastuzumab in neoadjuvant chemotherapy for breast cancers. A meta-analysis was performed for retrieved literatures meeting the inclusion criteria.</p><p><b>RESULTS</b>Three clinical trials were included. Meta-analysis showed that compared to chemotherapy only, regimens combined with trastuzumab could significantly improved the pCR rate of HER2-positive breast cancers (RR=1.65, 95% CI 1.28-2.13, P<0.0001) without increasing the frequencies of cardiac toxicity (RR=1.16, 95% CI 0.82-1.64, P=0.41).</p><p><b>CONCLUSION</b>In neoadjuvant chemotherapy for HER2-positive breast cancers, chemotherapy combined with trastuzumab is superior to exclusive chemotherapy.</p>