A Randomized Parallel Controlled Phase II Trial of Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy for Stage III Breast Cancer |
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| Institution: | 1. Research Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China;2. OHSU-PSU School of Public Health, Oregon Health and Science University, Portland, OR;3. Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China;4. Department of Hematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China;5. Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, TN;6. Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR;7. Division of Hematology/Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR;8. Department of Pathology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China;1. Research Center for Community Health, Minamisoma Municipal General Hospital, Minamisoma, Fukushima, Japan;2. Department of Surgery, Minamisoma Municipal General Hospital, Minamisoma, Fukushima, Japan;3. Graduate School of Public Health, Teikyo University, Itabashi-ku, Tokyo, Japan;4. Department of Global Health Policy, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan;5. Global Public Health Unit, School of Social and Political Science, University of Edinburgh, George Square, Edinburgh, United Kingdom;6. Department of Public Health, Fukushima Medical University School of Medicine, Fukushima, Japan;7. Department of Medical Oncology, Fukushima Medical University School of Medicine, Fukushima, Japan;8. Department of Internal Medicine, Soma Central Hospital, Fukushima, Japan;9. Department of Internal Medicine, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan;10. Research Institute of Innovative Medicine, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan;1. Department of Radiation Oncology, Emory University School of Medicine, Atlanta, GA;2. Glenn Family Breast Center, Winship Cancer Institute, Emory University, Atlanta, GA;3. Xiangya School of Medicine, Central South University, Changsha, China;1. Clinic Pharmacology Laboratory, Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215006, China;2. Department of Pharmacology, Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, College of Pharmaceutical Sciences, Soochow University, Suzhou 215123, China;3. Laboratory Department, Wuxi Center for Disease Control and Prevention, Wuxi 214023, China;1. Department of Clinical Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, IR, Iran;2. Safety Promotion and Injury Prevention Research Center, Shahid Beheshti University of Medical Sciences, Tehran, IR, Iran;1. Department of Medicine, Ohio State University College of Medicine, Columbus, OH;2. Division of Medical Oncology, Ohio State University Comprehensive Cancer Center, Columbus, OH;3. College of Public Health, Division of Biostatistics, Ohio State University, Columbus, OH;4. Department of Medical Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, Boston, MA;5. Blood Biopsy Team, Broad Institute of MIT and Harvard, Cambridge, MA |
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| Abstract: | BackgroundTo explore the potential advantage of preoperative anti-angiogenosis therapy, we implemented a study to evaluate the efficacy of recombinant human endostatin (EN) in combination with neoadjuvant chemotherapy in the treatment of stage III breast cancer.Patients and MethodsEighty-seven patients were randomized to neoadjuvant TEC (docetaxel, epirubicin, and cyclophosphamide) or to EN+TEC, followed by surgery. The primary endpoint was the objective response rate (ORR). Secondary endpoints included pathologic complete response (pCR), relapse-free survival (RFS), overall survival (OS), and safety.ResultsPatients receiving EN+TEC achieved significantly higher ORR (81.82%; 36/44) compared with those receiving TEC (58.14%; 25/43; P=0.016). There was a non-significant trend of increased pCR with EN treatment (15.91% vs. 6.98%). The median follow-up was 54 months and revealed a significantly higher RFS with EN+TEC (median, 67.3 months; 95% confidence interval CI], 61.0-73.7 months), compared with TEC (median, 55.0 months; 95% CI, 48.3-61.7 months; P =0.014). EN+TEC also significantly improved OS (74.2 months; 95% CI, 68.9-79.6 months), compared with TEC (59.1 months; 95% CI, 52.0-66.1 months; P =0 .006). The 3- and 5-year OS rates are estimated to be 88.5% and 82.8% with EN+TEC and 76.7% and 54.4% with TEC, respectively. Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0 .041). There was no significant difference in adverse events between EN+TEC and TEC.ConclusionThe combination of EN+TEC neoadjuvant chemotherapy significantly improved the ORR and OS, suggesting a benefit of adding anti-angiogenesis to standard chemotherapy in the treatment of locally advanced breast cancer. |
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| Keywords: | Breast cancer Neoadjuvant therapy Objective response rate Overall survival Recombinant human endostatin |
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