title: Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial.
abstract: This trial was designed to compare the efficacy and safety between epirubicin (E) and carboplatin (C) in combination with paclitaxel (P) and trastuzumab (H) in neoadjuvant setting. In 13 Chinese cancer centers, 100 patients with HER2-positive, locally advanced breast cancer were 1:1 randomized to receive medication as follows: trastuzumab and paclitaxel weekly combined with carboplatin weekly for PCH group, or epirubicin every 3 weeks for PEH group. Patients were given 4 to 6 cycles of chemotherapy. The primary endpoint was pathologic complete response (pCR) rate, which was no significant difference in PCH and PEH regimen (39.1% vs. 48.8%; p=0.365). However, PEH regimen achieved higher pCR in luminal-B (HER2-poitive) subgroup (55.0% vs. 24.0%; p = 0.033), but not in ERBB2+ subgroup (42.9% vs. 57.1%; p = 0.355). PEH regimen showed a favorable efficacy in PIK3CA mutated subgroup (69.2% vs.23.5%, p=0.012). No significant difference was observed in the subgroup analysis of TP53 mutation status, PTEN expression, FCGR2A SNP and FCGR3A SNP. Both regimens as neoadjuvant chemotherapy achieve similar efficacy and safety. PEH might improve pCR rate, especially in the luminal-B subtype and PIK3CA mutation subtype. PEH is feasible and less likely to increase the incidence of acute cardiac events compared to PCH.
authors.affiliation: Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China.|Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Huang
authors.affiliation: Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China.|Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Sheng
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.|Department of Pathology, Cancer Center/Cancer Institute, Shanghai, China.
authors.forename: Wentao
authors.initials: W
authors.lastname: Yang
authors.affiliation: Department of Medical Oncology, Cancer Institute and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Binghe
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Breast and Thyroid Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Huang
authors.affiliation: Department of Breast Tumor Surgery, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China.
authors.forename: Hongjian
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Head and Neck and Mammary Oncology, Cancer Center and State Key Laboratory of Biotherapy, Laboratory of Molecular Diagnosis of Cancer, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Breast Cancer Center, Shandong Cancer Hospital and Institute, Jinan, China.
authors.forename: Yongsheng
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
authors.forename: Erwei
authors.initials: E
authors.lastname: Song
authors.affiliation: 3rd Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Henan Breast Cancer Center, Henan Cancer Hospital, Zhengzhou, China.
authors.forename: Shude
authors.initials: S
authors.lastname: Cui
authors.affiliation: Department of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, China.
authors.forename: Da
authors.initials: D
authors.lastname: Pang
authors.affiliation: Department of Breast Surgery, Xiangya Hospital, Central South University, Changsha, China.
authors.forename: Lili
authors.initials: L
authors.lastname: Tang
authors.affiliation: Department of Breast Surgery, Peking University Third Hospital, Beijing, China.
authors.forename: Yutao
authors.initials: Y
authors.lastname: Lei
authors.affiliation: Department of Breast Cancer Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Cuizhi
authors.initials: C
authors.lastname: Geng
authors.affiliation: Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China.|Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Zhiming
authors.initials: Z
authors.lastname: Shao
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D058534:Class I Phosphatidylinositol 3-Kinases; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D051059:PTEN Phosphohydrolase / Q000235:genetics; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D019869:Phosphatidylinositol 3-Kinases / Q000235:genetics; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D017452:Receptors, IgG / Q000235:genetics; D012074:Remission Induction; D000068878:Trastuzumab / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D016159:Tumor Suppressor Protein p53 / Q000235:genetics
chemical_list: D016190:Carboplatin; D058534:Class I Phosphatidylinositol 3-Kinases; D015251:Epirubicin; D051059:PTEN Phosphohydrolase; D017239:Paclitaxel; D019869:Phosphatidylinositol 3-Kinases; D018719:Erb-b2 Receptor Tyrosine Kinases; D017452:Receptors, IgG; D000068878:Trastuzumab; D016159:Tumor Suppressor Protein p53; C445323:FCGR2A protein, human; C496124:FCGR3A protein, human; C484760:PIK3CA protein, human
keywords: anthracycline; carboplatin; clinical trial; neoadjuvant chemotherapy; pathological complete response; trastuzumab