Weekly docetaxel and gemcitabine in previously treated metastatic esophageal squamous cell carcinoma

作     者：Min-Young Lee Ki Sun Jung Hae Su Kim Ji Yun Lee Sung Hee Lim Moonjin Kim Hyun Ae Jung Sung Min Kim Jong Mu Sun Myung-Ju Ahn Jeeyun Lee Se Hoon Park Seong Yoon Yi In Gyu Hwang Sang-Cheol Lee Hee Kyung Ahn Do Hyoung Lim Soon Il Lee Keon Woo Park 

作者机构：Division of Hematology-OncologyDepartment of MedicineSamsung Medical CenterSungkyunkwan University School of Medicine Division of Hematology-OncologyDepartment of Internal MedicineInje University Ilsan-Paik Hospital Division of Hematology-OncologyDepartment of Internal MedicineChung-Ang University Hospital Division of Hematology-OncologyDepartment of Internal MedicineSoonchunhyang University Hospital Division of Hematology-OncologyDepartment of Internal MedicineGachon University Gil Hospital Division of Hematology-OncologyDepartment of Internal MedicineDankook University College of Medicine 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2015年第21卷第14期

页      面：4268-4274页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Supported by Dong-A ST(Seoul Korea)for kindly provided the study drug(gemcitabine) 

主　　题：Clinical trial Phase Ⅱ Chemotherapy Carcinoma,Esop 

摘      要：AIM: To assess the efficacy and safety of weekly docetaxel plus a fixed-dose rate(FDR) of gemcitabine in metastatic esophageal squamous cell carcinoma(SCC).METHODS: A multi-center, open-label, prospective phase Ⅱ study was ***-three esophageal SCC patients with documented progression after fluoropyrimidine/platinum-based first-line chemotherapy were enrolled and treated with docetaxel 35 mg/m2 and gemcitabine 1000 mg/m2 iv at a FDR(10 mg/m2 per minute) on days 1 and *** was repeatedevery twenty-one days until disease progression, unacceptable toxicity, or consent *** primary endpoint was response rate(RR), and secondary endpoints were safety, progression-free survival(PFS) and overall survival(OS).RESULTS: Combination of weekly docetaxel and FDR gemcitabine was well tolerated: the most common treatment-related adverse events were anemia(97%), fatigue(64%) and neutropenia(55%).One patient with multiple lung and lymph node metastases died of respiratory failure after receiving four cycles of chemotherapy, and the possibility of drug-induced pneumonitis could not be completely *** control(objective response plus stable disease) in the ITT population was achieved in 88% of patients, and the overall RR was 30%(95%CI: 15%-46%).The median PFS and OS were 4.0(95%CI: 3.4-4.6) and 8.8 mo(95%CI: 7.8-9.8 mo), ***: A combination of weekly docetaxel and FDR gemcitabine showed promising antitumor activity and tolerability in previously treated, metastatic esophageal SCC.