机构:[1]Key Laboratory of Carcinogenesis and TranslationalResearch (Ministry of Education/Beijing), Departmentof Gastrointestinal Oncology, Peking University CancerHospital and Institute, #52 Fucheng Road, Haidian District,Beijing 100142, People’s Republic of China[2]Department of Medical Oncology, The 4th Hospital, HebeiMedical University, Shijiazhuang, Hebei, China[3]Department of Oncology, Shanghai Zhong Shan Hospital, FuDan University, Shanghai, China[4]Department of Oncology, Anhui Provincial Hospital, Hefei,Anhui, China[5]Department of Oncology, The First Hospital of JiLinUniversity, Changchun, Jilin, China[6]Department of Oncology, The First Affiliated Hospitalof Zhengzhou University, Zhengzhou, Henan, China[7]Department of Gastrointestinal Oncology, Affiliated HospitalCancer Center, Academy of Military Medical Sciences,Beijing, Dongda Street 8, Fengtai District, Beijing 100071,People’s Republic of China[8]The First Affiliated Hospital of Zhejiang University Schoolof Medicine, Hangzhou, Zhejiang, China浙江大学医学院附属第一医院[9]Gastrointestinal Oncology Department, Harbin MedicalUniversity Cancer Hospital, Harbin, Heilongjiang, China[10]Department of Medical Oncology, The First AffiliatedHospital of Anhui Medical University, Hefei, China[11]Department of Medical Oncology, Shanghai Tenth People’sHospital, Tongji University, Shanghai, China[12]Department of Gastrointestinal Oncology, Shanxi CancerHospital, Xinghua District, Taiyuan, Shanxi, China[13]Department of Medical Oncology, Jilin Province People’sHospital, Changchun, Jilin, China[14]Department of Medical Oncology, Shanghai DongfangHospital, Tongji University, Pudong New District, Shanghai,China[15]Department of Abdominal Oncology, Guizhou CancerHospital, Yunyan District, Guiyang, Guizhou, China[16]Department of Medical Oncology, Jiangsu Province Hospital,Nanjing, Jiangsu, China江苏省人民医院
We compared efficacy and safety of paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) versus cisplatin/capecitabine therapy (XP) in advanced gastric cancer. Multicenter, randomized, phase III trial was conducted in China (December 2009-February 2014). Adults (n = 320) with histologically confirmed, untreated metastatic/unresectable gastric or gastroesophageal junction adenocarcinoma; with >= 1 measureable lesions according to Response Evaluation Criteria in Solid Tumors 1.0 criteria; Karnofsky performance score >= 70 and life expectancy >= 3 months were randomized (1:1) to PACX or XP. PACX group received paclitaxel 80 mg/m(2) intravenous on days 1 and 8; capecitabine 1000 mg/m(2) orally BD on days 1-14, followed by a 7-day rest interval for 4 cycles, followed by maintenance capecitabine at same dosage/schedule until disease progression, unendurable adverse events or death. XP group received cisplatin intravenous 80 mg/m(2) on day 1 and capecitabine at same dosage/schedule as PACX group per cycle for 6 cycles. Median progression-free survival (5.0 versus 5.3 months; hazard ratio [95% CI]: 0.906; 0.706-1.164; p = 0.44) and overall survival (12.5 versus 11.8 months; hazard ratio: 0.878 [0.685-1.125]; p = 0.30) were not significantly different between PACX and XP groups. Objective response rate was significantly higher (43.1 versus 28.8%; p = 0.012) and disease control rate was similar (77.5 versus 72.5%; p = 0.75) in PACX versus XP, respectively. Quality of life was significantly improved in PACX versus XP after three treatment cycles. Many treatment-related adverse events were significantly lesser in PACX than XP. First-line chemotherapy with PACX is effective with milder toxicities in advanced gastric cancer, but could not replace XP.
基金:
National Key Research and Development Program of China [2017YFC1308900, 2017YFC0908400]; Beijing Municipal Administration of Hospital Clinical Medicine Development of Special Funding Support [Z161100002616036, Z141107002514013]; Beijing Municipal Science & Technology Commission ProgramBeijing Municipal Science & Technology Commission [Z161100002616036, Z141107002514013]; Beijing Natural Science FoundationBeijing Natural Science Foundation [7161002]; Capital's Funds for Health Improvement and Research [2016-1-1021]
第一作者机构:[1]Key Laboratory of Carcinogenesis and TranslationalResearch (Ministry of Education/Beijing), Departmentof Gastrointestinal Oncology, Peking University CancerHospital and Institute, #52 Fucheng Road, Haidian District,Beijing 100142, People’s Republic of China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Lu Zhihao,Zhang Xiaotian,Liu Wei,et al.A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer[J].GASTRIC CANCER.2018,21(5):782-791.doi:10.1007/s10120-018-0809-y.
APA:
Lu, Zhihao,Zhang, Xiaotian,Liu, Wei,Liu, Tianshu,Hu, Bing...&Shen, Lin.(2018).A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer.GASTRIC CANCER,21,(5)
MLA:
Lu, Zhihao,et al."A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer".GASTRIC CANCER 21..5(2018):782-791