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A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer

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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 [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
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关键词: Stomach neoplasms Paclitaxel Capecitabine Cisplatin

摘要:
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.

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出版当年[2018]版:
大类 | 2 区 医学
小类 | 2 区 胃肠肝病学 2 区 肿瘤学
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 胃肠肝病学 2 区 肿瘤学
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出版当年[2018]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY Q1 ONCOLOGY
最新[2024]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY Q1 ONCOLOGY

影响因子: 最新[2024版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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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
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