晚期胃癌一线化疗后卡培他滨维持治疗的疗效和安全性Efficacy and safety of capecitabine maintenance therapy following first-line chemotherapy in patients with advanced gastric cancer
肖成华,阚捷,李海燕,王新国,吴昊
摘要(Abstract):
目的观察卡培他滨在晚期胃癌一线化疗后维持治疗的疗效和不良反应。方法 280例晚期胃癌患者经FOLFOX4方案(奥沙利铂+氟尿嘧啶+亚叶酸钙,6~9个周期)或XELOX方案(奥沙利铂+卡培他滨,4~6个周期)一线化疗后,疗效评价无疾病进展的172例患者,按照患者意愿分为维持组63例(卡培他滨维持治疗,1 000 mg/m2,每天2次,d1~14,每3周重复)和观察组109例。结果 FOLFOX4方案组和XELOX方案组的疾病控制率分别为64.4%(85/132)和65.5%(97/148),两者比较,差异无统计学意义(P=0.95)。XELOX方案的患者入维持组的比例高于FOLFOX4方案患者(P=0.009)。中位无进展生存期维持组为10.7个月(95%CI:9.6~11.8个月),观察组为7.3个月(95%CI:6.9~7.6个月,P<0.01)。中位生存期维持组优于观察组,分别为18.3个月(95%CI:17.5~19.0个月)和15.0个月(95%CI:14.5~15.5个月,P<0.01)。维持组常见不良反应为血液学和胃肠道毒性,以1~2级多见。结论卡培他滨作为晚期胃癌一线化疗后维持治疗延长PFS和OS,耐受性良好。
关键词(KeyWords): 胃肿瘤/药物疗法;脱氧胞苷/投药和剂量;脱氧胞苷/类似物和衍生物;抗肿瘤联合化疗方案/治疗应用;存活率;治疗结果
基金项目(Foundation):
作者(Author): 肖成华,阚捷,李海燕,王新国,吴昊
DOI: 10.13267/j.cnki.syzlzz.2018.05.011
参考文献(References):
- [1]Moore MA,Eser S,Igisinov N,et al.Cancer epidemiology and control in North-Western and Central Asia-past,present and future[J].Asian Pac J Cancer Prev,2010,11(Suppl 2):17-32.
- [2]Chen WQ,Zheng RS,Baade PD,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-132.
- [3]韩光锋.晚期胃癌的内科治疗现状和进展[J].实用肿瘤杂志,2017,32(6):569-574.
- [4]Coccolini F,Montori G,Ceresoli M,et al.Advanced gastric cancer:What we know and what we still have to learn[J].World J Gastroenterol,2016,22(3):1139-1159.
- [5]Eisenhauer EA,Therasse P,Bogaerts J,et al.New response evaluation criteria in solid tumours:revised RECIST guideline(version 1.1)[J].Eur J Cancer,2009,45(2):228-247.
- [6]US Department of Health and Human Services&National Institutes of Health&National Cancer Institue.Common terminology criteria for adverse events(CTCAE)version4.03[EB/OL].(2010-06-14)[2017-12-17].https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf.
- [7]Ferlay J,Soerjomataram I,Dikshit R,et al.Cancer incidence and mortality worldwide:sources,methods and major patterns in GLOBOCAN 2012[J].Int J Cancer,2015,136(5):E359-386.
- [8]Wagner AD,Syn NL,Moehler M,et al.Chemotherapy for advanced gastric cancer[J].Cochrane Database Syst Rev,2017,8:CD004064.
- [9]Cunningham D,Starling N,Rao S,et al.Capecitabine and oxaliplatin for advanced esophagogastric cancer[J].N Engl J Med,2008,358(1):36-46.
- [10]Lee JE,Chung CU.Update on the evidence regarding maintenance therapy[J].Tuberc Respir Dis(Seoul),2014,76(1):1-7.
- [11]Paz-Ares LG,de Marinis F,Dediu M,et al.PARAMOUNT:Final overall survival results of the phaseⅢstudy of maintenance pemetrexed versus placeboimmediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer[J].J Clin Oncol,2013,31(23):2895-2902.
- [12]Yalcin S,Uslu R,Dane F,et al.Bevacizumab+capecitabine as maintenance therapy after initial bevacizumab+XELOX treatment in previously untreated patients with metastatic colorectal cancer:phaseⅢ‘Stop and Go’study results-a Turkish Oncology Group Trial[J].Oncology,2013,85(6):328-335.
- [13]黎超.SOX方案一线化疗后替吉奥维持治疗晚期胃癌的临床观察[J].实用肿瘤杂志,2017,32(6):520-524.
- [14]Li WH,Zhao XY,Wang HJ,et al.Maintenance treatment of Uracil and Tegafur(UFT)in responders following first-line fluorouracil-basedchemotherapy in metastatic gastric cancer:a randomized phaseⅡstudy[J].Oncotarget,2017,8(23):37826-37834.
- [15]Qiu MZ,Wei XL,Zhang DS,et al.Efficacy and safety of capecitabine as maintenance treatment after first-line chemotherapy using oxaliplatin andcapecitabine in advanced gastric adenocarcinoma patients:a prospective observation[J].Tumour Biol,2014,35(5):4369-4375.
- [16]Gong J,Hu B,Zhang X,et al.The multicenter,phaseⅡprospective study of paclitaxel plus capecitabine as firstline chemotherapy in advanced gastric carcinoma[J].Oncologist,2014,19(2):173-174.
- [17]Eren OO,Ozturk MA,Sonmez OU,et al.Safety,feasibility,and efficacy of capecitabine maintenance in patients with advanced gastric cancer:a retrospective study[J].Am J Ther,2014,23(6):e1493-1497.
- [18]张瑞雪,闫涵,王民,等.XELOX方案与FOLFOXs方案治疗中国晚期胃癌患者的Meta分析[J].首都医科大学学报,2013,34(3):422-427.