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鼻咽癌的吉西他滨联合顺铂诱导化疗
Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma


Yuan Zhang ... 肿瘤 • 2019.05.31
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摘要


背景

铂类同步放化疗是局部区域晚期鼻咽癌患者的标准治疗。加用吉西他滨联合顺铂诱导化疗在2期试验中显示出很有前景的疗效。

 

方法

在一项平行组、多中心、随机、对照3期试验中,我们比较了吉西他滨联合顺铂诱导化疗加同步放化疗与单独采用同步放化疗的疗效。本试验以1∶1的比例将局部区域晚期鼻咽癌患者随机分组,分别接受吉西他滨(剂量为每平方米体表面积1 g,在第1日和第8日给药)联合顺铂(剂量为每平方米体表面积80 mg,在第1日给药)(上述两种药物均每3周给药1次,给药3个周期)加放化疗(同步应用顺铂[剂量为每平方米体表面积100 mg,每3周给药1次,给药3个周期]加调强放疗)或单独接受放化疗。主要终点是意向治疗人群的无复发生存期(即无疾病复发[远处转移或局部区域复发]且未死亡)。次要终点包括总生存期、治疗依从性和安全性。

 

结果

共有480例患者被纳入试验(诱导化疗组242例患者,标准治疗组238例患者)。在中位随访42.7个月时,诱导化疗组和标准治疗组的3年无复发生存率分别为85.3%和76.5%(复发或死亡的分层风险比,0.51;95%置信区间[CI],0.34~0.77;P=0.001)。3年总生存率分别为94.6%和90.3%(死亡的分层风险比,0.43;95% CI,0.24~0.77)。共有96.7%的患者完成了3个周期的诱导化疗。诱导化疗组和标准治疗组的3或4级急性不良事件发生率分别为75.7%和55.7%,诱导化疗组的中性粒细胞减少、血小板减少、贫血、恶心和呕吐发生率高于标准治疗组。诱导化疗组和标准治疗组的3或4级迟发性毒性作用发生率分别为9.2%和11.4%。

 

结论

在局部区域晚期鼻咽癌患者中,与单独采用放化疗相比,在放化疗的基础上加用诱导化疗显著提高了患者的无复发生存率和总生存率(由中国教育部创新团队发展计划等资助;在ClinicalTrials.gov注册号为NCT01872962)。





作者信息

Yuan Zhang, M.D., Ph.D., Lei Chen, M.D., Ph.D., Guo-Qing Hu, M.D., Ning Zhang, M.D., Xiao-Dong Zhu, M.D., Ph.D., Kun-Yu Yang, M.D., Feng Jin, M.D., Mei Shi, M.D., Ph.D., Yu-Pei Chen, M.D., Wei-Han Hu, M.D., Zhi-Bin Cheng, M.D., Si-Yang Wang, M.D., Ye Tian, M.D., Xi-Cheng Wang, M.D., Yan Sun, M.D., Ph.D., Jin-Gao Li, M.D., Wen-Fei Li, M.D., Ph.D., Yu-Hong Li, M.D., Ling-Long Tang, M.D., Ph.D., Yan-Ping Mao, M.D., Ph.D., Guan-Qun Zhou, M.D., Ph.D., Rui Sun, M.D., Xu Liu, M.D., Ph.D., Rui Guo, M.D., Ph.D., Guo-Xian Long, M.D., Ph.D., Shao-Qiang Liang, M.D., Ling Li, M.D., Ph.D., Jing Huang, M.D., Ph.D., Jin-Hua Long, M.D., Jian Zang, M.D., Qiao-Dan Liu, M.D., Ph.D., Li Zou, M.D., Ph.D., Qiong-Fei Su, M.D., Bao-Min Zheng, M.D., Ph.D., Yun Xiao, M.D., Ying Guo, Ph.D., Fei Han, M.D., Ph.D., Hao-Yuan Mo, M.D., Jia-Wei Lv, M.D., Xiao-Jing Du, M.D., Ph.D., Cheng Xu, M.D., Ph.D., Na Liu, M.D., Ph.D., Ying-Qin Li, M.D., Ph.D., Melvin L. K. Chua, M.D., Ph.D., Fang-Yun Xie, M.D., Ying Sun, M.D., Ph.D., and Jun Ma, M.D.
From the Departments of Radiation Oncology (Y.Z., L.C., Y.-P.C., W.-H.H., W.-F.L., L.-L.T., Y.-P.M., G.-Q.Z., R.S., X.L., R.G., F.H., J.-W.L., X.-J.D., C.X., N.L., Y.-Q.L., F.-Y.X., Ying Sun, J.M.), Medical Oncology (Y.-H.L.), and Nasopharyngeal Carcinoma (H.-Y.M.) and the Clinical Trials Center (Y.G.), Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy (Y.Z., L.C., Y.-P.C., W.-H.H., W.-F.L., L.-L.T., Y.-P.M., G.-Q.Z., R.S., X.L., R.G., F.H., J.-W.L., X.-J.D., C.X., N.L., Y.-Q.L., F.-Y.X., Ying Sun, J.M.), and the Department of Radiation Oncology, First Affiliated Hospital of Guangdong Pharmaceutical University (X.-C.W., Q.-F.S.), Guangzhou, the Cancer Center, Tongji Hospital Affiliated to Tongji Medical College (G.-Q.H., G.-X.L.), and the Cancer Center, Union Hospital, Tongji Medical College (K.-Y.Y., J.H.), Huazhong University of Science and Technology, Wuhan, the Department of Radiation Oncology, First People’s Hospital of Foshan, Foshan (N.Z., S.-Q.L.), the Department of Radiation Oncology, Affiliated Cancer Hospital of Guangxi Medical University, Nanning (X.-D.Z., L.L.), the Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guizhou Cancer Hospital, Guiyang (F.J., J.-H.L.), the Department of Radiation Oncology, XiJing Hospital of Fourth Military Medical University, Xi’an (M.S., J.Z.), the Cancer Center (Z.-B.C.), and the Department of Head and Neck Oncology (S.-Y.W., Q.-D.L.), Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, the Department of Radiation Oncology, Second Affiliated Hospital of Soochow University, Suzhou (Y.T., L.Z.), the Department of Radiation Oncology, Peking University Cancer Hospital, Beijing (Yan Sun, B.-M.Z.), and the Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang (J.-G.L., Y.X.) — all in China; and the Divisions of Radiation Oncology and Medical Sciences, National Cancer Center Singapore, and the Oncology Academic Program, Duke–National University of Singapore Medical School — both in Singapore (M.L.K.C.). Address reprint requests to Dr. Ma at the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Rd. E., Guangzhou 510060, China, or at majun2@mail.sysu.edu.cn.

 

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