Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study.
机构：[1]Department of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou, China.[2]Department of Medical Oncology, Jiangmen Central Hospital, Jiangmen, China.[3]Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.[4]Department of Medical Oncology, Zhongshan People's Hospital, Zhongshan, China.[5]Department of Medical Oncology, Dongguan People's Hospital, Dongguan, China.[6]Department of Medical Oncology, Peking University Shenzhen Hospital, Shenzhen, China.北京大学深圳医院深圳市康宁医院深圳医学信息中心[7]Department of Oncology, Shunde Hospital Guangzhou University of Chinese Medicine, Foshan, China.[8]Department of Radiotherapy, Cancer Hospital of Hunan Province, Changsha, China.[9]Department of Oncology, The First Affiliated Hospital of Gangnan Medical College, Gangnan, China.[10]Department of Radiotherapy, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.[11]Department of Radiotherapy, Zhongshan People's Hospital, Zhongshan, China.[12]Department of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.[13]Department of Oncology, Panyu Central Hospital, Guangzhou, China.[14]Department of Radiotherapy, Cancer Hospital of Zhejiang Province, Hangzhou, China.浙江省肿瘤医院[15]Department of Medical Oncology, The Affiliated Cancer Hospital of Shantou University, Shantou, China.[16]Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.[17]Department of Radiotherapy, The First Affiliated Hospital of Xiamen University, Xiamen, China.[18]Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.[19]Department of Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, China.中山大学附属第二医院[20]Department of Radiotherapy, Fujian Provincial Cancer Hospital, Fuzhou, China.[21]Department of Radiotherapy, Jiangxi Provincial Cancer Hospital, Nanchang, China.[22]Department of Radiotherapy, Cancer Hospital of Hangzhou City, Hangzhou, China.[23]Department of Medical Oncology, The First People's Hospital of Zhaoqing City, Zhaoqing, China.[24]Department of Chemotherapy, People's Hospital of Meizhou, Meizhou, China.[25]Department of Nasopharyngeal Carcinoma of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou, China.
GEM20110714 (ClinicalTrials.gov identifier: NCT01528618), the first randomized, phase III study of systemic chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC), reported significant progression-free survival improvement with gemcitabine plus cisplatin (GP) versus fluorouracil plus cisplatin (FP; hazard ratio, 0.55; 95% CI, 0.44 to 0.68; P < .001). Data from the final analysis of overall survival (OS) are presented here.From February 2012 to October 2015, 362 patients were randomly assigned to receive either GP (gemcitabine 1 g/m2 once daily on days 1 and 8 and cisplatin 80 mg/m2 once daily on day 1; n = 181) or FP (fluorouracil 4 g/m2 in continuous intravenous infusion over 96 hours and cisplatin 80 mg/m2 once daily on day 1; n = 181) once every 21 days. The primary end point was progression-free survival, which has been previously reported; OS was a secondary end point.After a median follow-up time of 69.5 months with GP and 69.7 months with FP, 148 (81.8%) and 166 (91.7%) deaths occurred in the GP and FP arms, respectively. The estimated hazard ratio for OS was 0.72 (95% CI, 0.58 to 0.90; two-sided P = .004). The median OS was 22.1 months (95% CI, 19.2 to 25.0 months) with GP versus 18.6 months (95% CI, 15.4 to 21.7 months) with FP. The OS probabilities at 1, 3, and 5 years were 79.9% versus 71.8%, 31.0% versus 20.4%, and 19.2% versus 7.8%, respectively. Poststudy therapy was administered in 51.9% and 55.2% of patients in the GP and FP arms, respectively.Among patients with previously untreated advanced nasopharyngeal carcinoma, those who receive GP have longer OS than those receive FP. Gemcitabine plus cisplatin should be considered a preferred front-line option for these patients.
第一作者机构：[1]Department of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou, China.
推荐引用方式(GB/T 7714)：
Hong Shaodong,Zhang Yaxiong,Yu Gengsheng,et al.Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study.[J].JOURNAL OF CLINICAL ONCOLOGY.2021,39(29):3273-+.doi:10.1200/JCO.21.00396.
APA：
Hong Shaodong,Zhang Yaxiong,Yu Gengsheng,Peng Peijian,Peng Jiewen...&Zhang Li.(2021).Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study..JOURNAL OF CLINICAL ONCOLOGY,39,(29)
MLA：
Hong Shaodong,et al."Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study.".JOURNAL OF CLINICAL ONCOLOGY 39..29(2021):3273-+
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