Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial
机构:[a]State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China临床科室其他部门放疗科华南肿瘤学国家重点实验室中山大学肿瘤防治中心[b]Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, 270 Dongan Road, Shanghai, 200032, People’s Republic of China[c]Department of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guang Ji Road, Hangzhou, 310022, People’s Republic of China[d]Department of Oncology, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, 128 San Yang Road, Wuhan, 430030, People’s Republic of China其他科室肿瘤科华中科技大学同济医学院附属同济医院[e]Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, 52 Mei Hua Road East, Zhuhai, 519000, People’s Republic of China[f]Department of Radiation Oncology, Beijing Cancer Hospital, 52 Bu Cheng Road, Beijing, 100142, People’s Republic of China[g]Department of Radiation Oncology, Guangdong General Hospital, 106 Zhong Shan Second Road, Guangzhou, 510080, People’s Republic of China广东省人民医院[h]Department of Radiation Oncology, The First People’s Hospital of Foshan, 81 Lingnan Avenue North, Foshan, 528000, People’s Republic of China[i]Clinical Trials Centre, Sun Yat-sen University Cancer Centre, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China[j]Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, 74 Zhongshan Second Road, Guangzhou, 510080, People’s Republic of China
Aim of the study: Previous results from our trial showed that adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve survival after concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) at 2 years. Here, we present the data of long-term survival and late toxicities to further assess the ultimate therapeutic index of adjuvant chemotherapy (AC). Methods: Patients with stage III-IVB (except T3-4N0) NPC were randomly assigned to receive CCRT plus AC or CCRT only at seven institutions in China. Patients in both groups received cisplatin 40 mg/m(2) weekly up to 7 weeks concurrently with radiotherapy. The CCRT plus AC group subsequently received adjuvant cisplatin 80 mg/m(2) and fluorouracil 800 mg/m(2)/d for 120 h every 4 weeks for three cycles. The primary end-point was failure free survival. Results: Two hundred and fifty-one patients were randomised to the CCRT plus AC group and 257 to the CCRT only group. After a median follow-up of 68.4 months, estimated 5-year failure-free survival rate was 75% in the CCRT plus AC group and 71% in the CCRT only group (hazard ratio 0.88, 95% confidence interval 0.64-1.22; p = 0.45). 66 (27%) of 249 patients in the CCRT plus AC group and 53 (21%) of 254 patients in the CCRT only group developed one or more late grade 3-4 toxicities (p = 0.14). Conclusion: Adjuvant cisplatin and fluorouracil chemotherapy still failed to demonstrate significant survival benefit after CCRT in locoregionally advanced NPC based on the longterm follow-up data, and addition of adjuvant cisplatin and fluorouracil did not significantly increase late toxicities. Registration number: NCT00677118. (C) 2017 Elsevier Ltd. All rights reserved.
基金:
Sun Yat-sen University [2007037]; National Science & Technology Pillar Program during the Twelfth Five-year Plan Period [2014BAI09B10]; Science and Technology Project of Guangzhou City, China [14570006]; Planned Science and Technology Project of Guangdong Province [2013B020400004]; Health & Medical Collaborative Innovation Project of Guangzhou City, China [201400000001]
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外文
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出版当年[2017]版:
大类|2 区医学
小类|2 区肿瘤学
最新[2025]版:
大类|1 区医学
小类|2 区肿瘤学
第一作者:
第一作者机构:[a]State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China
共同第一作者:
通讯作者:
通讯机构:[a]State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, 651 Dongfeng Road East, Guangzhou, 510060, People’s Republic of China
推荐引用方式(GB/T 7714):
Lei Chen,Chao-Su Hu,Xiao-Zhong Chen,et al.Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial[J].EUROPEAN JOURNAL OF CANCER.2017,75:150-158.doi:10.1016/j.ejca.2017.01.002.
APA:
Lei Chen,Chao-Su Hu,Xiao-Zhong Chen,Guo-Qing Hu,Zhi-Bin Cheng...&Jun Ma.(2017).Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial.EUROPEAN JOURNAL OF CANCER,75,
MLA:
Lei Chen,et al."Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial".EUROPEAN JOURNAL OF CANCER 75.(2017):150-158