title: Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial.
abstract: 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).
  
  
  
  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/m2weekly up to 7 weeks concurrently with radiotherapy. The CCRT plus AC group subsequently received adjuvant cisplatin 80 mg/m2and fluorouracil 800 mg/m2/d for 120 h every 4 weeks for three cycles. The primary end-point was failure-free survival.
  
  
  
  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).
  
  
  
  Adjuvant cisplatin and fluorouracil chemotherapy still failed to demonstrate significant survival benefit after CCRT in locoregionally advanced NPC based on the long-term follow-up data, and addition of adjuvant cisplatin and fluorouracil did not significantly increase late toxicities.
  
  
  
  NCT00677118.
authors.affiliation: 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.
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, 270 Dongan Road, Shanghai, 200032, People's Republic of China.
authors.forename: Chao-Su
authors.initials: CS
authors.lastname: Hu
authors.affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guang Ji Road, Hangzhou, 310022, People's Republic of China.
authors.forename: Xiao-Zhong
authors.initials: XZ
authors.lastname: Chen
authors.affiliation: 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.
authors.forename: Guo-Qing
authors.initials: GQ
authors.lastname: Hu
authors.affiliation: 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.
authors.forename: Zhi-Bin
authors.initials: ZB
authors.lastname: Cheng
authors.affiliation: Department of Radiation Oncology, Beijing Cancer Hospital, 52 Bu Cheng Road, Beijing, 100142, People's Republic of China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Radiation Oncology, Guangdong General Hospital, 106 Zhong Shan Second Road, Guangzhou, 510080, People's Republic of China.
authors.forename: Wei-Xiong
authors.initials: WX
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guang Ji Road, Hangzhou, 310022, People's Republic of China.
authors.forename: Yuan-Yuan
authors.initials: YY
authors.lastname: Chen
authors.affiliation: 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.
authors.forename: Fang-Yun
authors.initials: FY
authors.lastname: Xie
authors.affiliation: Department of Radiation Oncology, The First People's Hospital of Foshan, 81 Lingnan Avenue North, Foshan, 528000, People's Republic of China.
authors.forename: Shao-Bo
authors.initials: SB
authors.lastname: Liang
authors.affiliation: 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.
authors.forename: Yong
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, 270 Dongan Road, Shanghai, 200032, People's Republic of China.
authors.forename: Ting-Ting
authors.initials: TT
authors.lastname: Xu
authors.affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guang Ji Road, Hangzhou, 310022, People's Republic of China.
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Guo-Xian
authors.initials: GX
authors.lastname: Long
authors.affiliation: 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.
authors.forename: Si-Yang
authors.initials: SY
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, Beijing Cancer Hospital, 52 Bu Cheng Road, Beijing, 100142, People's Republic of China.
authors.forename: Bao-Min
authors.initials: BM
authors.lastname: Zheng
authors.affiliation: Clinical Trials Centre, Sun Yat-sen University Cancer Centre, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.affiliation: 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.
authors.forename: Ying
authors.initials: Y
authors.lastname: Sun
authors.affiliation: 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.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Mao
authors.affiliation: 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.
authors.forename: Ling-Long
authors.initials: LL
authors.lastname: Tang
authors.affiliation: 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.
authors.forename: Yu-Ming
authors.initials: YM
authors.lastname: Chen
authors.affiliation: 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.
authors.forename: Meng-Zhong
authors.initials: MZ
authors.lastname: Liu
authors.affiliation: 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. Electronic address: majun2@mail.sysu.edu.cn.
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000401:mortality / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods / Q000401:mortality; D017024:Chemotherapy, Adjuvant / Q000379:methods / Q000401:mortality; D002681:China / Q000453:epidemiology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002945:Cisplatin; D005472:Fluorouracil
keywords: Adjuvant chemotherapy; Long-term results; Nasopharyngeal carcinoma; Randomised clinical trial