• Eur. J. Cancer · Apr 2017

    Randomized Controlled Trial Multicenter Study Comparative Study

    Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial.

    • Lei Chen, Chao-Su Hu, Xiao-Zhong Chen, Guo-Qing Hu, Zhi-Bin Cheng, Yan Sun, Wei-Xiong Li, Yuan-Yuan Chen, Fang-Yun Xie, Shao-Bo Liang, Yong Chen, Ting-Ting Xu, Bin Li, Guo-Xian Long, Si-Yang Wang, Bao-Min Zheng, Ying Guo, Ying Sun, Yan-Ping Mao, Ling-Long Tang, Yu-Ming Chen, Meng-Zhong Liu, and Jun Ma.
    • 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.
    • Eur. J. Cancer. 2017 Apr 1; 75: 150-158.

    Aim Of The StudyPrevious 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).MethodsPatients 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/m2 weekly up to 7 weeks concurrently with radiotherapy. The CCRT plus AC group subsequently received adjuvant cisplatin 80 mg/m2 and fluorouracil 800 mg/m2/d for 120 h every 4 weeks for three cycles. The primary end-point was failure-free survival.ResultsTwo 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).ConclusionAdjuvant 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.Registration NumberNCT00677118.Copyright © 2017 Elsevier Ltd. All rights reserved.

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