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

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单位: [1]Sun Yat Sen Univ, Ctr Canc, Dept Radiat Oncol, State Key Lab Oncol South China,Collaborat Innova, 651 Dongfeng Rd East, Guangzhou 510060, Guangdong, Peoples R China [2]Fudan Univ, Shanghai Canc Ctr, Dept Radiat Oncol, 270 Dongan Rd, Shanghai 200032, Peoples R China [3]Zhejiang Canc Hosp, Dept Radiat Oncol, 38 Guang Ji Rd, Hangzhou 310022, Zhejiang, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Oncol, 128 San Yang Rd, Wuhan 430030, Peoples R China [5]Sun Yat Sen Univ, Affiliated Hosp 5, Dept Radiat Oncol, 52 Mei Hua Rd East, Zhuhai 519000, Peoples R China [6]Beijing Canc Hosp, Dept Radiat Oncol, 52 Bu Cheng Rd, Beijing 100142, Peoples R China [7]Guangdong Gen Hosp, Dept Radiat Oncol, 106 Zhong Shan Second Rd, Guangzhou 510080, Guangdong, Peoples R China [8]First Peoples Hosp Foshan, Dept Radiat Oncol, 81 Lingnan Ave North, Foshan 528000, Peoples R China [9]Sun Yat Sen Univ, Ctr Canc, Clin Trials Ctr, 651 Dongfeng Rd East, Guangzhou 510060, Guangdong, Peoples R China [10]Sun Yat Sen Univ, Sch Publ Hlth, Dept Med Stat & Epidemiol, 74 Zhongshan Second Rd, Guangzhou 510080, Guangdong, Peoples R China
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关键词: Nasopharyngeal carcinoma Adjuvant chemotherapy Randomised clinical trial Long-term results

摘要:
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.

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出版当年[2016]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
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出版当年[2015]版:
Q1 ONCOLOGY
最新[2024]版:
Q1 ONCOLOGY

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第一作者单位: [1]Sun Yat Sen Univ, Ctr Canc, Dept Radiat Oncol, State Key Lab Oncol South China,Collaborat Innova, 651 Dongfeng Rd East, Guangzhou 510060, Guangdong, Peoples R China
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