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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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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 [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 [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 [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
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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[2017]版:
大类 | 2 区 医学
小类 | 2 区 肿瘤学
最新[2023]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
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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
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