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IR@PKUHSC  > 北京大学临床肿瘤学院  > 肿瘤放疗科  > 期刊论文
学科主题: 临床医学
题名:
Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial
作者: Chen, Lei1; Hu, Chao-Su4; Chen, Xiao-Zhong5; Hu, Guo-Qing6; Cheng, Zhi-Bin7; Sun, Yan8; Li, Wei-Xiong9; Chen, Yuan-Yuan1; Xie, Fang-Yun1; Liang, Shao-Bo1; Chen, Yong1; Xu, Ting-Ting4; Li, Bin5; Long, Guo-Xian6; Wang, Si-Yang7; Zheng, Bao-Min8; Guo, Ying2; Sun, Ying1; Mao, Yan-Ping1; Tang, Ling-Long1; Chen, Yu-Ming3; Liu, Meng-Zhong1; Ma, Jun1
刊名: LANCET ONCOLOGY
发表日期: 2012-02-01
DOI: 10.1016/S1470-2045(11)70320-5
卷: 13, 期:2, 页:163-171
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: PROGRESSION-FREE SURVIVAL ; CISPLATIN-RADIOTHERAPY ; II TRIAL ; CANCER ; METAANALYSIS ; COMBINATION ; THERAPY ; HEAD ; NECK
英文摘要:

Background The effect of the addition of adjuvant chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to assess the contribution of adjuvant chemotherapy to concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone.

Methods We did an open-label phase 3 multicentre randomised controlled trial at seven institutions in China. Randomisation was by a computer-generated random number code. Patients were stratified by treatment centre and randomly assigned in blocks of four. Treatment allocation was not masked. We randomly assigned patients with non-metastatic stage III or IV (except T3-4N0) nasopharyngeal carcinoma to receive concurrent chemoradiotherapy plus adjuvant chemo therapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m(2) cisplatin weekly up to 7 weeks, concurrently with radiotherapy. Radiotherapy was given as 2.0-2.27 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumour and 60-66 Gy to the involved neck area. The concurrent chemoradiotherapy plus adjuvant chemotherapy group subsequently received 80 mg/m(2) adjuvant cisplatin and 800 mg/m(2) per day fluorouracil for 120 h every 4 weeks for three cycles. Our primary endpoint was failure-free survival. We did efficacy analyses in our intention-to-treat population. Our trial is ongoing; in this report we present the 2 year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov, number NCT00677118.

Findings 251 patients were assigned to the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 257 to the concurrent chemoradiotherapy alone group. After a median follow-up of 37.8 months (range 1.3-61.0), the estimated 2 year failure-free survival rate was 86% (95% CI 81-90) in the concurrent chemo radiotherapy plus adjuvant chemotherapy group and 84% (78-88) in concurrent chemoradiotherapy only group (hazard ratio 0.74, 95% CI 0.49-1.10; p=0.13). Stomatitis was the most commonly reported grade 3 or 4 adverse event during both radiotherapy (76 of 249 patients in the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 82 of 254 in the concurrent chemoradiotherapy alone group) and adjuvant chemotherapy (43 [21%] of 205 patients treated with adjuvant chemotherapy).

Interpretation Adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve failure-free survival after concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma. Longer follow-up is needed to fully assess survival and late toxic effects, but such regimens should not, at present, be used outside well-designed clinical trials.

语种: 英语
所属项目编号: 2007037 ; 2010-178
项目资助者: Sun Yat-sen University ; Science Foundation of Key Hospital Clinical Programme of Ministry of Health PR China ; Guangdong Province Universities and Colleges Pearl River Scholar
WOS记录号: WOS:000300197400041
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64268
Appears in Collections:北京大学临床肿瘤学院_肿瘤放疗科_期刊论文

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作者单位: 1.Sun Yat Sen Univ, Ctr Canc, State Key Lab Oncol S China, Dept Radiat Oncol, Guangzhou 510060, Guangdong, Peoples R China
2.Sun Yat Sen Univ, Ctr Canc, Clin Trials Ctr, Guangzhou 510060, Guangdong, Peoples R China
3.Sun Yat Sen Univ, Dept Med Stat & Epidemiol, Sch Publ Hlth, Guangzhou 510060, Guangdong, Peoples R China
4.Fudan Univ, Dept Radiat Oncol, Ctr Canc, Shanghai 200433, Peoples R China
5.Zhejiang Canc Hosp, Dept Radiat Oncol, Hangzhou, Zhejiang, Peoples R China
6.Huazhong Univ Sci & Technol, Dept Oncol, Tongji Hosp, Tongji Med Coll, Wuhan 430074, Peoples R China
7.Sun Yat Sen Univ, Dept Radiat Oncol, Affiliated Hosp 5, Zhuhai, Peoples R China
8.Peking Univ, Canc Hosp, Dept Radiat Oncol, Beijing 100871, Peoples R China
9.Guangdong Gen Hosp, Dept Radiat Oncol, Guangzhou, Guangdong, Peoples R China

Recommended Citation:
Chen, Lei,Hu, Chao-Su,Chen, Xiao-Zhong,et al. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial[J]. LANCET ONCOLOGY,2012,13(2):163-171.
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