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Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial

Summary 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 alon... Full description

Journal Title: The lancet oncology 2012, Vol.13 (2), p.163-171
Main Author: Chen, Lei, MD
Other Authors: Hu, Chao-Su, Prof , Chen, Xiao-Zhong, Prof , Hu, Guo-Qing, Prof , Cheng, Zhi-Bin, Prof , Sun, Yan, Prof , Li, Wei-Xiong, Prof , Chen, Yuan-Yuan, MD , Xie, Fang-Yun, MD , Liang, Shao-Bo, MD , Chen, Yong, MD , Xu, Ting-Ting, MD , Li, Bin, MD , Long, Guo-Xian, MD , Wang, Si-Yang, MD , Zheng, Bao-Min, MD , Guo, Ying, PhD , Sun, Ying, MD , Mao, Yan-Ping, MD , Tang, Ling-Long, MD , Chen, Yu-Ming, Prof , Liu, Meng-Zhong, Prof , Ma, Jun, Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/22154591
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title: Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial
format: Article
creator:
  • Chen, Lei, MD
  • Hu, Chao-Su, Prof
  • Chen, Xiao-Zhong, Prof
  • Hu, Guo-Qing, Prof
  • Cheng, Zhi-Bin, Prof
  • Sun, Yan, Prof
  • Li, Wei-Xiong, Prof
  • Chen, Yuan-Yuan, MD
  • Xie, Fang-Yun, MD
  • Liang, Shao-Bo, MD
  • Chen, Yong, MD
  • Xu, Ting-Ting, MD
  • Li, Bin, MD
  • Long, Guo-Xian, MD
  • Wang, Si-Yang, MD
  • Zheng, Bao-Min, MD
  • Guo, Ying, PhD
  • Sun, Ying, MD
  • Mao, Yan-Ping, MD
  • Tang, Ling-Long, MD
  • Chen, Yu-Ming, Prof
  • Liu, Meng-Zhong, Prof
  • Ma, Jun, Prof
subjects:
  • Adjuvant treatment
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Cancer
  • Carcinoma
  • Care and treatment
  • Chemoradiotherapy - methods
  • Chemotherapy, Adjuvant - methods
  • China
  • Cisplatin - administration & dosage
  • Cisplatin - adverse effects
  • Clinical trials
  • Disease-Free Survival
  • Female
  • Fluorouracil - administration & dosage
  • Fluorouracil - adverse effects
  • Follow-Up Studies
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Medical colleges
  • Middle Aged
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Neoplasms - epidemiology
  • Nasopharyngeal Neoplasms - therapy
  • Neoplasm Staging
  • Nuclear radiation
  • Public health
  • Young Adult
ispartof: The lancet oncology, 2012, Vol.13 (2), p.163-171
description: Summary 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 chemotherapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m2 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/m2 adjuvant cisplatin and 800 mg/m2 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 chemoradiotherapy 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 su
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleConcurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial
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creatorChen, Lei, MD ; Hu, Chao-Su, Prof ; Chen, Xiao-Zhong, Prof ; Hu, Guo-Qing, Prof ; Cheng, Zhi-Bin, Prof ; Sun, Yan, Prof ; Li, Wei-Xiong, Prof ; Chen, Yuan-Yuan, MD ; Xie, Fang-Yun, MD ; Liang, Shao-Bo, MD ; Chen, Yong, MD ; Xu, Ting-Ting, MD ; Li, Bin, MD ; Long, Guo-Xian, MD ; Wang, Si-Yang, MD ; Zheng, Bao-Min, MD ; Guo, Ying, PhD ; Sun, Ying, MD ; Mao, Yan-Ping, MD ; Tang, Ling-Long, MD ; Chen, Yu-Ming, Prof ; Liu, Meng-Zhong, Prof ; Ma, Jun, Prof
creatorcontribChen, Lei, MD ; Hu, Chao-Su, Prof ; Chen, Xiao-Zhong, Prof ; Hu, Guo-Qing, Prof ; Cheng, Zhi-Bin, Prof ; Sun, Yan, Prof ; Li, Wei-Xiong, Prof ; Chen, Yuan-Yuan, MD ; Xie, Fang-Yun, MD ; Liang, Shao-Bo, MD ; Chen, Yong, MD ; Xu, Ting-Ting, MD ; Li, Bin, MD ; Long, Guo-Xian, MD ; Wang, Si-Yang, MD ; Zheng, Bao-Min, MD ; Guo, Ying, PhD ; Sun, Ying, MD ; Mao, Yan-Ping, MD ; Tang, Ling-Long, MD ; Chen, Yu-Ming, Prof ; Liu, Meng-Zhong, Prof ; Ma, Jun, Prof
descriptionSummary 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 chemotherapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m2 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/m2 adjuvant cisplatin and 800 mg/m2 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 chemoradiotherapy 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. Funding Sun Yat-sen University Clinical Research 5010 Programme (No 2007037), Science Foundation of Key Hospital Clinical Programme of Ministry of Health PR China (No 2010–178), and Guangdong Province Universities and Colleges Pearl River Scholar Funded Scheme (2010).
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languageeng
publisherEngland: Elsevier Ltd
subjectAdjuvant treatment ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Cancer ; Carcinoma ; Care and treatment ; Chemoradiotherapy - methods ; Chemotherapy, Adjuvant - methods ; China ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Clinical trials ; Disease-Free Survival ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Follow-Up Studies ; Hematology, Oncology and Palliative Medicine ; Humans ; Kaplan-Meier Estimate ; Male ; Medical colleges ; Middle Aged ; Nasopharyngeal Carcinoma ; Nasopharyngeal Neoplasms - epidemiology ; Nasopharyngeal Neoplasms - therapy ; Neoplasm Staging ; Nuclear radiation ; Public health ; Young Adult
ispartofThe lancet oncology, 2012, Vol.13 (2), p.163-171
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4Cheng, Zhi-Bin, Prof
5Sun, Yan, Prof
6Li, Wei-Xiong, Prof
7Chen, Yuan-Yuan, MD
8Xie, Fang-Yun, MD
9Liang, Shao-Bo, MD
10Chen, Yong, MD
11Xu, Ting-Ting, MD
12Li, Bin, MD
13Long, Guo-Xian, MD
14Wang, Si-Yang, MD
15Zheng, Bao-Min, MD
16Guo, Ying, PhD
17Sun, Ying, MD
18Mao, Yan-Ping, MD
19Tang, Ling-Long, MD
20Chen, Yu-Ming, Prof
21Liu, Meng-Zhong, Prof
22Ma, Jun, Prof
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0Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial
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descriptionSummary 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 chemotherapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m2 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/m2 adjuvant cisplatin and 800 mg/m2 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 chemoradiotherapy 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. Funding Sun Yat-sen University Clinical Research 5010 Programme (No 2007037), Science Foundation of Key Hospital Clinical Programme of Ministry of Health PR China (No 2010–178), and Guangdong Province Universities and Colleges Pearl River Scholar Funded Scheme (2010).
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0Adjuvant treatment
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9Cisplatin - administration & dosage
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23Nasopharyngeal Carcinoma
24Nasopharyngeal Neoplasms - epidemiology
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28Public health
29Young Adult
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titleConcurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial
authorChen, Lei, MD ; Hu, Chao-Su, Prof ; Chen, Xiao-Zhong, Prof ; Hu, Guo-Qing, Prof ; Cheng, Zhi-Bin, Prof ; Sun, Yan, Prof ; Li, Wei-Xiong, Prof ; Chen, Yuan-Yuan, MD ; Xie, Fang-Yun, MD ; Liang, Shao-Bo, MD ; Chen, Yong, MD ; Xu, Ting-Ting, MD ; Li, Bin, MD ; Long, Guo-Xian, MD ; Wang, Si-Yang, MD ; Zheng, Bao-Min, MD ; Guo, Ying, PhD ; Sun, Ying, MD ; Mao, Yan-Ping, MD ; Tang, Ling-Long, MD ; Chen, Yu-Ming, Prof ; Liu, Meng-Zhong, Prof ; Ma, Jun, Prof
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6Chemoradiotherapy - methods
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9Cisplatin - administration & dosage
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eissn1474-5488
codenLANCAO
abstractSummary 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 chemotherapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m2 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/m2 adjuvant cisplatin and 800 mg/m2 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 chemoradiotherapy 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. Funding Sun Yat-sen University Clinical Research 5010 Programme (No 2007037), Science Foundation of Key Hospital Clinical Programme of Ministry of Health PR China (No 2010–178), and Guangdong Province Universities and Colleges Pearl River Scholar Funded Scheme (2010).
copEngland
pubElsevier Ltd
pmid22154591
doi10.1016/S1470-2045(11)70320-5