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Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial

Summary Background The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent... Full description

Journal Title: The lancet oncology 2016, Vol.17 (11), p.1509-1520
Main Author: Sun, Ying, Prof
Other Authors: Li, Wen-Fei, MD , Chen, Nian-Yong, Prof , Zhang, Ning, Prof , Hu, Guo-Qing, Prof , Xie, Fang-Yun, Prof , Sun, Yan, Prof , Chen, Xiao-Zhong, Prof , Li, Jin-Gao, Prof , Zhu, Xiao-Dong, Prof , Hu, Chao-Su, Prof , Xu, Xiang-Ying, Prof , Chen, Yuan-Yuan, MD , Hu, Wei-Han, Prof , Guo, Ling, Prof , Mo, Hao-Yuan, Prof , Chen, Lei, MD , Mao, Yan-Ping, MD , Sun, Rui, MD , Ai, Ping, MD , Liang, Shao-Bo, MD , Long, Guo-Xian, MD , Zheng, Bao-Min, MD , Feng, Xing-Lai, MD , Gong, Xiao-Chang, MD , Li, Ling, MD , Shen, Chun-Ying, MD , Xu, Jian-Yu, MD , Guo, Ying, PhD , Chen, Yu-Ming, Prof , Zhang, Fan, MD , Lin, Li, MD , Tang, Ling-Long, MD , Liu, Meng-Zhong, Prof , Ma, Jun, Dr Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/27686945
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title: Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial
format: Article
creator:
  • Sun, Ying, Prof
  • Li, Wen-Fei, MD
  • Chen, Nian-Yong, Prof
  • Zhang, Ning, Prof
  • Hu, Guo-Qing, Prof
  • Xie, Fang-Yun, Prof
  • Sun, Yan, Prof
  • Chen, Xiao-Zhong, Prof
  • Li, Jin-Gao, Prof
  • Zhu, Xiao-Dong, Prof
  • Hu, Chao-Su, Prof
  • Xu, Xiang-Ying, Prof
  • Chen, Yuan-Yuan, MD
  • Hu, Wei-Han, Prof
  • Guo, Ling, Prof
  • Mo, Hao-Yuan, Prof
  • Chen, Lei, MD
  • Mao, Yan-Ping, MD
  • Sun, Rui, MD
  • Ai, Ping, MD
  • Liang, Shao-Bo, MD
  • Long, Guo-Xian, MD
  • Zheng, Bao-Min, MD
  • Feng, Xing-Lai, MD
  • Gong, Xiao-Chang, MD
  • Li, Ling, MD
  • Shen, Chun-Ying, MD
  • Xu, Jian-Yu, MD
  • Guo, Ying, PhD
  • Chen, Yu-Ming, Prof
  • Zhang, Fan, MD
  • Lin, Li, MD
  • Tang, Ling-Long, MD
  • Liu, Meng-Zhong, Prof
  • Ma, Jun, Dr Prof
subjects:
  • Adult
  • Analysis
  • Antimitotic agents
  • Antineoplastic agents
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Cancer
  • Carcinoma
  • Chemoradiotherapy - adverse effects
  • Chemotherapy
  • Cisplatin - administration & dosage
  • Docetaxel
  • Female
  • Fluorouracil - administration & dosage
  • Head & neck cancer
  • Hematology
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Induction Chemotherapy - adverse effects
  • Male
  • Medical colleges
  • Medical prognosis
  • Metastasis
  • Middle Aged
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Neoplasms - mortality
  • Nasopharyngeal Neoplasms - therapy
  • Neutropenia
  • Radiation
  • Radiation therapy
  • Studies
  • Taxoids - administration & dosage
  • Yuan (China)
ispartof: The lancet oncology, 2016, Vol.17 (11), p.1509-1520
description: Summary Background The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone in a suitably powered trial. Methods We did an open-label, phase 3, multicentre, randomised controlled trial at ten institutions in China. Patients with previously untreated, stage III–IVB (except T3-4N0) nasopharyngeal carcinoma, aged 18–59 years without severe comorbidities were enrolled. Eligible patients were randomly assigned (1:1) to receive induction chemotherapy plus concurrent chemoradiotherapy or concurrent chemoradiotherapy alone (three cycles of 100 mg/m2 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy). Induction chemotherapy was three cycles of intravenous docetaxel (60 mg/m2 on day 1), intravenous cisplatin (60 mg/m2 on day 1), and continuous intravenous fluorouracil (600 mg/m2 per day from day 1 to day 5) every 3 weeks before concurrent chemoradiotherapy. Randomisation was by a computer-generated random number code with a block size of four, stratified by treatment centre and disease stage (III or IV). Treatment allocation was not masked. The primary endpoint was failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause; required sample size was 476 patients (238 per group). We did efficacy analyses in our intention-to-treat population. The follow-up is ongoing; in this report, we present the 3-year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov , number NCT01245959. Findings Between March 1, 2011, and Aug 22, 2013, 241 patients were assigned to induction chemotherapy plus concurrent chemoradiotherapy and 239 to concurrent chemoradiotherapy alone. After a median follow-up of 45 months (IQR 38–49), 3-year failure-free survival was 80% (95% CI 75–85) in the induction chemotherapy plus concurrent chemoradiotherapy group and 72% (66–78) in the concurrent chemoradiotherapy alone group (hazard ratio 0·68, 95% CI 0·48–0·97; p=0·034). The most common grade 3 or 4 adverse events during treatment in the 239 patients in the induction chemotherapy plus concurrent chemoradiotherapy group versus the 238 patients in concurrent chemoradiotherapy alone group were neutropenia (101 [42%] vs 17 [7%]), leucopenia
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleInduction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial
sourceAlma/SFX Local Collection
creatorSun, Ying, Prof ; Li, Wen-Fei, MD ; Chen, Nian-Yong, Prof ; Zhang, Ning, Prof ; Hu, Guo-Qing, Prof ; Xie, Fang-Yun, Prof ; Sun, Yan, Prof ; Chen, Xiao-Zhong, Prof ; Li, Jin-Gao, Prof ; Zhu, Xiao-Dong, Prof ; Hu, Chao-Su, Prof ; Xu, Xiang-Ying, Prof ; Chen, Yuan-Yuan, MD ; Hu, Wei-Han, Prof ; Guo, Ling, Prof ; Mo, Hao-Yuan, Prof ; Chen, Lei, MD ; Mao, Yan-Ping, MD ; Sun, Rui, MD ; Ai, Ping, MD ; Liang, Shao-Bo, MD ; Long, Guo-Xian, MD ; Zheng, Bao-Min, MD ; Feng, Xing-Lai, MD ; Gong, Xiao-Chang, MD ; Li, Ling, MD ; Shen, Chun-Ying, MD ; Xu, Jian-Yu, MD ; Guo, Ying, PhD ; Chen, Yu-Ming, Prof ; Zhang, Fan, MD ; Lin, Li, MD ; Tang, Ling-Long, MD ; Liu, Meng-Zhong, Prof ; Ma, Jun, Dr Prof
creatorcontribSun, Ying, Prof ; Li, Wen-Fei, MD ; Chen, Nian-Yong, Prof ; Zhang, Ning, Prof ; Hu, Guo-Qing, Prof ; Xie, Fang-Yun, Prof ; Sun, Yan, Prof ; Chen, Xiao-Zhong, Prof ; Li, Jin-Gao, Prof ; Zhu, Xiao-Dong, Prof ; Hu, Chao-Su, Prof ; Xu, Xiang-Ying, Prof ; Chen, Yuan-Yuan, MD ; Hu, Wei-Han, Prof ; Guo, Ling, Prof ; Mo, Hao-Yuan, Prof ; Chen, Lei, MD ; Mao, Yan-Ping, MD ; Sun, Rui, MD ; Ai, Ping, MD ; Liang, Shao-Bo, MD ; Long, Guo-Xian, MD ; Zheng, Bao-Min, MD ; Feng, Xing-Lai, MD ; Gong, Xiao-Chang, MD ; Li, Ling, MD ; Shen, Chun-Ying, MD ; Xu, Jian-Yu, MD ; Guo, Ying, PhD ; Chen, Yu-Ming, Prof ; Zhang, Fan, MD ; Lin, Li, MD ; Tang, Ling-Long, MD ; Liu, Meng-Zhong, Prof ; Ma, Jun, Dr Prof
descriptionSummary Background The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone in a suitably powered trial. Methods We did an open-label, phase 3, multicentre, randomised controlled trial at ten institutions in China. Patients with previously untreated, stage III–IVB (except T3-4N0) nasopharyngeal carcinoma, aged 18–59 years without severe comorbidities were enrolled. Eligible patients were randomly assigned (1:1) to receive induction chemotherapy plus concurrent chemoradiotherapy or concurrent chemoradiotherapy alone (three cycles of 100 mg/m2 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy). Induction chemotherapy was three cycles of intravenous docetaxel (60 mg/m2 on day 1), intravenous cisplatin (60 mg/m2 on day 1), and continuous intravenous fluorouracil (600 mg/m2 per day from day 1 to day 5) every 3 weeks before concurrent chemoradiotherapy. Randomisation was by a computer-generated random number code with a block size of four, stratified by treatment centre and disease stage (III or IV). Treatment allocation was not masked. The primary endpoint was failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause; required sample size was 476 patients (238 per group). We did efficacy analyses in our intention-to-treat population. The follow-up is ongoing; in this report, we present the 3-year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov , number NCT01245959. Findings Between March 1, 2011, and Aug 22, 2013, 241 patients were assigned to induction chemotherapy plus concurrent chemoradiotherapy and 239 to concurrent chemoradiotherapy alone. After a median follow-up of 45 months (IQR 38–49), 3-year failure-free survival was 80% (95% CI 75–85) in the induction chemotherapy plus concurrent chemoradiotherapy group and 72% (66–78) in the concurrent chemoradiotherapy alone group (hazard ratio 0·68, 95% CI 0·48–0·97; p=0·034). The most common grade 3 or 4 adverse events during treatment in the 239 patients in the induction chemotherapy plus concurrent chemoradiotherapy group versus the 238 patients in concurrent chemoradiotherapy alone group were neutropenia (101 [42%] vs 17 [7%]), leucopenia (98 [41%] vs 41 [17%]), and stomatitis (98 [41%] vs 84 [35%]). Interpretation Addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma with acceptable toxicity. Long-term follow-up is required to determine long-term efficacy and toxicities. Funding Shenzhen Main Luck Pharmaceuticals Inc, Sun Yat-sen University Clinical Research 5010 Program (2007037), National Science and Technology Pillar Program during the Twelfth Five-year Plan Period (2014BAI09B10), Health & Medical Collaborative Innovation Project of Guangzhou City (201400000001), Planned Science and Technology Project of Guangdong Province (2013B020400004), and The National Key Research and Development Program of China (2016YFC0902000).
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languageeng
publisherEngland: Elsevier Ltd
subjectAdult ; Analysis ; Antimitotic agents ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer ; Carcinoma ; Chemoradiotherapy - adverse effects ; Chemotherapy ; Cisplatin - administration & dosage ; Docetaxel ; Female ; Fluorouracil - administration & dosage ; Head & neck cancer ; Hematology ; Hematology, Oncology and Palliative Medicine ; Humans ; Induction Chemotherapy - adverse effects ; Male ; Medical colleges ; Medical prognosis ; Metastasis ; Middle Aged ; Nasopharyngeal Carcinoma ; Nasopharyngeal Neoplasms - mortality ; Nasopharyngeal Neoplasms - therapy ; Neutropenia ; Radiation ; Radiation therapy ; Studies ; Taxoids - administration & dosage ; Yuan (China)
ispartofThe lancet oncology, 2016, Vol.17 (11), p.1509-1520
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1Li, Wen-Fei, MD
2Chen, Nian-Yong, Prof
3Zhang, Ning, Prof
4Hu, Guo-Qing, Prof
5Xie, Fang-Yun, Prof
6Sun, Yan, Prof
7Chen, Xiao-Zhong, Prof
8Li, Jin-Gao, Prof
9Zhu, Xiao-Dong, Prof
10Hu, Chao-Su, Prof
11Xu, Xiang-Ying, Prof
12Chen, Yuan-Yuan, MD
13Hu, Wei-Han, Prof
14Guo, Ling, Prof
15Mo, Hao-Yuan, Prof
16Chen, Lei, MD
17Mao, Yan-Ping, MD
18Sun, Rui, MD
19Ai, Ping, MD
20Liang, Shao-Bo, MD
21Long, Guo-Xian, MD
22Zheng, Bao-Min, MD
23Feng, Xing-Lai, MD
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25Li, Ling, MD
26Shen, Chun-Ying, MD
27Xu, Jian-Yu, MD
28Guo, Ying, PhD
29Chen, Yu-Ming, Prof
30Zhang, Fan, MD
31Lin, Li, MD
32Tang, Ling-Long, MD
33Liu, Meng-Zhong, Prof
34Ma, Jun, Dr Prof
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descriptionSummary Background The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone in a suitably powered trial. Methods We did an open-label, phase 3, multicentre, randomised controlled trial at ten institutions in China. Patients with previously untreated, stage III–IVB (except T3-4N0) nasopharyngeal carcinoma, aged 18–59 years without severe comorbidities were enrolled. Eligible patients were randomly assigned (1:1) to receive induction chemotherapy plus concurrent chemoradiotherapy or concurrent chemoradiotherapy alone (three cycles of 100 mg/m2 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy). Induction chemotherapy was three cycles of intravenous docetaxel (60 mg/m2 on day 1), intravenous cisplatin (60 mg/m2 on day 1), and continuous intravenous fluorouracil (600 mg/m2 per day from day 1 to day 5) every 3 weeks before concurrent chemoradiotherapy. Randomisation was by a computer-generated random number code with a block size of four, stratified by treatment centre and disease stage (III or IV). Treatment allocation was not masked. The primary endpoint was failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause; required sample size was 476 patients (238 per group). We did efficacy analyses in our intention-to-treat population. The follow-up is ongoing; in this report, we present the 3-year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov , number NCT01245959. Findings Between March 1, 2011, and Aug 22, 2013, 241 patients were assigned to induction chemotherapy plus concurrent chemoradiotherapy and 239 to concurrent chemoradiotherapy alone. After a median follow-up of 45 months (IQR 38–49), 3-year failure-free survival was 80% (95% CI 75–85) in the induction chemotherapy plus concurrent chemoradiotherapy group and 72% (66–78) in the concurrent chemoradiotherapy alone group (hazard ratio 0·68, 95% CI 0·48–0·97; p=0·034). The most common grade 3 or 4 adverse events during treatment in the 239 patients in the induction chemotherapy plus concurrent chemoradiotherapy group versus the 238 patients in concurrent chemoradiotherapy alone group were neutropenia (101 [42%] vs 17 [7%]), leucopenia (98 [41%] vs 41 [17%]), and stomatitis (98 [41%] vs 84 [35%]). Interpretation Addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma with acceptable toxicity. Long-term follow-up is required to determine long-term efficacy and toxicities. Funding Shenzhen Main Luck Pharmaceuticals Inc, Sun Yat-sen University Clinical Research 5010 Program (2007037), National Science and Technology Pillar Program during the Twelfth Five-year Plan Period (2014BAI09B10), Health & Medical Collaborative Innovation Project of Guangzhou City (201400000001), Planned Science and Technology Project of Guangdong Province (2013B020400004), and The National Key Research and Development Program of China (2016YFC0902000).
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2Antimitotic agents
3Antineoplastic agents
4Antineoplastic Combined Chemotherapy Protocols - therapeutic use
5Cancer
6Carcinoma
7Chemoradiotherapy - adverse effects
8Chemotherapy
9Cisplatin - administration & dosage
10Docetaxel
11Female
12Fluorouracil - administration & dosage
13Head & neck cancer
14Hematology
15Hematology, Oncology and Palliative Medicine
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17Induction Chemotherapy - adverse effects
18Male
19Medical colleges
20Medical prognosis
21Metastasis
22Middle Aged
23Nasopharyngeal Carcinoma
24Nasopharyngeal Neoplasms - mortality
25Nasopharyngeal Neoplasms - therapy
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27Radiation
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30Taxoids - administration & dosage
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10Hu, Chao-Su, Prof
11Xu, Xiang-Ying, Prof
12Chen, Yuan-Yuan, MD
13Hu, Wei-Han, Prof
14Guo, Ling, Prof
15Mo, Hao-Yuan, Prof
16Chen, Lei, MD
17Mao, Yan-Ping, MD
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20Liang, Shao-Bo, MD
21Long, Guo-Xian, MD
22Zheng, Bao-Min, MD
23Feng, Xing-Lai, MD
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titleInduction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial
authorSun, Ying, Prof ; Li, Wen-Fei, MD ; Chen, Nian-Yong, Prof ; Zhang, Ning, Prof ; Hu, Guo-Qing, Prof ; Xie, Fang-Yun, Prof ; Sun, Yan, Prof ; Chen, Xiao-Zhong, Prof ; Li, Jin-Gao, Prof ; Zhu, Xiao-Dong, Prof ; Hu, Chao-Su, Prof ; Xu, Xiang-Ying, Prof ; Chen, Yuan-Yuan, MD ; Hu, Wei-Han, Prof ; Guo, Ling, Prof ; Mo, Hao-Yuan, Prof ; Chen, Lei, MD ; Mao, Yan-Ping, MD ; Sun, Rui, MD ; Ai, Ping, MD ; Liang, Shao-Bo, MD ; Long, Guo-Xian, MD ; Zheng, Bao-Min, MD ; Feng, Xing-Lai, MD ; Gong, Xiao-Chang, MD ; Li, Ling, MD ; Shen, Chun-Ying, MD ; Xu, Jian-Yu, MD ; Guo, Ying, PhD ; Chen, Yu-Ming, Prof ; Zhang, Fan, MD ; Lin, Li, MD ; Tang, Ling-Long, MD ; Liu, Meng-Zhong, Prof ; Ma, Jun, Dr Prof
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8Chemotherapy
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26Shen, Chun-Ying, MD
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30Zhang, Fan, MD
31Lin, Li, MD
32Tang, Ling-Long, MD
33Liu, Meng-Zhong, Prof
34Ma, Jun, Dr Prof
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jtitleThe lancet oncology
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Sun, Ying, Prof
1Li, Wen-Fei, MD
2Chen, Nian-Yong, Prof
3Zhang, Ning, Prof
4Hu, Guo-Qing, Prof
5Xie, Fang-Yun, Prof
6Sun, Yan, Prof
7Chen, Xiao-Zhong, Prof
8Li, Jin-Gao, Prof
9Zhu, Xiao-Dong, Prof
10Hu, Chao-Su, Prof
11Xu, Xiang-Ying, Prof
12Chen, Yuan-Yuan, MD
13Hu, Wei-Han, Prof
14Guo, Ling, Prof
15Mo, Hao-Yuan, Prof
16Chen, Lei, MD
17Mao, Yan-Ping, MD
18Sun, Rui, MD
19Ai, Ping, MD
20Liang, Shao-Bo, MD
21Long, Guo-Xian, MD
22Zheng, Bao-Min, MD
23Feng, Xing-Lai, MD
24Gong, Xiao-Chang, MD
25Li, Ling, MD
26Shen, Chun-Ying, MD
27Xu, Jian-Yu, MD
28Guo, Ying, PhD
29Chen, Yu-Ming, Prof
30Zhang, Fan, MD
31Lin, Li, MD
32Tang, Ling-Long, MD
33Liu, Meng-Zhong, Prof
34Ma, Jun, Dr Prof
formatjournal
genrearticle
ristypeJOUR
atitleInduction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial
jtitleThe lancet oncology
addtitleLancet Oncol
date2016
risdate2016
volume17
issue11
spage1509
epage1520
pages1509-1520
issn1470-2045
eissn1474-5488
codenLANCAO
abstractSummary Background The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone in a suitably powered trial. Methods We did an open-label, phase 3, multicentre, randomised controlled trial at ten institutions in China. Patients with previously untreated, stage III–IVB (except T3-4N0) nasopharyngeal carcinoma, aged 18–59 years without severe comorbidities were enrolled. Eligible patients were randomly assigned (1:1) to receive induction chemotherapy plus concurrent chemoradiotherapy or concurrent chemoradiotherapy alone (three cycles of 100 mg/m2 cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy). Induction chemotherapy was three cycles of intravenous docetaxel (60 mg/m2 on day 1), intravenous cisplatin (60 mg/m2 on day 1), and continuous intravenous fluorouracil (600 mg/m2 per day from day 1 to day 5) every 3 weeks before concurrent chemoradiotherapy. Randomisation was by a computer-generated random number code with a block size of four, stratified by treatment centre and disease stage (III or IV). Treatment allocation was not masked. The primary endpoint was failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause; required sample size was 476 patients (238 per group). We did efficacy analyses in our intention-to-treat population. The follow-up is ongoing; in this report, we present the 3-year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov , number NCT01245959. Findings Between March 1, 2011, and Aug 22, 2013, 241 patients were assigned to induction chemotherapy plus concurrent chemoradiotherapy and 239 to concurrent chemoradiotherapy alone. After a median follow-up of 45 months (IQR 38–49), 3-year failure-free survival was 80% (95% CI 75–85) in the induction chemotherapy plus concurrent chemoradiotherapy group and 72% (66–78) in the concurrent chemoradiotherapy alone group (hazard ratio 0·68, 95% CI 0·48–0·97; p=0·034). The most common grade 3 or 4 adverse events during treatment in the 239 patients in the induction chemotherapy plus concurrent chemoradiotherapy group versus the 238 patients in concurrent chemoradiotherapy alone group were neutropenia (101 [42%] vs 17 [7%]), leucopenia (98 [41%] vs 41 [17%]), and stomatitis (98 [41%] vs 84 [35%]). Interpretation Addition of TPF induction chemotherapy to concurrent chemoradiotherapy significantly improved failure-free survival in locoregionally advanced nasopharyngeal carcinoma with acceptable toxicity. Long-term follow-up is required to determine long-term efficacy and toxicities. Funding Shenzhen Main Luck Pharmaceuticals Inc, Sun Yat-sen University Clinical Research 5010 Program (2007037), National Science and Technology Pillar Program during the Twelfth Five-year Plan Period (2014BAI09B10), Health & Medical Collaborative Innovation Project of Guangzhou City (201400000001), Planned Science and Technology Project of Guangdong Province (2013B020400004), and The National Key Research and Development Program of China (2016YFC0902000).
copEngland
pubElsevier Ltd
pmid27686945
doi10.1016/S1470-2045(16)30410-7