Qi Yang1, Su-Mei Cao2, Ling Guo1, Yi-Jun Hua1, Pei-Yu Huang1, Xiao-Long Zhang1, Mei Lin1, Rui You1, Xiong Zou1, You-Ping Liu1, Yu-Long Xie1, Zhi-Qiang Wang1, Hai-Qiang Mai1, Qiu-Yan Chen1, Lin-Quan Tang1, Hao-Yuan Mo1, Ka-Jia Cao1, Chao-Nan Qian1, Chong Zhao1, Yan-Qun Xiang1, Xiu-Ping Zhang3, Zhi-Xiong Lin4, Wei-Xiong Li5, Qing Liu2, Ji-Bin Li6, Li Ling7, Xiang Guo8, Ming-Huang Hong9, Ming-Yuan Chen10. 1. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. 2. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, China. 3. Department of Radiation Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, China. 4. Department of Radiation Oncology, Cancer Center of Shantou University Medical College, Shantou, China. 5. Department of Radiation Oncology, Guangdong General Hospital, Guangzhou, China. 6. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China. 7. Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China. 8. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: guoxiang@sysucc.org.cn. 9. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: hongmh@sysucc.org.cn. 10. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: chenmy@sysucc.org.cn.
Abstract
BACKGROUND: Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results. PATIENTS AND METHODS: Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m2 d1) and fluorouracil (800 mg/m2 d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m2 cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population). RESULTS: After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029). CONCLUSION: IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients.
RCT Entities:
BACKGROUND: Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results. PATIENTS AND METHODS: Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m2 d1) and fluorouracil (800 mg/m2 d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m2 cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population). RESULTS: After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029). CONCLUSION: IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients.
Authors: Pierre Blanchard; Anne W M Lee; Alexandra Carmel; Ng Wai Tong; Jun Ma; Anthony T C Chan; Ruey Long Hong; Ming-Yuan Chen; Lei Chen; Wen-Fei Li; Pei-Yu Huang; Dora L W Kwong; Sharon S X Poh; Roger Ngan; Hai-Qiang Mai; Camille Ollivier; George Fountzilas; Li Zhang; Jean Bourhis; Anne Aupérin; Benjamin Lacas; Jean-Pierre Pignon Journal: Clin Transl Radiat Oncol Date: 2021-11-26
Authors: Kenneth C W Wong; Edwin P Hui; Kwok-Wai Lo; Wai Kei Jacky Lam; David Johnson; Lili Li; Qian Tao; Kwan Chee Allen Chan; Ka-Fai To; Ann D King; Brigette B Y Ma; Anthony T C Chan Journal: Nat Rev Clin Oncol Date: 2021-06-30 Impact factor: 66.675
Authors: Hye Ri Han; Sung Jun Ma; Gregory M Hermann; Austin J Iovoli; Kimberly E Wooten; Hassan Arshad; Vishal Gupta; Ryan P McSpadden; Moni A Kuriakose; Michael R Markiewicz; Jon M Chan; Mary E Platek; Andrew D Ray; Fangyi Gu; Wesley L Hicks; Anurag K Singh Journal: Ann Transl Med Date: 2021-05