Progress report of a randomized trial comparing long-term survival and late toxicity of concurrent chemoradiotherapy with adjuvant chemotherapy versus radiotherapy alone in patients with stage III to IVB nasopharyngeal carcinoma from endemic regions of China

Authors

  • Yong Chen MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Ying Sun MD, PhD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Shao-Bo Liang MD,

    1. Department of Radiation Oncology, Cancer Center, The First People's Hospital of Foshan, Foshan, People's Republic of China
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  • Jing-Feng Zong MD,

    1. Department of Radiation Oncology, Fujian Provincial Tumor Hospital, Fuzhou, People's Republic of China
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  • Wen-Fei Li MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Mo Chen MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Lei Chen MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Yan-Ping Mao MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Ling-Long Tang MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Ying Guo PhD,

    1. Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Ai-Hua Lin MD, PhD,

    1. Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China
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  • Meng-Zhong Liu MD,

    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
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  • Jun Ma MD

    Corresponding author
    1. State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China
    • Corresponding author: Jun Ma, MD, State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China; Fax: (011) 86-20-87343295; majun2@mail.sysu.edu.cn

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  • The first 2 authors contributed equally to this work.

  • We thank our colleagues from Sun Yat-sen University Cancer Center for their help in recruiting patients for this study. We are grateful to the staff at the Clinical Trials Center, Sun Yat-sen University Cancer Center, for trial monitoring, data management, and statistical analysis. We are indebted to Chao-Su Hu (Fudan University Shanghai Cancer Center), Hui-Qiang Huang (Sun Yat-sen University Cancer Center), and Yu-Ming Chen (School of Public Health, Sun Yat-sen University) in the Data Monitoring Committee for their contribution in this study. We also thank our patients and their families for their willingness to participate in this study.

Abstract

BACKGROUND

The objective of this study was to evaluate the long-term survival and late toxicities of concurrent-adjuvant chemotherapy in patients with stage III through IVB nasopharyngeal carcinoma (NPC) from endemic regions of China.

METHODS

Patients with stage III to IVB NPC were assigned randomly to receive radiotherapy (RT) alone (the RT group) or RT plus concurrent adjuvant chemotherapy (the CRT group). CRT patients received concurrent cisplatin (40 mg/m2) weekly during RT followed by cisplatin (80 mg/m2) and fluorouracil (800 mg/m2 daily for 5 days) every 4 weeks for 3 cycles. The primary endpoint was overall survival.

RESULTS

In total, 316 patients underwent randomization, with 158 to each group. At a median follow-up of 70 months, the 5-year overall survival rate was 72% for the CRT group and 62% for the RT group (hazard ratio, 0.69; 95% confidence interval, 0.48-0.99; P = .043). Failure-free survival was significantly higher in the CRT group (P = .020). Most late toxicities were similar (33% vs 26%; P = .089), except for cranial neuropathy (P = .042), peripheral neuropathy (P = .041), and ear damage (P = .048), which were significantly increased in the CRT group.

CONCLUSIONS

The addition of concurrent adjuvant chemotherapy to RT provides survival benefits to patients with stage III through IVB NPC in endemic regions of China, and it does not increase most late toxicities apart from cranial neuropathy, peripheral neuropathy, and ear damage. Cancer 2013;119:2230–2238. © 2013 American Cancer Society.

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