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Originally published as JCO Early Release 10.1200/JCO.2004.00.3863 on October 17 2005

Journal of Clinical Oncology, Vol 23, No 33 (November 20), 2005: pp. 8461-8468
© 2005 American Society of Clinical Oncology.

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Phase III Study Comparing Standard Radiotherapy With or Without Weekly Oxaliplatin in Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: Preliminary Results

Li Zhang, Chong Zhao, Pei-Jian Peng, Li-Xia Lu, Pei-Yu Huang, Fei Han, Shao-Xiong Wu

From the Departments of Medical Oncology and Radiation Oncology, Cancer Center of Sun Yat-Sen University, Guangzhou, People's Republic of China

Address reprint requests to L. Zhang, MD, Department of Medical Oncology, Cancer Center of Sun Yat-Sen University, 651 Dongfeng Rd E, Guangzhou 510060, People's Republic of China; e-mail: zhangl{at}gzsums.edu.cn

PURPOSE: A prospective, randomized, phase III study was performed to evaluate the feasibility and efficacy of concurrent weekly oxaliplatin with radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC).

PATIENTS AND METHODS: From January 2001 to January 2003, 115 patients with locoregionally advanced NPC were randomly assigned to either radiotherapy (RT) alone (56 patients) or concurrent chemoradiotherapy (CCRT; 59 patients). All patient characteristics were well balanced in both arms. CCRT with oxaliplatin 70 mg/m2 weekly was administered for six doses from the first day of RT.

RESULTS: All patients were eligible for toxicity and response analysis. Compliance with the protocol treatment was excellent, with 97% of patients completing all planned doses of oxaliplatin, and a lack of high-grade toxicity was observed. After a median follow-up time of 24 months, there was a significant difference in overall survival (OS), relapse-free survival (RFS), and metastasis-free survival (MFS) in favor of the CCRT arm. The 2-year OS rates were 100% for the CCRT arm and 77% for the RT arm (P = .01). The 2-year MFS rates were 92% for the CCRT arm and 80% for the RT arm (P = .02). The 2-year RFS rates were 96% for the CCRT arm and 83% for the RT arm (P = .02).

CONCLUSION: CCRT with weekly oxaliplatin is feasible and improves OS, MFS, and RFS rates in patients with locoregionally advanced NPC. Therefore, further randomized trials including oxaliplatin are warranted.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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