近日，国际著名杂志Journal of the National Cancer Institute 刊登了中山大学肿瘤防治中心鼻咽科麦海强教授等的最新研究成果“Concurrent Chemoradiotherapy vs Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: Phase III Randomized Trial
。”在文章中，研究者指出同期化放疗与单纯放疗相比，显著提高了II期鼻咽癌患者的总生存率、无进展生存率及无远处转移生存率。此项研究成果对II期鼻咽癌的临床治疗有重要的指导意义。
目前，世界上对于II期鼻咽癌是否需要加与化疗没有统一的定论，中国抗癌协会鼻咽癌专业委员会推荐单纯放疗， 2010年美国NCCN指南推荐II期鼻咽癌患者采用同期化放疗+辅助化疗，但是该指引缺乏有力的循证医学证据支持，因此，探讨同期化放疗对II期鼻咽癌的疗效有非常重要的临床意义。麦海强教授的研究团队自2003年10月起，历时四年，进行了同期化放疗治疗Ⅱ期鼻咽癌的前瞻性随机对照Ⅲ期临床试验，将230例患者随机分组，114例患者随机入组单纯放疗组，116例患者随机入组同期化放疗组,旨在比较同期化放疗与单纯放疗对II期鼻咽癌的疗效，探讨顺铂30mg/ m2 每周同期化疗方案能否提高II期（包括T1-2N1M0或T2N0M0伴咽旁间隙侵犯）鼻咽癌患者的生存率。结果显示同期化放疗与单纯放疗相比，显著提高了II期鼻咽癌患者的总生存率、无进展生存率及无远处转移生存率，但未提高无局部区域复发生存率。以顺铂为基础的同期化放疗方案改善了II期鼻咽癌患者的预后，使其总生存率、无进展生存率及无远处转移生存率的绝对获益分别为8.7%、10.1%、10.9%。尽管同期化放疗的急性毒副反应较单纯放疗明显增加，但是患者尚可耐受。
麦海强主持的此项研究是第一个比较同期化放疗与单纯放疗对II期鼻咽癌疗效的前瞻性随机临床试验，肯定了同期化放疗在II期鼻咽癌治疗中的重要地位,对II期鼻咽癌的临床治疗有重要指导意义。（生物谷Bioon.com）
doi:10.1093/jnci/djr432
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Concurrent Chemoradiotherapy vs Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: Phase III Randomized Trial
Qiu-Yan Chen, Yue-Feng Wen, Ling Guo, Huai Liu, Pei-Yu Huang, Hao-Yuan Mo, Ning-Wei Li, Yan-Qun Xiang, Dong-Hua Luo, Fang Qiu, Rui Sun, Man-Quan Deng, Ming-Yuan Chen, Yi-Jun Hua, Xiang Guo, Ka-Jia Cao, Ming-Huang Hong, Chao-Nan Qian and Hai-Qiang Mai
Background Concurrent chemoradiotherapy (CCRT) has been shown to improve outcomes for stage III–IV nasopharyngeal carcinoma (NPC) patients compared with radiotherapy (RT) alone, but the effectiveness of the combined therapy for stage II NPC patients is unknown. Methods Patients with Chinese 1992 stage II NPC were randomly assigned to receive either RT alone (n = 114) or CCRT (n = 116). The CCRT patients were given concurrent cisplatin (30 mg/m2 on day 1) weekly during RT. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), distant metastasis-free survival, and locoregional relapse-free survival. All patients were analyzed by the intent-to-treat principle. The Cox proportional hazards model was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) and in multivariable analyses to test the independent statistical significance of treatment intervention. Toxic effects and the response to treatment were analyzed using the χ2 test. All statistical tests were two-sided. Results With a median follow-up of 60 months, adding chemotherapy statistically significantly improved the 5-year OS rate (94.5% vs 85.8%; HR of death = 0.30, 95% CI = 0.12 to 0.76; P = .007), PFS (87.9% vs 77.8%; HR of progression = 0.45, 95% CI = 0.23 to 0.88; P = .017), and distant metastasis-free survival (94.8% vs 83.9%; HR of distant relapse = 0.27, 95% CI = 0.10 to 0.74; P = .007); however, there was no statistically significant difference in the 5-year locoregional relapse-free survival rate (93.0% vs 91.1%; HR of locoregional relapse = 0.61, 95% CI = 0.25 to 1.51; P = .29). Multivariable analysis showed that the number of chemotherapy cycles was the only independent factor that was associated with OS, PFS, and distant control in stage II NPC. The CCRT arm experienced statistically significantly more acute toxic effects (P = .001), although the rate of late toxic effects did not increase statistically significantly. Conclusion Concurrent chemotherapy and radiotherapy is associated with a considerable survival benefit for patients with stage II NPC.
