近日,，國際著名雜志Journal of the National Cancer Institute 刊登了中山大學(xué)腫瘤防治中心鼻咽科麥海強(qiáng)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療與單純放療相比，顯著提高了II期鼻咽癌患者的總生存率,、無進(jìn)展生存率及無遠(yuǎn)處轉(zhuǎn)移生存率,。此項(xiàng)研究成果對(duì)II期鼻咽癌的臨床治療有重要的指導(dǎo)意義。
目前,，世界上對(duì)于II期鼻咽癌是否需要加與化療沒有統(tǒng)一的定論,，中國抗癌協(xié)會(huì)鼻咽癌專業(yè)委員會(huì)推薦單純放療， 2010年美國NCCN指南推薦II期鼻咽癌患者采用同期化放療+輔助化療,，但是該指引缺乏有力的循證醫(yī)學(xué)證據(jù)支持,，因此，探討同期化放療對(duì)II期鼻咽癌的療效有非常重要的臨床意義,。麥海強(qiáng)教授的研究團(tuán)隊(duì)自2003年10月起,，歷時(shí)四年，進(jìn)行了同期化放療治療Ⅱ期鼻咽癌的前瞻性隨機(jī)對(duì)照Ⅲ期臨床試驗(yàn),，將230例患者隨機(jī)分組,，114例患者隨機(jī)入組單純放療組，116例患者隨機(jī)入組同期化放療組,旨在比較同期化放療與單純放療對(duì)II期鼻咽癌的療效,，探討順鉑30mg/ m2 每周同期化療方案能否提高II期（包括T1-2N1M0或T2N0M0伴咽旁間隙侵犯）鼻咽癌患者的生存率,。結(jié)果顯示同期化放療與單純放療相比，顯著提高了II期鼻咽癌患者的總生存率,、無進(jìn)展生存率及無遠(yuǎn)處轉(zhuǎn)移生存率,，但未提高無局部區(qū)域復(fù)發(fā)生存率。以順鉑為基礎(chǔ)的同期化放療方案改善了II期鼻咽癌患者的預(yù)后,，使其總生存率,、無進(jìn)展生存率及無遠(yuǎn)處轉(zhuǎn)移生存率的絕對(duì)獲益分別為8.7%、10.1%,、10.9%,。盡管同期化放療的急性毒副反應(yīng)較單純放療明顯增加，但是患者尚可耐受,。
麥海強(qiáng)主持的此項(xiàng)研究是第一個(gè)比較同期化放療與單純放療對(duì)II期鼻咽癌療效的前瞻性隨機(jī)臨床試驗(yàn),，肯定了同期化放療在II期鼻咽癌治療中的重要地位,對(duì)II期鼻咽癌的臨床治療有重要指導(dǎo)意義。（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.
