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同期放化疗对比单纯放疗治疗 II 期鼻咽癌的 III 期随机临床试验的 10 年生存和毒性结局。

Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma.

机构信息

Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China.

Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China.

出版信息

Eur J Cancer. 2019 Mar;110:24-31. doi: 10.1016/j.ejca.2018.10.020. Epub 2019 Feb 7.

Abstract

PURPOSE

Our previous results showed survival benefits of concurrent chemoradiotherapy (CCRT) in treating stage II nasopharyngeal carcinoma (NPC) compared with radiotherapy (RT) alone. Here, we present the updated 10-year survival results and late toxicity profile to assess the ultimate effectiveness of concurrent chemotherapy.

METHODS

Patients with stage II NPC were randomly assigned to RT arm (n = 114) or to CCRT arm (n = 116) with a concurrent weekly cisplatin regimen. The primary end-point was overall survival (OS).

RESULTS

With a median follow-up of 125 months, significant improvements in OS (83.6% vs 65.8%, P = 0.001), progression-free survival (76.7% vs 64.0%, P = 0.014), cancer-specific survival (86.2% vs 71.9%, P = 0.002), distant-metastasis free survival (94.0% vs 83.3%, P = 0.007) were observed in CCRT arm. In point of locoregional-relapse free survival, the impact of CCRT was not remarkable. The findings were in accordance with our previous report. The survival benefits earned by CCRT mainly reflected in T2N1 population. Although CCRT brought more acute toxic effects (P = 0.001), as presented in previous report, the late toxicities and treatment-associated deaths events were comparable between two arms.

CONCLUSIONS

Ten-year outcomes confirmed that CCRT could improve the OS of stage II patients without adding late toxicities compared with conventional RT.

摘要

目的

我们之前的研究结果表明,与单纯放疗(RT)相比,同期放化疗(CCRT)治疗 II 期鼻咽癌(NPC)可提高患者的生存率。在此,我们报告了 10 年的生存结果和晚期毒性概况,以评估同期化疗的最终疗效。

方法

将 II 期 NPC 患者随机分配至 RT 组(n=114)或 CCRT 组(n=116),接受每周顺铂同期化疗。主要终点为总生存(OS)。

结果

中位随访 125 个月后,CCRT 组在 OS(83.6% vs 65.8%,P=0.001)、无进展生存(76.7% vs 64.0%,P=0.014)、癌症特异性生存(86.2% vs 71.9%,P=0.002)和远处转移无复发生存(94.0% vs 83.3%,P=0.007)方面均有显著改善。在局部区域无复发生存方面,CCRT 的影响并不显著。这一发现与我们之前的报告一致。CCRT 的生存获益主要体现在 T2N1 人群中。虽然 CCRT 带来了更多的急性毒性反应(P=0.001),但正如之前的报告所示,两组的晚期毒性和与治疗相关的死亡事件相当。

结论

10 年的结果证实,与常规 RT 相比,CCRT 可提高 II 期患者的 OS,且不会增加晚期毒性。

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