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非常加速放疗或同期放化疗治疗 N3 期头颈部鳞状细胞癌:两项 GORTEC 随机试验的汇总分析。

Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials.

机构信息

Institut Gustave Roussy, Villejuif, France.

Institut Gustave Roussy, Villejuif, France.

出版信息

Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

Abstract

OBJECTIVE

To analyze the outcome of N3 patients treated with very accelerated radiotherapy (VART) or different schedules of concurrent chemoradiotherapy (CRT) within two phase III trials.

PATIENTS AND METHODS

Data of 179 patients with N3 HNSCC from two GORTEC randomized trials (96-01 and 99-02) were pooled. Patients received either VART: 64.8Gy/3.5weeks or one of the 3 following CRT regimens: Conventional CRT: 70Gy/7weeks+3 cycles carboplatin-5FU; Moderately accelerated CRT: 70Gy/6weeks+2 cycles carboplatin-5FU; Strongly intensified CRT: 64Gy/5weeks+cisplatin (days 2, 16, 30) and 5 FU (days 1-5, 29-33) followed by 2 cycles adjuvant cisplatin-5FU.

RESULTS

Median follow-up was 13.3 and 5.2years for GORTEC 96-01 and GORTEC 99-02, respectively. Five-year overall survival (OS) was 13.8%. No significant difference was observed between CRT versus VART in terms of OS (hazard ratio [HR]: 0.93, p=0.68), loco-regional progression (HR: 0.70, p=0.13), or distant progression (HR: 0.86, p=0.53). OS was worse for patients with T3-4 tumors versus early T stage (11.0% versus 25.7%, p=0.015). In multivariate analysis, the oropharyngeal subsite presented a higher risk of distant metastasis (as first event 46.5% vs 19.2%, p<0.001),). A significant interaction between treatment modalities and subsites has been observed concerning loco-regional and distant failures.

CONCLUSION

The outcome of N3 HNSCC was extremely poor despite treatment intensification and no difference between CRT and VART. Both distant metastases and loco-regional failures remain important treatment challenge.

摘要

目的

分析两项 III 期临床试验中接受超高速放射治疗(VART)或不同同步放化疗(CRT)方案治疗的 N3 患者的治疗结局。

方法

汇总了来自 GORTEC 两项随机试验(96-01 和 99-02)的 179 例 N3 头颈部鳞癌患者的数据。患者接受 VART:64.8Gy/3.5 周或以下 3 种 CRT 方案之一:常规 CRT:70Gy/7 周+3 个周期卡铂-5FU;中度加速 CRT:70Gy/6 周+2 个周期卡铂-5FU;强烈强化 CRT:64Gy/5 周+顺铂(第 2、16、30 天)和 5-FU(第 1、29、33 天),然后进行 2 个周期辅助顺铂-5FU。

结果

GORTEC 96-01 和 GORTEC 99-02 的中位随访时间分别为 13.3 年和 5.2 年。5 年总生存率(OS)为 13.8%。在 OS(风险比[HR]:0.93,p=0.68)、局部区域进展(HR:0.70,p=0.13)或远处转移(HR:0.86,p=0.53)方面,CRT 与 VART 之间无显著差异。T3-4 期肿瘤患者的 OS 较早期 T 期患者差(11.0%对 25.7%,p=0.015)。多变量分析显示,口咽亚部位远处转移风险更高(首次远处转移 46.5%比 19.2%,p<0.001)。治疗方式和亚部位之间存在显著的交互作用,涉及局部区域和远处失败。

结论

尽管治疗强度增加,但 N3 头颈部鳞癌患者的预后仍极差,CRT 和 VART 之间无差异。远处转移和局部区域失败仍然是重要的治疗挑战。

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