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一项 2 期研究的结果,该研究旨在探讨在 N(0-1)期鼻咽癌患者中省略颈部 IV 和 Vb 水平的选择性颈部照射的效果。

Results of a phase 2 study examining the effects of omitting elective neck irradiation to nodal levels IV and Vb in patients with N(0-1) nasopharyngeal carcinoma.

机构信息

Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China.

出版信息

Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):929-34. doi: 10.1016/j.ijrobp.2012.07.2356. Epub 2012 Sep 11.

DOI:10.1016/j.ijrobp.2012.07.2356
PMID:22975606
Abstract

PURPOSE

To evaluate the patterns of nodal failure and toxicity in clinically negative necks of N0-1 nasopharyngeal carcinoma (NPC) patients who were treated with intensity modulated radiation therapy (IMRT) but did not receive elective neck irradiation (ENI) to level IV and Vb nodes.

METHODS AND MATERIALS

We conducted a phase 2 prospective study in N0-1 NPC patients treated with IMRT. ENI included the retropharyngeal nodes and levels II to Va but omitted levels IV and Vb in clinically negative necks. Patterns of nodal failure, regional control (RC), and late toxicity were evaluated.

RESULTS

Between 2001 and 2008, a total of 212 patients (128 N0 and 84 N1) were enrolled in the study. Seven patients (4 in-field and 3 out-of-field) developed nodal failure. One patient (0.5%) developed nodal failure at level Vb, but no patients developed nodal failure at level IV. The 5-year RC rates of the entire group, N0 patients and N1 patients were 95.6%, 98.2%, and 91.3%, respectively. Fifteen patients (7.1%) developed distant metastases. The 5-year distant failure-free survival (DFFS) and overall survival (OS) rates were 91.4% and 89.8%, respectively. The rates of grade 2 or greater skin dystrophy, subcutaneous fibrosis and xerostomia were 6.2%, 16.6%, and 17.9%, respectively.

CONCLUSIONS

The rate of out-of-field nodal failure when omitting ENI to levels IV and Vb in clinically negative necks of patients with N0-1 NPC was extremely low; therefore, a further phase 3 study is warranted.

摘要

目的

评估接受调强放疗(IMRT)但未行选择性颈部照射(ENI)至 IV 区和 Vb 区的 N0-1 期鼻咽癌(NPC)患者临床阴性颈部的淋巴结失败和毒性模式。

方法和材料

我们对接受 IMRT 治疗的 N0-1 NPC 患者进行了一项 2 期前瞻性研究。ENI 包括咽后淋巴结和 II 至 Va 区,但在临床阴性颈部中省略了 IV 区和 Vb 区。评估了淋巴结失败、区域控制(RC)和迟发性毒性的模式。

结果

2001 年至 2008 年间,共有 212 例患者(128 例 N0 和 84 例 N1)入组该研究。7 例患者(4 例为场内和 3 例为场外)发生淋巴结失败。1 例(0.5%)患者在 Vb 区发生淋巴结失败,但无患者在 IV 区发生淋巴结失败。全组、N0 患者和 N1 患者的 5 年 RC 率分别为 95.6%、98.2%和 91.3%。15 例患者(7.1%)发生远处转移。5 年无远处失败生存(DFFS)和总生存(OS)率分别为 91.4%和 89.8%。2 级或更高级别的皮肤营养不良、皮下纤维化和口干发生率分别为 6.2%、16.6%和 17.9%。

结论

在 N0-1 NPC 患者临床阴性颈部省略 IV 区和 Vb 区的 ENI 时,场外淋巴结失败的发生率极低;因此,需要进一步进行 3 期研究。

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