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腮腺浅叶 sparing 调强放疗(SPLS-IMRT)对鼻咽癌患者口干影响的前瞻性 II 期随机对照研究。

Impact on xerostomia for nasopharyngeal carcinoma patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT): A prospective phase II randomized controlled study.

机构信息

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.

出版信息

Radiother Oncol. 2022 Oct;175:1-9. doi: 10.1016/j.radonc.2022.07.006. Epub 2022 Jul 8.

DOI:10.1016/j.radonc.2022.07.006
PMID:35817320
Abstract

PURPOSE

To compare the incidence of xerostomia in nasopharyngeal carcinoma (NPC) patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT) and conventional IMRT (C-IMRT).

METHODS

Patients with histologically confirmed NPC who met the eligibility criteria were randomly assigned to receive either SPLS-IMRT or C-IMRT. The primary endpoint was the incidence of xerostomia at 12 months post-IMRT. The secondary endpoints included the xerostomia questionnaire (XQ) score, unstimulated salivary flow rate (USFR), stimulated salivary flow rate (SSFR), and survival outcomes.

RESULTS

Ninety patients were enrolled. Eighty-two patients were included for xerostomia analysis (42 in the SPLS-IMRT group and 40 in the C-IMRT group). At 12 months post-IMRT, the incidence of xerostomia in the SPLS-IMRT group was significantly lower than that in the C-IMRT group (83.4% vs 95.0%; P = 0.007), especially the grade 3 xerostomia (0% vs 12.5%; P < 0.001). The median change in XQ score was similar between the two groups (11.9 points vs 14.1 points; P = 0.194). There was a significantly higher median fractional USFR (0.67 vs 0.35; P = 0.024) and SSFR (0.66 vs 0.32; P = 0.021) in the SPLS-IMRT group than the C-IMRT group. The 3-year LRRFS, DMFS, and OS in the SPLS-IMRT and C-IMRT groups were 92.5% vs 90.9%, 83.8% vs 81.7%, and 88.9% vs 88.2% (all P > 0.05).

CONCLUSION

SPLS-IMRT significantly reduced the incidence of xerostomia at 12 months post-IMRT in NPC by recovering parotid gland function earlier than C-IMRT, without compromising survivals. Phase III clinical trials are warranted. (ClinicalTrials.gov, number NCT05020067).

摘要

目的

比较腮腺浅叶保留调强放疗(SPLS-IMRT)与常规调强放疗(C-IMRT)治疗鼻咽癌(NPC)患者口干发生率。

方法

符合入选标准的经组织学证实的 NPC 患者被随机分配接受 SPLS-IMRT 或 C-IMRT。主要终点是 IMRT 后 12 个月时口干的发生率。次要终点包括口干问卷(XQ)评分、非刺激唾液流率(USFR)、刺激唾液流率(SSFR)和生存结局。

结果

共纳入 90 例患者。82 例患者纳入口干分析(SPLS-IMRT 组 42 例,C-IMRT 组 40 例)。IMRT 后 12 个月时,SPLS-IMRT 组口干发生率明显低于 C-IMRT 组(83.4%比 95.0%;P=0.007),特别是 3 级口干(0%比 12.5%;P<0.001)。两组 XQ 评分的中位数变化相似(11.9 分比 14.1 分;P=0.194)。SPLS-IMRT 组中位部分 USFR(0.67 比 0.35;P=0.024)和 SSFR(0.66 比 0.32;P=0.021)明显较高。SPLS-IMRT 组和 C-IMRT 组的 3 年局部区域无复发生存率(LRRFS)、无远处转移生存率(DMFS)和总生存率(OS)分别为 92.5%比 90.9%、83.8%比 81.7%和 88.9%比 88.2%(均 P>0.05)。

结论

SPLS-IMRT 通过更早恢复腮腺功能,显著降低 NPC 患者 IMRT 后 12 个月时的口干发生率,同时不影响生存。需要开展 III 期临床试验。(ClinicalTrials.gov,编号 NCT05020067)。

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