头颈癌放化疗期间预防性与反应性胃造瘘术后患者报告的吞咽结局：SwallPEG随机试验结果
Patient reported swallowing outcomes after prophylactic versus reactive gastrostomy during chemoradiotherapy for head and neck cancer: Results from the SwallPEG randomized trial.
文献信息
| PMID | 42951256 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Tatiana Dragan |
| 作者单位 | Department of Radiation Oncology, Head and Neck Cancer Unit, Jules Bordet Institute, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium. Electronic address: tatiana.dragan@hubruxelles.be. |
| 期刊 | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology |
| SCI 分区 | Q1 |
| IF | 5.8 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 比较局部晚期、非转移性头颈癌根治性放化疗（CRT）期间预防性（p-）与反应性（r-）经皮内镜下胃造瘘（PEG）置入，以吞咽相关生活质量（QoL）为主要终点。
材料与方法： SwallPEG是一项前瞻性、多中心、随机III期试验，纳入接受根治性顺铂为基础CRT的患者。患者按1:1随机分配至CRT前pPEG或根据预设营养标准实施rPEG。所有患者均接受标准化营养咨询、每周营养师评估和吞咽康复。主要终点为6个月时吞咽相关QoL，采用MD Anderson吞咽困难量表（MDADI）综合评分评估。次要终点包括营养结局、治疗相关毒性、PEG相关并发症和早期肿瘤学结局。
结果： 共分析57例患者（pPEG，n=28；rPEG，n=29）。在预设中期分析达到无效边界后，试验因入组缓慢而提前终止。6个月时MDADI综合评分中位数分别为69.5（Q1-Q3，60.0-80.0）和74.7（Q1-Q3，58.9-87.9）（P=0.595）。吞咽功能在CRT期间下降，随后恢复，组间无显著差异。6个月时体重下降相当（-7.0% vs -9.0%；P=0.67）。治疗相关毒性、PEG相关并发症、化疗实施或早期肿瘤学结局均未观察到显著差异。
结论： pPEG与rPEG策略之间未显示吞咽相关QoL差异。尽管解释受试验提前终止和样本量减少的限制，研究结果支持根据临床需要个体化实施PEG置入。
英文摘要
PURPOSE: To compare prophylactic (p-) versus reactive (r-) percutaneous endoscopic gastrostomy (PEG) placement during definitive chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck carcinoma, with swallowing-related quality of life (QoL) as the primary endpoint.
MATERIALS AND METHODS: SwallPEG is a prospective, multicenter, randomized phase III trial of patients undergoing definitive cisplatin-based CRT. Patients were randomized 1:1 to pPEG before CRT or rPEG based on predefined nutritional criteria. All received standardized nutritional counseling, weekly dietitian assessment, and swallowing rehabilitation. The primary endpoint was swallowing-related QoL at 6 months, assessed using the MD Anderson Dysphagia Inventory (MDADI) composite score. Secondary endpoints included nutritional outcomes, treatment-related toxicity, PEG-related complications, and early oncologic outcomes.
RESULTS: Fifty-seven patients were analyzed (pPEG, n = 28; rPEG, n = 29). Following a prespecified interim analysis that reached the futility boundary, the trial was closed early in the context of slow accrual. Median MDADI composite scores at 6 months were 69.5 (Q1-Q3, 60.0-80.0) and 74.7 (Q1-Q3, 58.9-87.9), respectively (P = 0.595). Swallowing function declined during CRT and subsequently recovered without a significant between-group difference. Weight loss at 6 months was comparable (-7.0 % vs - 9.0 %; P = 0.67). No significant differences were observed in treatment-related toxicity, PEG-related complications, chemotherapy delivery, or early oncologic outcomes.
CONCLUSION: No difference in swallowing-related QoL was demonstrated between (p-) and rPEG strategies. Although interpretation is limited by early trial closure and reduced sample size, the findings support individualized PEG placement based on clinical need.