在晚期头颈部癌症中增加化疗联合超分割放疗的疗效：一项荟萃分析。
Addition of chemotherapy to hyperfractionated radiotherapy in advanced head and neck cancer-a meta-analysis.
机构信息
Department of Radiation Oncology, Heinrich Heine University, Moorenstr. 5, 40225, Dusseldorf, Germany.
Division of Biostatistics and Bioinformatics, Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
出版信息
Strahlenther Onkol. 2019 Dec;195(12):1041-1049. doi: 10.1007/s00066-019-01511-z. Epub 2019 Oct 4.
BACKGROUND
Adding concurrent chemotherapy (CTx) to definitive radiation therapy (RT) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) improves overall survival. A comparable effect has been reported for hyperfractionated radiotherapy (HFX-RT) alone. Adding concurrent CTx to HFX-RT has been investigated in multiple trials, yet an evident effect on oncological outcomes and toxicity profile has not been established to date. Thus, the aim of the current study was to perform a meta-analysis on the clinical outcome and toxicity of the addition of CTx to HFX-RT.
PATIENTS AND METHODS
We performed a literature search for randomized controlled trials comparing HFX-RT alone to HFX-RT + concurrent CTx in patients with LA-HNSCC undergoing definite RT. A meta-analysis was performed using the event rates and effect-sizes for overall survival (OS), progression-free survival (PFS), cancer-specific survival (CSS), distant metastasis-free survival and distant recurrence-free interval (DMFS/DMFI) and locoregional recurrence (LRR) as investigated endpoints. Furthermore, we compared selected acute and late toxicities in the included studies. Statistical analysis was performed using the Microsoft Excel (Microsoft, Redmont, WA, USA) add-in MetaXL 5.3 (EpiGear International, Sunrise Beach, Australia), utilizing the inverse variance heterogeneity model.
RESULTS
We identified six studies (n = 1280 patients) randomizing HFX-RT alone and the concurrent addition of CTx. OS was significantly improved in the HFX-RT + CTx group (HR = 0.77, CI95% = 0.66-0.89; p = <0.001). We found similar results in PFS (HR = 0.74, CI95% = 0.63-0.87; p < 0.001) and CSS (HR = 0.72, CI95% = 0.60-0.88; p = 0.001). In contrast, acute toxicities (≥grade 3 mucositis, ≥grade 3 dysphagia) and late adverse events including ≥grade 3 xerostomia, ≥grade 3 subcutaneous, ≥grade 3 bone, ≥grade 3 skin toxicity, and ≥grade 3 dysphagia did not significantly differ between the two groups.
CONCLUSION
The addition of CTx to HFX-RT in the definitive treatment of advanced LA-HNSCC improves OS, CSS, PFS, and LRR without a significant increase in high-grade acute and late toxicities.
背景
在局部晚期头颈部鳞状细胞癌（LA-HNSCC）患者中，将同期化疗（CTx）加入根治性放疗（RT）中可提高总生存率。单独使用超分割放疗（HFX-RT）也有类似的效果。已经在多项试验中研究了将同期 CTx 加入 HFX-RT 的效果，但迄今为止，尚未确定其对肿瘤学结果和毒性特征的明显影响。因此，目前的研究旨在对 HFX-RT 联合 CTx 治疗 LA-HNSCC 患者的临床结果和毒性进行荟萃分析。
患者和方法
我们对比较 HFX-RT 单药治疗与 HFX-RT 联合同期 CTx 治疗 LA-HNSCC 患者根治性放疗的随机对照试验进行了文献检索。使用总生存率（OS）、无进展生存率（PFS）、癌症特异性生存率（CSS）、无远处转移生存率和无远处复发间隔（DMFS/DMFI）以及局部区域复发（LRR）的事件率和效应大小进行荟萃分析。此外，我们比较了纳入研究中的选定急性和晚期毒性。使用 Microsoft Excel（Microsoft，Redmont，WA，USA）中的 Microsoft Excel 插件 MetaXL 5.3（EpiGear International，Sunrise Beach，Australia）进行统计分析，采用逆方差异质性模型。
结果
我们确定了六项研究（n=1280 例患者），比较了 HFX-RT 单药治疗和同期 CTx 治疗。在 HFX-RT 联合 CTx 组中，OS 显著改善（HR=0.77，CI95%=0.66-0.89；p<0.001）。我们在 PFS（HR=0.74，CI95%=0.63-0.87；p<0.001）和 CSS（HR=0.72，CI95%=0.60-0.88；p=0.001）中也发现了类似的结果。然而，急性毒性（≥3 级黏膜炎、≥3 级吞咽困难）和晚期不良事件，包括≥3 级口干、≥3 级皮下组织、≥3 级骨、≥3 级皮肤毒性和≥3 级吞咽困难，在两组之间无显著差异。
结论
在局部晚期 LA-HNSCC 的根治性治疗中，将 CTx 加入 HFX-RT 可提高 OS、CSS、PFS 和 LRR，而不会增加高等级急性和晚期毒性。
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