Department of Head and Neck Surgery and Otolaryngology, A C Camargo Cancer Center, Brazil.
Department of Head and Neck Surgery and Otolaryngology, A C Camargo Cancer Center, Brazil.
Am J Otolaryngol. 2020 Nov-Dec;41(6):102626. doi: 10.1016/j.amjoto.2020.102626. Epub 2020 Jun 30.
The treatment of advanced stage laryngeal suffered a major shift away from surgery and towards larynx-preservation alternatives after the publication of major clinical trials. But its applicability in real-world situations is not consensual.
We reviewed a population-based database from Brazil regarding patients treated for laryngeal cancer and selected those with stage IV disease at presentation. Survival analysis was realized by the Cox proportional hazards method and propensity scores were used to compensate for non-random allocation to different treatment arms.
A total of 5577 patients were included in the analyses, with 4243 staged as CS IVa, 1010 as CS IVb and 324 as CS IVc. In univariate and multivariate analysis, gender, cT stage, cN stage, cM stage and treatment modality were significant predictors of disease-specific survival. In patients with CS IVa, age, gender, payment modality, location within the larynx, cT and cN stages and treatment modality were significant. After propensity score adjustment, treatment modality remained significant, favoring primary surgery with disease-specific survival (HR: 0.5041, 95% CI: 0.4494-0.5644, p < 0.001) and overall survival (HR: 0.5485, 95% CI: 0.4955-0.6072, p < 0.001) as outcomes of interest. Patients staged as cT4a cN0 were selected and analyzed as a distinct subset. In multivariate analysis, treatment modality was the only variable with significant prognostic impact with improved outcome for surgery-based treatment (HR: 2.521, 95% CI: 1.897-3.350, p < 0.001).
The extrapolation of clinical trials to the real-world facilities must be carefully weighted. The setting of trial conduction may influence its outcome and may not be reproducible. Our results show that patient selection and the facilities of clinical trials may play a significant role in the success of non-surgical approaches to non-metastatic stage IV laryngeal cancer.
在重大临床试验发表后，喉癌晚期治疗从手术转向了保留喉功能的替代治疗，这一转变意义重大。然而，其在实际情况下的适用性尚未达成共识。
我们回顾了巴西的一个基于人群的数据库，该数据库涉及接受喉癌治疗的患者，并选择了初诊为 IV 期疾病的患者。通过 Cox 比例风险模型进行生存分析，并使用倾向评分来补偿不同治疗组之间的非随机分配。
共有 5577 例患者纳入分析，其中 4243 例分期为 CS IVa，1010 例分期为 CS IVb，324 例分期为 CS IVc。在单因素和多因素分析中，性别、cT 分期、cN 分期、cM 分期和治疗方式是疾病特异性生存的显著预测因素。在 CS IVa 患者中，年龄、性别、支付方式、喉内位置、cT 和 cN 分期以及治疗方式是显著的预测因素。在进行倾向评分调整后，治疗方式仍然具有显著意义，首选手术治疗可提高疾病特异性生存率（HR：0.5041，95%CI：0.4494-0.5644，p<0.001）和总生存率（HR：0.5485，95%CI：0.4955-0.6072，p<0.001）。将分期为 cT4a cN0 的患者作为一个独立亚组进行分析。在多因素分析中，治疗方式是唯一具有显著预后影响的变量，手术治疗的效果更好（HR：2.521，95%CI：1.897-3.350，p<0.001）。
必须仔细权衡临床试验结果在实际环境中的应用。临床试验的实施环境可能会影响其结果，且可能无法复制。我们的结果表明，患者选择和临床试验的实施环境可能在非转移性 IV 期喉癌的非手术治疗方法的成功中发挥重要作用。
