Abstract
Background
There are few adequate randomized clinical trials directly comparing the therapeutic options of primary laryngectomy (pLE) vs. primary radio(system)therapy (pR(S)T) in patients with locally advanced laryngeal and hypopharyngeal carcinoma and thus little clear scientific evidence to decide which patients will benefit most from which procedure.
Aims/Objectives
Aim was to compare survival between the therapeutic options and to learn from the limitations of this study, especially in the context of improved clinical assessment.
Material and Methods
The clinical data of patients treated between January 2010 and February 2022 were obtained from the electronic database of the University Hospital Regensburg. Overall survival (OS) and progression-free survival (PFS) were compared between the treatment groups.
Results
The study included 193 patients (pLE n = 68, pR(S)T, n = 125). Median OS was 31.2 months and median PFS was 24.7 months with no significant difference between the treatment groups (p > .050). Patients who did not receive complete treatment as recommended by the tumor conference (n = 47, 24.4%) had a higher risk of death (p = .024).
Conclusions and Significance
The results of our study are consistent with the survival data reported in the literature. More detailed systematic data in clinical routine (e.g. relevant comorbidities) are required to ensure guideline-based recommended therapy.
Chinese Abstract
背景:对于晚期局部喉癌和下咽癌患者, 很少有足够的随机临床试验直接比较初级喉切除术 (pLE) 与初级放射(系统)治疗 (pR(S)T) 的治疗效果, 因此缺乏明确的科学证据来决定哪些患者将从哪种手术中受益最大。
目的:比较不同治疗方案之间的生存率并从中获得这项研究的局限性, 特别是在改进了临床评估的情况下。
材料与方法:从雷根斯堡大学医院的电子数据库中获得2010年1月至2022年2月期间接受治疗的患者的临床数据。 比较了治疗组之间的总生存期(OS)和无恶化生存期(PFS)。
结果:该研究包括 193 名患者(pLE n=68, pR(S)T n=125)。 中位 OS 为 31.2 个月, 中位 PFS 为 24.7 个月, 治疗组之间无显著差异 (p > .050)。未按照肿瘤协会建议接受完整治疗的患者(n=47, 24.4%)的死亡风险较高 (p = .024)。
结论和意义:我们的研究结果与文献中报告的生存数据一致。 需要更详细的临床常规系统数据(例如相关合并症), 以确保基于指南而推介的治疗法。
Ethics approval
This study was conducted according to the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the University Regensburg (Date 4 May 2022/No. 22-2879-101).
Authors’ contributions
All authors contributed to the study conception and design. Material preparation and data collection were performed by Julia Maurer, Veronika Vielsmeier, Christoph Suess, and Oreste Concato. Analysis was performed by Julia Maurer and Karolina Mueller. The first draft of the manuscript was written by Julia Maurer, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Consent to participate
Informed consent was obtained from all participants included in the survey regarding QoL.
Disclosure statement
No potential conflict of interest was reported by the authors.
Availability of data and materials
Data available on request from the authors.