Department of Oral and Maxillofacial Surgery, Johannes Gutenberg University, Medical Center, Mainz, Germany.
Strahlenther Onkol. 2011 Jun;187(6):337-43. doi: 10.1007/s00066-011-2206-x. Epub 2011 May 16.
The positive effect of radiation therapy for patients with advanced oropharyngeal squamous cell carcinoma (OSCC) has been substantially verified. The present work investigated whether a meta-analysis of current data is able to evaluate the effectiveness of postoperative radiotherapy (PORT) in patients with small OSCC (pT1, pT2) and a single ipsilateral lymph node metastasis (pN1).
The meta-analysis comprises randomized and non-randomized studies. High-risk tumors were excluded and defined by size ≥ pT3/pT4, lymph node involvement ≥ pN2, or presence of additional histological risk factors, e.g., involved positive resection margins, extra nodal spread of the disease, or lymphangiosis carcinomatosa. The primary outcome analyzed mortality between the different treatment arms.
Only one prospective randomized clinical trial and six retrospective observational studies were adequate for evaluation. Descriptive analysis revealed a marginally higher mortality in the irradiation group (44% vs. 34%). In contrast, a forest plot presentation of two of seven studies with and without events in the control and therapy arms presented an advantage for the irradiation group with the limitation of large heterogeneity and a lack of statistical significance.
Present data are poor and exhibit limited internal and external validity; thus, direct comparison was not possible with the eligible studies. Therefore, a meta-analysis of present data may not serve as the basis for a general treatment recommendation but underlines the need of prospective, randomized, controlled clinical trials.
放射治疗对晚期或口咽鳞状细胞癌(OSCC)患者的积极作用已得到充分证实。本研究旨在探讨对小型 OSCC(pT1、pT2 且同侧单个淋巴结转移 pN1)患者进行术后放疗(PORT)的有效性是否能通过当前数据的荟萃分析来评估。
荟萃分析包括随机和非随机研究。排除高危肿瘤,其定义为大小≥pT3/pT4、淋巴结受累≥pN2,或存在其他组织学危险因素,如阳性切缘受累、疾病的淋巴结外扩散或淋巴管癌病。主要结局分析不同治疗组之间的死亡率。
仅有一项前瞻性随机临床试验和六项回顾性观察性研究适合评估。描述性分析显示,照射组的死亡率略高(44% vs. 34%)。相比之下,在有和没有对照和治疗组事件的七项研究中的两项的森林图显示,照射组具有优势,但存在较大的异质性和缺乏统计学意义的限制。
目前的数据较差,显示出有限的内部和外部有效性;因此,与合格的研究无法进行直接比较。因此,当前数据的荟萃分析可能无法作为一般治疗建议的基础,但强调了需要进行前瞻性、随机、对照临床试验的必要性。