Cancer Clinic, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway.
Acta Oncol. 2013 May;52(4):727-35. doi: 10.3109/0284186X.2013.747695. Epub 2013 Feb 11.
The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system for grading of side effects after radiotherapy was proposed several years ago. Only a few studies have previously been performed on the validity of the LENT/SOMA. The aim of the present study was to validate the LENT/SOMA scoring system for recto-anal side effects after treatment for prostate cancer in a randomized trial.
A total of 875 patients with locally advanced prostate cancer were randomized to either hormonal treatment alone or hormonal treatment plus radiotherapy in the Scandinavian Prostate Cancer Group 7 (SPCG-7) study. At least three years after treatment was started, the 178 patients that were randomized at St. Olavs Hospital were approached. One hundred and three patients of these accepted inclusion. The side effects according to LENT/SOMA were graded by oncologist and nurse. In addition, side effects were graded according to the European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group (EORTC/RTOG) toxicity scale and patient-reported health-related quality of life (HRQOL) questionnaires. Content/face validity, sensitivity and inter-rater reliability of the LENT/SOMA tables for rectum were analyzed.
Content/face analysis of LENT/SOMA revealed serious problems. Significant correlations (Spearman's rho > 0.4) were found between three of 15 LENT/SOMA items and similar HRQOL items. LENT/SOMA score made it possible to detect significant differences between the two groups of patients (p < 0.001), EORTC/RTOG toxicity score did not (p = 0.138). Inter-rater reliability was acceptable.
LENT/SOMA scoring system for recto-anal side effects after radiotherapy for prostate cancer displays serious difficulties in the present study. Replacement of LENT/SOMA tables for rectum by a combination of patient-reported HRQOL questionnaires, clinical examination and objective physiological measurements might be called for.
几年前提出了用于放疗后副作用分级的晚期正常组织/主观客观管理分析（LENT/SOMA）系统。之前只有少数研究对 LENT/SOMA 的有效性进行了研究。本研究的目的是在一项随机试验中验证 LENT/SOMA 评分系统在前列腺癌放疗后直肠肛门副作用的适用性。
875 例局部晚期前列腺癌患者被随机分为单独激素治疗或激素联合放疗的斯堪的纳维亚前列腺癌研究 7 组（SPCG-7）。治疗开始至少 3 年后，对在圣奥拉夫医院随机分组的 178 例患者进行了调查。其中 103 例患者同意入组。由肿瘤学家和护士根据 LENT/SOMA 对副作用进行分级。此外，还根据欧洲癌症研究与治疗组织/放射治疗肿瘤组（EORTC/RTOG）毒性量表和患者报告的健康相关生活质量（HRQOL）问卷对副作用进行分级。分析了 LENT/SOMA 直肠部分的内容/表面有效性、敏感性和评分者间信度。
LENT/SOMA 的内容/表面分析显示出严重的问题。LENT/SOMA 的 15 项中的 3 项与类似的 HRQOL 项之间存在显著相关性（Spearman's rho > 0.4）。LENT/SOMA 评分能够检测出两组患者之间的显著差异（p < 0.001），而 EORTC/RTOG 毒性评分则不能（p = 0.138）。评分者间信度可接受。
在本研究中，LENT/SOMA 评分系统在前列腺癌放疗后直肠肛门副作用的应用存在严重困难。可能需要用患者报告的 HRQOL 问卷、临床检查和客观生理测量来替代直肠的 LENT/SOMA 表格。
