Prasad Srinivasa R, Saini Sanjay, Sumner James E, Hahn Peter F, Sahani Dushyant, Boland Giles W
Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
J Comput Assist Tomogr. 2003 May-Jun;27(3):380-4. doi: 10.1097/00004728-200305000-00014.
Radiologic assessment of "response-to-treatment" during clinical trials of anticancer drugs has been conventionally based on bidirectional tumor measurement. Recently, the revised guidelines were published, which recommended unidirectional tumor measurements. The purpose of this study was to compare response to treatment between the two measurement techniques in breast cancer patients with lung and liver metastases.
Contrast-enhanced computed tomography studies of 86 breast cancer patients who had lung (n = 27) and liver (n = 59) metastases and who were enrolled in a phase-III oncology trial were evaluated before initiation of treatment and at 6 months after treatment. Lesions were measured by subspecialist radiologists on digitized images using electronic calipers. The largest diameter of the lesions was extracted from bidimensional measurements. Response to treatment was categorized into one of four categories: complete response indicating lesion disappearance, partial response indicating >30% decrease in tumor diameter, or >50% reduction in tumor area, disease progression indicating >20% increase in tumor diameter, or >25% increase in tumor area, and stable disease (neither complete response, partial response, nor disease progression). Response to treatment between the two measurement techniques was compared statistically using the chi2 test.
Response to treatment was concordant in 76 patients between unidimensional and bidimensional measurement techniques. In 5 patients (2 lung and 3 liver metastases) the response assessment was improved using unidimensional criteria and in 5 patients (2 lung and 3 liver metastases) the response was worse using unidimensional guidelines. Thus, the overall response rate was 50% for both unidimensional and bidimensional measurement techniques. There was no statistical difference between the two techniques.
Unidimensional measurements are appropriate for measuring the size of liver and lung metastases for determining response to treatment during clinical testing of oncologic drugs.
在抗癌药物临床试验期间，对“治疗反应”的放射学评估传统上基于双向肿瘤测量。最近，修订后的指南发布，推荐采用单向肿瘤测量。本研究的目的是比较两种测量技术在伴有肺和肝转移的乳腺癌患者中的治疗反应。
对86例伴有肺转移（n = 27）和肝转移（n = 59）且参加III期肿瘤学试验的乳腺癌患者，在治疗开始前和治疗后6个月进行对比增强计算机断层扫描研究。由专科放射科医生使用电子卡尺在数字化图像上测量病变。从二维测量中提取病变的最大直径。治疗反应分为四类之一：完全缓解表示病变消失，部分缓解表示肿瘤直径减小> 30%，或肿瘤面积减小> 50%，疾病进展表示肿瘤直径增加> 20%，或肿瘤面积增加> 25%，以及疾病稳定（既非完全缓解、部分缓解，也非疾病进展）。使用卡方检验对两种测量技术之间的治疗反应进行统计学比较。
76例患者的单向和双向测量技术的治疗反应一致。在5例患者（2例肺转移和3例肝转移）中，使用单向标准时反应评估得到改善，而在5例患者（同样是2例肺转移和3例肝转移）中，使用单向指南时反应更差。因此，单向和双向测量技术的总体反应率均为50%。两种技术之间无统计学差异。
在肿瘤药物临床试验期间，单向测量适用于测量肝和肺转移灶的大小以确定治疗反应。
