Pneumonology Department, Careggi Hospital, Florence, Italy.
J Thorac Oncol. 2013 Jul;8(7):866-75. doi: 10.1097/JTO.0b013e31828f68d6.
Recruitment and nodule management are critical issues of lung cancer screening with low-dose computed tomography (LDCT). We report subjects' compliance and results of LDCT screening and management protocol in the active arm of the ITALUNG trial.
Three thousand two hundred six smokers or former smokers invited by mail were randomized to receive four annual LDCT (n = 1613) or usual care (n = 1593). Management protocol included follow-up LDCT, 2-[18F]fluoro-2-deoxy-D glucose positron emission tomography (FDG-PET), and CT-guided fine-needle aspiration biopsy (FNAB).
One thousand four hundred six subjects (87%) underwent baseline LDCT, and 1263 (79%) completed four screening rounds. LDCT was positive in 30.3% of the subjects at baseline and 15.8% subsequently. Twenty-one lung tumors in 20 subjects (1.5% detection) were found at baseline, and 20 lung tumors in 18 subjects (0.5% detection) in subsequent screening rounds. Ten of 18 prevalent (55%) and 13 of 17 incident (76%) non-small-cell cancers were in stage I. Interval growth enabled diagnosis of lung cancer in 16 subjects (42%), but at least one follow-up LDCT was obtained in 741 subjects (52.7%) over the screening period. FDG-PET obtained in 6.5% of subjects had 84% sensitivity and 90% specificity for malignant lesions. FNAB obtained in 2.4% of subjects showed 90% sensitivity and 88% specificity. Positivity of both FDG-PET and FNAB invariably predicted malignancy. Surgery for benign lesions was performed on four subjects (10% of procedures) but followed protocol violations on three subjects.
High-risk subjects recruited by mail who entered LDCT screening showed a high and stable compliance. Efficacy of screening is, however, weakened by low detection rate and specificity. Adhesion to management protocol might lessen surgery for benign lesions.
在低剂量计算机断层扫描（LDCT）肺癌筛查中，招募和结节管理是关键问题。我们报告了 ITALUNG 试验主动臂中 LDCT 筛查和管理方案的受试者依从性和结果。
通过邮件邀请了 3206 名吸烟者或前吸烟者，将其随机分为接受 4 次年度 LDCT（n=1613）或常规护理（n=1593）。管理方案包括随访 LDCT、2-[18F]氟-2-脱氧-D 葡萄糖正电子发射断层扫描（FDG-PET）和 CT 引导下细针抽吸活检（FNAB）。
1406 名受试者（87%）接受了基线 LDCT，1263 名（79%）完成了 4 轮筛查。基线时，30.3%的受试者 LDCT 结果阳性，随后 15.8%的受试者阳性。20 名受试者的 21 个肺肿瘤（检出率为 1.5%）和 18 名受试者的 20 个肺肿瘤（检出率为 0.5%）在随后的筛查中发现。18 例新发（76%）非小细胞癌中有 13 例（76%）和 17 例（55%）已确诊的癌症为 I 期。间隔性生长使 16 名受试者（42%）的肺癌得以诊断，但在筛查期间，至少有 741 名受试者（52.7%）进行了 1 次以上的 LDCT 随访。在 6.5%的受试者中进行的 FDG-PET 检查对恶性病变的敏感性为 84%，特异性为 90%。在 2.4%的受试者中进行的 FNAB 检查显示敏感性为 90%，特异性为 88%。FDG-PET 和 FNAB 的阳性结果都预示着恶性肿瘤的发生。对 4 名受试者（手术率为 10%）进行了良性病变的手术，但其中 3 名违反了方案。
通过邮件招募的高危受试者参加 LDCT 筛查的依从性较高且稳定。然而，由于检测率和特异性较低，筛查的效果受到了削弱。遵守管理方案可能会减少对良性病变的手术。
