Picozzi G, Paci E, Lopez Pegna A, Bartolucci M, Roselli G, De Francisci A, Gabrielli S, Masi A, Villari N, Mascalchi M
Radiodiagnostica I, Dipartimento di Fisiopatologia Clinica, Università degli Studi di Firenze, Italy.
Radiol Med. 2005 Jan-Feb;109(1-2):17-26.
To report the results of a three-year observational pilot study of lung cancer screening with low dose computed tomography (CT) and to present the study design of a randomised clinical trial named as ''Italung-CT''.
Sixty (47 males and 13 females, mean age 64+/-4.5 years) heavy smokers (at least 20 packs-year) underwent three low-dose spiral CT screening tests one year apart on a single slice or multislice CT scanner. Indeterminate nodules were managed according to the recommendations of the Early Lung Cancer Action Project.
and Indeterminate nodules were observed in 33 (55%) of the subjects (60% at the baseline screening test, 24% at the first annual test and 16% at the second annual test). The size of the largest indeterminate nodule was <5 mm in diameter in 20 subjects, 10 of whom showed the nodule at the baseline test. Forty-five subjects (75%) completed the first annual test and 42 (70%) the second annual test. One (1.6%) prevalent lung cancer (adenosquamous carcinoma) and one (2.2%) incident lung cancer (small cell cancer at the first annual examination) were observed, as well as a pulmonary localisation of Hodgkin's lymphoma (at the second annual test). In addition, one subject underwent lung surgery for a chondromatous hamartoma.
The results of the pilot study are substantially in line with those of other observational studies of greater sample size. This justifies optimism about the reliability of the results in the screened arm of the ''Italung CT'' trial which has just begun.
报告一项为期三年的低剂量计算机断层扫描（CT）肺癌筛查观察性试点研究结果，并介绍一项名为“Italung-CT”的随机临床试验的研究设计。
60名（47名男性和13名女性，平均年龄64±4.5岁）重度吸烟者（至少20包年）在单层或多层CT扫描仪上每年接受一次，共进行三次低剂量螺旋CT筛查。根据早期肺癌行动计划的建议处理不确定结节。
33名（55%）受试者观察到不确定结节（基线筛查时为60%，首次年度检查时为24%，第二次年度检查时为16%）。20名受试者中最大的不确定结节直径<5mm，其中10名在基线检查时发现该结节。45名受试者（75%）完成了首次年度检查，42名（70%）完成了第二次年度检查。观察到1例（1.6%）现患肺癌（腺鳞癌）和1例（2.2%）新发肺癌（首次年度检查时为小细胞癌），以及1例霍奇金淋巴瘤肺部定位（第二次年度检查时）。此外，1名受试者因软骨瘤性错构瘤接受了肺手术。
试点研究结果与其他样本量更大的观察性研究结果基本一致。这为刚刚开始的“Italung CT”试验筛查组结果的可靠性带来了乐观预期。
