DANTE试验，螺旋CT筛查肺癌的临床试验，7年的结果
O05.01 | The DANTE trial, a randomized study of lung cancer screening with spiral CT: 7-year results
Authors: Maurizio V. Infante1, Silvio Cavuto2, Fabio R. Lutman1, Eliseo Passera3, Giuseppe Chiesa3, Giorgio Brambilla1, Enzo Angeli3, Maurizio Chiarenza4, Giuseppe Aranzulla4, Martina Andresi1, Valentina Errico1, Edoardo Bottoni1, Emanuele Voulaz1, Armando Santoro1, Marco Alloisio1
1Istituto Clinico Humanitas, Rozzano (Milano)/ITALY, 2IRCCS-Arcispedale Santa Maria Nuova, Reggio Emilia,/ITALY, 3Humanitas - Gavazzeni, Bergamo/ITALY, 4Humanitas - Catania Oncology Centre, Catania/ITALY
Background
The purpose of this study was to explore the effect of screening with spiral CT on lung cancer mortality in comparison with no screening in a high-risk population. Secondary endpoints were incidence, stage and resectability.
Methods
Male subjects, aged 60-75, smokers of 20+ pack-years were randomized to screening with low-dose spiral CT or control. Prospective participants were pre-assessed for eligibility and randomized during a telephone interview, while formal enrolment took place at a later date.
All enrolled participants underwent a structured medical interview and physical examination, a baseline, once-only chest X-ray (CXR) and sputum cytology examination. Screening-arm subjects had a LDCT upon accrual, which was repeated every year for four additional years (5 rounds), while controls had a yearly clinical review only, with further testing only if needed.
Results
Between March 2001 and February 2006, 2811 subjects were pre-assessed and randomized (CT arm: 1403, control arm:1408). 20 cases of double registration and two test records have been identified in the database, and 2540 subjects actually appeared for assessment (1229 CTR arm, 1299 CT arm), of whom 2450 (1264 CT arm and 1186 Controls) were eligible and enrolled.
The two study groups are comparable for age, smoking exposure, and comorbid conditions. As per inclusion criteria, all subjects are males and 99.8 % are 60 or older.
As of December 2012, median follow-up was 73.1 months in the control arm and 75.5 months in the screening arm. Altogether, 152 patients were detected during active follow-up with 161 lung cancers: 92 CT-arm subjects (7.27%) versus 60 controls (5.05%), p< 0,0237.
82% of CT-arm lung cancers were detected at scheduled CT examinations, and 55% were stage I disease at the time of diagnosis compared with 27% in the Control arm. The absolute number of lung cancer cases with stage II-IV disease was virtually the same as in the control arm. Resectability rate was similar in the two groups.
After linkage with population registries, vital status information is now available for 2528 subjects (99.5%). Overall, 370 subjects have died, for 104 of whom we are currently investigating mortality causes.
Conclusion
While the number of participants is relatively small, smoking exposure and average age of participants are higher than in similar trials. A comparatively high number of events has been observed. To date, 28% of such events cannot yet be attributed to a specific cause. Health registry data necessary to complete mortality comparisons is expected to become available in the next few weeks. Merging of all European trials may yield robust data about this strategy in the future.
