Lung cancer screening with low-dose spiral computed tomography: evidence from a pooled analysis of two Italian randomized trials

Maurizio Infante, Stefano Sestini, Carlotta Galeone, Alfonso Marchianò, Fabio R Lutman, Enzo Angeli, Giuseppina Calareso, Giuseppe Pelosi, Gabriella Sozzi, Mario Silva, Nicola Sverzellati, Silvio Cavuto, Carlo La Vecchia, Armando Santoro, Marco Alloisio, Ugo Pastorino

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Abstract

The benefits and harms of lung cancer (LC) screening with low-dose computed tomography (LDCT) are debatable. Positive results from the US National Lung Screening Trial were not evident in the European trials, possibly due to their smaller sample sizes. To address this issue, we conducted a patient-level pooled analysis of two Italian randomized controlled trials. Data from DANTE and MILD trials were combined for a total of 3640 individuals in the LDCT arm and 2909 in the control arm. LC and overall mortality were analyzed using multivariate hazard ratios (HRs) and log-rank tests stratified by study. The median follow-up was 8.2 years, with a total of 30 480 person-years in the LDCT arm and 22 157 in the control arm. A total of 192 patients developed LC in the LDCT arm and 105 in the control arm. Half of the LC cases in the LDCT arm had stage IA or IB cancer, as compared with 21% in the control arm. Overall mortality rates/100 000 person-years were 925 in the LDCT arm and 1074 in the control arm, and LC mortality rates were 299 and 357, respectively. The multivariate pooled overall mortality HR was 0.89 (95% confidence interval: 0.74-1.06) and the LC mortality HR was 0.83 (95% confidence interval: 0.61-1.12) for the LDCT arm as compared with the control arm. The present pooled analysis shows a nonsignificant 11% reduction in overall mortality in individuals undergoing LDCT screening as compared with the control arm. A pooled analysis of all European trials would be a useful contribution to assess the real benefit of LDCT screening.

Original languageEnglish
JournalEuropean Journal of Cancer Prevention
DOIs
Publication statusE-pub ahead of print - May 24 2016

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Spiral Computed Tomography
Early Detection of Cancer
Lung Neoplasms
Tomography
Mortality
Confidence Intervals
Sample Size
Randomized Controlled Trials
Lung

Keywords

  • Journal Article

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Lung cancer screening with low-dose spiral computed tomography : evidence from a pooled analysis of two Italian randomized trials. / Infante, Maurizio; Sestini, Stefano; Galeone, Carlotta; Marchianò, Alfonso; Lutman, Fabio R; Angeli, Enzo; Calareso, Giuseppina; Pelosi, Giuseppe; Sozzi, Gabriella; Silva, Mario; Sverzellati, Nicola; Cavuto, Silvio; La Vecchia, Carlo; Santoro, Armando; Alloisio, Marco; Pastorino, Ugo.

In: European Journal of Cancer Prevention, 24.05.2016.

Research output: Contribution to journalArticle

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AU - Infante, Maurizio

AU - Sestini, Stefano

AU - Galeone, Carlotta

AU - Marchianò, Alfonso

AU - Lutman, Fabio R

AU - Angeli, Enzo

AU - Calareso, Giuseppina

AU - Pelosi, Giuseppe

AU - Sozzi, Gabriella

AU - Silva, Mario

AU - Sverzellati, Nicola

AU - Cavuto, Silvio

AU - La Vecchia, Carlo

AU - Santoro, Armando

AU - Alloisio, Marco

AU - Pastorino, Ugo

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N2 - The benefits and harms of lung cancer (LC) screening with low-dose computed tomography (LDCT) are debatable. Positive results from the US National Lung Screening Trial were not evident in the European trials, possibly due to their smaller sample sizes. To address this issue, we conducted a patient-level pooled analysis of two Italian randomized controlled trials. Data from DANTE and MILD trials were combined for a total of 3640 individuals in the LDCT arm and 2909 in the control arm. LC and overall mortality were analyzed using multivariate hazard ratios (HRs) and log-rank tests stratified by study. The median follow-up was 8.2 years, with a total of 30 480 person-years in the LDCT arm and 22 157 in the control arm. A total of 192 patients developed LC in the LDCT arm and 105 in the control arm. Half of the LC cases in the LDCT arm had stage IA or IB cancer, as compared with 21% in the control arm. Overall mortality rates/100 000 person-years were 925 in the LDCT arm and 1074 in the control arm, and LC mortality rates were 299 and 357, respectively. The multivariate pooled overall mortality HR was 0.89 (95% confidence interval: 0.74-1.06) and the LC mortality HR was 0.83 (95% confidence interval: 0.61-1.12) for the LDCT arm as compared with the control arm. The present pooled analysis shows a nonsignificant 11% reduction in overall mortality in individuals undergoing LDCT screening as compared with the control arm. A pooled analysis of all European trials would be a useful contribution to assess the real benefit of LDCT screening.

AB - The benefits and harms of lung cancer (LC) screening with low-dose computed tomography (LDCT) are debatable. Positive results from the US National Lung Screening Trial were not evident in the European trials, possibly due to their smaller sample sizes. To address this issue, we conducted a patient-level pooled analysis of two Italian randomized controlled trials. Data from DANTE and MILD trials were combined for a total of 3640 individuals in the LDCT arm and 2909 in the control arm. LC and overall mortality were analyzed using multivariate hazard ratios (HRs) and log-rank tests stratified by study. The median follow-up was 8.2 years, with a total of 30 480 person-years in the LDCT arm and 22 157 in the control arm. A total of 192 patients developed LC in the LDCT arm and 105 in the control arm. Half of the LC cases in the LDCT arm had stage IA or IB cancer, as compared with 21% in the control arm. Overall mortality rates/100 000 person-years were 925 in the LDCT arm and 1074 in the control arm, and LC mortality rates were 299 and 357, respectively. The multivariate pooled overall mortality HR was 0.89 (95% confidence interval: 0.74-1.06) and the LC mortality HR was 0.83 (95% confidence interval: 0.61-1.12) for the LDCT arm as compared with the control arm. The present pooled analysis shows a nonsignificant 11% reduction in overall mortality in individuals undergoing LDCT screening as compared with the control arm. A pooled analysis of all European trials would be a useful contribution to assess the real benefit of LDCT screening.

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