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Risk-Benefit Analysis of X-Ray Exposure Associated with Lung Cancer Screening in the Italung-CT Trial

¹ Sezione di Radiodiagnostica, Dipartimento di Fisiopatologia Clinica, Università di Firenze, Viale Morgagni 85, 50134 Firenze, Italia.
² Fisica Sanitaria, Azienda Ospedaliera Careggi, Firenze, Italia.
³ Centro di Studio e Prevenzione Oncologica, Firenze, Italia.
⁴ U.O. Radiologia Diagnostica, Azienda Ospedaliera Careggi, Firenze, Italia.
⁵ U.O. Pneumologia, Azienda Ospedaliera Careggi, Firenze, Italia.

View larger version (16K): [in a new window]   Fig. 1A —Risk-to-benefit ratios for study participants. Risk-to-benefit ratio (log units) histograms for male (A) and female (B) never-smokers, ex-smokers, and current smokers associated with four annual screening examinations with MDCT (MD) and single-detector (SD) (low-dose thick-collimation plus one full-dose thin-collimation package) scanners in the Italung-CT Trial. Three different levels of expected benefit—namely, 10%, 20%, and 30% reduction of lung cancer mortality—are considered. Assuming 10% reduction of mortality, risk-benefit ratio is over the unit—that is, the number of radiation-induced deaths overcomes the estimated number of lives saved, for male (1.13) and female (1.66) never-smokers examined with the single-detector scanner. At the same level of screening efficacy, the ratio is between 1 and 0.1 and close to the critic value of 0.5, implying only two lives saved for one radiation-induced death, for male (0.53) or female (0.78) never-smokers examined with an MDCT scanner, for female former smokers examined with a single-detector (0.87) or MDCT (0.41) scanner, and for male former smokers examined with a single-detector scanner (0.53). Assuming 20% or 30% screening efficacy, the ratio is around or below 0.1 for male and female current smokers examined with either a single-detector or MDCT scanner.

View larger version (15K): [in a new window]   Fig. 1B —Risk-to-benefit ratios for study participants. Risk-to-benefit ratio (log units) histograms for male (A) and female (B) never-smokers, ex-smokers, and current smokers associated with four annual screening examinations with MDCT (MD) and single-detector (SD) (low-dose thick-collimation plus one full-dose thin-collimation package) scanners in the Italung-CT Trial. Three different levels of expected benefit—namely, 10%, 20%, and 30% reduction of lung cancer mortality—are considered. Assuming 10% reduction of mortality, risk-benefit ratio is over the unit—that is, the number of radiation-induced deaths overcomes the estimated number of lives saved, for male (1.13) and female (1.66) never-smokers examined with the single-detector scanner. At the same level of screening efficacy, the ratio is between 1 and 0.1 and close to the critic value of 0.5, implying only two lives saved for one radiation-induced death, for male (0.53) or female (0.78) never-smokers examined with an MDCT scanner, for female former smokers examined with a single-detector (0.87) or MDCT (0.41) scanner, and for male former smokers examined with a single-detector scanner (0.53). Assuming 20% or 30% screening efficacy, the ratio is around or below 0.1 for male and female current smokers examined with either a single-detector or MDCT scanner.

View larger version (15K): [in a new window]   Fig. 2A —Risk-to-benefit histograms for men and women stratified by age. Risk-to-benefit ratio (log units) histograms for males (A) and females (B) commencing 4 years of annual screening rounds on an MDCT (MD) or single-detector (SD) (low-dose thick-collimation plus one full-dose thin-collimation package) scanner in different age categories: 55-59, 60-64, and 65-69 years. Efficacy of screening is assumed to be 20% in reducing mortality in 8 years after start of program. For current smokers, risk-benefit ratio ranges between 0.21 in women who are 55-59 years old examined on a single-detector scanner and 0.008 in men who are 65-69 years old examined on an MDCT scanner.

View larger version (13K): [in a new window]   Fig. 2B —Risk-to-benefit histograms for men and women stratified by age. Risk-to-benefit ratio (log units) histograms for males (A) and females (B) commencing 4 years of annual screening rounds on an MDCT (MD) or single-detector (SD) (low-dose thick-collimation plus one full-dose thin-collimation package) scanner in different age categories: 55-59, 60-64, and 65-69 years. Efficacy of screening is assumed to be 20% in reducing mortality in 8 years after start of program. For current smokers, risk-benefit ratio ranges between 0.21 in women who are 55-59 years old examined on a single-detector scanner and 0.008 in men who are 65-69 years old examined on an MDCT scanner.

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