【每日动态】老年前列腺癌筛查
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Prostate cancer screening in men aged 50–69years (STHLM3): a prospective population-based diagnostic study
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00361-7/fulltext
Background
The prostate-specific antigen (PSA) test isused to screen for prostate cancer but has a high false-positive rate thattranslates into unnecessary prostate biopsies and overdiagnosis of low-riskprostate cancers. We aimed to develop and validate a model to identifyhigh-risk prostate cancer (with a Gleason score of at least 7) with better testcharacteristics than that provided by PSA screening alone.
Methods
The Stockholm 3 (STHLM3) study is aprospective, population-based, paired, screen-positive, diagnostic study of menwithout prostate cancer aged 50–69 years randomly invited by date of birth fromthe Swedish Population Register kept by the Swedish Tax Agency. Men withprostate cancer at enrolment were excluded from the study. The predefinedSTHLM3 model (a combination of plasma protein biomarkers [PSA, free PSA, intactPSA, hK2, MSMB, MIC1], genetic polymorphisms [232 SNPs], and clinical variables[age, family, history, previous prostate biopsy, prostate exam]), and PSAconcentration were both tested in all participants enrolled. The primary aimwas to increase the specificity compared with PSA without decreasing thesensitivity to diagnose high-risk prostate cancer. The primary outcomes werenumber of detected high-risk cancers (sensitivity) and the number of performedprostate biopsies (specificity). The STHLM3 training cohort was used to train theSTHLM3 model, which was prospectively tested in the STHLM3 validation cohort.Logistic regression was used to test for associations between biomarkers andclinical variables and prostate cancer with a Gleason score of at least 7. Thisstudy is registered with ISCRTN.com, number ISRCTN84445406.
Findings
The STHLM3 model performed significantlybetter than PSA alone for detection of cancers with a Gleason score of at least7 (p<0·0001), the area under the curve was 0·56 (95% CI 0·55–0·60) with PSAalone and 0·74 (95% CI 0·72–0·75) with the STHLM3 model. All variables used inthe STHLM3 model were significantly associated with prostate cancers with aGleason score of at least 7 (p<0·05) in a multiple logistic regression model. At the same level ofsensitivity as the PSA test using a cutoff of ≥3 ng/mL to diagnose high risk prostate cancer, use of the STHLM3model could reduce the number of biopsies by 32% (95% CI 24–39) and could avoid44% (35–54) of benign biopsies.
Interpretation
The STHLM3 model could reduce unnecessarybiopsies without compromising the ability to diagnose prostate cancer with aGleason score of at least 7, and could be a step towards personalisedrisk-based prostate cancer diagnostic programmes.
Funding
Stockholm County Council (Stockholms LänsLandsting).
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00361-7/fulltext
Background
The prostate-specific antigen (PSA) test isused to screen for prostate cancer but has a high false-positive rate thattranslates into unnecessary prostate biopsies and overdiagnosis of low-riskprostate cancers. We aimed to develop and validate a model to identifyhigh-risk prostate cancer (with a Gleason score of at least 7) with better testcharacteristics than that provided by PSA screening alone.
Methods
The Stockholm 3 (STHLM3) study is aprospective, population-based, paired, screen-positive, diagnostic study of menwithout prostate cancer aged 50–69 years randomly invited by date of birth fromthe Swedish Population Register kept by the Swedish Tax Agency. Men withprostate cancer at enrolment were excluded from the study. The predefinedSTHLM3 model (a combination of plasma protein biomarkers [PSA, free PSA, intactPSA, hK2, MSMB, MIC1], genetic polymorphisms [232 SNPs], and clinical variables[age, family, history, previous prostate biopsy, prostate exam]), and PSAconcentration were both tested in all participants enrolled. The primary aimwas to increase the specificity compared with PSA without decreasing thesensitivity to diagnose high-risk prostate cancer. The primary outcomes werenumber of detected high-risk cancers (sensitivity) and the number of performedprostate biopsies (specificity). The STHLM3 training cohort was used to train theSTHLM3 model, which was prospectively tested in the STHLM3 validation cohort.Logistic regression was used to test for associations between biomarkers andclinical variables and prostate cancer with a Gleason score of at least 7. Thisstudy is registered with ISCRTN.com, number ISRCTN84445406.
Findings
The STHLM3 model performed significantlybetter than PSA alone for detection of cancers with a Gleason score of at least7 (p<0·0001), the area under the curve was 0·56 (95% CI 0·55–0·60) with PSAalone and 0·74 (95% CI 0·72–0·75) with the STHLM3 model. All variables used inthe STHLM3 model were significantly associated with prostate cancers with aGleason score of at least 7 (p<0·05) in a multiple logistic regression model. At the same level ofsensitivity as the PSA test using a cutoff of ≥3 ng/mL to diagnose high risk prostate cancer, use of the STHLM3model could reduce the number of biopsies by 32% (95% CI 24–39) and could avoid44% (35–54) of benign biopsies.
Interpretation
The STHLM3 model could reduce unnecessarybiopsies without compromising the ability to diagnose prostate cancer with aGleason score of at least 7, and could be a step towards personalisedrisk-based prostate cancer diagnostic programmes.
Funding
Stockholm County Council (Stockholms LänsLandsting).
