Background
Methods
Study registration
Literature search strategy
Inclusion and exclusion criteria
Literature selection for the systematic review and meta-analysis
Data abstraction
Statistical analyses
Results
Calibration of the Gail model
Reference | Author | Publication year | Geographic background | Gail model version | 5/10-year risk | Sample size | Mean age (years) | Study population | Risk for breast cancera | Time period | Follow-up period | E/O (95% CI) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
[9] | Bondy | 1994 | America | 1 | 5 | 1981 | 30–75 | American Cancer Society 1987 Texas Breast Screening Project (with family history of breast cancer) | High risk | 1987–1992 | 5.0 | 1.31 (0.96–1.79) |
[10] | Spiegelman | 1994 | America | 1 | 5 | 115,172 | 29–61 | Nurses’ Health Study (NHS) | General population | 1976–1981 | 6.0 | 1.33 (1.28–1.39) |
[12] | Costantino-1 | 1999 | America | 1 | 5 | 5969 | > 35 | Placebo group of Breast cancer prevention trial (BCPT) | General population | 1992–1998 | 4.03 (0.1–5.83) | 0.84 (0.73–0.97) |
[12] | Costantino-2 | 1999 | America | 2 | 5 | 5969 | > 35 | Placebo group of Breast cancer prevention trial (BCPT) | General population | 1992–1998 | 4.03 (0.1–5.83) | 1.03 (0.88–1.21) |
[11] | Rockhill | 2001 | America | 2 | 5 | 82,109 | 45–71 | Nurses’ Health Study (NHS) | General population | 1992–1997 | 5.0 | 0.94 (0.89–0.99) |
[30] | Amir | 2003 | United Kingdom | 2 | 10 | 3150 | 44 (21–73) | Women attending the Family History Screening Programme in University Hospital of South Manchester | Not defined | 1987–2001 | 5.27 (0.1–15) | 0.69 (0.54–0.90) |
[13] | Bernatsky | 2004 | America | 1 | 5 | 871 | 41 ± 13 | Systemic lupus erythematosus clinic cohorts at Canada, Northwestern and UK center | High risk | 1984–2000 | 9.1 | 0.48 (0.29–0.80) |
[14] | Olson | 2004 | America | 1 | 5 | 674 | 31–90 | Women with possible bilateral oophorectomy identified from the Mayo Clinic Surgical Index | Low risk | 1994–2004 | NA | 1.37 (0.92–2.04) |
[28] | Boyle | 2004 | Italy | 2 | 5 | 5383 | NA | Women participated in RCT of tamoxifen for breast cancer prevention in Italy | General population | 1992–2001 | 5.0 | 1.16 (0.89–1.49) |
[29] | Decarli | 2006 | Italy | 2 | 5 | 10,031 | 35–64 | Florence—European Prospective Investigation Into Cancer and Nutrition Cohort (EPIC) | General population | 1993–2002 | 9.0 | 0.93 (0.81–1.07) |
[31] | Chlebowski | 2007 | America | 2 | 5 | 147,916 | 63 (50–79) | Women’s Health Initiative (WHI) | General population | 1993–2005 | 5.0 | 0.79 (0.77–0.82) |
[15] | Tice | 2008 | America | 2 | 5 | 629,229 | 40–74 | National Cancer Institute-funded Breast Cancer Surveillance Consortium (BCSC) | General population | since 1994 | 5.3 | 0.88 (0.86–0.90) |
[16] | Schonfeld-1 | 2010 | America | 2 | 5 | 181,979 | 62.8 | National Institutes of Health-American Association of Retired Persons (NIH-AARP) | General population | 1995–2003 | 7.5 | 0.87 (0.85–0.89) |
[16] | Schonfeld-2 | 2010 | America | 2 | 5 | 64,868 | 62.3 | Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) | General population | 1993–2006 | 8.6 | 0.86 (0.82–0.90) |
[17] | Tarabishy | 2011 | America | 2 | 5 | 4726 | 18–85 | Mayo Benign Breast Disease (BBD) | High risk | 1991–1996 | 5.0 | 1.08 (0.88–1.33) |
[38] | Chay-1 | 2012 | Singapore | 3 | 5 | 28,104 | 50–64 | Singapore Breast Cancer Screening Project (SBCSP) | General population | 1997–2007 | 5.0 | 2.51 (2.14–2.96) |
[38] | Chay-2 | 2012 | Singapore | 3 | 10 | 28,104 | 50–64 | Singapore Breast Cancer Screening Project (SBCSP) | General population | 1997–2007 | 10.0 | 1.85 (1.68–2.04) |
[52] | Maclnnis | 2012 | Australia | NA | NA | 2000 | NA | Female relatives of the breast cancer cases in Australia | High risk | NA | 10.0 | 0.89 (0.73–1.09) |
[32] | Pastor-Barriuso | 2013 | Spain | 2 | 5 | 54,649 | 45–68 | Population-based Navarre Breast Cancer Screening Program (NBCSP) | General population | 1996–2005 | 7.7 | 1.46 (1.36–1.56) |
[33] | Buron | 2013 | Spain | 2 | 5 | 2200 | 49–64 | Participants with a positive screening mammogram in “Parc de Salut Mar” breast cancer screening program | High risk | 2003–2010 | 6.0 | 0.58 (0.54–0.63) |
[41] | Min-1 | 2014 | Korea | 2 | 5 | 40,229 | > 10 | Women routinely screened in Women’s Healthcare Center of Cheil General Hospital | Not defined | 1999–2004 | 5.0 | 2.46 (2.10–2.87) |
[41] | Min-2 | 2014 | Korea | 3 | 5 | 40,229 | > 10 | Women routinely screened in Women’s Healthcare Center of Cheil General Hospital | Not defined | 1999–2004 | 5.0 | 1.29 (1.11–1.51) |
[18] | Powell | 2014 | America | 2 | 5 | 12,843 | NA | Marin Women’s Study with high rate of breast cancer, null parity and delayed childbirth | High risk | 2003–2007 | 5.0 | 0.81 (0.71–0.93) |
[19] | McCarthy | 2015 | America | 2 | 5 | 464 | 48.7 ± 13.2 | Women referred for biopsy with abnormal (Breast Imaging Reporting And Data System, BI-RADS 4) mammograms at the Hospital of the University of Pennsylvania | High risk | 2003–2012 | 5.0 | 3.78 (2.78–5.13) |
[34] | Dartois | 2015 | France | 2 | 5 | 13,174 | 42–72 | Women in French E3N prospective cohort to investigate the cancer risk factors | General population | 1993–1998 | 5.0 | 0.97 (0.84–1.12) |
[39] | Hu | 2015 | China | 2 | 5 | 42,908 | 35–69 | Women participated in the breast cancer screening in Zhejiang eastern coastal areas of China | General population | 2008–2014 | 5.0 | 2.09 (1.73–2.52) |
[20] | Schonberg-1 | 2015 | America | 2 | 5 | 71,293 | 70 ± 7.0 | Nurses’ Health Study (NHS) | High risk | 2004–2009 | 5.0 | 1.20 (1.13–1.26) |
[20] | Schonberg-2 | 2015 | America | 2 | 5 | 79,611 | 71 ± 6.8 | Women’s Health Initiative (WHI), extensive study | High risk | 2005–2010 | 5.0 | 1.05 (1.00–1.10) |
[35] | Brentnall | 2015 | United Kingdom | 2 | 10 | 50,628 | 47–73 | 15 screening areas in Greater Manchester, UK | General population | 2009–2014 | 3.2 | 2.67 (2.46–2.90) |
Trial sequential analysis
Discrimination of the Gail model
Reference | Author | Publication year | Geographic background | Study design | Gail model version | 5/10-year risk | Sample size | Mean age (years) | Study population | Risk for breast cancera | Time period | Follow-up period | C-statistic/AUC (95% CI) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[11] | Rockhill | 2001 | America | Cohort | 2 | 5 | 82,109 | 45–71 | Nurses’ Health Study (NHS) | General population | 1992–1997 | 5.0 | 0.58 (0.56–0.60) |
[30] | Amir | 2003 | United Kingdom | Cohort | 2 | 10 | 3150 | 21–73 | Women attending the Family History Screening Programme in University Hospital of South Manchester | Not defined | 1987–2001 | 5.0 | 0.74 (0.67–0.80) |
[21] | Tice | 2005 | America | Cohort | 2 | 5 | 81,777 | 55.9 | Community-based registry San Francisco Mammography Registry (SFMR) | General population | 1993–2002 | 5.1 (0.1–15) | 0.67 (0.65–0.68) |
[29] | Decarli | 2006 | Italy | Cohort | 2 | 5 | 10,031 | 35–64 | Florence—European Prospective Investigation Into Cancer and Nutrition cohort (EPIC) | General population | 1993–2002 | 9.0 | 0.59 (0.55–0.63) |
[36] | Crispo | 2008 | Italy | Case–control | 1 | 5 | 1765 | 53.7 | National Cancer Institute of Naples (southern Italy) | NA | 1997–2000 | NA | 0.55 (0.53–0.58) |
[15] | Tice | 2008 | America | Cohort | 2 | 5 | 251,789 | 40–74 | National Cancer Institute-funded Breast Cancer Surveillance Consortium (BCSC) | General population | since 1994 | 5.3 | 0.61 (0.60–0.62) |
[42] | Pan | 2009 | China | Cross-sectional | 1 | 5 | 2133 | > 35 | Breast cancer risk assessment, evaluation and health education program, in Beijing and Guangzhou community | NA | 2006–2007 | NA | 0.64 (0.61–0.67) |
[43] | Liu | 2010 | China | Cross-sectional | 2 | 5 | 246 | 49.82 | High-risk breast cancer screening model and chemical intervention study at the community level | NA | 2007–2009 | NA | 0.56 (0.49–0.64) |
[44] | Wang | 2010 | China | Case–control | 1 | 5 | 228 | 32–75 | Shenzhou Hospital of Shenyang Medical College-based breast cancer cases and control | NA | 1998–2007 | NA | 0.93 (0.89–0.97) |
[17] | Tarabishy | 2011 | America | Cohort | 2 | 5 | 4726 | 18–85 | Mayo Benign Breast Disease (BBD) | High risk | 1982–1991 | 16.2 | 0.64 (0.62–0.66) |
[22] | Vacek | 2011 | America | Cohort | 1 | 5 | 19,779 | > 70 | Vermont Breast Cancer Surveillance System (VBCSS) | High risk | 2001–2009 | 7.1 | 0.54 (0.52–0.56) |
[27] | Banegas | 2012 | America | Cohort | 2 | 5 | 128,976 | 63.51 | Women’s Health Initiative (WHI) | General population | 1993–2005 | 5.0 | 0.58 (0.57–0.59) |
[23] | Quante | 2012 | America | Cohort | 2 | 10 | 1857 | 44 | Women with high risk for breast or ovarian cancer in New York site of the Breast Cancer Family Registry (BCFR) | High risk | 1995–2011 | 8.1 | 0.63 (0.58–0.69) |
[32] | Pastor-Barriuso | 2013 | Spain | Cohort | 2 | 5 | 54,649 | 45–68 | Population-based Navarre Breast Cancer Screening Program (NBCSP) | General population | 1996–2005 | 7.7 | 0.54 (0.52–0.57) |
[51] | Dite | 2013 | Australia | Case–control | 2 | 5 | 1425 | 45.4 | Cases and controls from the Australian Breast Cancer Family Registry (ABCFR) | NA | 1992–1998 | NA | 0.58 (0.55–0.61) |
[40] | Anothaisintawee | 2013 | Thailand | Cross-sectional | NA | NA | 15,718 | NA | Ramathibodi Hospital and two tertiary hospitals | NA | 2011–2013 | NA | 0.41 (0.36–0.46) |
[24] | Ronser | 2013 | America | Cohort | 2 | 5 | 11,419 | 54.0 ± 3.3 | Postmenopausal women in California Teachers Study (CTS) | High risk | 1995–2009 | 5.0 | 0.55 (0.53–0.56) |
[41] | Min-1 | 2014 | Korea | Cohort | 2 | 5 | 40,229 | > 10 | Breast cancer screening patients routinely screened in Women’s Healthcare Center of Cheil General Hospital | Not defined | 1999–2004 | 5 | 0.55 (0.50–0.59) |
[41] | Min-2 | 2014 | Korea | Cohort | 3 | 5 | 40,229 | > 10 | Breast cancer screening patients routinely screened in Women’s Healthcare Center of Cheil General Hospital | Not defined | 1999–2004 | 5 | 0.54 (0.50–0.59) |
[18] | Powell | 2014 | America | Cohort | 2 | 5 | 12,843 | NA | Marin Women’s Study with high rate of breast cancer, null parity and delayed childbirth | High risk | 2003–2007 | 7.7 | 0.62 (0.59–0.66) |
[45] | Duan | 2014 | China | Case–control | 2 | 5 | 400 | 35–74 | Breast cancer cases and controls in the First Affiliate Hospital of KunMing Medical University | NA | 2007–2011 | NA | 0.54 (0.49–0.60) |
[19] | McCarthy | 2015 | America | Cohort | 2 | 5 | 464 | 48.7 ± 13 | Women referred for biopsy with abnormal (Breast Imaging Reporting And Data System, BI-RADS 4) mammograms at the Hospital of the University of Pennsylvania | High risk | 2003–2012 | 5.0 | 0.71 (0.65–0.78) |
[34] | Dartois-1 | 2015 | France | Cohort | 2 | 5 | 5843 | 42–72 | Premenopausal Women in French E3N (E´ tude E´ pide´miologique aupre`s des femmes de laMutuelle Ge´ne´rale de l’E´ ducation Nationale (MGEN)) prospective cohort to investigate the cancer risk factors | General population | 1993–1998 | 5.0 | 0.61 (0.55–0.68) |
[34] | Dartois-2 | 2015 | France | Cohort | 2 | 5 | 7331 | 42–72 | Postmenopausal Women in French E3N (E´ tude E´ pide´miologique aupre`s des femmes de laMutuelle Ge´ne´rale de l’E´ ducation Nationale (MGEN)) prospective cohort to investigate the cancer risk factors | High risk | 1993–1998 | 14.0 | 0.55 (0.50–0.60) |
[39] | Hu | 2015 | China | Cohort | 2 | 5 | 42,908 | 35–69 | Women participated in the breast cancer screening in Zhejiang eastern coastal areas of China | General population | 2008–2014 | 5.0 | 0.59 (0.47–0.70) |
[35] | Brentnall | 2015 | United Kingdom | Cohort | 2 | 10 | 50,628 | 47–73 | 15 screening areas in Greater Manchester, UK | General population | 2009–2014 | 3.2 | 0.54 (0.52–0.56) |
[20] | Schonberg-1 | 2015 | America | Cohort | 2 | 5 | 71,293 | 70.0 ± 7.0 | Nurses’ Health Study (NHS) | High risk | 2004–2009 | 5.0 | 0.57 (0.55–0.58) |
[20] | Schonberg-2 | 2015 | America | Cohort | 2 | 5 | 79,611 | 71.0 ± 6.8 | Women’s Health Initiative (WHI), extensive study | High risk | 2005–2010 | 5.0 | 0.58 (0.56–0.59) |
[46] | Rong | 2016 | China | Case–control | 1 | 5 | 816 | 48.9 | Breast cancer cases and controls in the Shenzhen Maternal and Child Health Care hospital | NA | 2011–2013 | NA | 0.69 (0.68–0.71) |
Diagnostic accuracy of the Gail model
Ref | Author | Publication year | Geographic background | Study design | Gail model version | Sample size | Mean age (years) | Study population | Time period | TP | FP | FN | TN |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[11] | Rockhill | 2001 | America | Cohort | 2 | 82,109 | 45–71 | Nurses’ Health Study (NHS) | 1992–1997 | 596 | 27,457 | 758 | 53,298 |
[25] | Weik | 2005 | America | Cross-sectional | 2 | 543 | 20–80 | Women who underwent a stereotactic or ultrasound-guided breast biopsy examination | 2001–2003 | 58 | 95 | 81 | 309 |
[26] | Adams-Campbell-1 | 2007 | America | Nested case–control | 1 | 1450 | 21–69 | Black Women’s Health Study (BWHS) | 1995–2003 | 130 | 102 | 595 | 623 |
[26] | Adams-Campbell-2 | 2007 | America | Nested case–control | 3 | 1450 | 21–69 | Black Women’s Health Study (BWHS) | 1995–2003 | 30 | 19 | 695 | 706 |
[31] | Chlebowski | 2007 | America | Cohort | 2 | 64,568 | 63 | Predicted ER-positive breast cancer in Women’s Health Initiative (WHI) study | 1993–2005 | 462 | 22,276 | 461 | 41,369 |
[15] | Tice | 2008 | America | Cohort | 2 | 629,229 | 40–74 | National Cancer Institute-funded Breast Cancer Surveillance Consortium (BCSC) | Since1994 | 2442 | 103,852 | 6342 | 516,593 |
[47] | Li | 2009 | China | Case–control | 2 | 420 | 40–75 | Bao’an Maternal and Child Health Care Hospital, Shenzhen | 2003–2008 | 98 | 20 | 5 | 297 |
[44] | Wang | 2010 | China | Case–control | 1 | 228 | 56 | Breast cancer and controls in Shenzhou Hospital of Shenyang Medical College | 1998–2007 | 65 | 10 | 4 | 149 |
[37] | Ulusoy | 2010 | Turkey | Case–control | 2 | 1290 | 49.49 | Breast cancer and controls in Ankara University School of Medicine | 2002–2008 | 87 | 51 | 563 | 589 |
[33] | Buron | 2013 | Spain | Cohort | 2 | 2200 | 49–64 | Participants with a positive screening mammogram in “Parc de Salut Mar” breast cancer screening program | 1996–2010 | 24 | 449 | 28 | 1161 |
[48] | Zhou | 2014 | China | Case–control | 1 | 280 | 48.62 | Breast cancer and controls in Huangpu District in Shanghai of China | 2010 | 72 | 11 | 71 | 126 |
[45] | Duan | 2014 | China | Case–control | 2 | 400 | 52.58 | Breast cancer and controls in the First Affiliated Hospital of KunMing Medical University | 2007–2011 | 24 | 7 | 176 | 193 |
[49] | Huang | 2015 | China | Case–control | 1 | 317 | 54.1 | Breast cancer and controls in Guangxi Maternal and Child Health Care Hospital | 2012–2014 | 116 | 13 | 41 | 147 |
[50] | An | 2016 | China | Case–control | 2 | 567 | > 40 | Breast cancer and controls in China Japan Union Hospital of Jilin University | 2011–2015 | 207 | 105 | 93 | 162 |