提示: 手机请竖屏浏览!

MRI靶向活检和标准活检用于前列腺癌筛查的比较
MRI-Targeted or Standard Biopsy in Prostate Cancer Screening


Martin Eklund ... 肿瘤 • 2021.09.02
相关阅读
• MRI靶向、系统性和联合活检诊断前列腺癌的比较 • MRI靶向活检或标准活检用于前列腺癌诊断的比较

MRI靶向活检降低过度诊疗,且仍能有效检出前列腺癌

 

黄晓波

北京大学人民医院泌尿与碎石中心;北京大学应用碎石研究所

 

据估计,全球每年大约有140万男性被诊断出前列腺癌,375,000人死于该疾病。前列腺癌是2020年男性第二大常见癌症和癌症死亡的第五大原因1。20世纪90年代初,前列腺特异性抗原(PSA)广泛应用于前列腺癌筛查,随之诊断出的前列腺癌患者迅速增加,同时死亡率在接下来的25年降低50%2。但是使用PSA检测结合传统活检筛查,可能会导致过度诊断,从而增加不必要的活检。因此,如何避免过度诊断是大规模人群前列腺癌筛查的一个关键问题。MRI联合靶向活检显示出解决这一问题的潜力3,但其在大规模前列腺癌筛查人群中的应用尚不清楚。

查看更多

摘要


背景

过度诊断率高是实施有组织的前列腺癌筛查的一个关键障碍。磁共振成像(MRI)靶向活检显示出解决这一挑战的潜力,但在有组织的前列腺癌筛查中应用MRI靶向活检的意义尚不明确。

 

方法

我们对前列腺癌筛查开展了一项基于人群的非劣效性试验,并通过邮件邀请一般人群中的50~74岁男性参与试验;我们以2∶3的比例将前列腺特异性抗原(PSA)水平≥3 ng/mL的参与者随机分组,一组接受标准活检(标准活检组),另一组接受MRI检查,并在MRI结果提示前列腺癌的情况下接受靶向活检和标准活检(实验性活检组)。主要结局是意向治疗人群中被诊断出有临床意义癌症(格利森评分≥7分)的男性比例。关键次要结局是检出无临床意义癌症(格利森评分=6分)。

 

结果

在本试验纳入的12,750名男性中,1,532名的PSA水平≥3 ng/mL,并被随机分配至两个活检组:603名被分配至标准活检组,929名被分配至实验性活检组。在意向治疗分析中,实验性活检组192名男性(21%)被诊断出有临床意义癌症,而标准活检组为106名男性(18%)(差异,3个百分点;95%置信区间[CI],-1~7;非劣效性的P<0.001)。实验性活检组中检出无临床意义癌症的百分比低于标准活检组(4%[41名参与者] vs. 12%[73名参与者];差异,-8个百分点;95% CI,-11~-5)。

 

结论

在此项基于人群的受邀筛查试验中,在检测有临床意义前列腺癌方面,进行MRI检查并对MRI结果提示前列腺癌的男性进行靶向和标准活检不劣于标准活检,且前一种方案降低了无临床意义癌症的检出率(由瑞典研究理事会[Swedish Research Council]等资助,STHLM3-MRI在ClinicalTrials.gov注册号为NCT03377881)。





作者信息

Martin Eklund, Ph.D., Fredrik Jäderling, M.D., Ph.D., Andrea Discacciati, Ph.D., Martin Bergman, M.D., Magnus Annerstedt, M.D., Markus Aly, M.D., Ph.D., Axel Glaessgen, M.D., Ph.D., Stefan Carlsson, M.D., Ph.D., Henrik Grönberg, M.D., Ph.D., and Tobias Nordström, M.D., Ph.D. for the STHLM3 consortium*
From the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran’s Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) — all in Stockholm. Address reprint requests to Dr. Eklund at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, SE-17177 Stockholm, or at martin.eklund@ki.se. *A list of the members of the STHLM3 consortium is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 2014;384:2027-2035.

2. Hugosson J, Roobol MJ, Månsson M, et al. A 16-yr follow-up of the European Randomized study of Screening for Prostate Cancer. Eur Urol 2019;76:43-51.

3. Welch HG, Albertsen PC. Reconsidering prostate cancer mortality — the future of PSA screening. N Engl J Med 2020;382:1557-1563.

4. Shoag JE, Nyame YA, Gulati R, Etzioni R, Hu JC. Reconsidering the trade-offs of prostate cancer screening. N Engl J Med 2020;382:2465-2468.

5. Roobol MJ. Screening for prostate cancer: are organized screening programs necessary? Transl Androl Urol 2018;7:4-11.

6. Drost F-JH, Osses DF, Nieboer D, et al. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev 2019;4:CD012663-CD012663.

7. Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017;389:815-822.

8. Sathianathen NJ, Omer A, Harriss E, et al. Negative predictive value of multiparametric magnetic resonance imaging in the detection of clinically significant prostate cancer in the Prostate Imaging Reporting and Data System era: a systematic review and meta-analysis. Eur Urol 2020;78:402-414.

9. Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 2018;378:1767-1777.

10. Ahdoot M, Wilbur AR, Reese SE, et al. MRI-targeted, systematic, and combined biopsy for prostate cancer diagnosis. N Engl J Med 2020;382:917-928.

11. Rouvière O, Puech P, Renard-Penna R, et al. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol 2019;20:100-109.

12. Kasivisvanathan V, Stabile A, Neves JB, et al. Magnetic resonance imaging-targeted biopsy versus systematic biopsy in the detection of prostate cancer: a systematic review and meta-analysis. Eur Urol 2019;76:284-303.

13. Nordström T, Picker W, Aly M, et al. Detection of prostate cancer using a multistep approach with prostate-specific antigen, the Stockholm 3 test, and targeted biopsies: the STHLM3 MRI Project. Eur Urol Focus 2017;3:526-528.

14. Nordström T, Jäderling F, Carlsson S, Aly M, Grönberg H, Eklund M. Does a novel diagnostic pathway including blood-based risk prediction and MRI-targeted biopsies outperform prostate cancer screening using prostate-specific antigen and systematic prostate biopsies? Protocol of the randomised study STHLM3MRI. BMJ Open 2019;9(6):e027816-e027816.

15. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-207.

16. Pepe MS. The statistical evaluation of medical tests for classification and prediction. Oxford statistical science series no. 31. New York: Oxford University Press, 2003.

17. Pepe MS, Alonzo TA. Comparing disease screening tests when true disease status is ascertained only for screen positives. Biostatistics 2001;2:249-260.

18. Alonzo TA, Pepe MS, Moskowitz CS. Sample size calculations for comparative studies of medical tests for detecting presence of disease. Stat Med 2002;21:835-852.

19. Grönberg H, Adolfsson J, Aly M, et al. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol 2015;16:1667-1676.

20. Ström P, Nordström T, Aly M, Egevad L, Grönberg H, Eklund M. The Stockholm-3 model for prostate cancer detection: algorithm update, biomarker contribution, and reflex test potential. Eur Urol 2018;74:204-210.

21. Moore CM, Kasivisvanathan V, Eggener S, et al. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an international working group. Eur Urol 2013;64:544-552.

22. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332-c332.

23. Grönberg H, Eklund M, Picker W, et al. Prostate cancer diagnostics using a combination of the Stockholm3 blood test and multiparametric magnetic resonance imaging. Eur Urol 2018;74:722-728.

24. Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA. The 2014 International Society of Urological Pathology (ISUP) consensus conference on Gleason grading of prostatic carcinoma: definition of grading patterns and proposal for a new grading system. Am J Surg Pathol 2016;40:244-252.

25. Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MGM. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol 2015;68:438-450.

26. Hernán MA, Robins JM. Per-protocol analyses of pragmatic trials. N Engl J Med 2017;377:1391-1398.

27. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine — reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-2194.

28. Klotz L, Chin J, Black PC, et al. Comparison of multiparametric magnetic resonance imaging-targeted biopsy with systematic transrectal ultrasonography biopsy for biopsy-naive men at risk for prostate cancer: a phase 3 randomized clinical trial. JAMA Oncol 2021;7:534-542.

29. Dell’Oglio P, Stabile A, Soligo M, et al. There is no way to avoid systematic prostate biopsies in addition to multiparametric magnetic resonance imaging targeted biopsies. Eur Urol Oncol 2020;3:112-118.

30. Kuhl CK, Bruhn R, Krämer N, Nebelung S, Heidenreich A, Schrading S. Abbreviated biparametric prostate MR imaging in men with elevated prostate-specific antigen. Radiology 2017;285:493-505.

31. van der Leest M, Israël B, Cornel EB, et al. High diagnostic performance of short magnetic resonance imaging protocols for prostate cancer detection in biopsy-naïve men: the next step in magnetic resonance imaging accessibility. Eur Urol 2019;76:574-581.

32. Bass EJ, Pantovic A, Connor M, et al. A systematic review and meta-analysis of the diagnostic accuracy of biparametric prostate MRI for prostate cancer in men at risk. Prostate Cancer Prostatic Dis 2020 November 20 (Epub ahead of print).

33. Callender T, Emberton M, Morris S, Pharoah PDP, Pashayan N. Benefit, harm, and cost-effectiveness associated with magnetic resonance imaging before biopsy in age-based and risk-stratified screening for prostate cancer. JAMA Netw Open 2021;4(3):e2037657-e2037657.

服务条款 | 隐私政策 | 联系我们