Análisis de la reforma constitucional de mayo de

Diseño del Consejo de la Judicatura y sus atribuciones disciplinarias

3.1 Integración del Consejo de la Judicatura

3.1.3 Análisis de la reforma constitucional de mayo de

• Prostate cancer is the most common cancer among men, with over 200,000 new cases identified each year in the United States.1,2 The median age at diagnosis is 66 years.3 Older men are more likely to be affected than younger men, and African American men have higher rates compared to men of other ethnic backgrounds.3

• Screening programs for prostate cancer allow for its early detection. Screening is typically performed by prostate-specific antigen (PSA) test and digital rectal examination (DRE).2,6

• Diagnosis is confirmed by prostate biopsy.4-6 Biopsy is typically performed by a collection approximately 12 needle biopsy cores.6

• Initial biopsies only detect 65-77% of prostate cancers, and repeat biopsies are frequently performed.7,8 The false negative rate of biopsy may be as high as 25%.9

• The ConfirmMDx™ test (MDx Health) is a proprietary epigenetic assay that measures gene methylation associated with the presence of cancer. Results are intended to assist in determining which patients likely have a true negative biopsy, and which patients are at increased risk for occult cancer. Results may prevent unnecessary repeat biopsies in unaffected men, and triage higher risk patients for repeat biopsies and treatment, as needed.10

Test Information

• ConfirmMDxTM

measures the methylation levels (using quantitative methylation PCR) of 3 genes (GSTP1, APC and RASSF1) associated with prostate cancer. The test is performed on formalin-fixed, paraffin-embedded prostate specimens from a 12-core biopsy.

• Results are reported with methylation positive/negative for each biopsy core, along with a map of the regions where methylation is distributed.10

• Negative predictive value of the test is approximately 90%, based on results of a large, blinded clinical evaluation study.11

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Guidelines and Evidence

• Prostate cancer screening (2014) and treatment (2015) guidelines from the National Comprehensive Cancer Network (NCCN) do not address or recommend ConfirmMDx testing.5,6

• While the clinical validity of the test has been established,11

data regarding the clinical utility of the ConfirmMDx test is still emerging. There is no clear evidence at this time that use of the ConfirmMDx assay reduces repeat prostate biopsies. • The Prostate Assay Specific Clinical Utility at Launch study (PASCUAL;

ClinicalTrials.gov identifier NCT02250313) is a large, prospective clinical trial to evaluate the impact of ConfirmMDx on clinical decision-making and procedure costs. The study started in September 2014 and is expected to continue for 2 years.12

Criteria

• This test is considered investigational and/or experimental.

o Investigational and experimental (I&E) molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, RNA, or gene

products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.

o In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.

References

1. Centers for Disease Control and Prevention. Cancer Among Men. Available at: http://www.cdc.gov/cancer/dcpc/data/men.htm.

2. National Cancer Institute. Prostate cancer treatment (PDQ). Available at:

http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfessional#_1679_toc. 3. National Cancer Institute. SEER Stat Fact Sheet: Prostate Cancer. Available at:

http://seer.cancer.gov/statfacts/html/prost.html.

4. Centers for Disease Control and Prevention. Prostate Cancer. Available at: http://www.cdc.gov/cancer/prostate/index.htm.

5. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology. Prostate Cancer. v.1.2015. Available at:

http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.

6. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology. Prostate Cancer Early Detection. v.1.2014. Available at:

http://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf.

7. Djavan B, Ravery V, Zlotta A, et al. Prospective evaluation of prostate cancer detected on biopsies 1, 2, 3 and 4: when should we stop? J Urol. 2001;166(5):1679-83. doi:

10.1016/S0022-5347(05)65652-2.

Lab Management Guidelines V1.0.2016

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8. Roehl KA, Antenor JA, Catalona WJ. Serial biopsy results in prostate cancer screening study.

J Urol. 2002;167(6):2435-9. doi: 10.1016/S0022-5347(05)64999-3.

9. Kronz JD, Allan CH, Shaikh AA, Epstein JI. Predicting cancer following a diagnosis of high- grade prostatic intraepithelial neoplasia on needle biopsy: data on men with more than one follow-up biopsy. Am J Surg Pathol. 2001 Aug;25(8):1079-85.

10. ConfirmMDx website. Available at: http://mdxhealth.com/products-and- technology/products/confirmmdx-for-prostate-cancer.

11. Stewart GD, Van Neste L, Delvenne P, et al. Clinical utility of an epigenetic assay to detect occult prostate cancer in histopathologically negative biopsies: results of the MATLOC study.

J Urol. 2013 Mar;189(3):1110-6. doi: 10.1016/j.juro.2012.08.219. Epub 2012 Oct 8.

12. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02250313.

Corus CAD for Obstructive Coronary

In document Los modelos de integración del Consejo de la Judicatura y su relación con la independencia del Poder Judicial (página 92-96)