1 / 28

Mack Roach III MD Professor of Radiation Oncology and Urology University of California

Why Conclusions and Recommendations from the American Cancer Society, the US Preventative Task Force (USPTF) and PIVOT (Prostatectomy vs Observation Trial) are Dangerous for African American Men. Mack Roach III MD Professor of Radiation Oncology and Urology University of California

rveras
Download Presentation

Mack Roach III MD Professor of Radiation Oncology and Urology University of California

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Why Conclusions and Recommendations from the American Cancer Society, the US Preventative Task Force (USPTF) and PIVOT (Prostatectomy vs Observation Trial) are Dangerous for African American Men Mack Roach III MD Professor of Radiation Oncology and Urology University of California San Francisco

  2. What is the Prostate?

  3. Goals of this Presentation (in 15 min.): • Discuss the Guidelines ACS • Discuss the conclusions of the US Preventative Task Force (USPTF) on Screening for prostate ca. • Discuss the PIVOT study • Explain why their conclusions/recommendations are inconsistent with “Evidence Based Medicine” and wrong for AA Men!

  4. Nearly 50% drop in age-adjusted prostate cancer mortality since early 1990s Siegel et al. CA Cancer J Clin 2014; 64:9

  5. National Prostate Cancer Screening Rates After the 2012 US Preventative Services Task Force Recommendation Discouraging Prostate-Specific Antigen-Based Screening. Drazer et al. JCO 33: 2416-2423, 2015

  6. ACS Recommendations for Prostate Cancer Early Detection The American Cancer Society (ACS) recommends that men have a chance to make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risks, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information. The discussion about screening should take place at: Age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.  Age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65). Age 40 for men at even higher risk (those with more than one first-degree relative who had prostate cancer at an early age).  After this discussion, men who want to be screened should be tested with the prostate-specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.  If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the man’s general health preferences and values. 

  7. The UPTF said: …lets not have anyone without “conflicts” participate. I translate that into: … lets get a group of people who know nothing about the issue … (eliminate experts!) Let them frame the questions (e.g. question #3) (“garbage in”) Let them answer theses questions (“garbage out”) … if two studies conflict throw out both (don’t believe the better study)

  8. Screening evidence updates: ERSPC 21% relative risk reduction (29% with adjustment for noncompliance) NNI 781, NND 27 Schröder et al. Lancet epub 2014

  9. Draft Recommendation Statement, Prostate Cancer: Screening This opportunity for public comment expired on May 8, 2017 at 8:00 PM EST. Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.

  10. Analytic Framework: USPSTF Methodology Question #3 (Harris et al., 2001)

  11. Background & Rationale • … the 3rd question posed by the USPTF: “What are the benefits of treatment of early-stage or screening-detected prostate cancer?” • This question was not adequately addressed by including only 2 trials, they ignored: • What is meant by “early-stage” prostate ca? • When the benefit should be seen? • How much of an improvement in survival? • Are there subsets of pts who benefit from Tx? • What types of treatments should be included?

  12. EVIDENCED BASED MEDICINE? The review of the literature by the USPSTF included only 2 RCT (Bill-Axelson 2011 & Iversen et al. 1995) for evaluating the impact of RP on localized disease! THEY IGNORED ALL RADIATION TRIALS However there were at least n=50 randomized control trials (RCTs) at we were aware of addressing outcomes of men with clinically localized prostate cancer that we THEY IGNORED DATA FROM 96% OF ALL RANDOMIZED TREATMENT TRIALS!

  13. Completed Contemporary Phase III Prostate Cancer Trials (ADT +/- RT) Widmark et al. (2009) Warde et al. (2011) Conclusion: Better survival with RT+ADT (LHRH drug used) Median-Follow Up: 6; NNT: 9.9; Curves separate beyond 5 years Conclusion: Better survival with ADT (mostly anti-androgens) + RT Median-Follow Up: 7.6; NNT: 10.2; Curves separate beyond 5 years

  14. Radical prostatectomy versus observation for localized prostate cancer. Wilt et al. NEJM . 2012

  15. Let’s focus on the “facts” “Everyone has a right to their own opinion but not their own facts” -Quote from Patrick Moynihan

  16. The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer Wilt & Brawer. J Urol1994 … PIVOT will enroll 2,000 participants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less than 75 years old will be randomized to either RP with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. The primary study end point will be all cause mortality. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in prostate cancer specific mortality rate …

  17. Original Article Follow-up of Prostatectomy versus Observation for Early Prostate Cancer Timothy J. Wilt, M.D., M.P.H., Karen M. Jones, M.S., Michael J. Barry, M.D., Gerald L. Andriole, M.D., Daniel Culkin, M.D., Thomas Wheeler, M.D., William J. Aronson, M.D., and Michael K. Brawer, M.D. Kaplan–Meier Plots of Mortality. Wilt TJ et al. N Engl J Med 2017;377:132-142

  18. Follow-up of Prostatectomy versus Observation for Prostate Cancer. Wilt et al. NEJM 2017

  19. “Common Sense” Approach to Screening: Screen 100 Men (after discussing risk of a blood test) 5 “abnormal test” (discuss risk & benefits of biopsy 95 “normal test” (-) Bx ( 3 or 4 men) “Reassure” “Biopsy” +Bx ( 1 or 2 men) Discuss risk & benefits of treatment Intermediate risk (“intermediate Tx” Low risk (e.g. AS) High risk (“aggressive Tx”) Chen CP, Staggers FE, Roach M, 3rd: Benefits and pitfalls of prostate cancer screening: "no proof of benefit" does not equal "proof of no benefit". Oncology 25:466, 468, 2011.

  20. What I am not arguing against • Informed consent (delivered “appropriately”) • PSA screening: risk of blood test • Risk of Biopsy if test is abnormal: pain, bleeding, infection … diagnosis of CaP • Risk and benefits of treatment if needed • Active Surveillance (when appropriate) • Evidence based Treatment (when appropriate)

  21. Final Conclusions: Abandonment of PSA-based early detection is creating a public health disaster. The better solution to the ongoing problem of over-diagnosis and over-treatment is to implement “smarter” early detection efforts and to selectively and rationally decouple diagnosis from treatment.

  22. “If you don’t treat for Cure, you won’t cure those you treat”

More Related