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Use of screening research to boost overdiagnosis: the MyPeBS (My Personal Breast Screening) trial

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Use of screening research to boost overdiagnosis: the MyPeBS (My Personal Breast Screening) trial

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Presentation « Use of screening research to boost overdiagnosis : the MyPeBS trial » by Dr. Jean Doubovetzky, Family Medecine - member of Cancer Rose (www.cancer-rose.fr) and editor at independent medical journal Prescrire (https://english.prescrire.org), during the International Congress "Preventing Overdiagnosis", Sydney, 5-7 décembre 2019.
Cancer Rose is a French non-profit organization of health professionals. 
Independent French medical doctors and a doctor in toxicology, have created the site www.cancer-rose.fr to inform you of the most recent and relevant data on breast cancer mass screening.
By decoding and popularizing the most recent research findings published in the most important international medical journals, analyzing the controversy and providing a social and feminine analysis, our objective is to inform women concerned by breast cancer mass screening in order to help them making their choice and to provide independent information resources to interested physicians.
Cancer Rose has no sponsorships, honoraria, monetary support or conflict of interest from any commercial sources.

Presentation « Use of screening research to boost overdiagnosis : the MyPeBS trial » by Dr. Jean Doubovetzky, Family Medecine - member of Cancer Rose (www.cancer-rose.fr) and editor at independent medical journal Prescrire (https://english.prescrire.org), during the International Congress "Preventing Overdiagnosis", Sydney, 5-7 décembre 2019.
Cancer Rose is a French non-profit organization of health professionals. 
Independent French medical doctors and a doctor in toxicology, have created the site www.cancer-rose.fr to inform you of the most recent and relevant data on breast cancer mass screening.
By decoding and popularizing the most recent research findings published in the most important international medical journals, analyzing the controversy and providing a social and feminine analysis, our objective is to inform women concerned by breast cancer mass screening in order to help them making their choice and to provide independent information resources to interested physicians.
Cancer Rose has no sponsorships, honoraria, monetary support or conflict of interest from any commercial sources.

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Use of screening research to boost overdiagnosis: the MyPeBS (My Personal Breast Screening) trial

  1. 1. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 1 Free Powerpoint Templates Jean Doubovetzky Family medicine (Cancer-Rose group, Prescrire editor) Conflicts of interest: None Use of screening research to boost overdiagnosis: the MyPeBS trial
  2. 2. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 2 Remember In France, sept 2016, an independant Civil and Scientific Inquiry into Mammographic Screening recommanded: * Complete stopping of the screening program Or * Stopping the screening as existing and undergo complete revision The French National Institute of Cancer (INCa) replied “abandoning screening programme would be a complete nonsense” Instead, it would propose “a screening based on the risk level” Ref. http://www.concertation-depistage.fr/
  3. 3. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 3 The MyPeBS trial MyPeBS for “My Personal Breast Screening” is an international randomized study which compares - a personalized Risk Stratified BCS - to standard BCS - in women aged 40-70 The protocol is not public. We had to trick in order to read it. MyPeBS should involve 85000 women in France, Belgium, Italy, Israël, the UK During 6 years Seems similar to the US Wisdom Study https://clinicaltrials.gov/ct2/show/NCT02620852
  4. 4. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 4 Objectives The study primary objective is to show the non-inferiority - of the risk-stratified screening strategy vs standard screening - in terms of incidence of Breast Cancer of stage 2 and higher Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 The study secondary objective is to show its superiority
  5. 5. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 5 Methods “Personalized” arm: 4 subgroups according to their risk of Breast Cancer. * Low risk → no screening * Moderate risk → Mammogram +/- US every 2 years * High risk → Mammogram +/- US every year * Very high risk → idem + MRI scan every year After 4 years, every woman will undergo a mammography screening. “standard” arm: usual screening program in the concerned geographical areas: every 1 to 3 years, from age 45 or 50. Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50
  6. 6. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 6 Problem with overall design There is no “no screening” arm Promoters consider breast cancer screening benefits as firmly established Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 Controversy on efficacity is not addressed
  7. 7. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 7 Risk levels issue “Personalized” arm: The risk of Breast Cancer is computed from age, personal and family history, breast density and genetic testing. However this risk assessment method has not been fully validated. The low risk group (risk < 1%) might be very small, leading to a sharp increase of screening under age 50. Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50
  8. 8. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 8 Homogeneity issues “Standard” arm: considered homogenous despite differences between countries Women under age 50 will have more screening Women over age 50 should have less screening Reasons for accepting inclusion will be opposite before and after age 50 Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 “Standard” arm: includes women over age 50 (or age 45 in a few italian regions) “Personalized” arm: includes women age 40 to 70 This will lead to many statistical post hoc corrections, making the results hardly convincing
  9. 9. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 9 Non inferiority trial Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 ∆ = 25% betterworse Non inferiority threshold Observed efficacy of standard screening > than threshold Non inferior < or = threshold Non inferiority Not demonstrated CI 95
  10. 10. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 10 Non inferiority issue * With a threshold as low as 25% one can predict that personalized screening will be “non inferior” to Standard screening. Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 * Indeed, Personalized screening might be “non inferior” to Standard screening, and, at the same time, not different from no screening at all. * But you will never know ! * Promoters of MyPeBS expect about 400 new cases of advanced cancers in the Standard group. If there is less than 510 cases in the Personalized screening group, the result will be considered “non inferior” to Standard
  11. 11. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 11 Ethical issues The accepted lowering of the decrease of Advanced Breast Cancer Incidence has no demonstrated positive counterpart Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 The MyPeBS trial may lead to consider a Personalized screening “equivalent to” or “as effective as” Standard screening, even if it doesn’t lower Breast Cancer Mortality. DO WOMEN LIVES MATTER?
  12. 12. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 12 Information issues The consent booklet information is untrue and misled women. There is no explanation about overdiagnosis overtreatment and even non inferiority Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 None of these terms appear in the booklet
  13. 13. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 13 A marketing trial ? If this trial is not a scientific one, It must be a marketing trial. So what does it market ? Ref. UNICANCER: Protocol n° UC-0109/1805 - ID RCB: 2018-A00535-50 - Beginning at age 40 - Using genetic testing - Using MRI for “high risk” women MyPeBS markets technological development and OVERDIAGNOSIS Warning : this is an opinion
  14. 14. www.cancer-rose.fr Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 14 Thank you for listening If you enjoyed this presentation please support Prescrire International (in English) https://english.prescrire.org/ Cancer Rose Ask online for the free, monthly "Independent Drug & Healthcare Newsletter" In English, video on BCS https://tinyurl.com/t63m53 Leaflet on BCS https://tinyurl.com/rd64yu5 Pitch on BCS https://tinyurl.com/uoje2sy www.cancer-rose.fr You want the pdf : ask jvdoubov@gmail.com

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