prostate cancer: insurance problems and critical illness
TRANSCRIPT
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Prostate cancer: insurance problems and critical illness
Tommaso Ciro Camerota, MD, Urologist, PhD studentResponsible of Urology at IRCCS Salvatore Maugeri Foundation, Pavia
University of Milan IRCCS Salvatore Maugeri Foundation Victor BabeŞ University Timisoara
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May 25th, 2016
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Prostate
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Prostate
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‐ Male sex accessory gland
‐ Contributes secretions to ejaculate
‐ Growth under androgenic hormones control
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Normal function
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Prostate cancer is nowadays the first malignancy in male population, with an increasedincidence since 1986 (FDA approval of PSA serum test).
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Trends in incidence ratesmale population1975‐2010
Siegel R et al. Cancer Statistics 2014. CACancer J Clin 2014;64:9‐29
Epidemiology
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Afro‐american population: 149/100.000/year
Caucasian population: 107/100.000/year
Asiatic population: 28/100.000/year
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Epidemiology
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Prostate cancer is nowadays the first malignancy in male population, with an increasedincidence since 1986 (FDA approval of PSA serum test).
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Siegel R et al. Cancer Statistics 2014. CACancer J Clin 2014;64:9‐29
Epidemiology
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Epidemiology
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Prostatic cancer is mostly diagnosed in early stages, increasingly in young Patients (50‐60 years‐old).
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Siegel R et al. Cancer Statistics 2014.CA Cancer J Clin 2014;64:9‐29
Stage distribution at diagnosismale population, 2003‐2009
Epidemiology
Siegel R et al. Cancer Statistics 2016.CA Cancer J Clin 2016;66:7‐30
Stage distribution at diagnosismale population, 2005‐2011
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Death rates from prostate cancer are low.
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Siegel R et al. Cancer Statistics 2014. CACancer J Clin 2014;64:9‐29
Epidemiology
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Death rates from prostate cancer are decreasing.
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Epidemiology
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Death rates from prostate cancer are low.
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Five‐year relative survival rates at diagnosismale population, 2005‐2011
Epidemiology
70% of deaths due toprostate cancer occur afterage 75 years.
SEER Cancer Statistic Review, 1975‐2008, Bethesda, National CancerInstitute
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2014 SIUrO (Italian Society for Uro‐Oncology)
2015 expectations data for Italy: 323.000 persons with a diagnosis of PCa 35.000 new cases/year 1/16 men over 50 years is at risk of disease 50% of the new cases are low risk diseases (active surveillance)
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Epidemiology
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14Source: Gapminder www.gapminder.org
Fonti‐ World Bank‐ WHO‐ UN‐ FAO‐ UNESCO‐ OECD‐ UNAIDS‐ IARC‐ UNICEF‐ The Lancet‐ et al.
Epidemiology
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15Source: Gapminder www.gapminder.org
Epidemiology
Italy
Japan
Australia
USEthnic and geneticbackground
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16Source: Gapminder www.gapminder.org
Epidemiology
Italy
US
Overdiagnosis
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Mostly an asymptomatic disease detected by
‐ Digital rectal examination
‐ PSA test (total, ratio, PSA density, PSA velocity)
‐ Transrectal ultrasound‐guided prostate biopsy
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Diagnosis
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‐ Hypoechoic nodule at transrectal ultrasound
PROBABILITY OF GETTING PROSTATE CANCER DIAGNOSIS
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Diagnosis
High PSA Normal PSA
DRE + 71% 26%
DRE ‐ 34% 6%
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‐ Serum PSA level
‐ Gleason score
‐ CT scan
‐ Endorectal coil MRI
‐ Bone scan
‐ Choline PET‐CT
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Staging
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PCa stages
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PCa stage migration
Data collected from 1.317 radical prostatectomies aged 50‐80 yrs, 1983‐2003
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PCa stage migration
Ward JF et al. Radical prostatectomy for clinically advanced (cT3) prostate cancer since the advent of prostate‐specific antigen testing: 15‐year outcome. BJU Int 2005;95:751‐6
cT1c
cT3
cT1c PSA increaseNo nodule
Bioptic detection
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‐ (Watchful waiting)
‐ Active surveillance
‐ (Focal Treatment)
‐ Radical prostatectomy (open, RALP, laparoscopic)
‐ Radiation therapy (conventional external beam vs three‐dimensionalconformal RT vs intensity‐modulated RT vs tomotheraphy vsbrachytherapy)
‐ (Hormonotheraphy)
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TreatmentLocalized disease
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Focal Treatment
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TreatmentLocalized disease
Van den Bos W et al. Focal Therapy in Prostate Cancer: International Multidisciplinary Consensus on Trial Design.Eur Urol 2014;65:1078–83
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Da Vinci Surgical System (Intuitive) price between $1.5 and $2.5 million per machine annual maintenance ($150 000)
‐ RRP costs ranged from $ 4.075 to $ 6.296‐ RALP/LRP costs ranged from $ 5.058 to $ 11.806
No differences in continence, potency and positive margins bysurgical approach.
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TreatmentLocalized disease ‐ costs
Ficarra V, Novara G, Artibani W, et al. Retropubic, laparoscopic, and robot‐assisted radical prostatectomy: asystematic review and cumulative analysis of comparative studies. Eur Urol 2009;55:1037–63
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Cost effectiveness of new technologies should be assessed beforewidespread adoption. To date, in the lone study to evaluate this,RALP was not found to be cost effective from a health care,economic standpoint.
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TreatmentLocalized disease ‐ costs
Bolenz C et al. Costs of Radical Prostatectomy for Prostate Cancer: A Systematic Review. Eur Urol 2014;65:316–24
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The most consistent benefits of LRP and RALP across multiplestudies include lower blood loss, fewer transfusions, and a shorterLOS. From a patient perspective, however, RALP often induces highexpectations for improved outcomes, mainly regarding erectilefunction recovery, and RALP has been associated with greaterdissatisfaction likely because of higher expectations for a new andbetter procedure compared to RRP.
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TreatmentRALP
Schroeck FR, Krupski TL, Stewart SB, et al. Pretreatment expectations of patients undergoing robotic assistedlaparoscopic or open retropubic radical prostatectomy. J Urol 2012;187:894–8.
Schroeck FR, Krupski TL, Sun L, et al. Satisfaction and regret after open retropubic or robot‐assisted laparoscopicradical prostatectomy. Eur Urol 2008;54:785–93
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TreatmentAdvanced disease
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TreatmentAdvanced disease ‐ costs
Costs do not include physician fees and treatment of adverse events.
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The initial treatment costs per patient, which included the cost of biopsyand subsequent surgical or nonsurgical treatment, were € 3171 in the UK,€ 4057 in Germany, € 5851 in France, € 5226 in Italy and € 3256 in Spain.
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TreatmentPCa economic burden
Fourcade RO et al. Treatment costs of prostate cancer in the first year after diagnosis: a short‐term cost of illnessstudy for France, Germany, Italy, Spain and the UK . BJU Int 2010;105:49–56
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DRG (diagnosis‐related groups) ‐ unit costs for RP ≈
€2000 in the UK€ 2600–3700 in Germany€ 3500–4500 in Spain
€ 4800 in Italy€ 6500 in France
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TreatmentPCa economic burden
Fourcade RO et al. Treatment costs of prostate cancer in the first year after diagnosis: a short‐term cost of illnessstudy for France, Germany, Italy, Spain and the UK . BJU Int 2010;105:49–56
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Mean direct costs of the first year after diagnosis, by stage.
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TreatmentPCa economic burden
Fourcade RO et al. Treatment costs of prostate cancer in the first year after diagnosis: a short‐term cost of illnessstudy for France, Germany, Italy, Spain and the UK . BJU Int 2010;105:49–56
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The total costs for all diagnosed patients in the first year after diagnosiswere € 116.7 million (UK), € 179 million (Germany), € 167.5 million(France), € 106.7 million (Italy) and € 114.6 million (Spain).
The estimated cost per patient in Italy was € 6600.
Total 5‐year costs, including costs of both diagnosis and treatment ofprostate cancer were € 269 million (UK), € 618 million (France), € 486million (Germany), € 364 million (Italy) and € 198 million (Spain).
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TreatmentPCa economic burden
1. Fourcade RO et al. Treatment costs of prostate cancer in the first year after diagnosis: a short‐term cost of illness study forFrance, Germany, Italy, Spain and the UK . BJU Int 2010;105:49–56
2‐ Lazzaro C et al. Managing patients with prostate cancer in Italy during the first year after diagnosis. A cost descriptionbased on a sample of 8 urological wards . Arch Ital Urol Androl 2003;75:138–49
3. Fourcade RO et al. Long term costs of prostate cancer: estimates for France, Germany, Italy, Spain and the UK. BJU Int2010 ; 105 : 49 – 56
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Prostate cancer is a clinically heterogeneous disease.
Autopsy studies have shown that approximately one third of menaged 40 to 60 years have histologically evident prostate cancer.
The proportion increases to as high as 75% in men older than 85years.
Most cases represent microscopic, well‐differentiated lesions thatare unlikely to be clinically important.
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Prostate cancer
1. Sakr WA, Haas GP, Cassin BF, Pontes JE, Crissman JD. The frequency of carcinoma and intraepithelial neoplasia of theprostate in young male patients. J Urol. 1993;150:379‐85
2. Gronberg H. Prostate cancer epidemiology. Lancet. 2003;361:859‐64
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Adequate evidence shows that:‐ up to 5 in 1000 men will die within 1 month of prostate cancer
surgery‐ between 10 and 70 men will have serious complications but
survive.
Critical illness or chronic disease?
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Prostate cancer
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According to the most recent data, when including all stages ofprostate cancer:
The relative 5‐year survival rate is almost 100%
The relative 10‐year survival rate is 99%
The relative 15‐year survival rate is 94%
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Survival
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Survival
Stage 5‐year relative survival rate
Local Nearly 100%
Regional Nearly 100%
Distant 28%
American Cancer Society, 2014
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1. Familiar clusters of prostate cancer (genetic predisposition)2. Environmental factors cause wide geographic variation (diet rich in animal fats and
meats and poor in fruits and vegetables)3. Chronic or recurrent inflammation4. Tobacco/alcohol5. Viral infections ?
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1. Morganti G et al. Recherches clinicostatistiques et genetiques sur les neoplasies de la prostate. Acta Gent 1956;6:304‐52. Mandair D et al. Prostate cancer and the influence of dietary factors and supplements: a systematic review. Nutr
Metab 2014;11:303. Nelson WG. Prostate Cancer. N Engl J Med 2003; 349:366‐381
PCa risk factors
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Primary ‐ prevent the onset of specific diseases via risk reduction: by alteringbehaviours or exposures that can lead to disease, or by enhancing resistance tothe effects of exposure to a disease agent (eg: smoking cessation, vaccination,ecc).
Secondary ‐ procedures that detect and treat pre‐clinical pathological changesand thereby control disease progression. Screening procedures (eg:mammography).
Tertiary ‐ once a disease has developed and has been treated in its acuteclinical phase, it seeks to soften the impact caused by the disease on thepatient’s function, longevity, and quality of life (eg: cardiac rehabilitationfollowing a myocardial infarction).
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Prevention
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Prevention
Cuzick J et al. Prevention and early detection of prostate cancer. Lancet Oncol. 2014 Oct;15(11):e484‐92
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Increase consumption of fruits and vegetables, reduce consumption of red meat,saturated fats.
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PreventionLifestyle
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Prostate Cancer Prevention Trial (PCPT)‐ 18.882 men, PSA of 3.0ng/mL or less, normal digital rectal examination‐ randomization: treatment with finasteride 5mg/day or placebo‐ PSA elevation or abnormal rectal examination prostate biopsy‐ at the end of the treatment period, a prostate biopsy was planned for all men‐ study closed 15 months before (9060 men evaluable)
Results‐ PCa in 18.4% of men treated with finasteride versus 24.4% in the placebo group‐ High grade PCa more frequent in the finasteride group (effective in low risk PCa or
increasing the risk?)‐ Side effects of finasteride treatment (reduced ejaculate volume, erectile dysfuntion,
loss of libido, gynecomastia)
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PreventionReduce inflammation
Thompson IM et al. The influence of finasteride on the development of prostate cancer. NEng J Med 2003;349:215‐24
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Prostate Cancer Prevention Trial (PCPT) – updateResults‐ 10‐year overall survival was the same for men in the finasteride group (79.3 percent)
and the men in the placebo group (79.5 percent)
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PreventionReduce inflammation
Thompson IM et al. Long‐term survival of participants in the prostate cancer preventiontrial. N Eng J Med 2013;369:603‐10
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Prostate Cancer Prevention Trial (PCPT) – updateResults
The difference in prostate cancer diagnoses was entirely due to fewer low‐gradeprostate cancers in the finasteride arm (Gleason score 2‐6) Patients suitable foractive surveillance protocol.
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PreventionReduce inflammation
Thompson IM et al. Long‐term survival of participants in the prostate cancer preventiontrial. N Eng J Med 2013;369:603‐10
Finasteride group
n = 9.423PCa cases = 989
High‐grade PCa = 333
Placebo group
n = 9.457PCa cases = 1,412
High‐grade PCa = 286
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SELECT study‐ prospective, randomized, placebo‐controlled clinical trial‐ Selenium and Vitamin E‐ Over 35.000 men, age 50 and older
Results‐ September 2008: selenium and vitamin E, taken alone or together for an average of
five and a half years, did not prevent prostate cancer.
‐ In 2011, men taking vitamin E had a 17 percent increased risk of prostate cancercompared to men taking the placebo.
‐ In 2014, men who started the trial with high levels of selenium doubled their risk ofdeveloping a high‐grade prostate cancer by taking selenium supplements and menwho had low levels of selenium at the start of the trial doubled their risk of high‐grade prostate cancer by taking vitamin E.
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PreventionReduce inflammation
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‐ Diagnosis of disease
‐ Reduction in mortality
‐ Costs/benefits ratio
‐Mantaining quality of life
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Ideal screening
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Moyer VA et al. Screening for prostate cancer: U.S. Preventive Services Task Force recommendationstatement. Ann Intern Med 2012;157(2):120‐34
U.S. Preventive Services Task Force Reccomendation Statement
Screening
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Screening goal
The primary goal of prostate cancer screening is to reducedeaths due to prostate cancer and, thus, increase length oflife.
An additional important outcome would be a reduction inthe development of symptomatic metastatic disease.
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Screening
Men with screen‐detected cancer can potentially fall into 1of 3 categories:‐ those whose cancer will result in death despite early
diagnosis and treatment‐ those who will have good outcomes in the absence of
screening‐ those for whom early diagnosis and treatment improve
survival.
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Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, et al. The influence of finasteride onthe development of prostate cancer. N Engl J Med. 2003;349:215‐24
Screening
The number of cancer cases that could be detected in ascreened population is large; a single study in which meneligible for PSA screening had biopsy regardless of PSA leveldetected cancer in nearly 25% of men.
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Lifetime risk (from age 0 to age 90 years) of death from prostatecancer is 3%, and the lifetime risk of a diagnosis of prostatecancer is 17%.
Thus, in the absence of markers that accurately identify thosemen who have life‐threatening cancers, screening will result inthe overdiagnosis and overtreatment of some men.
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Screening
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200 men need to be treated activelyover 12 years to prevent 1 prostatecancer death.
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Screening
Wong YN et al. Survival associated with treatment vs observation of localized prostate cancer in elderlymen. JAMA 2006;296:2683‐93
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‐ European Randomized Study of Screening for Prostate Cancer(ERSPC)
‐ Prostate, Lung, Colon and Ovarian Trial (PLCO)
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Screenings
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Screening
Schroder FH et al. Screening and prostate‐cancer mortality in a randomized Europen study. NEJM2009;360(13): 1320‐8
Schroder FH et al. Screening and prostate cancer mortality: results of the European Randomised Study ofScreening for Prostate Cancer (ERSPC) at 13 years of follow‐up. Lancet 2014; S0140‐6736(14)60525‐0
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ScreeningPCa mortality
Schroder FH et al. Screening and prostate cancer mortality: results of the European Randomised Study ofScreening for Prostate Cancer (ERSPC) at 13 years of follow‐up. Lancet 2014; S0140‐6736(14)60525‐0
162.388 men aged 55–69 years
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Screening
Andriole GL et al. Mortality results from a randomized prostate‐cancer screening trial. NEJM 2009;360(13): 1310‐9
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ScreeningPLCO
Andriole GL et al. Mortality results from a randomized prostate‐cancer screening trial. NEJM 2009;360(13):1310‐9
up, laAfter 13 years, prostate cancer cumulative incidence was approximately 11% in the screeninggroup and 10% in the control group, and prostate cancer mortality was approximately 0.4% inboth groups.
No statistically significant effect of screening.
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Screening
National Cancer Institute website
The infographic below depicts the benefits and harms of PSA screeningfor prostate cancer. The estimates appeared in the U.S. PreventiveServices Task Force Recommendation Statement, published July 17 inthe Annals of Internal Medicine. The estimates were based on 13‐ and11‐year follow‐up data from the Prostate, Lung, Colorectal and OvarianCancer Screening Trial and the European Randomized Study ofScreening for Prostate Cancer.
According to the two trials, the best evidence of possible benefit ofPSA screening is in men aged 55 to 69.
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Screening
National CancerInstitute website
Breast cancer2.000 womenshould undergomammographicscreening for 10years to avoid 1death fromdisease. In themeanwhile, 10women aretreated for falsepositive tests.
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Screening
National Cancer Institute website
The infographic below depicts the benefits and harms of PSA screeningfor prostate cancer. The estimates appeared in the U.S. PreventiveServices Task Force Recommendation Statement, published July 17 inthe Annals of Internal Medicine. The estimates were based on 13‐ and11‐year follow‐up data from the Prostate, Lung, Colorectal and OvarianCancer Screening Trial and the European Randomized Study ofScreening for Prostate Cancer.
According to the two trials, the best evidence of possible benefit ofPSA screening is in men aged 55 to 69.
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Moyer VA et al. Screening for prostate cancer: U.S. Preventive Services Task Force recommendationstatement. Ann Intern Med 2012;157(2):120‐34
U.S. Preventive Services Task Force Reccomendation Statement
Screening
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Moyer VA et al. Screening for prostate cancer: U.S. Preventive Services Task Force recommendationstatement. Ann Intern Med 2012;157(2):120‐34
U.S. Preventive Services Task Force Reccomendation Statement
Screening
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Moyer VA et al. Screening for prostate cancer: U.S. Preventive Services Task Force recommendationstatement. Ann Intern Med 2012;157(2):120‐34
U.S. Preventive Services Task Force Reccomendation Statement
Screening
The USPSTF concluded that choosing not to have PSAtesting will result in a patient living a similar length of life,with little to no difference in prostate cancer–specificmortality, while avoiding harms associated with PSA testingand subsequent diagnostic procedures and treatments.
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Trends in incidence rates – male population, 1975‐2012
Screening
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Trends in death rates – male population, 1930‐2012
Screening
NO IMPACT FROM PSA TEST SCREENING!
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Malvezzi M et al. European cancermortality predictions for the year 2016with focus on leukaemias. Ann Oncol.2016 Apr;27(4):725‐31
Trends in death rates – male population, predictions for 2016
Screening
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Siegel R et al. Cancer Statistics 2016. CACancer J Clin 2016;66:7‐30
Total number of cancer deaths averted, from 1991 to 2012
Cancer deaths in US
The blue line represents the actualnumber of cancer deaths recorded ineach year, and the red linerepresents the number of cancerdeaths that would have beenexpected if cancer death rates hadremained at their peak.
1.199.200 saved lives in 20 years
How to manage prostatecancer in this population?
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Bosetti C et al. Trends in mortality fromurologic cancers in Europe, 1970‐2008. EurUrol. 2011 Jul;60(1):1‐15.
Pca cancer deaths
Limitations of the study:‐ Numeric evaluation‐ No informations on death/incidence
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Bosetti C et al. Trends in mortality fromurologic cancers in Europe, 1970‐2008. EurUrol. 2011 Jul;60(1):1‐15.
Trend for other urological cancers
Bladder cancerTestis cancer
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Lu‐Yao G, Stukel TA, Yao SL. Changing patterns in competing causes of death in men with prostate cancer: apopulation based study. J Urol. 2004;171:2285‐90
Pca cancer deaths
In a prespecified subgroup of men aged 55 to 69 years in theERSPC trial, a small (0.09%) absolute reduction in prostate cancerdeaths was seen after a median follow‐up of 11 years. The timeuntil any potential cancer‐specific mortality benefit (should itexist) for PSA‐based screening emerges is long (at least 9 to 10years), and most men with prostate cancer die of causes otherthan prostate cancer.
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Heijndijk EA et al. Cost‐effectiveness of prostate cancer screening: a simulation study based on ERSPC data. JNatl Cancer Inst. 2014 Dec 13;107(1):366
Pca cancer deaths
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The PSA test may give false‐positive or false‐negative results.
A false‐positive test result occurs when a man’s PSA level is elevated butno cancer is actually present.
A false‐positive test result may create anxiety for a man and his familyand lead to additional medical procedures, such as a prostate biopsy,that can be harmful. Possible side effects of biopsies include seriousinfections, pain, and bleeding.
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PSA limitations
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The risk for prostate cancer among men with elevated PSAlevels is lower in men with urinary symptoms than in menwithout symptoms.
Obstruction increases PSA values due to chronicinflammation and urine reflux into the gland.
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PSA limitations
Collin SM, Metcalfe C, Donovan J, Lane JA, Davis M, Neal D, et al. Associations of lower urinary tractsymptoms with prostate‐specific antigen levels, and screen‐detected localized and advanced prostatecancer: a case‐control study nested within the UK population‐based ProtecT (Prostate testing for cancerand Treatment) study. BJU Int. 2008;102:1400‐6.
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PCa stages
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Overdiagnosis
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For an individual wondering whether or not he should betested, there are two simple numbers that count: 0% and100%. Either he has life‐threatening PCa or he does not. So,what should clinicians do when a man requests a PSA test?
The aforementioned population‐based estimates will not beof help. The keywords for this dilemma are risk stratification,informed consent, and shared decision making.
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Roobol MJ, Schroder FH. The rate of overdiagnosis inextricably linked to Prostate‐specific antigen‐basedscreening for Prostate Cancer can be quantified in several ways, but what is the practicable message? EurUrol 2014;65(6):1056/7
Overdiagnosis
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A cancer diagnosis in men with shorter life expectanciesbecause of chronic diseases or age is much more likely to beoverdiagnosis.
Estimates from the 2 largest trials suggest overdiagnosisrates of 17% to 50% for prostate cancer screening.
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Miller AB. New data on prostate‐cancer mortality after PSA screening [Editorial]. N Engl J Med.2012;366:1047‐8
Overdiagnosis
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Overdiagnosis is the detection of pseudodisease‐screening‐detected abnormalities thatmeet the pathologic definition of cancer but will never progress to cause symptoms.
The consequence of overdiagnosis is overtreatment – surgery, chemotherapy, orradiation – that provides the patient no benefits, but only adverse effects.
“Are patients informed about overdiagnosis by their physicians when discussing cancerscreening? How much overdiagnosis would they tolerate when deciding to start orcontinue screening?”
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Overdiagnosis
Wegwarth O, Gigerenzer G. Overdiagnosis and Overtreatment: Evaluation of What Physicians Tell TheirPatients About Screening Harms. JAMA Intern Med 2013;173(22):2086‐7
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There is adequate evidence that false‐positive PSA test resultsare associated with negative psychological effects, includingpersistent worry about prostate cancer.
Men who have a false‐positive test result are more likely to haveadditional testing, including 1 or more biopsies, in the followingyear than those who have a negative test result.
Over 10 years, approximately 15% to 20% of men will have a PSAtest result that triggers a biopsy, depending on the PSAthreshold and testing interval used.
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Overdiagnosis
Schro¨der FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, et al; ERSPC Investigators.Screening and prostate‐cancer mortality in a randomized European study. N Engl J Med.2009;360:1320‐8
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In 2013
Online survey on 317 US men and women, aged 50 to 69 years population with thehighest exposure to screening programs.
Results – already underwent to screening
‐ 19.9% attended 1 routine cancer screening‐ 36.0% reported 2 screenings‐ 27.1%reported 3 or more
‐ 17.0% indicated none
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Overdiagnosis
Wegwarth O, Gigerenzer G. Overdiagnosis and Overtreatment: Evaluation of What Physicians Tell TheirPatients About Screening Harms. JAMA Intern Med 2013;173(22):2086‐7
= 83%!!!
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Results ‐ 1
‐ only 9.5% of the individuals (n = 30) said that their physician had informed themabout the possibility of overdiagnosis and overtreatment when discussing cancerscreening
‐ eighty percent of all participants expressed the desire to be told about screeningharms before undergoing the testing
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Overdiagnosis
Wegwarth O, Gigerenzer G. Overdiagnosis and Overtreatment: Evaluation of What Physicians Tell TheirPatients About Screening Harms. JAMA Intern Med 2013;173(22):2086‐7
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Results ‐ 2
‐ 69% of the sample indicated that they would not start screening if overdiagnosiswas as high (ie, ≥10 cases per 1 life saved) as it is in mammography and PSA testing
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Overdiagnosis
Wegwarth O, Gigerenzer G. Overdiagnosis and Overtreatment: Evaluation of What Physicians Tell TheirPatients About Screening Harms. JAMA Intern Med 2013;173(22):2086‐7
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False messages
Even today, woman are simply told to go for mammographic screening and are given nodetailed estimates of the benefit. In the US the Food and Drug Administration’s Officeof Women’s Health leaflet (in pink) says on its first page that “Mammograms can helpsave lives.” Similarly, the American Cancer Society’s 2014 pamphlet Breast Cancer:Early Detection tells women, “Most doctors feel that early detection tests for breastcancer save thousands of lives each year, and that many more lives could be saved ifeven more women and their health care providers took advantage of these tests,” andthe National Cancer Institute’s fact sheet says, “Screening mammography can helpreduce the number of deaths from breast cancer among women ages 40 to 70,especially for those over age 50.”
In each case, no information is given about how large the benefit is!
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Overdiagnosis
Gigerenzer G. Breast cancer screening pamphlets mislead women. BMJ 2014;348:g2636
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Overdiagnosis
Siegel R et al. Cancer Statistics 2014. CACancer J Clin 2014;64:9‐29
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American Cancer Society’s 2014 Prostate Cancer fact sheet “At this time, there isinsufficient evidence to recommend for or against routine prostate cancer screeningfor average‐risk men. For this reason, the American Cancer Society does notrecommend routine screening for prostate cancer. Rather, the ACS recommendsaverage‐risk men, beginning at age 50, have the opportunity to make an informeddecision about screening after discussing the potential benefits and limitations ofprostate cancer early detection testing with a health care professional.” and theNational Cancer Institute’s fact sheet says, “Although some organizations continue torecommend PSA screening, there is widespread agreement that any man who isconsidering getting tested should first be informed in detail about the potential harmsand benefit.”
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Overdiagnosis
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As a result, almost all women and men
have a false impression of the benefit of mammography and PSA screening respectively.
86
Overdiagnosis
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Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, et al; ERSPC Investigators. Prostate‐cancer mortality at 11 years of follow‐up. N Engl J Med. 2012;366:981‐90
Reducing harms of screening
Lengthening the interval between screening tests mayreduce harms without affecting cancer mortality; the onlyscreening trial that demonstrated a prostate cancer–specific mortality benefit generally used a 2‐ to 4‐yearscreening interval.
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Actual recomendations for PCa testing
The American Urological Association recommends that PSA screening, in conjunctionwith a digital rectal examination, should be offered to asymptomatic men aged 40years or older who wish to be screened, if estimated life expectancy is greater than 10years.
The American Cancer Society emphasizes informed decision making for prostatecancer screening: men at average risk should receive information beginning at age 50years, and black men or men with a family history of prostate cancer should receiveinformation at age 45 years.
The American College of Preventive Medicine recommends that clinicians discuss thepotential benefits and harms of PSA screening with men aged 50 years or older,consider their patients’ preferences, and individualize screening decisions.
The American Academy of Family Physicians is in the process of updating its guideline,and the American College of Physicians is currently developing a guidance statementon this topic.
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Actual recomendations for PCa testing
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Economical and social costs linked to: long‐term survival rates of PCa patients
90
Open questions
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91
Cancer survivors
De Santis CE et al. Cancer Treatment and Survivorship Statistics, 2014. CA Cancer J Clin2014;64:252‐271
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Economical and social costs linked to: long‐term survival rates of PCa patients side effects of treatments (which – in some cases – are not
affecting survival rates of PCa patients)
92
Open questions
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Other than the oncological control of disease, the preservation of pelvic functions is amajor goal of radical surgical procedures (the precise location of nerves is still unclear).
93
Side effects
Resnick MJ et al. Long‐term functional outcomes after treatment forlocalized prostate cancer. N Eng J Med 2013;368(5):436‐45
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Other than the oncological control of disease, the preservation of pelvic functions is amajor goal of radical surgical procedures (the precise location of nerves is still unclear).
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Resnick MJ et al. Long‐term functional outcomes after treatment forlocalized prostate cancer. N Eng J Med 2013;368(5):436‐45
Side effects
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Economical and social costs linked to: long‐term survival rates of PCa patients side effects of treatments (which – in some cases – are not
affecting survival rates of PCa patients) tailored evaluation. Not all patients (40 versus 70 years‐old)
and not all the diseases are equivalent (Gleason score, TNM,histotype, ecc).
95
Open questions
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Economical and social costs linked to: long‐term survival rates of PCa patients side effects of treatments (which – in some cases – are not
affecting survival rates of PCa patients) tailored evaluation. Not all patients (40 versus 70 years‐old)
and not all the diseases are equivalent (Gleason score, TNM,histotype, ecc)
aging population.
96
Open questions
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97
Open questions
EUROSTAThttp://ec.europa.eu/eurostat/statistics‐explained/index.php/File:Population_structure_by_major_age_groups,_EU‐28,_2014%E2%80%9380_(%C2%B9)_(%25_of_total_population)_YB15.png (last consultation, April 17th 2016)
18.5%
28.7%
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Open questions
EUROSTAThttp://ec.europa.eu/eurostat/statistics‐explained/index.php/Mortality_and_life_expectancy_statistics (lastconsultation, April 17th 2016)
Economic development and the improvement in someenvironmental conditions (for example in many urban areas),improved lifestyles, advances in healthcare and medicine,including reduced infant mortality, have resulted in a continuousincrease in life expectancy at birth across Europe during the lastcentury.This process has been going on for longer in Europe than in mostother parts of the world, placing the EU‐28 among the worldleaders for life expectancy.
Life expectancy at birth in 2002: 77.7 yearsLife expectancy at birth in 2013: 80.6 years
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Individualized, risk‐stratified screening (considering factors otherthan PSA level alone such as new biomarkers, development ofnomograms and risk calculators, and suggestions forindividualized screening intervals) to avoid unnecessaryprostate biopsies and, perhaps even more important, to improveproper staging/grading of the PCa, enabling the optimal choice oftreatment.
Patients awareness!
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Open questions
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May 25th, 2016
Thank You for the attention and kind invitation!