clinical evidence and treatment recommendations in ... · united kingdom czech republic italy spain...

Clinical evidence and treatment recommendations in localized and locally advanced prostate

cancer

M. Babjuk, L. Dušek FN Motol, 2. LF UK

IBA MUNI, ÚZIS

How should be the care organized and its quality controled?

Data from national databases and

registries

Evaluation of results

Treatment recommendations

System of care providers, centers etc

Quality criteria

Another sources: international

guidelines, evidence analyses

Reimbursement

Incidence and prevalence trends in ČR (epidemiological data from ČR)

7,049 patients with prostate cancer were diagnosed in the Czech

Republic in 2015 (8.2% of all cancers).

53,769 persons with a history of prostate cancer lived in the Czech

Republic on 31/12/2015 (9.9 % of all cancers).

New CNCR data: total prostate cancer burden

1,327 persons died due to prostate cancer in the Czech Republic in

2015 (4.9% of all cancer-related deaths).

2008 2009 2010 2011 2012 2013 2014 2015

Incidence 5 443 6 286 6 942 7 077 7 007 6 967 6 693 7 049

Mortality* 1 291 1 305 1 348 1 314 1 360 1 422 1 509 1 327

Prevalence 28 196 31 612 35 557 39 450 43 193 46 846 50 153 53 769

Czech National Cancer Registry – prostate cancer (C61) Mean

interannual

change

2011–2015

+0.4%

-0.1%

+8.6%

*Source: Czech Statistical Office

0

20

40

60

80

100

120

140

160

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

Poče

t na

100

000

muž

ů

Year

Prostate cancer (C61)

0

5

10

15

20

25

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

Poče

t na

100

000

osob

Year

Bladder cancer (C67)

0

5

10

15

20

25

30

35

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

Poče

t na

100

000

osob

Year

Kidney cancer (C64)

0

5 000

10 000

15 000

20 000

25 000

30 000

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

0

2 000

4 000

6 000

8 000

10 000

12 000

14 000

16 000

18 000

20 000

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

0

10 000

20 000

30 000

40 000

50 000

60 000

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

Poče

t žijí

cích

s ná

dore

m

Year

Poče

t žijí

cích

s ná

dore

m

Year

Poče

t žijí

cích

s ná

dore

m

Year

-6.0%

+4.0%

+9.7%

-17.4%

+153.0%

Main urinary system cancers: time trends

Prostate cancer (C61) Bladder cancer (C67) Kidney cancer (C64)

+24.6% +54.0%

Trend of prevalence

incidence mortality Trends of incidence and mortality

%: trend between years 2005–2015

Source: incidence and prevalence: Czech National Cancer Registry, IHIS CZ; mortality 1994–2015: Czech Statistical Office

!

?

0 %

20 %

40 %

60 %

80 %

100 %

1977

1979

1981

1983

1985

1987

1989

1991

1993

1995

1997

1999

2001

2003

2005

2007

2009

2011

2013

2015

Trends in the diagnosis of clinical stages

Clinical stage:

unknown

–

objective

reasons

unknown

–

incomplete

record

Year

TNM 2nd ed.

TNM 3rd ed.

TNM 4th ed.

TNM 5th ed.

TNM 6th ed.

1 2 3 4

Epidemiology of C61: still existing

high proportion of advanced stages

%: trend between years 2005–2015 TNM

7th ed.

0

10 000

20 000

30 000

40 000

50 000

60 000

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

+153.0%

Trend of C61 prevalence

Nu

mb

er o

f p

erso

ns

Epidemiology of the urinary system cancers in the Czech Republic

Source: incidence and prevalence: Czech National Cancer Registry, IHIS CZ; mortality – Czech Statistical Office

*C60–C62, **C64–C67, m per 100 000 men

Czech National Cancer Registry: recent data (year) 2015

Diagnosis

Incidence (2015)

Mortalitay (2015)

Prevalence (on 31/12/2015)

Absol.

number

Number

per 100,000

persons

Absol.

number

Number

per 100,000

persons

Absol.

number

Number

per 100,000

persons

C60 MN of penis 126 2.4m 34 0.7m 822 15.9m

C61 MN of prostate 7,049 136.1m 1,327 25.6m 53,769 1,038.0m

C62 MN of testis 527 10.2m 27 0.5m 9 983 192.7m

C63 MN of other and unspecified male

genital organs 10 0.2m - - 126 2.4m

Total (C60–C63) 7,712 148.9m *1,388 *26.8m 64,563 1,246.3m

C64 MN of kidney, exc. renal pelvis 2,988 28.3 1,055 10.0 24,385 231.3

C65 MN of renal pelvis 177 1.7 101 1.0 1 064 10.1

C66 MN of ureter 87 0.8 23 0.2 456 4.3

C67 MN of bladder 2,158 20.5 813 7.7 18,359 174.1

C68 MN of other and unspecified urinary

organs 16 0.2 - - 146 1.4

Total (C64–C68) 5,426 51.5 **1,992 **18.9 43,687 414.4

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

Source: Cancer Incidence in Five Continents Annual Dataset: Germany-Saarland; Cancer Mortality Database

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

incidence

mortality

C61 incidence and mortality in international comparison

0

20

40

60

80

100

120

197719

7919

8119

8319

8519

8719

8919

9119

9319

9519

9719

9920

0120

0320

0520

0720

0920

1120

1320

15

incidence

mortality

incidence

mortality

incidence

mortality

incidence

mortality

incidence

mortalita

incidence

mortality

incidence

mortality

incidence

mortality

Source: Czech National Cancer Registry Source: Cancer Incidence in Five Continents Annual Dataset, Cancer Mortality database

Source: Cancer Incidence in Five Continents Annual Dataset; Cancer Mortality Database

Source: Cancer Incidence in Five Continents Annual Dataset: Austria-Tyrol; Cancer Mortality Database


Czech Republic Slovakia Sweden

Germany Austria Norway

Slovenia Netherlands Finland

AS

R (

W)

Source: Cancer Incidence in Five Continents Annual Datase; Cancer Mortality Database

Source: Cancer Incidence in Five Continents Annual Dataset: Nizozemí-Eindhoven; Cancer Mrotality Database


0 50 100 150 200 250 0 50 100 150

ASR (W) WORLD

other countries

European countries

neighbouring countries

Czech Republic CR ranking 34th globally

World

EUROPE

European countries

neighbouring

countries

Czech Republic CR ranking 18th in

Europe

Europe

Norway

Sweden

Ireland

Switzerland

Iceland France (metropolitan)

Finland

Estonia

Denmark

Belgium The Netherlands

Slovenia

Latvia

Luxembourg

Germany Austria

United Kingdom

Czech Republic Italy

Spain Portugal

Lithuania

Cyprus

Malta

Slovakia Croatia

Hungary

Serbia

Poland

Belarus Montenegro

Russian Federation

FYR Macedonia

Romania

Bulgaria Bosnia Herzegovina

Ukraine

Greece

Republic of Moldova

Albania

ASR (W)

67.1 +

32.4–67.1

19.5–32.4

10.8–19.5

< 10.8

No data

ASR (W): world age-standardised incidence per 100,000 persons

92.0 +

73.8–92.0

50.5–73.8

29.6–50.5

< 29.6

No data

C61 incidence in international comparison

Source: Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F.GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide:

IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, 22/7/2017

0 5 10 15 20 250 15 30 45 60

C61 mortality in international comparison

ASR (W) WORLD

World

other countries

European countries


Czech Republic

CR ranking 98th

globally

ASR (W)

Europe

European countries


Czech Republic CR ranking 23rd in Europe

EUROPE

Lithuania

Estonia

Denmark

Slovenia

Latvia Norway

Sweden

Croatia

Iceland

Montenegro FYR Macedonia

The Netherlands

Serbia

Slovakia

United Kingdom Belarus

Belgium

Ireland

Russian Federation

Poland Switzerland

Finland

Czech Republic Portugal

Bulgaria Hungary

Germany

Luxembourg

Austria

Cyprus Ukraine

France (metropolitan)

Republic of Moldova

Greece

Romania Bosnia Herzegovina

Spain

Albania

Italy

Malta

Source: Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F.GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide:

IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, 22/7/2017

20.2 +

13.9–20.2

10.0–13.9

6.2–10.0

< 6.2

No data

ASR (W): world age-standardised mortality per 100,000 persons

14.8 +

12.8–14.8

10.6–12.8

10.0–10.6

< 10.0

No data

Treatment outcomes in ČR (in different historical periods)

Prostate cancer – year 2015

Incidence in 2015:

- total: 7,049 men

- of which clinical stage III–IV: 24.7%

Prevalence in 2015:

- total: 53,769 men

- of which clinical stage III–IV at diagnosis : 19.4%

0

5

10

15

20

25

30

< 50

50–54

55–59

60–64

65–69

70–74

75–79

80–84

85+

% o

f cases in t

he

resp

ective

ca

teg

ory

Age

Age structure

- 13.8% of men were under 60 years

Newly diagnosed cancers in the period 2011–2015

- 56.6 % of men were under 70 years

Source: Czech National Cancer Registry, IHIS CZ

0

5

10

15

20

25

30

< 50

50–5455–5960–6465–6970–7475–7980–84

85+

% o

f ca

ses

in t

he

resp

ecti

ve

cate

gory

Age at diagnosis

Age structure Age-specific incidence

Period:

1986–1990

1991–1995

1996–2000

2001–2005

2006–2010

2011–2015

N = 7,823 N = 10,192 N = 14,095 N = 20,066 N = 28,877 N = 34,793

Mean 72 years 73 years 72 years 71 years 69 years 69 years

Median 73 years 72 years 73 years 72 years 69 years 68 years

25th–75th perc. 66–78 years 67–79 years 67–78 years 65–77 years 63–76 years 63–74 years

% of persons below 70 35.8% 35.8% 35.1% 40.8% 51.5% 56.6%

0

100

200

300

400

500

600

700

800

900

< 50

50–5455–5960–6465–6970–7475–7980–84

85+

Num

ber

of

case

s per

100,0

00

men

in t

he

resp

ecti

ve

age

cate

gory

Age at diagnosis

Age of prostate cancer patients in time

! Source: Czech National Cancer Registry, IHIS CZ

5Yr OS

Cohort analysis

1990–1994

Cohort analysis

1995–1999

Cohort analysis

2000–2004

Cohort analysis

2005–2008

Cohort analysis

2009–2012

Analysis of the period 2013–2016

Stage 1 + 2 59,7 % 66,6 % 75,2 % 80,7 % 83,7 % 84,1 %

Stage 3 45,0 % 58,8 % 66,6 % 75,5 % 81,3 % 81,8 %

Stage 4 20,8 % 24,6 % 24,5 % 29,4 % 33,6 % 35,1 %

All 42,5 % 51,8 % 61,8 % 71,7 % 76,6 % 77,2 %

0 %

10 %

20 %

30 %

40 %

50 %

60 %

70 %

80 %

90 %

100 %

Analysis of the period 2013–2016

Cohort analysis 2009–2012





5Yr OS: treated patients with C61

PCa (C61)

5 Y

r O

S

Stage 3 All cases Stage 4 Stage

1 + 2

Patients with anticancer treatment

Age standardized.

Treatment trends and results in individual treatment modalities

(example: radical prostatectomy)

Trends in number and percentage of patients with PCa and radical prostatectomy

Nu

mb

er o

f ca

ses

Yr of radical prostatectomy

No. Of patients with radical prostatectomy

Perc

enta

ge o

f ca

ses


Percentage of pts.

Trends in number and percentage of patients with PCa and radical prostatectomy

Open surgery Laparoskopic surgery Robot assisted surgery

Type of surgery:


Nu

mb

er o

f ca

ses

Perc

enta

ge o

f ca

ses

Open surgery Laparoskopic surgery Robotic assisted surgery


> 40%

30–40%

< 30%

Kraj bydliště

STC

JHC

PLK

JHM

VYS ZLK

ULK

MSK

OLK

PAK

HKK

LBK

KVK PHA

Ústecký kraj

Olomoucký kraj

Středočeský kraj Karlovarský kraj

Hlavní město Praha

Vysočina

Liberecký kraj

Jihomoravský kraj

Česká republika

Královéhradecký kraj

Pardubický kraj

Jihočeský kraj Plzeňský kraj

Zlínský kraj

Moravskoslezský kraj

Percentage of pts. with radical prostatectomy in regions (2014–2017)

Percentage (%) of surgeries from all detected cases with Pca (2014–2016):

Radical prostatectomies in regions (2014–2017)

Open surgery Laparoskopic surgery Robotic assisted surgery

Type of surgery (average 2014–2017):

Česká republika

Kraj bydliště Olomoucký kraj

Ústecký kraj

Kraj Vysočina

Zlínský kraj

Pardubický kraj

Hlavní město Praha

Jihomoravský kraj

Liberecký kraj

Královéhradecký kraj

Středočeský kraj Karlovarský kraj

Moravskoslezský kraj

Plzeňský kraj Jihočeský kraj

3Yr and 5Yr OS: patients after radical prostatectomy

OS

3Yr 5Yr

All stages 96,1 % 90,4 %

Stage 1+2 96,4 % 91,6 %

Stage 3 95,6 % 86,9 %

Stage 4 94,1 % 81,8 %

3Yr and 5Yr OS after radical prostatectomy achieved 96,1%, and 90,4% respectivelly.

5Yr OS: patients after radical prostatectomy

5Y

r O

S

All Open surgery Laparoscopic surgery

Robotic assisted surgery

All cases 90,4 % (n = 12 647) 88,8 % (n = 4 960) 92,0 % (n = 2 456) 92,5 % (n = 5 231)

Stage 1+2 91,6 % (n = 8 807) 92,1 % (n = 3 308) 94,0 % (n = 1 789) 93,0 % (n = 3 710)

Stage 3 86,9 % (n = 2 177) 86,1 % (n = 915) 88,5 % (n = 387) 85,7 % (n = 875)

Stage 4 81,8 % (n = 483) 82,6 % (n = 265) 86,1 % (n = 70) 83,3 % (n = 148)

Prediction

Prostate cancer: estimated incidence rates

Prostate cancer (C61) Estimated incidence rates (90 % confidence interval)

2016 2017 2018

.

.

.

2020

.

.

.

2025

Stage I+II 4,926

(4,542; 5,311)

4,969

(4,545; 5,394)

4,989

(4,524; 5,456)

5,002

(4,206; 5,799)

4,877

(3,770; 5,984)

Stage III 785

(720; 849)

769

(700; 837)

750

(677; 823)

648

(551; 746)

525

(400; 649)

Stage IV 875

(811; 940)

879

(809; 949)

878

(802; 955)

781

(673; 889)

721

(566; 876)

Stage unknown1 390

(304; 476)

400

(307; 494)

409

(308; 510)

364

(222; 506)

366

(170; 561)

TOTAL 6,976

(6,377; 7,576)

7,017

(6,361; 7,674)

7,026

(6,311; 7,744)

6,795

(5,652; 7,940)

6,489

(4,906; 8,070)

1 Objective reasons for missing clinical stage are DCO/autopsy-diagnosed tumours, early deaths, patients not treated due to

contraindication or refusal of the anticancer therapy. If a reason for missing stage is not explained, the record is considered as

incomplete. The incomplete records are not included in the estimated number of patients with the anticancer therapy.

Prostate cancer: estimated prevalence rates

1 Objective reasons for missing clinical stage are DCO/autopsy-diagnosed tumours, early deaths,

patients not treated due to contraindication or refusal of the anticancer therapy. If a reason for

missing stage is not explained, the record is considered as incomplete.

Prostate cancer (C61)

Estimated prevalence rates (90 % confidence interval)

2016 2017 2018

.

.

.

2020

.

.

.

2025

Stage I+II 43,926

(43,581; 44,271)

46,702

(46,347; 47,057)

49,369 (49,004; 49,734)

55,675

(55,287; 56,063)

66,983 (66,557; 67,409)

Stage III 7,541

(7,398; 7,684)

7,917

(7,771; 8,063)

8,249

(8,100; 8,398)

8,849

(8,694; 9,004)

9,734

(9,572; 9,896)

Stage IV 5,169

(5,051; 5,287)

5,223

(5,104; 5,342)

5,249

(5,130; 5,368)

5,409

(5,288; 5,530)

5,315

(5,195; 5,435)

Stage unknown1 3,714

(3,614; 3,814)

3,628

(3,529; 3,727)

3,565

(3,467; 3,663)

3,529

(3,431; 3,627)

3,546

(3,448; 3,644)

TOTAL 60,350

(59,946; 60,754)

63,470 (63,056; 63,884)

66,432

(66,008; 66,856)

73,462 (73,016; 73,908)

85,578

(85,097; 86,059)

Number of patients referred for treatment

according to region and phase of treatment

0 1 000 2 000 3 000 4 000 5 000

Number

Total number of patients referred for treatment

according to region

Regional estimates of numbers of prostate cancer (C61) patients with anticancer therapy in 2018

Newly diagnosed and treated patients

Non-terminal recurrences and progressions

Terminal recurrences and progressions

Prague

South Moravian Region

Moravian-Silesian Region

Central Bohemian Region

Ústí nad Labem Region

Zlín Region

Olomouc Region

Hradec Králové Region

South Bohemian Region

Pardubice Region

Vysočina Region Plzeň Region

Liberec Region

Karlovy Vary Region

0–1 250

1 251–2 000

2 001–2 750

2 751–3 500

3 501 and higher

2 942

1 492

1 365

3 295

1 367

2 998

2 101

1 668

642

1 596

1 405

1 678

1 046

3 713



3 049

1 566

1 353

3 479

1 467

3 169

2 185

1 756

667

1 660

1 522

1 759

1 083

3 935

Number


according to region


Expected change +4.9%

from 2018 to 2020

Prague





Zlín Region

Olomouc Region



Pardubice Region


Liberec Region

Karlovy Vary Region

0 1 000 2 000 3 000 4 000 5 000

0–1 250

1 251–2 000

2 001–2 750

2 751–3 500

3 501 and higher






3 239

1 673

1 424

3 724

1 571

3 387

2 327

1 863

710

1 765

1 613

1 871

1 151

4 185

Number


according to region


Expected change +11.7%

from 2018 to 2025

Prague





Zlín Region

Olomouc Region



Pardubice Region


Liberec Region

Karlovy Vary Region

0 1 000 2 000 3 000 4 000 5 000

0–1 250

1 251–2 000

2 001–2 750

2 751–3 500

3 501 and higher




Treatment recommendations (source data)

Treatment recommendations available guidelines

International guidelines:

• EAU, ESMO

National guidelines:

• NCCN, AUA, NICE etc.

Prospective controlled trials

• ProtecT study

• Localized CaP

• PSA 4.6ng/ml, 77% GS 6, 76% T1c

Treatment recommendations in localized and locally advanced PCa

critical points

• Staging methods

• Risk assessment and stratification

• Deferred treatment (active surveillance, WW)

• Active treatment (surgery, RT)

• Monitoring

• Definition of treatment failure

• Secundary measures

Prostate cancer as

a subsequent

primary cancer in

cancer patients

Epidemiology of prostate cancer in the Czech Republic Epidemiology-related challenges for organising the healthcare

INSTITUTE OF BIOSTATISTICS AND ANALYSES, Faculty of

Medicine, Masaryk University, Brno

Diagnosis First/subsequent cancer

Period 1986–1995

Period 1996–2005

Period 2006–2015

N per year (% of

newly diagnosed) N per year (% of

newly diagnosed) N per year (% of

newly diagnosed)

Prostate cancer (C61) first cancer 1,646 (91.4%) 2,952 (86.4%) 5,430 (85.3%)

subsequent primary cancer 155 (8.6%) 464 (13.6%) 937 (14.7%)

Incidence: first and subsequent primary cancers in the Czech Republic

Source: Czech National Cancer Registry, IHIS

CZ

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