surgery as primary treatment - Over Group Provider ECM · surgery as primary treatment ... Fig. 1 Patient flow chart. ... • Riduzione della curva di apprendimento

surgery as primary treatmentsurgery as primary treatment in prostate cancer

Donata VillariSod Urologia IISod Urologia IIAzienda Ospedaliera Universitaria CareggiFirenze

Prostatectomia radicale (PR)

Terapia "gold standard” del tumore prostatico localizzato mediante rimozione in blocco di prostata e vescicole seminali

• Life expectancy >10 anni• Età ≤75 anni (?)Stadio cT1b T2 N0 M0• Stadio cT1b-T2, N0, M0

• T3a, GS>8, PSA<20ng/mL

Prostatectomia retropubica“open”

Prostatectomia videolaparoscopicaProstatectomia videolaparoscopica

Prostatectomia robotica

Stadiazione clinica accurata - il paziente ideale

Età e performance statusFamiliarità

ERPSA alla diagnosi

Gleason score bioptico, numero e sede dei frustoli positivinumero e sede dei frustoli positivi

T clinicoIIEF-5

Fig. 4 Number of men aged ≥70 years and ≥80 years in more developed countries. Men over the age of 70 years are the fasted growing segment of the population. Data from 2010 to 2050 are projections <ce:cross-ref refid="bib8"> [8]</ce:cross-ref> .

Jean-Pierre Droz , Lodovico Balducci , Michel Bolla , Mark Emberton , John M. Fitzpatrick , Steven Joniau , Michae...

Background for the proposal of SIOG guidelines for the management of prostate cancer in senior adults

Critical Reviews in Oncology/Hematology, Volume 73, Issue 1, 2010, 68 - 91

Fig. 6 Life expectancy in senior adults: a large variability reflecting health status variability. For a given age, a proportion of men in the top 25th percentile have a good health status and may have a longer life expectancy than men who are 5, 10 or eve...




Fig. 7 General scheme for the treatment decision-making in senior adults with prostate cancer.g g p




Fig. 7 General scheme for the treatment decision-making in senior adults with prostate cancer.g g p




2014

Low risk < 25% PSA failure

≤ T2a and Gleason ≤ 6 and PSA < 10 ng/ml

Intermediate risk 25-50% PSA failure

T2b or Gleason 7 or PSA 10-20 ng/ml

High risk > 50 % PSA failure

T2c or Gleason 8-10 or PSA> 20 ng/ml

Contemporary Trends in Low Risk Prostate Cancer: Risk Assessment and TreatmentJ Urol. 2007Matthew R. Cooperberg,* Jeannette M. Broering,* Philip W. Kantoff† and Peter R. Carroll‡,§7

Biochemical survival among radical prostatectomy patients with low‐risk prostate cancer. Kaplan‐Meier curves for biochemical recurrence‐free survival among patientscancer. Kaplan Meier curves for biochemical recurrence free survival among patients with low‐risk prostate cancer undergoing radical prostatectomy, stratified by Cancer of the Prostate Risk Assessment (CAPRA) score.

L’importanza delle categorie di rischio

J Clin Oncol 2011

Click to edit the outline text format

Second Outline Level

− Third Outline Level

Fourth Outline LevelFourth Outline Level−Fifth Outline Level

La stadiazione clinica

GLEASON+PSAPSA=STADIO PRESUNTO

VOLUME

Partin AW Combination of Prostate-specific antigen,clinical stage, and Gleason score to predict pathological stage of localized prostate cancer :a multiisituzional update JAMA 1997

VOLUME DELLA NEOPLASIAVOLUME DELLA NEOPLASIA

PENETRAZIONE CAPSULARE

T2 (intra)

T2 (intra)T3(extra) T3(extra)

Very promising techniqueUseful in selected cases. Could suggest to perform first or repeated biopsy

2014

Fascio vasculo-nervoso

T1 T2

“Achieving the balance between preserving the neurovascularbundles and eliminating the entire tumour continues to be abundles and eliminating the entire tumour continues to be adifficult task.”

The more the crucial structures are spared, the higher thechance that parts of the tumour will be left behind.

Trifecta outcomes in radical prostatectomy series according to the literature

Quality of life

Fig. 1 Patient flow chart. CaPSURE = Cancer of the Prostate Strategic Urologic Research Endeavor; QoL = quality of life.g g g ; q ySanoj Punnen , Janet E. Cowan , June M. Chan , Peter R. Carroll , Matthew R. Cooperberg

Long-term Health-related Quality of Life After Primary Treatment for Localized Prostate Cancer: Results from the CaPSURE Registry

European Urology, 2014

Median follow up:74 mo (50‐102)

Adjusted mean summary scores for theAdjusted mean summary scores for the Medical Outcomes Studies 36-item Short Form (a) physical function and (b) mental health, and for the University of California, Los Angeles, Prostate Cancer Index (c) sexual function, (d) sexual bother, (e) urinary function (f) urinary bother (g) bowelfunction, (f) urinary bother, (g) bowel function, and (h) bowel bother are displayed over time by primary treatment type among 3294 men in the study cohort.

BT = brachytherapy; EBRT = external beam radiotherapy; NSRP = nerve-sparing

di l t t t N NSRPradicalprostatectomy;NonNSRP=non nerve sparing radical prostatectomy PADT = primary androgen deprivation therapy; PRE = before treatment; py; ;WW/AS = watchful waiting/active surveillance.

Sanoj Punnen , Janet E. Cowan , June M. Chan , Peter R. Carroll , Matthew R. Cooperberg Eur Urol 2014

Long-term Health-related Quality of Life After Primary Treatment for Localized Prostate Cancer: Results from the CaPSURE Registry

Mean health-related quality of life summary scores at baseline for 3294 men inthe study cohort by primary treatment modalityBT brach therap EBRT e ternal beam radiotherap NSRP ner e sparing radical prostatectom PADT primar

Health NSRP Non‐NSRP BT EBRT PADT WW/AS

BT = brachytherapy; EBRT = external beam radiotherapy; NSRP = nerve-sparing radical prostatectomy; PADT = primary androgen deprivation therapy WW/AS = watchful waiting/active surveillance

Health domain

NSRP Non NSRP BT EBRT PADT WW/AS

SF‐36

Physical 93 (14) 88 (19) 82 (22) 78 (23) 74 (24) 71 (29)Physical function

93 (14) 88 (19) 82 (22) 78 (23) 74 (24) 71 (29)

Mental health

79 (16) 78 (16) 79 (15) 81 (15) 80 (16) 77 (19)

UCLA PCI

Sexual function

65 (26) 54 (28) 43 (30) 35 (28) 32 (26) 32 (28)

Sexual bother

71 (34) 61 (37) 54 (39) 53 (40) 55 (41) 44 (41)

Urinary 93 (12) 93 (13) 92 (13) 91 (14) 90 (16) 87 (22)Urinary function

93 (12) 93 (13) 92 (13) 91 (14) 90 (16) 87 (22)

Urinary bother

89 (19) 85 (24) 83 (24) 81 (27) 79 (28) 77 (33)

Bowel function

90 (12) 88 (14) 88 (14) 87 (13) 84 (17) 86 (17)

Bowel 93 (16) 90 (20) 88 (21) 86 (23) 83 (25) 87 (22)bother

( ) ( ) ( ) ( ) ( ) ( )

Data are shown as mean (standard deviation).

2014

CHIRURGIA ROBOT-ASSISTED IN ITALIA

L’Italia è il secondo paese in Europa e il quarto nel mondo per numero di robot «Da Vinci» attualmente in uso:

1.U.S.A. (2000)Gi (138)2.Giappone (138)

3.Francia (69)Italia (64)4.Italia (64)

Oltre 9000 procedure robotiche eseguite in Italia nel 2013

POLO DI CHIRURGIA ROBOTICA

DELLA REGIONE TOSCANA

.1361 procedure a Settembre2014Dept Of Urology AOUC Careggi FlorenceDept. Of Urology, AOUC Careggi, Florence

12

8

10

6

4

2

0



Stratificazione per tipo di intervento

Dept. Of Urology, AOUC Careggi, Florence

0 2 4 6 8 10 120 2 4 6 8 10 12



Vantaggi dell’impiego del sistema robotico monodisciplinare in struttura con alto volume operatorio

• Rapida acquisizione di casistica adeguata

Riduzione della curva di apprendimento• Riduzione della curva di apprendimento

• Formazione rapida di una equipe

Miglioramento “outcomes”Miglioramento outcomes oncologici e funzionali e riduzione

dei costidei costi



RAPN

Dept. Of Urology, AOUC Careggi, Florence

Open VS. Simple Laparoscopic VS. Robot‐assisted procedures

138140

107118

100

120

4943 394547

60

80Open

VLP43

0

3945

15

3520

32

0

35

0900

20

40VLP

Robot

0 0 0 002009 2010 2011 2012 2013 J an‐

S ept20142014

Dati intraoperatori

Clinica Urologica, AOUC Careggi

Procedure

( ) ( )Radical (non‐NS) (5,6%)

NS Monolateral (18.3%)( )

NS Bilateral (76.3%)

Linfoadenectomy (8,9%)

Operative time (min) mean (range) 208 (70 540)Operative time (min) mean (range) 208 (70‐540)

Consolle time (min) mean (range) 178 (40‐510)

Estimated Blood Loss (cc) mean (range) 240 (50‐800)

Dati peri e postoperatoriCli i U l i AOUC C i

Open (1) Robot (2) P


Catheter removal (day) 14 (10‐21) 7 (6‐12) 0.003

Drainage removal (day) 5 2 (3‐34) 3 (2‐14) 0 05Drainage removal (day) 5.2 (3 34) 3 (2 14) 0.05

Length of hospitalization (days) 6.5 (4‐36) 4 (2‐16) 0.04

Positive surgical margins

Open (1) Robot (2) Pmargins

Overall 9.5% 16.1% <0.0001

ApexLateralPosterior

4%3.3%2.1%

5.1%6.4%4.6%

pT2a‐bpT2cpT3a

05.9%11 2%

2.1%13.2%34 6%pT3a

pT3b11.2%23.4%

34.6%35.7%

ComplicanzeCli i U l i AOUC C iClinica Urologica, AOUC Careggi

Perioperative complications ( ) ( )PPerioperative complications

(INTRA + POST) OPEN (1) ROBOT (2)P

Conversion to open ‐ 0 ‐

Bleeding requiring transfusion 3,4% 0,8% 0.08

Bleeding requiring reintervention 0,6% 0 ‐

Infections 5,2% 4,0% 0.55

Drain leakage for urine fistula * 4,6% 2,7%

Reintervention for urine fistula 0 0 ‐

Drain leakage for lymphorrea 7,6% Not applicable ‐

Thrombosis/Embolisms 2,1% 1,3% 0,74

Bowel lesions (suture) 1,2% 0,4% 0.65

Overall surgical complications 24% 9,1% 0,0001

Clavien grade 3‐4 surgical complications 4,9% 0,4% 0,0007

* Ratio drainage creatinine/serum creatinine ≥ 2

Cardiac/respiratory 3,4% 3,5% 0,89

ContinenzaCli i U l i AOUC C i

URINARY CONTINENCE Open (1) Robot (2) P


CONTINENCE(zero pad)

Open (1) Robot (2) P

1° month 46.8% 64.4 % 0.0046

3° month 79.5 % 82.7 % 0.0650

6° month 87.2 % 88.0 % 0.6117

12° month 92.3 % 94.1 % 0.559

PotenzaCli i U l i AOUC C i

Open (1) RALP (2) P


p ( ) ( )

NS Bilateral6 – months potency rate:

38.3%77.7%

74.3%79.5% 0.24p y

NS Monolateral 29% 17.3%6 – months potency rate: 43.0% 62.5% 0.032

Non – NS 32.7% 8.4%6 – months potency rate: ‐ ‐ ‐

UTILIZZO DEL SISTEMA ROBOTICO «MONODISCIPLINARE»

ANOMALIA??ANOMALIA??

Documents

surgery as primary treatment - Over Group Provider ECM · surgery as primary treatment ... Fig. 1 Patient flow chart. ... • Riduzione della curva di apprendimento