Date post: | 04-Jan-2016 |
Category: |
Documents |
Upload: | ashley-lyons |
View: | 215 times |
Download: | 1 times |
Rashid TG, Dudderidge T,
Zahur S, Kini M, Ogden CW
Overview
Method
Results
Patient Characteristics & Treatment Factors
Oncological Results
Functional Results
Summary
Method
Patient group: 30 patients undergoing RALP (DaVinci robot)
30 patients undergoing HIFU (Sonablate ® 500)
Consecutive cases, all performed by Chris Ogden over the same time period
Functional questionnaires
PSA follow-up
At 0, 3, 6, 9, 12, 18 and 24 months
Patient CharacteristicsRALP HIFU
N 30 25 (Primary) 5 (Salvage)
Age (yrs)§ Median (range) 60 (42-74) 67 (51-78) 71 (61-79)
Presenting PSA (ng/dL)*
Median (range) 7.0 (2.4-18.0) 6.6 (3.0-14.0) 6.0 (4.1-20.0)
Gleason score*
≤6 14 11 0
=7 14 10 2
>7 2 1 0
Unknown 0 9 3∞
T stage*
T1c 5 3 0
T2a 6 4 1
T2b 2 2 0
T2c 14 4 2
T3a 0 0 0
T3b 0 0 0
Unknown 3 12 2
Pre-treatment hormones
1 4 1
§Significant difference between RALP and HIFU groups using Mann-Whitney, p=0.003
*No significant difference between RALP and HIFU groups using Mann-Whitney or Fisher’s exact test, p=0.003
∞Post-radiotherapy
Treatment factors
RALP HIFU (Primary) HIFU (Salvage)
Length of stay (days) Median (range) 2 (1-4) 1 1
Catheter typeU = urethral
SP = suprapubic 30 U
3 SP22 U
1 SP4 U
Catheter time (days) Median (range) 14 (10-48) 10 (10-24) 10 (7-16)
Oncological Outcomes
Median follow-up
18 months (3-24)
Cancer Recurrence
Recurrence RALPHIFU
Primary Salvage
N 30 25 5
PSA € 2 7 3
ASTRO∞ - 7 3
Phoenix* - 8 3
Re-Biopsy - 3 1
RALP recurrences
2/30 PSA recurrences
G4+5 T3b
G4+3 T3a
€ PSA Recurrence defined as PSA >0.2ng/dL (RALP) or >0.5ng/dL (HIFU)∞ ASTRO criteria: 3 consecutive rises in PSA, with time of recurrence defined as mid-way between nadir and recurrence months* Phoenix criteria: nadir + 2ng/mL, time of recurrence at call
HIFU recurrences
7/25 Primary HIFU PSA recurrences
3 post-HIFU biopsies
1 had repeat HIFU, the remainder are undergoing PSA monitoring
3/5 salvage HIFU PSA recurrences
1 moved to USA
1 repeat biopsy
1 PSA surveillance
Cancer Recurrence – time to relapse
Months from treatment2520151050
% R
ela
ps
e-f
ree
1.0
0.8
0.6
0.4
0.2
0.0
Time to relapse (Surgery PSA>0.2, HIFU PSA>0.5)
HIFU SalvageSurgeryHIFU Primary
Treatment
Months from
treatment
Relapsed
RALPHIFU
(Primary)HIFU
(Salvage)
3 0 2 2
6 1 1 1
9 0 1 0
12 0 1 0
18 1 1 0
24 0 1 0
Total 2 7 3
There was a significant difference in time of PSA recurrence between all groups, (Wilcoxon (Gehan) statistic, p<0.001)
Treatment type remained significant after adjusting for age (p=0.001, HR 0.11 with 95% CI 0.029 to 0.416).
Functional Outcomes
Median follow-up
18 months (3-24)
Sexual Function
From 6 months, HIFU patients demonstrate a significantly higher rate of return to baseline function (p<0.05)
Potency
Ability to achieve erections sufficiently hard enough for penetrative sexual intercourse (with or without pharmaceutical assistance)
Significant differences seen only at 9 and 24 months1 with HIFU patients being more successful
1 p<0.007, p<0.026 respectively, Fisher’s exact test
Urinary Symptoms
There is no significant difference in urinary symptoms for this cohort of patients, p<0.05
Urinary Continence
3 HIFU patients (1 primary, 2 salvage) required artificial urinary sphincters
cf 1 RALP patient The remainder in both groups have good urinary control
Those who wear pads do so for security only
Overall Functional Well-Being
There is no significant difference in functional well-being between the two cohorts, p<0.05
ComplicationsComplication RALP
HIFU (Primary)
HIFU (Salvage)
Anastomotic leak 1* - -
Stricture 2 4 -
Infection 1 3 1
Debris passage - 6 -
Fistula -
AUR/blocked catheter 1 4 -
Intervention – DiagnosticFlexible cystoscopy 2 6 1
GA cystoscopy - 1 2
Intervention - Therapeutic
TURP - 3€ -
BNI - - 1
Weck clip removal 1 - -
Dilatation 2 4 2
Artificial sphincter 1 1 2
Non-surgical
TIA 1 - -
PE 1 - -
Lung cancer - 1 -
Death - 1 (lymphoma) -
*Associated small pelvic collection, not requiring intervention but delaying discharge€ 2 procedures on same patient
In-patient
Stay
Catheter time
(days)
Recurrence rate
Sexual function
Urinary Symptoms
Complications (C)
Diagnostic interventions (D)
Therapeutic interventions (T)
No. of patients
requiring >1 therapeutic intervention
RALPMedian
2(1-4)
Median 14
(10-48)
2 (6.7%)
Earlier return to baseline in HIFU
No significant difference in symptoms
10 (C)7 (D)2 (T)
0
HIFU (Primary)
Day caseMedian
10 (10-24)
7 (28.0%)
22 (C)10 (D)12 (T)
3 (12%)
HIFU (Salvage)
Day caseMedian
10 (7-15)
3 (60.0%)
9 (C)5 (D)9 (T)
3 (60%)
Thank you for your attention