cr07 results and informed patient consent david sebag-montefiore leeds cancer centre
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CR07 results and informed patient consent
David Sebag-Montefiore Leeds Cancer Centre
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N=1350
Clinically operable adenocarcinoma of the rectum <15cm from anal verge; no metastases
Adjuvant chemotherapy given as per local policy
POST
Post-op CRT45Gy / 25F
+ concurrent5FU
PRE
Pre-operative RT25Gy / 5F
Surgery
Pathology
Surgery
Pathology
CRM-ve CRM+ve
No RT
Trial Design
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LR by treatment (ITT)
100
676 594 457 333 214 115POST
0
10
20
30
40
50
60
70
80
90
0 1 2 3 4 5
Time (years)
LR
rat
e (%
)
At risk:
674 587 475 338 236 134PRE
N Events 3yr LR 5yr LRPRE 674 27 4% 5%POST 676 71 10% 15%
HR(95%CI)=2.50(1.66, 3.72) p<0.0001
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676 557 414 309 196 109POST
DF
S R
ate
(%)
0
10
20
30
40
50
60
70
80
90
100
Time (years)
0 1 2 3 4 5
At risk:
674 556 436 312 219 126PRE
N Events 3yr 5yrPRE 674 147 77% 73%POST 676 188 73% 65%
HR(95%CI)=1.30 (1.05, 1.61) p=0.0154
DFS by treatment (ITT)
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100
676 608 484 359 232 121POST
0
10
20
30
40
50
60
70
80
90
0 1 2 3 4 5
Time (years)
Su
rviv
al (
%)
674 593 484 343 239 136PRE
N Events 3yr OS 5yr OSPRE 674 153 81% 71%POST 676 173 80% 66%
HR(95%CI)=1.12(0.90, 1.40) p=0.2886
Survival by treatment arm (ITT)
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Subset analyses
• Treatment effect for:-
• Low mid and upper rectum
• Anterior resection and APER
• By stage (increased difference with higher stage
• Irrespective of plane of surgery achieved
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Bowel problems
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
25. Frequent bowel movementsduring day?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
26. Frequent bowel movementsduring night?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
27. Urge to move bowels withoutproducing stool?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
28. Unintentional release of stools?
Worse
Better
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Sexual problems
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
20. Difficultly getting an erection?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
21. Problems with ejaculation?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
22. Dry vagina during intercourse?
02
55
07
51
00
Pro
po
rtio
n 'q
uite
a b
it' o
r 'v
ery
mu
ch'
0 6 12 18 24Assessments (months)
Pre-op RT
Selective post-op RT
23. Pain during intercourse?
Worse
Better
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Informed patient consent
• Clinical oncologist required!
• Planned operation important• Perineal wound re APER• Bowel funnction re AR
• Erectile dysfunction• Sterility• Small bowel stricture• Pelvic insufficiency fractures
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Three key issues
• Pre-operative radiotherapy works – the question is where to define the threshold where radiotherapy is considered
• If surgery first and node positive (irrespective of margin status), post-operative chemoradiation should be considered
• Radiation causes late toxicity
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LR by stage III
0
10
20
30
40
50
60
70
80
90
100
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5Time (years)
LR
ra
te (
%)
N 3 yr 5 yr
PRE 252 9.0% 10.2%
POST 271 17.4% 25.6%
p=0.008
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LR for node +ve CRM -ve
0
10
20
30
40
50
60
70
80
90
100
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5
Time (years)
LR
rate
(%
)
N 3 yr 5 yr
PRE 214 6.7% 8.2%
POST 221 17.1% 24.5%
p=0.0039
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Which patients not to treat?
T1/2 N0
CRM -ve
T3++/T4
CRM +ve
NNT= 18X
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Which patients to treat?
T1/2 N0
CRM -ve
T3++/T4
CRM +ve
T3/4 Tany N0 N+
CRM -ve
NNT= 9
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Which patients to treat?
T1/2 N0
CRM -ve
T3++/T4
CRM +ve
Tany N+ve
CRM -ve
NNT= 6
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Different scenarios
T1/2 N0
CRM -ve
T3++/T4
CRM +ve
CRT S
SCPRT
>2mm T3/N+ CRM-ve>5mm T3/N+ CRM-ve
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LN+ rate by extramural spread of T 3 tumours (YCN data) n=4731
0
20
40
60
80
100
<=2mm >2-5mm >5-10mm >10mmN=1948 N=1279 N=786 N=718
41% 59%
32%68%
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Use of radiotherapy according to selection criteria used for T3 tumours
>2mm cut off >5mm cut off
Pre Post Pre Post
SCPRT 59 32
Receive SCPRT 56 30
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Use of radiotherapy according to selection criteria used for T3 tumours
>2mm cut off >5mm cut off
Pre Post Pre Post
SCPRT 59 32
Receive SCPRT 56 30
Surgery first 41 68
LN+ve 13 23
Receive post-op CRT 9 16
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Use of radiotherapy according to selection criteria used for T3 tumours
>2mm cut off >5mm cut off
Pre Post Pre Post
SCPRT 59 32
Receive SCPRT 56 30
Surgery first 41 68
LN+ve 13 23
Receive post-op CRT 9 16
RT courses 65 48
RT fractions 505 400
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Yorkshire audit
• Network agreed MRI reporting proforma• Includes the MRI T stage and N stage
• SCPRT criteria to agree (predicted CRM-ve)• >2mm or 5mm (unit policy)• N+
• Document if SCPRT given or reasons why not given
• Histopathology
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Conclusion
• Identify patients without threatened margins at significant risk of LR
• There is not a definitive answer!
• Share practice
• Prospective audit
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Some need 5x5 in the middle!
Its chemorads or nothing!