EMBRACE 9 th Annual Meeting. Bladder toxicity: Risk factors. Sofia Spampinato, Lars Fokdal, Jacob Lindegaard, Kari Tanderup, Richard Pötter

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1 EMBRACE 9 th Annual Meeting Bladder toxicity: Risk factors Sofia Spampinato, Lars Fokdal, Jacob Lindegaard, Kari Tanderup, Richard Pötter Vienna. Friday. 23 th March Saturday. 24 th. March 2018

Locally Advanced Cervical Cancer (LACC) Radiochemotherapy with Image Guided Adaptive Brachytherapy (IGABT) Bladder

2 Hypothesis Urinary morbidity is a complex outcome of dose distribution and radiation sensitivity of different functional subunits of the bladder. Locally Advanced Cervical Cancer (LACC) Radiochemotherapy with Image Guided Adaptive Brachytherapy (IGABT) Bladder Dose and correlation with morbidity are currently evaluated through contouring of the outer bladder wall Investigate contouring and dose in bladder sub-structures potentially responsible for late urinary morbidity 2

3 Points & Distances Which structures? Volumes ICRU Bladder point PIBS point PIBS+2cm point Vaginal Reference Length (VRL) Bladder (D 2cm3. D 0.1cm3 ) Trigone (D 2cm3. D 0.1cm3 ) Bladder neck (D 0.1cm3 ) Urethra (D 2cm3.D 0.1cm3 ) 3

4 Bladder Trigone Bladder neck Urethra VRL PIBS point VRL PIBS point SHORT VRL LONG VRL 4

5 Trigone dose Should be linked to endpoints such as frequency and incontinence. 105 patients contoured on BT plans (2 fx PDR). Doses are expressed in total EQD2. The EBRT contribution was considered equal to the prescription dose (α/β= 3) 5

6 Univariate analysis on a smaller EMBRACE I cohort Selection criteria No bladder wall infiltration CTC Baseline morbidity assessment and at least one CTC FUP assessment Number of patient enrolled > 50 Coherence between Baseline CTC and EORTC morbidity assessment for Bladder Frequency and Incontinence 6

7 Frequency Baseline Morbidity CTC Incontinence Baseline Morbidity CTC N N EORTC EORTC N

CTC Crude Incidence Overview (N = 451 pts) Cystitis G Center 1 2 3 4 5 Total 0 Count 102 69 63 78 47 359 % 86.4% 87.3% 75.9% 87.6% 67.1% 81.8% 1 Count 8 8 9 5 11 41 % 6.8% 10.1% 10.8% 5.6% 15.7% 9.

5% Bleeding G Center 1 2 3 4 5 Total 0 Count 112 78 72 84 60 406 % 94.9% 98.7% 86.7% 94.4% 85.7% 92.5% 1 Count 6 1 5 3 7 22 % 5.1% 1.3% 6.0% 3.4% 10.0% 5.0% 2 Count 0 0 6 2 2 10 % 0% 0% 7.2% 2.2% 2.9% 2.

8 CTC Crude Incidence Overview (N = 451 pts) Cystitis G Center Total 0 Count % 86.4% 87.3% 75.9% 87.6% 67.1% 81.8% 1 Count % 6.8% 10.1% 10.8% 5.6% 15.7% 9.3% 2 Count % 6.8% 2.5% 12.0% 5.6% 15.7% 8.2% 3 Count % 0% 0% 0% 0% 1.4% 0.2% 4 Count % 0% 0% 1.2% 1.1% 0% 0.5% Bleeding G Center Total 0 Count % 94.9% 98.7% 86.7% 94.4% 85.7% 92.5% 1 Count % 5.1% 1.3% 6.0% 3.4% 10.0% 5.0% 2 Count % 0% 0% 7.2% 2.2% 2.9% 2.3% 3 Count % 0% 0% 0% 0% 1.4% 0.2% G 1 18,2% G 1 7,5% Frequency G Center Total 0 Count % 37.3% 29.1% 50.6% 48.3% 28.6% 39.2% 1 Count % 54.2% 58.2% 33.7% 42.7% 52.9% 48.5% 2 Count % 8.5% 11.4% 15.7% 9.0% 14.3% 11.4% 3 Count % 0% 1.3% 0% 0% 4.3% 0.9% Incontinence G Center Total 0 Count % 61.9% 48.1% 59.0% 68.5% 52.9% 58.8% 1 Count % 29.7% 35.4% 33.7% 16.9% 31.4% 29.2% 2 Count % 8.5% 12.7% 7.2% 14.6% 12.9% 10.9% 3 Count % 0% 2.5% 0% 0% 2.9% 0.9% 4 Count % 0% 1.3% 0% 0% 0% 0.2% G 1 60,8% G 1 41,2% 8

9 Diagnosis and dose parameters Bladder D2cm3 T stage Center N Total T1 (%) T2 (%) T3(%) T4 (%) ,2 79,2 12,8 0, ,4 64,2 28, ,6 44, ,8 71,4 18, ,7 71,8 8,5 0 Total ,2 67,4 16,2 0, BT Technique Center N Total IC IC/IS ,8 47, ,6 70, ,6 61, ,9 68, ,4 60,6 Total ,3 60,7 ICRU Bladder point

10 Frequency (events G 2 = 52) T stage* P HR 95,0% CI for HR I Reference II III Patient characteristics P HR 95,0% CI for HR Age ,044 Tumor width 0, CTV HR Volume Laparoscopic staging «No» Reference Smoking «No» Reference Previous Pelvic- Abdominal Surgery «No» Reference Univariate analysis Treatment parameters EBRT technique «3DCRT» Reference EBRT prescription dose BT technique P HR 95,0% CI for HR «3DCRT» Reference BT dose rate «HDR» Reference Bladder D2cm ICRU BP D2cm 3 /ICRU BP , *The patient with stage T4 was excluded from the analysis 10

11 Incontinence (events G 2 = 51) T stage P HR 95,0% CI for HR I Reference II III Patient characteristics P HR 95,0% CI for HR Age < Tumor width CTV HR Volume Laparoscopic staging «No» Reference Smoking «No» Reference Previous Pelvic- Abdominal Surgery «No» Reference Univariate analysis Treatment parameters EBRT technique «3DCRT» Reference EBRT prescription dose BT technique P HR 95,0% CI for HR «3DCRT» Reference BT dose rate «HDR» Reference Bladder D2cm ICRU BP D2cm 3 /ICRU BP *The patient with stage T4 was excluded from the analysis 11

12 Conclusion and future perspectives Urinary morbidity endpoints such as incontinence and frequency may not correlate with to particular base substructures. A survey on sub-structures dose parameters performed on 105 patients showed how the trigone hotspots are related to the ICRU Bladder point. A smaller cohort in the EMBRACE I database was selected to check if the ICRUBP and other parameters are significant for frequency and incontinence. The univariate analysis showed how Age, Smoker status, ICRUBP and D2cm 3 /ICRUBP are significant for both frequency and incontinence. EBRT technique was significant only for incontinence, while T stage was significant for frequency. Multivariable analysis will show whether the combination of these factors is still significant. 12

EMBRACE I Data completeness Database dump

EMBRACE 10 th Annual Meeting EMBRACE I Data completeness Database dump Christian Kirisits, Sofia Spampinato, Kari Tanderup Vienna, Friday, 23 th March Saturday, 24 th, March 2018 EMBRACE I Overview 23