EMBRACE II Disease and Morbidity

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Bernard Harrison
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1 EMBRACE th Annual Meeting EMBRACE II Disease and Morbidity Sofia Spampinato, Kathrin Kirchheiner, Kari Tanderup, Richard Pötter Vienna, Friday, 23 th March Saturday, 24 th, March 218

2 EMBRACE II Database Overview N. Patients included: 157 N. Patients with Baseline Morbidity assessed: 115 N. Of Patients with Treatment&DVH data available: 4 Median Overall Treatment Time(OTT)*: 42 [32-54] days Median Follow up (FUP)**: 5 [-18] months *OTT was calculated as the difference between the EBRT start date and the maximum between the last EBRT date and the last BT fx date (variable End_Treatment). **Last FUP was calculated as the difference between the maximum FUP CTC Assessment date and the End of Treatment date. 2

3 Centers Overview Center n. of patients Median FUP Range FUP Aarhus 36 3 [-11] Arnheim 4 3 [1-5] Leiden 16 5 [3-6] Ljubljana 3 ///// Only early morbidity Mumbai 4 ///// Only early morbidity Utrecht 3 7 [3-18] Vienna 34 5 [2-18] Oslo 17 ///// Only early morbidity Cambridge 2 ///// Only early morbidity Amsterdam

4 Disease analysis Local, Nodal and Distant Disease The presence of disease events from 3 months up to 18 months (last available) FUP was verified. Unplanned FUPs have also been verified tho check presence of disease event. The total number of patients with information available on local, nodal and distant disease at 3 months FUP is 73. 4

5 Disease events overview Pt 1 Pt 2 Pt 3 Pt 4 Pt 5 Pt 6 Pt 7 Pt 8 FUP Endpoint T Stage N stage # nodes Vital status 3M systemic recurrence, persisting local and nodal 3M systemic recurrence IB2 N1 4 3M 3M systemic recurrence, local uncertain, persisting nodal systemic recurrence, persisting local and nodal IIB N Alive at 3M FUP (last) Dead for disease progression IIIB N1 8 Alive at 6M FUP (last) IIB N1 Alive at 6M FUP (last) 6M systemic recurrence IIB N1 9 Alive after 9 months 6M systemic reccurrence IIB N1 Dead for disease progression 9M systemic recurrence IIIB N1 2 Alive after 9 months 18M local and nodal recurrence IIB N Alive at 18M FUP (last) 5

6 Early Morbidity Four weeks after start of RT End of treatment Early Morbidity Late Morbidity 6

7 Diarrhea Proc s G 1 =7% G 1 =72% G 1 =67% N= grade N=115 N=111 N=115 G 1 =1% G 1 =23% G 1 =23% N=115 N=111 grade Fecal Urgency Abdominal Pain or Cramping G 1 =5% G 1 =32% G 1 =34% N= grade N=115 N=9 N=115 G 1 =29% G 1 =3% G 1 =33% N=115 N=1 GI grade 7

8 Frequency Urgency G 1 =36% G 1 =43% G 1 =53% N= grade N=115 N=111 N=115 G 1 =24% G 1 =29% G 1 =35% N=115 N=1 grade Cys s G 1 =4% G 1 =26% G 1 =2% N=115 N=114 N=111 grade Urinary 8

9 Bleeding Discharge G 1 =63% G 1 =28% G 1 =31% N= grade N=113 N=111 N=115 G 1 =41% G 1 =35% G 1 =% N=113 N=111 grade Dryness G 1 =4% G 1 =47% G 1 =61% N=115 N=1 N=1 Not Assessed grade Vaginal 9

Fa gue Insomnia Hot Flashes 9 7 6 5 3 2 G 1 =48% G 1 =9% G 1 =87% N=114 9 7 6 5 3

N=114 G 1 =25% G 1 =37% G 1 =31% N=115 N=111 grade Nausea Vomi ng 9 7 6 5 3 2 G 1

10 Fa gue Insomnia Hot Flashes G 1 =48% G 1 =9% G 1 =87% N= grade N=115 N=111 N=114 G 1 =35% G 1 =44% G 1 =39% grade N=115 N=1 N=114 G 1 =25% G 1 =37% G 1 =31% N=115 N=111 grade Nausea Vomi ng G 1 =49% G 1 =58% N=112 N=9 9 7 grade G 1 =14% G 1 =18% N=112 N=9 grade Other

11 Late Morbidity Crude incidence The Crude incidence was calculated as MAXIMUM CTCAE score verified in all the FUPs from 3 to 18 months (last available), including unplanned FUPs. New CTCAE Grade 3 events 1 Abdominal Pain or Cramping 1 Vaginal Mucositis 1 Ureter stricture (plus 2 pts with persistent G=3 during FUPs AND at baseline) No Fistula events 11

12 G 1 =7% G 1 =19% G 1 =5% G 1 =25% N=115 N=73 N=115 N=73 G 1 =33% G 1 =26% N=115 N=73 GI Other endpoints showed a very low burden 12

13 G 1 =36% G 1 =33% G 1 =24% G 1 =3% N=115 N=73 N=115 N=73 G 1 =2% G 1 =18% Urinary Other endpoints showed a very low burden N=115 N=73 13

14 G 1 =4% G 1 =36% G 1 =11% G 1 =38% G 1 =6% G 1 =29% Vaginal N=115 N=73 N=115 N=73 N=115 N=73 G 1 =63% G 1 =27% G 1 =42% G 1 =19% G 1 =% G 1 =29% N=115 N=73 N=115 N=73 N=115 N=73 14

Fibrosis Back Pain Pelvic Pain 9 7 6 5 3 2 9 7 6 5 3 2 G 1 =4% G 1 =12% N=115 N=73 Baseline Max during

1 =26% G 1 =27% N=115 N=73 Baseline Max during FUP Lymphocele G 1 =2% G 1 =7% N=114 N=73 Baseline Max

15 Fibrosis Back Pain Pelvic Pain G 1 =4% G 1 =12% N=115 N=73 Baseline Max during FUP Limb Edema G 1 =9% G 1 =14% N=114 N=73 Baseline Max during FUP grade grade G 1 =26% G 1 =27% N=115 N=73 Baseline Max during FUP Lymphocele G 1 =2% G 1 =7% N=114 N=73 Baseline Max during FUP G 1 =28% 5 grade 3 2 N=115 Baseline G 1 =18% N=73 Max during FUP grade Lymphatics grade 15Muscle

16 G 1 =48% G 1 =56% G 1 =33% G 1 =35% N=114 N=73 N=114 N=73 G 1 =35% G 1 =56% Other N=114 N=73 16

17 Baseline and 3 months FUP Comparison with EMBRACE I Only the three centers that included the most patients were selected by the cohort of EMBRACE I (Aarhus, Utrecht, Vienna) 17

18 G 1 =6% G 1 =2% G 1 =7% G 1 =15% G 1 =1% G 1 =5% G 1 =1% G 1 =1% N=115 N=345 N=73 N=3 N=115 N=345 N=73 N=3 Proc s G 1 =3% G 1 =7% G 1 =1% G 1 =6% GI 2 N=115 N=345 N=73 N=3 BL E2 BL E1 3M FUP E2 3M FUP E1 grade 18

19 G 1 =29% G 1 =3% G 1 =36% G 1 =25% G 1 =13% G 1 =19% G 1 =2% G 1 =15% N=115 N=345 N=73 N=3 N=115 N=345 N=73 N=3 G 1 =6% G 1 =5% G 1 =4% G 1 =3% Urinary N=115 N=345 N=73 N=3 19

20 G 1 =11% G 1 =33% G 1 =4% G 1 =27% G 1 =5% G 1 =31% G 1 =11% G 1 =19% N=115 N=345 N=73 N=39 N=115 N=345 N=73 N=39 G 1 =8% G 1 =24% G 1 =6% G 1 =25% N=115 N=344 N=73 N=39 G 1 =65% G 1 =22% G 1 =63% G 1 =22% N=115 N=345 N=73 N=39 2Vaginal

21 N=44 N=64 N=73 N=59 N=47 N=65 N=41 N=59 Vaginal N=47 N=65 N=41 N=59 21

22 N=46 N=65 N=41 N=59 Vaginal N=47 N=65 N=41 N=59 22

Fibrosis 9 7 6 5 3 2 G 1 =1% G 1 =25% G 1 =4% G 1 =% N=115 N=345 N=73 N=39 BL E2 BL E1 3M FUP E2 3M FUP E1 grade Muscle Limb

23 Fibrosis G 1 =1% G 1 =25% G 1 =4% G 1 =% N=115 N=345 N=73 N=39 BL E2 BL E1 3M FUP E2 3M FUP E1 grade Muscle Limb Edema G 1 =6% G 1 =11% G 1 =9% G 1 =11% N=114 N=344 N=73 N=3 BL E2 BL E1 3M FUP E2 3M FUP E1 grade Lymphatics 23

24 G 1 =37% G 1 =39% G 1 =48% G 1 =47% G 1 =26% G 1 =21% G 1 =35% G 1 =26% N=114 N=3 N=73 N=3 N=114 N=341 N=73 N=3 G 1 =17% G 1 =33% G 1 =25% G 1 =52% Other N=114 N=341 N=73 N=3 24

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