EMBRACE I Data completeness Database dump

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1 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

2 EMBRACE I Overview 23 centers included: Aarhus, Amsterdam, Arnheim, British Columbia, Cambridge, Chandigarh, Edmonton,Kaposvar, Kuopio, Leeds, Leiden, Leuven, Ljubljana, London, Maastricht, Milwaukee, Mumbai, Oslo, Pamplona, Paris, Trondheim, Utrecht, Vienna FIGO stage: all the pts have information CTC Baseline Morbidity (BM): 1332 pts have CTC BM assessment EORTC Baseline Morbidity (BM): 1044 pts have EORTC BM assessment Treatment and DVH: 1337 pts have info on treatment (based on EBRT_StartDate ) CTC Follow up (FUP): 1271 pts have at least 1 FUP with CTC assessment EORTC Follow up (FUP): 1062 pts have at least 1 FUP with EORTC assessment FUP&BM: 1266 pts with BM and at least 1 FUP EORTC assessment and 962 pts with BM and at least 1 FUP EORTC assessment 2

3 Status at Diagnosis FIGO Stage A B Total % stage I stage II state III stage IV Count % 0.0% 100.0% Count % 9.1% 90.9% Count % 5.9% 94.1% Count % 32.40% 67.6% BT Technique (1st fx) Count % IC IC/IS EMBRACE I Overview Technique 3D-CRT IMRT BT Dose rate (1st fx) Count % HDR PDR Median CTV HR volume at 1st BT fx: 28.9 [ ] cm 3 Median CTVHR D90 (EQD2): 89.8 [ ] Gy Median FUP: 35 [1-91] months BT Median Overall Treatment Time: 46 [30-86] days EBRT prescription dose Total % <= 45 Gy >45 Gy Count % 68.4% 31.6% Count % 65.4% 34.6% EBRT BT applicator (1st fx) Count % Ring Ovoid Mould Cylinder Other

4 Patients excluded from the analysis Patients were excluded for the Disease and the Morbidity&QoL analysis when: did not fulfill the inclusion and exclusion criteria were not treated according to the protocol died during treatment did not provide information for analysis Centers can put patients off studies for 4 reasons: Lost to Follow-up Major Protocol Violation (MPV) Death Other 4

5 OFF STUDY (OS): Major Protocol Violation 71 patients were put OS for Major Protocol Violation (MPV) - OffStudyReason_OS=4 The variable "GeneralComments_OS" has been checked to verify the reason for MPV Four different categories have been identified: 1. Not fulfilling inclusion and exclusion criteria (19 patients) 2. Non-compliance to treatment (37 patients) 3. Patients died during treatment death not related to treatment (2 patients) 4. No MRI (15 patients) Patients from category 1. and 3. have been removed from the database Patient from category 2. and 4. were kept for further analysis Following the details 5

6 OFF STUDY (OS): Major Protocol Violation 1. Not fulfilling inclusion and exclusion criteria (19 patients) Metastatic disease at diagnosis (8 patients) Second malignancy at diagnosis (6 patients) Wrong histology (3 patients) Inclusion criteria not fulfilled (2 patients) 2. Non-compliance to treatment (37 patients) Treatment time exceeded (3 patients) EBRT technique (1 patient) No treatment (1 patient) No Brachytherapy for patient decision (7 patients) No Brachytherapy for general status (10 patients) No Brachytherapy for technical issues (15 patients) 6

7 No information or RT not delivered as planned After removing the patients classifiable as real MPVs, an analysis was conducted on: Status at Diagnosis Baseline Morbidity Assessment Treatment and DVH Status at Brachytherapy Follow up The analysis showed that: In 17 patients no information available on patient status, tumour, treatment characteristics and morbidity For 39 patients RT was not delivered as planned. Most of these patients fall into category 2. of MPV (Non-compliance to treatment) These patients are not included in analyses for outcome and morbidity 7

- 20 pts: selection criteria not met prior to treatment

to treatment: G=5) - 2 pts: Died during treatment (death

and Morbidity analysis (treated according to protocol)

1338 pts NOTE: Patients with no MRI at BT but FU are

information available **38 pts without FUP, 10 pts with

8 - 20 pts: selection criteria not met prior to treatment *1 further patient died during treatment (death related to treatment: G=5) - 2 pts: Died during treatment (death not related to treatment)* Patient available for Disease and Morbidity analysis (treated according to protocol) The Final FLOWCHART 1416 pts 1396 pts 1379 pts 1377 pts 1338 pts NOTE: Patients with no MRI at BT but FU are removed from MPV - 17 pts: registered, but no information available **38 pts without FUP, 10 pts with No BT have info on treatment and DVH - 39 pts: RT not delivered as planned** 8

9 From EMBRACE I to EMBRACE II: What s new Individual centers can only provide information only on the Vital status. 9

10 Plans for EMBRACE I analysis Datadump for final outcome analysis will be January 2019 End of 2018: Complete updates of FUP and VITAL STATUS 10

EMBRACE II Disease and Morbidity

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 EMBRACE II Database