SLIDE 1
The PORTEC-3 trial
R
Pelvic RT (48.6 Gy)
- uniform schedule
- upfront pathology review
- quality of life analysis
PORTEC - 3
Pelvic RT plus 2x cisplatin
- > 4x carboplatin/paclitaxel
- High risk Endometrial Cancer
686
GCIG updates PORTEC-3 and PORTEC-4a Chicago, June 2-3, 2016 Carien - - PowerPoint PPT Presentation
GCIG updates PORTEC-3 and PORTEC-4a Chicago, June 2-3, 2016 Carien - - PowerPoint PPT Presentation
GCIG updates PORTEC-3 and PORTEC-4a Chicago, June 2-3, 2016 Carien Creutzberg Leiden University Medical Centre, The Netherlands The PORTEC-3 trial High risk Endometrial Cancer Pelvic RT (48.6 Gy) R 686 Pelvic RT plus 2x cisplatin
SLIDE 2
SLIDE 3
PORTEC-3 trial – toxicity and quality of life
Presented at ASCO 2015; accepted to Lancet Oncology
SLIDE 4
PORTEC-3 – progress and analysis
- Radiotherapy QA to be completed this year
- Ongoing data checks, queries, FU information and QOL
- ANZGOG: patient preferences substudy submitted
TROG benchmarking short report submitted
- Analysis of pathology review in preparation (NL-UK)
- TransPORTEC consortium for translational research
- Final analysis of PORTEC-3 expected 2017
- depending on timely follow-up information and prompt
reporting of events!
SLIDE 5
Molecular characteristics of endometrial cancer
TGCA, Kandoth et al, Nature 2013
SLIDE 6
Molecular analysis PORTEC-1 and 2 cohort (N=834)
Stelloo et al, Clinical Cancer Research 2016
5 1 0 0 .0 0 .5 1 .0 T im e (ye a rs) C um ula tive probability of lo coreg ion a l re cu rre n ce P -value < 0.001 5 1 0 0 .0 0 .5 1 .0 T im e (ye a rs) C um ula tive probability of d ista n t re cu rre n ce P -va lu e < 0.0 01 5 1 0 0 .0 0 .5 1 .0 T im e (ye a rs)
O verall S urvival
P -value < 0.001
P O LE N SM P M S I p53 I
The 4 TCGA subgroups by surrogate markers in PORTEC-1/2
SLIDE 7
Stelloo et al, Clinical Cancer Research 2016
Molecular integrated risk profile PORTEC-1/2 cohort
SLIDE 8
Molecular integrated risk profile PORTEC-1/2 cohort
Stelloo et al, Clinical Cancer Research 2016
- Molecular integrated risk profile is a stronger risk stratification model with
improved risk prediction
- Decrease overtreatment and undertreatment
0 .0 0 .2 0 .4 0 .6 0 .8 1 .0 A rea U nder the C urve
* * * * * * * *
L o co re g io n a l re cu rre n ce D ista n t re cu rre n ce O ve ra ll su rviva l
M ole cu la r in te grate d ( M olecular (P A in de pe
C lin ica l ( M olecular (P A independent)
N=834
SLIDE 9
New PORTEC-4a trial design
- Molecular integrated vs standard indications for adjuvant treatment:
Endometrial carcinoma Surgery and pathology diagnosis FIGO 2009 – high intermediate risk Stage IA (with invasion), any age and grade 3 (with or without LVSI) Stage IB, grade 1-2 and age > 60 Stage IB, grade 1-2 and LVSI+ Stage IB, grade 3 without LVSI Stage II (microscopic), grade 1 Randomisation
Utrecht Ijsselmeer Groningen Drenthe Noord Holland Gelderland Limburg Flevoland Zuid Holland Noord Brabant Zeeland Overijssel Friesland Waddenzee SLIDE 10
New PORTEC-4a trial design
- Molecular integrated vs standard indications for adjuvant treatment:
Individual treatment recommendation based on molecular pathology analysis 2 1 Standard treatment recommendation based on clinicopathological factors Vaginal brachytherapy Vaginal brachytherapy (~40%) Observation (~55%) External beam radiation therapy (~5%) Follow-up and Quality of Life Randomisation
Favourable Intermediate Unfavourable
SLIDE 11
PORTEC-4a - started June 1st 2016
- Pilot phase: N = 50 (Netherlands)
- Endpoints: logistics, patient acceptance
- Proceed into full trial (international)
- Endpoints: vaginal recurrence, recurrence-free survival, AE and
QOL, health costs
- Validation of molecular profile procedure in pathology centers -
> 3-4 in NL and in participating countries
- NCRI UK and ANZGOG planning to participate
- Interested in participation? Please contact us!
SLIDE 12
PORTEC - 3
International Intergroup Trial