![Page 1: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/1.jpg)
Endometrial Cancer Commitee MinutesPrague, 21 October 2010
David Miller, Ketta Lorusso
![Page 2: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/2.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEWSTAGING
LYTEC LYmphadenectomy Trial in Endometrial Cancer
![Page 3: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/3.jpg)
Treatment Algorithm
![Page 4: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/4.jpg)
Participating InstitutionsEndorsed by ENGOT 2/2010
• AGO Aust GROIN
• EORTC GCG ICORG
• BGOG MANGO
• GEICO MITO• HECOG NCRI
• GINECO NOGGO
• NSGO DGC
• JGOG KGOG• TRSGO
![Page 5: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/5.jpg)
Adjuvant Endometrial Cancer Trial [email protected]
Five phase 3 trials will collaborate internationally to answer 4 major questions in the management of endometrial cancer:
• Does proper lymphadenectomy improve survival?LYTEC Trial & AGO-ECLAT trial
• Is there a need for adjuvant chemotherapy in node negative high-risk early stage patients?
ENGOT-EN2-DGCG trial
• Is adjuvant chemo followed by RT better than chemo alone in high-risk nodal status unknown early stage or stage 3 patients?
NSGO trial
• Can combination of standard chemotherapy with targeted therapy compared to combination chemotherapy alone improve disease control rate of advanced or chemo-naïve relapsed endometrial cancer?
AGO/NOGGO trial
![Page 6: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/6.jpg)
Clinically presumed: FIGO IB-II any histo type, FIGO I A G3 endometroid, FIGO IA/B histo type II
FIGO III not Ro and pos. LN or cytology only; FIGO IVRecurrent FIGO I/II
R
Standard arm:Carbo-paclitaxel+ Placebo
Experim. arm:Carbo-paclitaxel+ mTOR inhibitor
surgery
Bulky LN
LNE
N- N+
No bulky LN
R
In OP
LNE* no LNE
N- N+
R Chemo 1Carbo-paclitaxel
Chemo +.Radiotherapy
R
Chemo 1Carbo-paclitaxel
observation
+ extra LN disease
with
out e
xtra
LN d
iseas
e
ENGOT-NESTEC: NEtwork STudy in Endometrial Cancer under the ENGOT umbrella and in cooperation with the Mayo clinic.
R Mayo trial (Dowdy, Mariani)AGO ECLAT trial (Emons)
R NSGO trial (Hogberg)R AGO/NOGGO trial (Sehouli)
R DGCG trial (Mirza)
![Page 7: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/7.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
NEW PROPOSAL:
ENGOT-EN2-DGCGA phase III trial of postoperative chemotherapy or no further treatment for patients with node negative stage I-II intermediate or high risk endometrial cancer: Interested groups: AGO Germ, Belgian GOG, EORTC, MANGO
![Page 8: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/8.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
ADVANCED/RECURRENT
GOG-0238 A randomized trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in patients with pelvic-only recurrence of carcinoma of the uterine corpus. 25/164Paricipating Group: RTOGInterested groups: NCRI, SWOG
![Page 9: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/9.jpg)
GOG-0238
![Page 10: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/10.jpg)
GOG0238• Objectives
– PFS– Sites of recurrence– OS
• Stats– Phase II-III– Interim analysis > 60 failures– Opened Feb ‘08– N = 25/164
![Page 11: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/11.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
ADVANCED/RECURRENT
NCIC CTG EN8 Randomized Phase III trial on Progestational Hormone Therapy vs Deferolimus in women with recurrent or metastatic endometrial cancerInterested Groups: ACRIN, AGO-AUST, AGO-OVAR, ANZOG, Dutch GOG, EORTC, GEICO, GINECO, MANGO, MITO, JGOG, NCRI, NSGO, SWOG
PROPOSED GCIG STUDIES FOR REVIEW
![Page 12: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/12.jpg)
Schema
Sample size: Approximately 460 patients
Arm 2:medroxy progesterone 200 mgor megestrol 160 mg (as per local practice) po dailyChemotherapy options
Survivalfollow-up
Diseaseprogression
Imagingq 8 weeks
Arm 1: ridaforolimus 40 mg po days 1-5 each weekR
ANDOMIZE
Women with recurrent or metastatic
endometrial cancer
1-2 Prior Chemotherapy
![Page 13: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/13.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
TROPHOBLASTIC NEOPLASIA ANZGOG: 1. CHM with negative HCG 8 weeks post evacuation2. PHM reaching negative HCG
Cross registry analysis or randomized trial of current local policy FU vs discontinuation of FU according to the above findings. End point: comparison of incidence of persistent GTN in either arms.
Follow up with ISSTD
![Page 14: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/14.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
TROPHOBLASTIC NEOPLASIA
GOG UC 1005 A sequential phase II/III randomized trial comparing 3 widely used regimens for the management of low risk Gestational Trophoblastic Neoplasia (John Tidy: [email protected]). Interested groups: AGO Aust., JGOG, MITO
![Page 15: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/15.jpg)
Schema
Low Risk GTDWHO Score* 0-6
* WHO 2002 scoring
Randomize
Pulse Act-D 1.25 mg/m2 every2 weeks IV
Multiday MethotrexateInstitutional preference of
Either 0.4mg/kg daily x5 IV q 2weeks orCC 8 day regimen with leukovorin rescue
Statistical considerations: power to test if experimental (MTX) arm is superior based on GOG 174: based on CR .70 for control arm and .80 for experimental arm power 90%
![Page 16: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/16.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
UPDATE ON ACTIVE STUDIES: DGOG
PORTEC 3
Randomized phase III trail comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with palvic Radiation Alone in High Risk and Advanced Endometrial Carcinoma Participating groups: NCRI, MaNGO, ANZGOG, NCIC-CTG. NSGO interestd.
![Page 17: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/17.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
UPDATE ON ACTIVE STUDIES: GOG
GOG-0248 A randomized phase II trial of Temsirolimus or the combination of Hormonal Therapy plus Temsirolimus in women with advanced or recurrent endometrial carcinoma: 60/84
GOG-0249A phase III trial of pelvic RT vs Vaginal Cuff Brachitherapy followed by Paclitaxel-Carboplatin Chemotherapy in patients with high risk, early stage endometrial cancer: 158/562Interested group: RTOG
![Page 18: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/18.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
UPDATE ON ACTIVE STUDIES: GOG
GOG-0258 A randomized phase III trial of Cisplatin and Tumor Directed RT followed by Carboplatin/Paclitaxel vs Carboplatin/Paclitaxel for optimally debulked advanced endometrial cancer: 120/804. Interested group: RTOG
GOG-0261A randomized phase III trial of Carboplatin-Paclitaxel vs Ifosfamide-Paclitaxel in chemotherapy naive patients with newly diagnosed stage I-IV, persistent or recurrent uterine MMT: 83/424. Interested groups: NCRI, GINECO, JGOG, RTOG
![Page 19: Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso](https://reader035.vdocument.in/reader035/viewer/2022062523/5a4d1ae77f8b9ab059979645/html5/thumbnails/19.jpg)
Endometrial Cancer Commitee AgendaPrague October 21, 2010
UPDATE ON ACTIVE STUDIES: NCIC CTG
NCIC CTG IND 192Ridaforolimus in treating patients with recurrent metastatic and/or locally advanced endometrial cancer: Completed
NCIC CTG IND 179Phase I of Temsirolimus, Paclitaxel and Carboplatin; have an expanded cohort in endometrial cancer that will continue: completed