Transcript Endometrial Cancer Commitee Agenda Prague October 21, 2010

Endometrial Cancer
Commitee Minutes
Prague, 21 October 2010
David Miller, Ketta Lorusso
Endometrial Cancer Commitee Agenda
Prague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
STAGING
LYTEC LYmphadenectomy Trial in Endometrial Cancer
Treatment Algorithm
Participating Institutions
Endorsed by ENGOT 2/2010
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AGO Aust
GROIN
EORTC GCG
ICORG
BGOG
MANGO
GEICO
MITO
HECOG
NCRI
GINECO
NOGGO
NSGO
DGC
JGOG
KGOG
TRSGO
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
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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
Adjuvant Endometrial Cancer Trial
[email protected]
ENGOT-NESTEC: NEtwork STudy in Endometrial Cancer
under the ENGOT umbrella and in cooperation with the Mayo clinic.
Clinically presumed: FIGO IB-II any histo type, FIGO
I A G3 endometroid, FIGO IA/B histo type II
R
R
surgery
R
R
No bulky LN
Bulky LN
In OP
LNE
R
NLNE*
N-
AGO/NOGGO trial (Sehouli)
DGCG trial (Mirza)
FIGO III not Ro and pos. LN or cytology
only; FIGO IV
Recurrent FIGO I/II
N+
R
no LNE
N+
Standard arm:
Carbo-paclitaxel
+ Placebo
R
Chemo 1
Carbo-paclitaxel
R
Chemo +.
Radiotherapy
observation
Mayo trial (Dowdy, Mariani)
AGO ECLAT trial (Emons)
NSGO trial (Hogberg)
Chemo 1
Carbo-paclitaxel
Experim. arm:
Carbo-paclitaxel
+ mTOR inhibitor
Endometrial Cancer Commitee Agenda
Prague October 21, 2010
NEW PROPOSAL:
ENGOT-EN2-DGCG
A 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
Endometrial Cancer Commitee Agenda
Prague 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. 25/164
Paricipating Group: RTOG
Interested groups: NCRI, SWOG
GOG-0238
GOG0238
• Objectives
– PFS
– Sites of recurrence
– OS
• Stats
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Phase II-III
Interim analysis > 60 failures
Opened Feb ‘08
N = 25/164
Endometrial Cancer Commitee Agenda
Prague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
ADVANCED/RECURRENT
NCIC CTG EN8 Randomized Phase III trial on
Progestational Hormone Therapy vs Deferolimus in women
with recurrent or metastatic endometrial cancer
Interested Groups: ACRIN, AGO-AUST, AGO-OVAR,
ANZOG, Dutch GOG, EORTC, GEICO, GINECO, MANGO,
MITO, JGOG, NCRI, NSGO, SWOG
Schema
R
A
Women with
N
recurrent or
D
metastatic
O
endometrial
M
cancer
I
1-2 Prior
Z
Chemotherapy
E
Arm 1: ridaforolimus 40 mg
po days 1-5 each week
Imaging
Disease
Survival
q8
progression follow-up
weeks
Arm 2:
medroxy progesterone 200 mg
or
megestrol 160 mg (as per local
practice) po daily
Chemotherapy options
Sample size: Approximately 460 patients
Endometrial Cancer Commitee Agenda
Prague October 21, 2010
PROPOSED GCIG STUDIES FOR REVIEW
TROPHOBLASTIC NEOPLASIA
ANZGOG:
1. CHM with negative HCG 8 weeks post evacuation
2. 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
Endometrial Cancer Commitee Agenda
Prague 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
Schema
Pulse Act-D 1.25 mg/m2 every
2 weeks IV
Low Risk GTD
WHO Score* 0-6
Randomize
* WHO 2002 scoring
Multiday Methotrexate
Institutional preference of
Either 0.4mg/kg daily x5 IV q 2weeks or
CC 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%
Endometrial Cancer Commitee Agenda
Prague 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.
Endometrial Cancer Commitee Agenda
Prague 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-0249
A phase III trial of pelvic RT vs Vaginal Cuff Brachitherapy
followed by Paclitaxel-Carboplatin Chemotherapy in patients
with high risk, early stage endometrial cancer: 158/562
Interested group: RTOG
Endometrial Cancer Commitee Agenda
Prague 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-0261
A 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
Endometrial Cancer Commitee Agenda
Prague October 21, 2010
UPDATE ON ACTIVE STUDIES:
NCIC CTG
NCIC CTG IND 192
Ridaforolimus in treating patients with recurrent
metastatic and/or locally advanced endometrial
cancer: Completed
NCIC CTG IND 179
Phase I of Temsirolimus, Paclitaxel and
Carboplatin; have an expanded cohort in
endometrial cancer that will continue: completed