Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso

Endometrial Cancer Commitee MinutesPrague, 21 October 2010

David Miller, Ketta Lorusso

Endometrial Cancer Commitee AgendaPrague October 21, 2010

PROPOSED GCIG STUDIES FOR REVIEWSTAGING

LYTEC LYmphadenectomy Trial in Endometrial Cancer

Treatment Algorithm

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

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

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)


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


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

GOG-0238

GOG0238• Objectives

– PFS– Sites of recurrence– OS

• Stats– Phase II-III– Interim analysis > 60 failures– Opened Feb ‘08– N = 25/164


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


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



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



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

mailto:[email protected]

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%


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.


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


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


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

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Endometrial Cancer Commitee Minutes Prague, 21 October 2010 David Miller, Ketta Lorusso