Endometrial Cancer Committee October 2016 - - PowerPoint PPT Presentation

Gynecologic Cancer InterGroup Endometrial Cancer Committee October 2016 Lisbon GCIG Group: SGOG

2 most important caveats in treatment of endometrial cancer

• Cost-effectiveness analysis of ovary

preservation for young low risk endometrial cancer patients

Clinical trials should be done to investigate  The safety of ovary preservation for young low risk endometrial cancer  Identify those who are at risk of ovarian involvement  Evaluate the cost-effect of ovary preservation

2 most important caveats in treatment of endometrial cancer

• Establishment of prognostic model to

identify proper patient for proper fertility preserving treatment or those who are at high risk of such treatment

Ongoing trial of SGOG

• Effect of fertility preserving treatment using

megestrol acetate plus metformin vs megestrol acetate in patients with endometrial atypical hyperplasia and early state endometrial cancer: a multicenter randomized controlled trial

ClinicalTrials.gov Identifier: NCT01968317

Study design

Phase II open labelled multicenter randomized trial

Patients with EAH or EC IaG1(no prior progestin usage) Stratification

• EAH/EC

Randomization 1:1 N=75 Megestrol acetate 160mg po. Qd N=75 Megestrol acetate 160mg po. qd+ Metformin 500mg po. tid

 Primary endpoint:

 Pathological response rate [Time Frame: 12 months]

 Secondary endpoint:

 The response period  The safety of MA combined with metformin  Relapse and fertility rate [Time Frame: 2 years]

Endpoint

Stratified by pathological type

 Inclusion criteria

 Ages Eligible for Study: 18 Years to 45 Years  Pathological diagnosis

 EAH: diagnosed for the first time on endometrial biopsy  Endometrioid EC (1aG1) :

 diagnosed as G1 for the first time on endometrial biopsy  Confined in endometrium only  no evidence for myometrial invasion or metastasis on MRI(pelvic and

abdominal) or ultrasound

 Strong desire for preserving reproductive function  Informed consent  High compliance to treatment and can be followed-up

Enrollment

 Exclusion criteria

 Complicated with serious medical diseases  Other malignant neoplasm in reproductive system, or

complicated with progestin-dependent neoplasms

 Progestin treatment in the past 6 months  High risk for deep vein thrombosis, apoplexy or myocardial

infarction

 Smokers

Enrollment

Flow chart for treatment:

medical treatment for 3 months. Then hysteroscopy +D&C or biopsy CR Medical treat 3months

desire for pregnance: ART follow-up for pregnance

• ther：

OCP/LNG-IUD ultrasound ± biopsy per 3 - 6months

★ PR/NR continue treatment for 3months. hysteroscopy

CR: as PR/NR： as★ or add dose/change medicine

CR：as

PR/NR：as

CR：as PR/NR: surgery(advise)

PD

surgery(advise)

Study