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 N=75 Patients with 1:1 Randomization Megestrol acetate 160mg po. EAH or EC Qd IaG1(no prior progestin usage) N=75 Stratification Megestrol acetate 160mg po. • EAH/EC qd+ Metformin 500mg po. tid

Endpoint  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] Stratified by pathological type

Enrollment  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

Study Flow chart for treatment: desire for follow-up for pregnance: pregnance ART Medical treat  CR ultrasound ± 3months other ： biopsy medical OCP/LNG-IUD treatment for per 3 - CR: as  6months 3 months. ★ PR/NR Then hysteroscopy continue  PR/NR ： CR ： as  treatment for CR ： as  as ★ or add +D&C or 3months. hysteroscopy biopsy dose/change PR/NR ： as  medicine PR/NR: surgery(advise) PD surgery(advise)