Queensland Centre for Gynaecological Cancer Research

feMMe & related studies

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Endometrial cancer is the most common gynaecological cancer in Australia, with an estimated 2200 women diagnosed each year. Obesity is a proven risk factor for endometrial cancer. The obesity epidemic has seen its incidence rise by 1% each year in women under 40. This type of cancer is currently under-researched.

The current standard treatment includes a total hysterectomy. While highly effective, there are side effects involved for:

  • women with severe medical co-morbidities and/or morbid obesity who are at risk for surgical complications and for whom surgery is unsafe. Comorbidity is the presence of one or more additional disorders (or diseases) co-occurring with endometrial cancer
  • young women who still wish to have children and would lose their fertility by having a hysterectomy.

feMMe aims to treat women with endometrial cancer less-invasively through the use of the Mirena, an intra-uterine device. This is the same device that is commonly used as a contraceptive (the IUD).

Metformin is the most widely used anti-diabetes drug in the world and evidence suggests it is also a powerful anti-cancer drug.  feMMe aims to treat endometrial cancer by loading the Mirena with Metformin; this treats cancer from inside the uterus. This is a far less invasive treatment than a radical hysterectomy, and allows at-risk women to avoid the complications and side effects associated with surgery. It also allows women to retain their reproductive organs.

The causal link between endometrial cancer and obesity is undeniable. Weight loss interventions are feasible and safe and are already being implemented by gynaecological oncologists to make women eligible for surgery.

This study targets a steadily increasing population of morbidly obese, young or co-morbid patients with early endometrial cancer. The gains of a successful project will include the reduction of hospital bed days, radical surgery, surgical complications and their associated costs. It will allow an increasing number of women to maintain their fertility and have children.

The recruitment phase of the trial was completed in November 2019, recruiting a total of 165 patients with early endometrial cancer (or endometrial hyperplasia with atypia) who are either young and wish to retain fertility, or are unsuitable for surgery due to medical co-morbidities.

Patients were recruited from:

  • Auckland Hospital, NZ
  • Chris O'Brien Lifehouse, NSW
  • Christchurch Women's Hospital, NZ
  • Gold Coast Hospital, QLD
  • Greenslopes Private Hospital, QLD
  • King Edward Memorial Hospital, WA
  • Mater Health Services, QLD
  • Middlemore Hospital, NZ
  • Monash Medical Centre, VIC
  • Royal Adelaide Hospital, SA
  • Royal Brisbane & Women's Hospital, QLD
  • Royal Women's Hospital, VIC
  • St John of God Hspital, WA
  • The Wesley Hospital, QLD
  • Townsville Hospital, QLD
  • Wellington Hospital, NZ

We recruited participants to the feMMe Trial for 7 years. The last feMMe patient enrolled in the early phase of this endometrial cancer trial finished at the Mater in late April 2020 so this trial is now closed to recruitment.

 

feMMe Trial long term follow-up

feMMe Trial participants were followed up for a six month period but there were still unanswered questions. This prompted the feMMe Long Term Follow Up (feMMe LTFU) study to examine the long term outcomes in these patients. The QCGC Research team cleaned the feMMe Trial data, reviewed pathology samples in preparation for data analysis, and wrote reports, presentations and publications. Following this, the long-term follow-up commenced with all participants receiving a questionaire via mail to complete, with questions based on obtaining information including:

  • if patients continued to be treated with the Mirena after the trial, and if so, for how long
  • whether the Mirena is an effective treatment after the six month period
  • if women had a hysterectomy (removal of the uterus) following the treatment with the Mirena
  • for women who retained their fertility, we wanted to know if they attempted pregnancy and if they were successful in having a baby(ies).
  • and finally questions relating to their quality of life and health.

This study is ongoing.

 

Qualitative Study - feMMe patient experiences of conservative treatment

The aim of the study was to obtain an in-depth understanding of the experience of women who received non-surgical treatment for endometrial adenocarcinoma (EAC) or endometrial hyperplasia with atypia (EHA). Enhanced understanding of women’s experiences of non-surgical treatment is essential to inform counselling of the growing number of patients in this field.

21 women were interviewed in total - 10 received conservative treatment for early stage EAC and 11 received conservative treatment for EHA. Five overarching themes were identified:

  • extensive information and support needs (e.g. understanding of how the LNG-IUD treatment worked)
  • gratitude for treatment choice and non-surgical options (e.g. avoidance of potential risks associated with surgery)
  • onco-fertility (e.g. desire to maintain reproductive potential)
  • patient experience of overweight and obesity related to EAC development (e.g. history of trauma and disordered eating, multiple unsuccessful weight loss attempts)
  • patient experience of treatment options and actual non-surgical treatment (e.g. desire for early referral to counselling services)

This qualitative investigation allowed novel insights into the treatment preferences and decision-making process of women with newly diagnosed EHA and EAC when being offered non-surgical treatment options, as well as the patient experience of non-surgical treatment. Findings from this study can contribute to the development of practical guidance to assist clinicians with decision support, which could be taken forward in future clinical trials or translation into clinical practice.

This study is now closed/complete.