Kinder and gentler treatment for endometrial cancer

Tagged surgery, endometrial cancer; Posted 7 years ago by Andreas Obermair

In 2000, when I was a young gynaecological oncology trainee, all our endometrial cancer patients who required surgery at the Queensland Centre for Gynaecological Cancer had a laparotomy. Sometimes patients were so big that we enlisted the assistance of a plastic surgeon to gain access to the pelvis. Some of these patients required an apronectomy and I remember one patient who had an apron of 12 kg removed. Not uncommonly those patients developed serious complications postoperatively and their hospital stay was measured in weeks rather than days.

In 2002, I had the great privilege to work with Dr. Tony McCartney, the then doyen of laparoscopic surgery in gynaecological oncology in Australia. I will forever remember his patience in training me.

I was not only blown away by his Total Laparoscopic Hysterectomy (TLH) technique using his purpose-built vaginal tube but even more so by the super-quick recovery that patients made after surgery. Patients who would typically be bedbound for days, were up and about the day following surgery and some patients would go home on day 1 after surgery.

After having published extensively on Dr. McCartney’s retrospective data that pointed to enormous health benefits for patients, our group considered a randomized trial to compare TLH with open surgery. The road blocks to such a trial were incredible and funding was almost impossible to obtain.

Most granting bodies claimed that such a clinical trial was too ambitious and cannot possibly be performed in a small country like Australia. Others claimed that even if this operation was feasible, safe and oncologically equivalent to abdominal, open surgery, only a handful of surgeons in Australia mastered this technique at that time. Others again were convinced that we lacked the expertise to manage a trial of these dimensions.

After more than 2 years applying for funding unsuccessfully, we finally received 2 private donations, employed our first research nurse and started enrolling patients into the “Laparoscopic Approach to Carcinoma of the Endometrium – LACE” trial in October 2005. Data from the initial years were used for subsequent grant applications and a total of $3 million were raised to complete the LACE trial to date.

We accredited every single surgeon on this trial to ascertain the highest surgical quality.

The last patent was enrolled in July 2010 and multiple papers were published on short-term outcomes since. TLH was associated with better Quality of Life, less pain, shorter hospital stay and a lower incidence of complications. TLH was proven cost effective, saving funders of healthcare $4000 for every operation that is performed laparoscopically compared to open, abdominal surgery.

The results of disease-free and overall survival were recently in JAMA, demonstrating equivalence of survival outcomes. Reassuringly, disease-free survival was virtually identical. It was 81.3% at 4.5 years in the Abdominal surgery group and 81.6% in the Laparoscopic group.

Reassured by better short-term outcomes, we are now confident that TLH is better for women requiring surgery for early stage endometrial cancer.

The study showed that adopting TLH as a preferred standard of care for uterine cancer patients prevents 120 Australian patients from developing a severe surgical complication every year; saves 2000 patients from staying in hospital for an average of 5 days compared to only 2 days this year; and saves funders of healthcare $8 million per annum in health care expenditure.

I would argue that the results of the LACE trial, which was conducted on cancer patients also has implications for women requiring a hysterectomy for non-cancer reasons.

Some 30,000 women in Australia each year require a hysterectomy for many different reasons and there is basis to say they shouldn’t have the traditional Abdominal operation either. Given the very severe disadvantages of open hysterectomy (longer recovery and hospital stay; more pain and a higher risk of surgical complications) many women who need a hysterectomy for reasons other than cancer should discuss with their gynaecologist if they are suitable for a laparoscopic approach if the vaginal route is infeasible.

Celebrating a great success story would not be complete without thanking the many people who made the transition from open to minimally invasive surgery for endometrial cancer possible.

First and foremost, I would like to thank the 760 patients from Australia, New Zealand, Hong Kong and Scotland who trusted the trial surgeons enough to be randomly allocated to one treatment arm.

Without the massive effort of our 27 trial surgeons who agreed to be trained, scrutinised and assessed; without you this trial would not have been possible. We all realise it takes much greater effort and time to treat a patient on a clinical trial than as a matter of clinical routine.

I am forever grateful to the team of academic researchers and in particular Monika Janda and Val Gebski. I also would like to acknowledge the tireless effort of our many research staff who made sure that we adhere to governance and accepted international standards, avoid trial violations, and make the LACE trial management committee aware of any issues as they arise.

Finally, I would like to thank Dr. Tony McCartney, who developed the concept of TLH and was willing to share it to the benefits of the thousands of patients who could potentially benefit every year. Dr. McCartney unfortunately passed away in 2011.

There are still unresolved issues and some funding will still be required to answer those open questions.

Some secondary trial outcomes are still in progress.

1. Some patients were able to use their endometrial cancer diagnosis as a wakeup call, changed their lifestyle behaviour and lost weight, while others did not. In a follow, up study we are presently exploring the barriers and enablers of lifestyle change. 
2. Morbidly obese patients with multiple medical co-morbidities are still at enormous risk of developing surgical complications, even when they have a TLH (Gynecol Oncol Res Pract. 2016 Feb 9;3:1). Similarly, young patients who have not completed their family as yet, will suffer unspeakable despair from a hysterectomy. We currently explore the effectiveness of conservative treatment for endometrial cancer in another randomised-controlled trial and hope to complete that trial by 2019. This trial is as revolutionary as LACE was 15 years ago and to obtain funding for it has been and will remain challenging.

Overall, I am most excited and proud of having been given an opportunity to making a difference in contemporary endometrial cancer treatment.

Let’s continue!

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