It was a big day for The Queensland Centre for Gynaecological Cancer (QCGC). On 30th October 2016, as part of the 16th Biennial Meeting of the International Gynecologic Cancer Society in Lisbon, Portugal, Professor Andreas Obermair presented the ground-breaking results of the LACE – Laparoscopic Approach to Carcinoma of the Endometrium – Trial.
Over the course of 15 years, Andreas alongside 27 other surgeons and supported by clinical research staff, assessed the disease free survival of women with stage 1 endometrial cancer, comparing the outcomes of Total Laparoscopic Hysterectomy (TLH) with Total Abdominal Hysterectomy (TAH).
Ahead of returning to Australia, we spoke to Andreas to learn more about the LACE trial and its importance.
What was the aim of the LACE Trial?
In 2003 my colleagues and I championed a clinical trial that would compare the outcomes of Total Laparoscopic Hysterectomy (TLH; key hole surgery) with Total Abdominal Hysterectomy (TAH; open, abdominal incision).
Back then, the standard treatment of endometrial cancer was hysterectomy through an open abdominal incision (TAH). Patients stayed in hospital for 5 to 7 days (at least) and took another 6 weeks to recover from surgery.
A new way of treating patients was key hole surgery (TLH), utilising the McCartney Tube – a trans-vaginal access device that enabled us to perform a hysterectomy in its entirety laparoscopically, baring lower operative and post-operative risk for the patient. The initial results were mesmerizing. Better recovery not only after 6 weeks but even after 6 months from surgery. Less pain for the patient; less surgical adverse events (complications), which were reduced by one third; and last but not least cost savings of $4,000 per surgical case.
However, and most importantly, it remained unknown until recently if the laparoscopic approach, that was able to save the government important health care dollars, would produce similar survival rates when compared to the old, traditional procedure.
A big undertaking. How did you get started?
Back in 2003, the QCGC Research team and I planned a large clinical trial, which at the time was thought to be undoable; potential funders of the trial believed it was too big an undertaking and too ambitious. However, with help from two surgical device companies we were able to employ our first part-time research nurse. In 2005 we started the trial and enrolled the first patients. The data was so convincing that more and more funds were secured over time which allowed us to continue the research and expand the trial.
A clinical trial of this size is not available without the assistance of others? Who participated in the research?
We trained surgeons and assessed them painstakingly. A total of 27 gynaecological cancer surgeons from 21 cancer centres contributed to this research. We needed 760 patients to trust us with their lives and be randomly allocated to either TAH or TLH. Never in Australia’s history a trial so large has been conducted in gynaecological oncology. By July 2010, we assessed more than 1800 patients and enrolled 760.
And the results?
More than half of patients received a TLH. The two treatment groups (TAH and TLH) were strikingly similar in patients’ features (tumour, age, body weight, etc.). Only 7% of patients who were supposed to have a TLH ended up having a TAH. This is a favourable number when compared internationally. It speaks for the excellent surgical quality that our surgeons provided.
Earlier this year, Prof Val Gebksi from the Clinical Trial Centre in Sydney and his team helped us to assess the data. Unfortunately, 55 patients developed a tumour recurrence. But to all our relief, the disease-free survival (time to disease progression) was extremely similar for both patient groups. The chance of being without tumour recurrence was 81.3% and 81.6%, respectively. The study has proven that TLH produces similar survival outcomes than TAH! The new operation (TLH) did not disadvantage patients.
Were there similar studies undertaken?
Yes. However, previous studies were unable to demonstrate this most important fact. In 2012, a study from the UK pooled the data from 359 patients and claimed that the differences in survival were similar. However, the study was way too small to make such a claim and the findings from this study have to be disqualified as irrelevant and overstated.
Another very large trial from the United States enrolled more than 2,500 patents and unfortunately, patients who had laparoscopic surgery (TLH, LAVH, robotic surgery) did worse.
Our study was the first properly designed research trial that has shown that patients diagnosed with endometrial cancer should have a laparoscopic hysterectomy (TLH). Given the very severe disadvantages of open hysterectomy (longer recovery, more pain, higher complication rates, more expensive), TAH is outdated and should not be offered to patients who wish to have a hysterectomy any longer.
What is next?
At the Queensland Centre for Gynaecological Cancer we have taken steps now to train gynaecologists in TLH. This program will start in 2017 and I look forward to keeping you updated.