My talk today, the topic that I talked today about, was the oncologic safety of a minimal invasive approach in the treatment of early stage cervical cancer. Even though we knew from many retrospective data that patients who have had a laparoscopic or robotic radical hysterectomy had lower complications, had a shorter hospital stay and that’s why on a broader basis we had an establishment of the minimal invasive approach worldwide – nationally and internationally – we never had a prospective randomised trial that actually proved the oncologic safety of the minimal invasive approach. For that reason, for the first time, there was a study, a phase III multicentre study, conducted by Pedro Ramirez from MD Anderson who practically took patients, around 600 patients, half of them were allocated to have a minimal invasive surgery, either laparoscopically or robotically, and the other half had an open radical hysterectomy and lymph node dissection.
The study had to be finished early, had to be terminated early, earlier than initially thought. Why? Because of the unsafety of one arm. The investigators initially thought it was a problem probably with the open arm in terms of complications but what turned out to be was that the laparoscopic/robotic arms, so the minimal invasive arm, showed a significantly higher risk for death and recurrence compared to the open arm. That’s why the study was terminated for lack of oncologic safety of the experimental arm.
What was very interesting to hear from the actual investigators of the studies that when they initially started the study many centres didn’t want to participate because they said, ‘Why will I offer an open surgery to somebody who can have it minimally invasive?’ So it was a very important study that showed actually that quality of surgery and type of surgery matters for the life of patients. If not, this is what the study showed.
We have now clear data in a prospective, randomised design with a hazard ratio of 6, so a six times higher risk of death from the minimal invasive arm. We have to say that the majority of the patients in the minimal invasive arm had a laparoscopic approach and not a robotic approach. There were no differences in terms of parametrial invasion, vaginal resection, margins, adjuvant treatment, so the patients were well-balanced between the two groups. That’s why it’s a study that we cannot any more ignore and we have to discuss with our patients before we treat them and decide how to operate on them.
I did an international survey of the records of key opinion leaders worldwide which I also presented that showed that most people throughout America, the USA, Europe, Asia, Australia, what they will do is that they will abandon doing radical hysterectomies, at least for larger tumours more than 2cm. Many people will just abandon them completely. Teams who are mainly operating robotically, they are more reluctant to abandon their robotic approach and they say that the study was mainly about laparoscopy and not about robotic. So many of them would rather continue but, of course, after discussing with the patients the risks and benefits.
Apart from the prospective randomised trials there were two other retrospective meta-analyses that were presented in ASCO SGO a few months ago that showed that in thousands of patients in national registry databases in the US in retrospective fashion also the robotic approach was significantly worse in terms of survival, PFS and OS, so risk of death and risk of recurrence, also in a retrospective design.
So what will happen now within the WGCS is that we will do a national audit to see how our data in the UK are and how we are going to change practice based on this new data.
Why might this be?
There are many theories. One theory is the vaginal manipulation because when you do a radical hysterectomy minimally invasive you somehow need to have a vaginal manipulator to be able to move the uterus. Many centres of the LACC trial, this is the trial of prospective randomised design, did not use any vaginal manipulator so we don’t know whether this is the cause.
[??] can be a possibility, we don’t really know. The final publication is submitted and accepted from The New England Journal of Medicine so perhaps we will have more data than what was just presented in SGO but we need to see. I don’t think we’ll be able to answer why.