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>> The JAMA Network.
>> James Fleshman: Hi, I'm James Fleshman.
I'm the Chairman and Seeger Professor at Baylor University Medical Center in Dallas, Texas,
and Professor of Surgery at Texas A & M. I'm here to talk to you about the laparoscopic
versus open resection of rectal cancer trial, Z60-51, that recently finished in 2013.
Our goal was to identify the different aspects of rectal cancer, which could be used
as a surrogate for long-term survival.
This is an NIH-sponsored randomized trial through the American College
Of Surgeons Oncology Group, utilizing 46 fully trained, expert surgeons who are credentialed
at 35 sites across the United States and Canada.
We randomized 480 patients with stage II and stage III rectal cancer
who had received neoadjuvant therapy prior to their operation.
The end point of the study was a composite of pathologic oncology endpoints,
the mesorectal completeness, the circumferential radial margin negativity,
and the distal margin negativity.
We also had short-term outcomes of length of stay,
complication rate, anastomotic leak, and discharge.
We also did a quality-of-life study, and an instrumentation study on the side
to verify the effect of these techniques on the use of instruments,
as well as their quality of life in the patients.
The trial yielded a result of the composite outcomes.
That is, the completeness of the TME, the circumferential radial margin negativity,
and the distal margin negativity that showed that laparoscopic treatment
of rectal cancer cannot be called non-inferior to an open resection
or treatment of the rectal cancer.
The overall results of the trial showed that the surgery was really pretty good.
At least 90% of all patients had a complete resection, but when you split them
into the two groups, laparoscopy had a higher incidence
of incomplete total mesorectal excision and positive circumferential radial margins
that made it slightly inferior to the open operation.
The results have actually made us take a second look of laparoscopic treatment of rectal cancer.
There may be a use for laparoscopy in patients with rectal cancer, especially in those
with small lesions high in the rectum.
However, we now know that we cannot say that laparoscopic treatment
of rectal cancer is absolutely equivalent or non-inferior to open treatment of rectal cancer.
There will be some soul searching going on as we move forward.
There may be a discussion about whether
or not robotic minimally invasive surgery is appropriate for patients with rectal cancer.
We do know that the open arm of this trial gave good results for patients with stage II
and stage III rectal cancer, and the laparoscopic arm,
while it was just slightly less good, cannot be called non-inferior.
The next steps of this research are to continue following the patients
and to present the long-term, overall survival of our patients
and the disease-free survival at a five-year point.
We think that this will tell us whether or not we've impacted the surgical survival
or the oncologic outcomes of these patients.
In the setting of a early lesion and a high tumor that is not low in the pelvis,
laparoscopy may be completely appropriate.
We'll need to be able to do a subset analysis and look at those patients who had the problems
with their surgical treatment, and find out what are the features that would allow us to predict
that there's going to be a poor outcome.
I think those are the next steps as we go forward, and we'll be looking
at the study critically at that point.