COLORADO SPRINGS — Overall and disease-free survival at 5 years were equivalent in patients with curable colon cancer assigned to laparoscopic, compared with open, colectomy in the randomized prospective Clinical Outcomes of Surgical Therapy trial, Dr. Heidi Nelson said at the annual meeting of the American Surgical Association.
The 5-year COST trial results expand upon the previously reported interim 3-year data (N. Engl. J. Med. 2004;350:2050–9), noted Dr. Nelson, COST lead investigator and professor of surgery and chair of colon and rectal surgery at the Mayo Clinic, Rochester, Minn.
COST was a National Cancer Institute-funded study involving 872 patients with curable colon cancer randomized to laparoscopic or open colectomy at 48 participating centers. The study was undertaken in response to concerns arising in the mid-1990s that laparoscopic colectomy might produce inferior oncologic outcomes. Indeed, the procedure's introduction into clinical practice stalled at that point because of reported extremely high rates of recurrent cancer at surgical wound sites as a result of intraoperative tumor cell dissemination. The question became whether the poor outcomes were caused by suboptimal performance of a new procedure or to problems inherent in the operation.
At 5 years' follow-up in COST, laparoscopic and open colectomy showed similar rates of both local and distant recurrences, and the rate of wound site recurrences was less than 1% in each group.
Prior COST analyses showed faster recovery and significantly better quality-of-life scores in patients undergoing laparoscopic colectomy than in those who had open colectomy. A cost-effectiveness comparison is planned as well.
A much-quoted single-center, 219-patient randomized trial by University of Barcelona surgeons concluded that the risks of tumor relapse and all-cause and cancer-specific mortality were significantly lower in patients with stage III tumors treated laparoscopically (Lancet 2002;359:2224–9). But a new COST subgroup analysis was unable to confirm this finding; in COST, designed by statisticians as a noninferiority study, patients with stage III disease had closely similar recurrence and mortality rates regardless of which surgery they received, according to Dr. Nelson.
Discussant Dr. David A. Rothenberger hailed COST as “a landmark study” and recalled how controversial it was early on.
“I remember that my group had several heated discussions about whether or not we wanted to participate in this trial and ultimately voted against doing so because of concerns about the oncologic outcomes and our worries that we just weren't at that point good enough to be doing laparoscopic colectomy for cancer. I'm certainly happy our fears were unfounded and that you had the courage and tenacity to fight for and complete this trial,” said Dr. Rothenberger, professor of surgery and chief of the divisions of colon and rectal surgery and surgical oncology at the University of Minnesota, Minneapolis.
Dr. Michael Zenilman, professor and chairman of surgery at the State University of New York, Brooklyn, said COST “sets the standard” for how to appropriately introduce new surgical procedures into broad clinical practice.
He noted that as a condition of involvement in the trial, the 66 participating COST surgeons had to undergo a unique credentialing procedure. Each had to submit 20 laparoscopic colectomy operative pathology reports along with an unedited video of the surgeon performing critical elements of the procedure. Surgeons also agreed to ongoing monitoring of their techniques by video audit to ensure they were doing laparoscopic colectomy at a high level of expertise.
Perhaps similar clinical trials, carried out by credentialed surgeons, could be used to evaluate novel procedures such as natural orifice surgery—which may be the next big wave in surgical innovation—before they become widely disseminated, Dr. Zenilman said.
Dr. Nelson predicted that's quite likely, since COST has created the organizational structure needed to conduct further large randomized trials addressing key questions in cancer surgery.
As a senior board examiner for the American Board of Colon and Rectal Surgery, she likes the idea of incorporating unedited surgical videos into the board certification process and requests for hospital privileges.
“There's no reason down the road a trainee couldn't go into their board exam and hand over a videorecorded procedure that can be viewed and defended,” she said.
All papers presented at the 127th annual meeting of the ASA are subsequently submitted to the Annals of Surgery for consideration.
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