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| Laparoscopic Colectomy For Cancer Is Not Inferior To Open Surgery Based On 5-Year Data From the COST Study Group Trial | Heidi Nelson1, James Fleshman2, Daniel Sargent*1, Erin Green*1, Mehran Anvari*3, Steven Stryker*4, Robert Beart, Jr.5, Micheal Hellinger*6, Richard Flanagan, Jr.*7, Walter Peters*8
1Mayo Clinic, Rochester, MN;2Washington University School of Medicine, St. Louis, MO;3McMaster University, Hamilton, ON, Canada4Northwestern Surgical Associates, Chicago, IL;5University of Southern California, Los Angeles, CA;6University of Miami, Miami, FL;7St. Joseph Mercy Hospital, Ann Arbor, MI;8Boone Hospital Center, Columbia, MO
| OBJECTIVE(S): Oncologic concerns from high wound recurrence rates prompted a multi-institutional randomized trial to test the hypothesis that disease-free and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted (LAC) or open colectomy.
METHODS: 872 patients with curable colon cancer were randomly assigned to undergo LAC or open colectomy at one of 48 institutions by one of 66 credentialed surgeons. Patients were followed for 8 years, with 5 year data on 90% of patients. The primary endpoint was time to recurrence, tested using a non-inferiority trial design. Secondary endpoints included overall survival (OS) and disease-free survival (DFS). (Kaplan Meier)
RESULTS: As of November 2006, 169 patients have recurred and 251 died. At five years, cumulative incidence of recurrence (any and local), and overall and disease-free survival were similar (Table 1). Sites of first recurrence were distributed similarly between arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%, LAC: wound 0.90%, liver 5.5%, lung 4.8%, other 6.1%). Recurrence rates, OS, or DFS did not differ by arm for patients by stage (5 yr OS for stage 1: 93% vs. 85%, p=0.05, stage 2: 81% vs. 77%, p=0.71, stage 3: 61% vs. 69%, p=0.36 for Open and LAC respectively).
CONCLUSIONS: Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
Table 1| Outcome | Open | LAC | p | | Overall Survival | 75.1% | 76.6% | 0.94 | | Disease Free Survival | 69.1% | 69.4% | 0.96 | | Local Recurrence Rates | 2.6% | 2.3% | 0.79 | | Overall Rates of Recurrence | 21.8% | 19.4% | 0.25 |
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