Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial

James Fleshman, Daniel J. Sargent, Erin Green, Mehran Anvari, Steven J. Stryker, Robert W. Beart, Michael Hellinger, Richard Flanagan, Walter Peters, Heidi Nelson

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744 Scopus citations

Abstract

PURPOSE: 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 or open colectomy. METHODS: Eight hundred seventy-two patients with curable colon cancer were randomly assigned to undergo laparoscopic-assisted or open colectomy at 1 of 48 institutions by 1 of 66 credentialed surgeons. Patients were followed for 8 years, with 5-year data on 90% of patients. The primary end point was time to recurrence, tested using a noninferiority trial design. Secondary endpoints included overall survival and disease-free survival. (Kaplan-Meier) RESULTS: As of March 1, 2007, 170 patients have recurred and 252 have died. Patients have been followed a median of 7 years (range 5-10 years). Disease-free 5-year survival (Open 68.4%, Laparoscopic 69.2%, P = 0.94) and overall 5-year survival (Open 74.6%, Laparoscopic 76.4%, P = 0.93) are similar for the 2 groups. Overall recurrence rates were similar for the 2 groups (Open 21.8%, Laparoscopic 19.4%, P = 0.25). These recurrences were distributed similarly between the 2 treatment groups. Sites of first recurrence were distributed similarly between the treatment arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%; Laparoscopic: wound 0.9%, liver 5.5%, lung 4.6%, other 6.1%). CONCLUSION: Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.

Original languageEnglish (US)
Pages (from-to)655-662
Number of pages8
JournalAnnals of surgery
Volume246
Issue number4
DOIs
StatePublished - Oct 1 2007

ASJC Scopus subject areas

  • Surgery

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    Fleshman, J., Sargent, D. J., Green, E., Anvari, M., Stryker, S. J., Beart, R. W., Hellinger, M., Flanagan, R., Peters, W., & Nelson, H. (2007). Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Annals of surgery, 246(4), 655-662. https://doi.org/10.1097/SLA.0b013e318155a762