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


CONCLUSIONS
Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
Fleshman
James
J
Department of Surgery, Washington University School of Medicine, MO, and Department of General and Colorectal Surgery, St. Joseph Mercy Hospital, MI, USA.
Sargent
Daniel J
DJ
Green
Erin
E
Anvari
Mehran
M
Stryker
Steven J
SJ
Beart
Robert W
RW
Hellinger
Michael
M
Flanagan
Richard
R
Peters
Walter
W
Nelson
Heidi
H
D003082:Colectomy / Q000379:methods*; D003110:Colonic Neoplasms / Q000601:surgery*; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007813:Laparotomy / Q000379:methods*; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009366:Neoplasm Seeding; D011446:Prospective Studies; D015996:Survival Rate