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.
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)
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%).
Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
A multicenter prospective trial of 872 patients randomly assigned to undergo laparoscopic or open colectomy for curable cancer was performed. Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on 5-year overall survival, disease-free survival, and overall and site-specific rates of recurrence.
From the *Department of Surgery, Washington University School of Medicine, MO; †Department of Biostatistics, Mayo Clinic, MN; ‡Department of Surgery, St. Joseph's HealthCare, McMaster University, Ontario, Canada; §Department of Surgery, Northwestern University, Feinberg School of Medicine, IL; ¶Division of Colon and Rectal Surgery, University of Southern California, Keck School of Medicine, CA; ∥Division of Colon and Rectal Surgery, University of Miami/Jackson Memorial Medical Center, FL; **Department of General and Colorectal Surgery, St. Joseph Mercy Hospital, MI; ††Department of Surgery, Boone Hospital Center, MO and §§Division of Colon and Rectal Surgery, Mayo Clinic, MN.‡‡The preparation of this article was overseen by the writing committee [authors in author line] who assume responsibility for the overall content and integrity of the article.
Supported by the following National Cancer Institute grants: CA65157 (Mayo Clinic), CA25224 (North Central Cancer Treatment Group), CA21115 (Eastern Cooperative Oncology Group), CA32102 (Southwest Oncology Group), CA77202 (National Cancer Institute of Canada Clinical Trials Group), CA12027 (National Surgical Adjuvant Breast and Bowel Project), CA31946 (The Cancer and Leukemia Group B), and U10 CA21661 (Radiation Therapy Oncology Group).
Members all participating members of the Clinical Outcomes of Surgical Therapy Study Group are listed in the Appendix.
Reprints: Heidi Nelson, MD, Mayo Clinic, 200 First St S.W., Rochester, MN 55905. E-mail: Clasemann.Heidi@mayo.edu.