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Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer

Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial

Fleshman, James, MD*; Branda, Megan E., MS; Sargent, Daniel J., PhD; Boller, Anne Marie, MD§; George, Virgilio V., MD; Abbas, Maher A., MD||; Peters, Walter R. Jr, MD**; Maun, Dipen C., MD††; Chang, George J., MD‡‡; Herline, Alan, MD§§; Fichera, Alessandro, MD¶¶; Mutch, Matthew G., MD||||||; Wexner, Steven D., MD***; Whiteford, Mark H., MD†††; Marks, John, MD‡‡‡; Birnbaum, Elisa, MD§§§; Margolin, David A., MD¶¶¶; Larson, David W., MD||||||; Marcello, Peter W., MD****; Posner, Mitchell C., MD††††; Read, Thomas E., MD****; Monson, John R. T., MD‡‡‡‡; Wren, Sherry M., MD§§§§; Pisters, Peter W. T., MD‡‡; Nelson, Heidi, MD||||||

doi: 10.1097/SLA.0000000000003002
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Objective: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection.

Background: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051.

Methods: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months.

Results: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4–84.9) and OPEN 83.2% (95% CI 78.3–88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.

Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21–2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85–3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40–3.79); positive distal margin (HR 2.53, 95% CI 1.30–3.77).

Conclusion: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

*Baylor University Medical Center, Department of Surgery, 3500 Gaston Avenue, 1st Floor Roberts Hospital, Dallas, TX

Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN

Formerly with Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN

§Northwestern University, Keck School of Medicine, Chicago, IL

Medical University of South Carolina, Charleston, SC

||Dubai Colorectal and Digestive Clinic, Dubai, United Arab Emirates

**Baylor University Medical Center, Dallas, TX

††Franciscan Health, Indianapolis, IN

‡‡The University of Texas M.D. Anderson Cancer Center, Houston, TX

§§Augusta University, Augusta, GA

¶¶University of North Carolina, Chapel Hill, NC

||Washington University School of Medicine, St. Louis, MO

***Cleveland Clinic-Weston, Fort Lauderdale, FL

†††The Oregon Clinic, Oregon Health and Sciences University, Portland, OR

‡‡‡Lankenau Hospital, Main Line Health, Wynnewood, PA

§§§University of Colorado Denver, Denver, CO

¶¶¶Ochsner Clinic Foundation, New Orleans, LA

||||||Mayo Clinic, Rochester, MN

****Lahey Hospital & Medical Center, Burlington, MA

††††University of Chicago Medicine, Chicago, IL

‡‡‡‡Florida Hospital Medical Group, Orlando, FL

§§§§Stanford University School of Medicine, Palo Alto Veterans Health Care System, Palo Alto, CA.

Reprints: James Fleshman, MD, Baylor University Medical Center, Department of Surgery, 3500 Gaston Avenue, 1st Floor Roberts Hospital, Dallas, TX 75246. E-mail: james.fleshman@bswhealth.org.

Funding: Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10CA180790, U10CA180833, U10CA18036, and U10CA180858. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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