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Randomized Controlled Trial
. 2019 Apr;269(4):589-595.
doi: 10.1097/SLA.0000000000003002.

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

James Fleshman  1 , Megan E Branda  2 , Daniel J Sargent  3 , Anne Marie Boller  4 , Virgilio V George  5 , Maher A Abbas  6 , Walter R Peters Jr  7 , Dipen C Maun  8 , George J Chang  9 , Alan Herline  10 , Alessandro Fichera  11 , Matthew G Mutch  12 , Steven D Wexner  13 , Mark H Whiteford  14 , John Marks  15 , Elisa Birnbaum  16 , David A Margolin  17 , David W Larson  12 , Peter W Marcello  18 , Mitchell C Posner  19 , Thomas E Read  18 , John R T Monson  20 , Sherry M Wren  21 , Peter W T Pisters  9 , Heidi Nelson  12
Affiliations
Randomized Controlled Trial

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

James Fleshman et al. Ann Surg. 2019 Apr.

Abstract

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.

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Figures

Figure 1:
Figure 1:
Disease Free Survival of Laparoscopic Resection compared to Open Resection of Stage II-III Rectal Cancer
Figure 2:
Figure 2:
Disease Free Survival of Surgical Approach
See this image and copyright information in PMC

Comment in

References

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